Fresenius Kidney Care South Congaree

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 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. This Standard is not met as evidenced by: 41879 Based on observations, staff interviews and facility policy and procedure review, the End Stage Renal Dialysis facility staff failed to follow acceptable principles for infection control practices to prevent potential cross transmission of infectious agents in the renal setting for patient safety for one of three Patient Care Technicians (PCT) observed. (PCT #1) The findings are: On 02/20/2024 at 10:50 AM, observations in the dialysis treatment area revealed PCT #1 providing care to a random patient at dialysis station #1. The patient at dialysis station #1 was holding pressure to the right fistula site with a glove on the left hand. The patient at dialysis station #1 removed the glove on the left hand, packed their personal belongings, and proceeded to the scale area touching surfaces near the scale area with the left hand. The patient at dialysis station #1 did not perform nor was encouraged to perform hand hygiene after glove removal. The findings were verified with PCT #1 on 02/20/2024 at 12:00 PM. Facility policy, titled, “Hand Hygiene”, reads, “Patients should perform hand hygiene if able, prior to and after each dialysis treatment. Gloves must be provided to patients when performing procedures which risk exposure to blood or bodily fluids, such as when self-cannulating or holding access sites post treatment to achieve hemostasis. To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed.””

“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: 41879 Based on observations, staff interviews, and facility policy and procedure review, the End Stage Renal Dialysis facility staff failed to follow accepted principles for infection control practices for two of three Patient Care Technicians (PCT) observed, and one of three Registered Nurses (RN) observed in the provision of patient care. (PCT #2, PCT #3, and RN #1) The findings are: On 02/21/2024 at 9:33 AM, PCT #2 was observed in the dialysis treatment area providing care to a random patient at dialysis station #16. After PCT #2 performed hand hygiene and donned clean gloves, PCT #2 touched multiple surfaces in the dialysis station including the dialysis chair and the patient. Without performing hand hygiene and donning clean gloves, PCT #2 initiated the removal of the fistula needle. The findings were verified with PCT #2 on 02/21/2024 at 10:30 AM. On 02/21/2024 at 9:40 AM, observations in the dialysis treatment area revealed PCT #3 disconnecting a fistula at dialysis station #17. Observations showed PCT #3 touching the dialysis machine wearing glove. After touching the dialysis machine, PCT #3 did not perform hand hygiene and don clean gloves before removing the fistula needles. The findings were verified with PCT #3 on 02/21/2024 at 9:50 AM. On 02/20/2024 at 10:45 AM, observations in the dialysis treatment area revealed RN #1 discontinuing a Central Venous Catheter (CVC). Wearing gloves, RN #1 touched numerous surfaces in the dialysis station. RN #1 gathered retrieved several clean gloves from a box of gloves and placed the gloves at chairside. RN #1 gathered the clean gloves wearing the contaminated gloves. RN #1 initiated the patient’s CVC care using the contaminated gloves retrieved from the chairside. The findings were verified with RN #1 on 02/20/2024 at 11:00 AM. Facility policy, titled, Hand Hygiene, reads, “Decontamination using alcohol-based hand rub or by washing hands with antimicrobial soap and water should be done; before and after direct contact with patients, entering and leaving the treatment areas, before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications, immediately after removing gloves, after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled, after contact with inanimate objects near the patient.””

“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 observations, interviews, review of the facility policy, titled, “Medication Preparation and Administration” and of the APIC Position Paper, titled, “Safe Injection, Infusion, and medication vial practices in healthcare”, dialysis clinic nursing staff failed to ensure a multi-dose vial had been dated when opened to determine the beyond use date. Nursing staff had stored needles/syringes out of the original packaging in a drawer which could lead to possible contamination of the syringes. The findings included: Observations on 2/20/24 at 10:10 AM in the dialysis treatment room revealed a medication storage drawer that contained an opened multi-dose vial of Hectorol 4 micrograms/2 milliliters that had not been dated when opened to determine a beyond use date. The finding was verified by Registered Nurse #1 and #2 during an interview on 2/20/24 at 10:12 AM. Observations on 2/20/24 at 10:38 AM revealed four (10 milliliter) syringes with needles attached stored out of their packaging in a medication storage drawer. Observations on 2/20/24 at 11:52 AM with RN #1 and #2 revealed the 4 needle/syringes out of the packaging, were exposed to potential cross contamination which RN #1 and RN #2 verified. Review on 2/22/24 of the facility policy, titled, “Medication Preparation and Administration” revealed the nurse must label any open multi-dose vial that is not used immediately and that opened multi-dose vials must be discarded 28 days after opening or per manufacturer’s expiration date. Review on 2/22/24 of the APIC Position Paper, entitled, “Safe Injection, Infusion, and medication vial practices in healthcare” by S.A Dolan- Et al, Copyright 2010, revealed information that the needle, cannula, syringe, and/or accessory items should be removed from sterile packaging immediately before use.”

“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 review of the facility’s total Chlorine logs and interviews, the dialysis clinic nursing staff failed to ensure a total Chlorine check was documented timely at least every 4 hours for patients dialyzing on 2/3/24. There was no check documented between 8:20 AM and 2:20 PM. The findings included: On 2/20/24 at 2:18 PM, review of the facility’s total Chlorine logs revealed an entry on 2/3/24 where nursing staff checked the total Chlorine on 8:20 AM and again at 2:20 PM. There was an entry missing between 8:20 AM and 2:20 PM. The Clinic Manager verified the finding during an interview on 2/21/24 and verified the total Chlorine check should have been completed around 11:30 AM. The Clinic Manager was unable to find a paper copy where the total Chlorine check would have been documented if the electronic system had gone down. During an interview on 2/22/24 at 9:18 AM, Patient Care Technician (PCT) #1 verified they do checks every 3 to 4 hours, and that a total Chlorine check should have been documented between 8:20 AM and 2:20 PM. PCT #1 stated that if there was a problem with the electronic documentation system (TMS), they would document on a hard copy piece of paper and this sheet would be inputted into TMS as a late entry with comments that TMS was down.”

“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 review of the facility’s heat/disinfection machine logs for January 2024 and February 2024 and interviews, the clinic’s Patient Care Technicians (PCTs) failed to document the clinic’s 24 hemodialysis machines had gone through an integrated heat process to disinfect the dialysis machine supply lines. Two of two PCT’s interviewed (PCT #1 and #4) were not knowledgeable of the integrated heat process and how to identify if a dialysis machine did not go through integrated heat. The findings included: On 2/20/24 at 2:30 PM, review of the facility’s hemodialysis machine heat/disinfection logs for January 2024 and February 2024 revealed integrated heat was not documented as completed for dialysis machine #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #17, #18, #19, #20, #21, #22, and #24. For dialysis machine #16 and #23, there was no integrated heat documented at in January 2024. In February 2024, integrated heat was incorrectly documented on 2/5/24 for dialysis machine 16 and for dialysis machine 23 on 2/6/24, and was documented weekly on Saturdays. The dialysis machines would not have gone through integrated heat on a Monday/Tuesday (2/5/24 and 2/6/24) due to the dialysis machines set to turn on to have the integrated heat done only on Saturday nights. Observation and interview on 2/20/24 at 3:40 PM with the Area Technical Manager revealed the facility’s Continuous Water Purifier (CWP) was set to heat and the clinic’s 24 hemodialysis machines set to turn on automatically so integrated heat disinfection of the dialysis machine supply lines would be done weekly on Saturday nights. According to the Area Technical Manager, the dialysis machines turned on automatically and would turn off automatically once the process completed. Patient Care Technicians document on Saturdays that the dialysis machines are scheduled to go through integrated heat and would be able to identify if the integrated heat process had not been completed if the dialysis machine was still on (had not turned off automatically) when the PCTs came in on Monday mornings. If the dialysis machines were left on, the PCTs would need to alert the Biomedical Technician. The Area Technical Manager was informed during the interview that staff (Patient Care Technicians) had not been documenting the clinic’s dialysis machines had been scheduled to or had gone through integrated heat in January 2024 and February 2024. During an interview on 2/22/24 at 8:48 AM, Patient Care Technician #4 (PCT) stated she/he has worked in the dialysis clinic 4 days a week for about a year (full time) though she/he is a floater and works PRN (As Needed). When asked if she/he knew what integrated heat did, when it occurred, what to document, or how to identify if the procedure had not been completed, PCT #4 reported she/he assumed integrated heat was done on Sundays, but she/he didn’t document the process, it would be documented in TMS which is the facility’s electronic system for documentation. During an interview on 2/22/24 at 9:18 AM, PCT #1 was asked what integrated heat does. PCT #1 reported he/she thought it had something to do with the dialysis machines. PCT #1 was unsure how to identify if the integrated heat procedure had not been completed.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 28883 Based on observations, interview, and review of the pH test strip instructions for use, Patient Care Technician (PCT) #1, one of one PCTs observed performing an independent check of the pH, failed to perform the test properly by not dipping the test strip in the dialysate for the appropriate timeframe which could alter the result of the test. The findings included: Observations on 2/20/24 at 10:29 AM revealed Patient Care Technician (PCT) #1 at dialysis machine 23 getting a dialysate sample for an independent check of the pH. PCT #1 dipped the test strip in the dialysate for 3 seconds and immediately compared the test strip color to the container. Observations on 2/20/24 at 11:00 AM revealed Patient Care Technician (PCT) #1 performing an independent pH check of dialysate using test strips at dialysis machine 1. PCT #1 dipped the test strip in dialysate for 5 seconds, and then immediately compared the strip to the color on the container. During an interview on 2/20/24 at 11:05 AM, PCT #1 reported she/he dips the test strip in the dialysate for 10 seconds. When asked how she/he knew it was 10 seconds, PCT #1 stated she/he counts in her/his head. Review of the pH test strip container with PCT #1 revealed the dip time should be 1-2 seconds.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 41879 Based on observations, staff interview, and facility policy and procedure review, the End Stage Dialysis facility failed to provide a safe and sanitary environment when white residue was observed on the hoses and wall boxes in the dialysis treatment area and a buildup of white residue at the connectors observed in 4 of 20 dialysis stations and the water treatment area. (Dialysis station 17, Dialysis station 18, Dialysis station 19, and Dialysis station 9) The findings are: Observations on 02/20/2024 at 9:35 AM revealed dialysis station 17, dialysis station 18, dialysis station 19, and dialysis station 9 had wall boxes covered with a white residue on the connectors and some white residue buildup on connectors and wall box area. The findings were verified with RN # on 02/20/2024 at 1200 PM. Facility policy, titled, “Cleaning and Disinfecting the Dialysis Station,” reads, “ Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. All surfaces shall be surface disinfected with 1:100 bleach solution. Special attention should be given to removing build-up and or cleaning splatter and spray of concentrate solution.” 28883 Observations on 2/20/24 at 9:40 AM in the water treatment room revealed a white crystalline buildup on the acid mixer, the floor, the walls, the hoses, and hose connectors. Observations on 2/22/24 at 10:30 AM with the Biomedical Technician revealed the same white crystalline buildup on the acid mixer, floor, wall, hoses, hose connectors, and pressure regulator connections. During an interview on 2/22/24 at 10:33 AM, the Biomedical Technician stated the responsibility for cleaning this area was the patient care technicians and the Biomedical Technician, but there was no cleaning schedule and because of staffing schedules/issues, the PCTs are not able to stay later to do the cleaning.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 28883 Based on record reviews, interview, and review of the facility policy, titled, “Comprehensive Interdisciplinary Assessment and Plan of Care”, the dialysis clinic interdisciplinary team failed to document an initial interdisciplinary assessment/plan of care for Patient #1 who was one of one patient reviewed for new admission. The findings included: Record review on 2/21/24 at 11:58 AM revealed Patient #1 was admitted on 12/28/23 to in-center hemodialysis after hospitalization and previous home dialysis treatment at another clinic. Review of the patient’s care plan documentation revealed no care plan was completed by the clinic staff. The patient completed at least 13 outpatient hemodialysis sessions and had been admitted at least 30 calendar days. During an interview on 2/22/24 at 11:15 AM, the Clinic Manager verified the finding. Review of the facility policy provided by the dialysis clinic, entitled, “Comprehensive Interdisciplinary Assessment and Plan of Care” revealed that patients changing modality are classified as new patients and must have plans of care with the same frequency as patients new to dialysis.””

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 28883 Based on observations, record reviews, interviews, and review of the facility policy, titled, “Patient Monitoring and Safety checks During Hemodialysis Treatment,” one of four random patients observed for dialysis treatment initiation did not have the dialysate flow rate or Bicarbonate level set in the dialysis machine as ordered. Review of the dialysis treatment sheets revealed 3 of 5 patients reviewed, Patient #4, #5, and #6, did not have a blood flow rate/dialysate flow rate as ordered during treatment, and vital signs for 2 of 5 patients (Patient #2 and #6) was not documented timely at least every 45 minutes. The findings included: Observations on 2/20/24 at 10:30 AM revealed Patient Care Technician (PCT) #1 at dialysis machine 23 in dialysis station 12 initiating a dialysis treatment for a patient. PCT #1 started the treatment at 10:43 AM. During observations on 2/20/24 at 10:46 AM, the surveyor reviewed the machine settings and physician orders with PCT #1. During an interview on 2/20/24 at 10:47 AM, PCT #1 verified the patient’s dialysate flow rate had not been set as ordered, and was at 800 instead of 500 and verified the Bicarbonate level was not set in the machine as ordered and was at 29 instead of 35. Record review on 2/21/24 at 1:38 PM of the dialysis treatment sheets for Patient #2 revealed vital signs had not been documented timely on 2/10/24, 2/8/24, and 1/27/24. On 2/10/24, vital signs had been documented at 2:31 PM and again at 3:43 PM. On 2/8/24, vital signs had been documented at 11:23 AM and again at 12:58 PM. On 1/27/24, vital signs had been documented at 1:06 PM and again at 2:07 PM. Record review on 2/21/24 at 2:05 PM of the dialysis treatment sheets for Patient #4 revealed dialysate flow rates were not set as ordered for dialysis treatments on 2/13/24 and on 2/17/24. On 2/13/24, the dialysate flow rate was set at 600 and not 2.0 autoflow which would have been 800. On 2/17/24, the dialysate flow rate was set at 500 instead of 800. 41879 Patient 5 Review of Patient 5’s dialysis treatment sheets on 02/21/24 at 12:35 PM revealed three of ten dialysis treatment sheets documented incorrect Dialysis Flow Rate (DFR). Review of the patient’s “Hemo Treatment Orders” dated 02/03/2024, read, “Blood Flow Rate: 300 and Dialysis Flow Rate: 2.0.” On 02/06/2024, Patient 5’s dialysis treatment started at 11:25 AM with a DFR of 100. The DFR increased to 500 at 12:03 PM. The DFR ran at 500 the rest of the dialysis treatment which ended at 14:46 PM. On 02/08/2024, Patient 5’s dialysis treatment started at 12:01 PM with a DFR of 500. The DFR ran at 500 until the end of the dialysis treatment at 14:38 PM. On 02/13/2024, Patient 5’s dialysis treatment started at 11:23 AM with a DFR of 400. At 11:31 AM, the DFR increased to 500. The DFR ran at 500 the rest of the dialysis treatment ending at 14:39 PM. Patient 6 Review of Patient 6’s dialysis treatment sheets on 02/21/2024 at 1:02 PM revealed three of ten dialysis treatment sheets documented incorrect BFR. Review of the patient’s “Hemo Treatment Orders” dated 07/17/2023 read, “Blood Flow rate 450 and Dialysis Flow Rate auto 2.0.” On 01/29/2024, Patient 6’s dialysis treatment started at 12:21 PM with a BFR of 400. The BFR ran at 400 the entire dialysis treatment which ended at 15:55 PM. On 02/09/2024, Patient 6’s dialysis treatment started at 12:50 PM with a BFR of 400. The BFR ran at 400 the entire treatment which ended at 16:09 PM. On 02/16/2024, Patient 6’s dialysis treatment started at 13:15 PM with a BFR of 400. The BFR ran at 400 until the end of the dialysis treatment when it was decreased to 150 at 16:03 PM. Review of Patient 6’s dialysis treatment sheets revealed on 02/16/2024, the vital signs for Patient 6 were obtained at 14:29 PM. The next set of vital signs and safety check was not documented until the end of the patient’s dialysis treatment at 16:04 PM. The findings were verified with Registered Nurse 1 on 02/22/2024 at 9:36 AM. Facility policy, titled, “Patient Monitoring and Safety checks During Hemodialysis Treatment,” reads, “Patient Monitoring: Monitor and document every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations in the FKC Treatment record. Patient monitoring includes: Changes in patient status, Blood pressure, pulse and respirations. Policy, “Patient Monitoring and Safety Checks During Hemodialysis Treatment,” reads, “Verify dialysate lines are attached and in correct position and DFR, BFR, and UFR is set and functioning per treatment physician order.””