Fmc North Suburban Dialysis Center (Bma Essex County)

“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: 37349 Based on observation, staff interview, and policy review, the facility failed to ensure that 2 of 2 staff observed (Certified Clinical Hemodialysis Technician (CCHT) #6 and Patient Care Technician [PCT] #1) followed its policy and procedure for Intravenous (IV) Drug administration to ensure IV medications are prepared according to acceptable infection control standards to prevent the risk of contamination. Findings include: Review of the facility’s policy, entitled Medication Preparation and Administration Procedure Addendum: Drawing Saline Flushes during a pre-filled saline syringe shortage, published 1/11/22, included the following: *Flushes in the clinic setting must be drawn at the medication station an not at the patient station. * 1. Gather supplies. * 2. Take saline bag to medication area to prepare saline flushes. * 3. Wipe the rubber stopper of the saline bag with an alcohol prep pad. * 4. Withdraw 10 mls of normal saline into the syringe. * 5. Continue to follow steps 3-4 with up to 4 needles and syringes as needed. 1. On 2/18/25 at 10:05 A.M., the surveyor observed CCHT #6 as she was preparing normal saline for intravenous use during termination of dialysis for a patient. CCHT #6 brought 2 needles/syringes and one alcohol prep pad to station 20. CCHT #6 opened a new saline bag hanging in the dialysis station, she disinfected the IV port of the normal saline bag with an alcohol prep pad. CCHT #6 inserted the needle/syringe into the normal saline bag and withdrew approximately 10 milliliters (ml) of normal saline. CCHT #6 then without disinfecting the port with alcohol, inserted a second needle/syringe into the bag of normal saline, increasing the risk of cross contamination, and withdrew approximately 10 ml of normal saline to be used to flush the patient’s access. During an interview on 2/18/25 at 11:00 A.M., CCHT #6 said she should have disinfected the port on the saline before accessing it a second time. She further said she did not know the policy says saline should have been prepared at the medication preparation station, not the patient station. 10249 2. On 2/18/25 at 9:55 A.M., the surveyor observed PCT #1 initiate treatment for Patient #16 who used a Central Venous Catheter (CVC) for dialysis treatment. After PCT #1 completed exit site care, she left station 6 and obtained 2 needles/syringes and one alcohol prep pad from the heparin station. PCT #1 returned to station 6 and disinfected the IV port on the normal saline bag, which was hanging from the IV pole on the dialysis machine. PCT #1 then inserted the needle/syringe into the normal saline and withdrew 10 ml of normal saline. PCT #1 then, without disinfecting the port with alcohol, inserted a second needle/syringe into the bag of normal saline, increasing the risk of cross contamination, and withdrew approximately 10 ml of normal saline to be used to flush the patient’s access. During an interview on 2/18/25 at 10:30 A.M., PCT #1 said if it was greater than 5 minutes between withdrawing the normal saline she would of wiped the port, but because it was so close together she did not.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 10249 NOT CORRECTED Based on observation, staff interview, and policy review, the facility failed to ensure that 2 of 2 staff members (Patient Care Technician [PCT] #1 and #4) observed, evaluated a vascular access to ensure functionality by listening for the bruit the length of the access (swooshing sound heard with the stethoscope placed over the access) for 2 of 2 applicable patients (#17 and #18) with a Arteriovenous Fistula/Graft (AVF/G) access site, out of a total sample of 7 patients. Findings include: Review of the facility policy, entitled Access Assessment and Cannulation, published 5/6/24, included the following; *Before each treatment, the internal access must be assessed for patency, signs of infection and any abnormal findings. *Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session. *Look. *Listen: Staff should listen to the entire length of the access for changes in the sound of the bruit- a normal low-pitched bruit should be present. If no sound present, assume the access is thrombosed and do not attempt cannulation. *Feel: Thrill should have one of two sensations - a purring like a cat, or a vibration like a cell phone. It should not pulsate. Strong pulsation suggests that there is a flow issue due to a stenosis and needs to be referred immediately for further evaluation and possible intervention. 1. During an observation on 2/18/25 at 11:50 A.M., the surveyor observed PCT #4 as she prepared Patient #17 for his/her dialysis treatment via an AVF. PCT #4 looked at the AVF and felt the vascular access with her fingertips. She then disinfected the site, applied the tourniquet, and then inserted the needle into the lower access. She then repeated this process and inserted the second needle into the upper access. PCT #4 failed to listen to the length of the access for the presence of a bruit prior to using the access. During an interview on 2/18/25 at 12:05 P.M., PCT #4 said she can feel if there are any problems, but probably should have used a stethoscope. 2. During an observation on 2/18/25 at 12:50 P.M., the surveyor observed PCT #1 as she prepared Patient #18 for his/her dialysis treatment via an AVF. PCT #1 looked at the AVF and felt the vascular access with her fingertips. She then disinfected the site, applied the tourniquet, and then inserted the needle into the lower access. She then repeated this process and inserted the second needle into the upper access. PCT #1 failed to listen to the length of the access for the presence of a bruit prior to using the access. During an interview on 2/18/25 at 2:00 P.M., PCT #1 said she did not listen with a stethoscope. During an interview on 2/18/25 at 2:30 P.M., the Clinic Manager said staff should listened with a stethoscope to assess the site.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 30889 Based on observations, record reviews, staff interviews, document review, and policy reviews, the facility failed to ensure that the condition of infection control was met. Six (6) of Twelve (12) facility staff observed, (Registered Nurse [RN] #5 and RN #7, Certified Clinical Hemodialysis Technician [CCHT] #1, CCHT #4, CCHT #6 and CCHT #7) failed to perform adequate infection control measures to ensure the health and safety of all patients. Findings include: 1. The facility failed to ensure infection control practices related to wearing gloves in the Isolation room (designated room utilized by patients with a positive Hepatitis B surface Antigen, indicating a Hepatitis B infection) for 1 of 2 staff observed (CCHT #4). Refer to V113. 2. The facility failed to ensure that there was separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to 1.) ensure staff removed potentially contaminated personal protective equipment (PPE) before entering a clean area for preparation of intravenous (IV) medications for 2 of 2 staff (CCHT #6, and #7) observed, and 2.) ensure contaminated PPE did not come into contact with “clean” and “dirty” surfaces. Refer to V117. 3. The facility failed to 1.) ensure 1 of 2 staff members (CCHT #4) observed, adequately cleaned and disinfected contaminated surfaces within the dialysis station in the isolation room, increasing the risk of cross contamination of blood borne pathogens; and 2.) ensure 10 of 27 blood pressure (BP) cuffs observed were free from lint and debris to allow for proper disinfection. Refer to V122. 4. The facility failed to ensure that 2 of 2 staff members (CCHT #4 and RN #5) observed, removed personal protective equipment (PPE) before exiting the isolation room. Refer to V130. 5. The facility failed to ensure that 2 of 2 staff members observed (CCHT #1 and RN #7), implemented adequate infection control practices during initiation of dialysis treatment for 2 of 2 patients (#11 and #12) with an arteriovenous fistula or graft (AVF/G), out of a total sample of 14 patients. Refer to V142. 6. The facility failed to ensure that 1 of 2 staff members RN #5) observed, implemented adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 patients (#6) observed with a Central Venous Catheter (CVC), out of a total sample of 14 patients. Refer to V147.”

“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: 44223 Based on observation, interview, and policy review, the facility failed to ensure infection control practices related to wearing gloves in the Isolation room (designated room utilized by patients with a positive Hepatitis B surface Antigen, indicating a Hepatitis B infection) for 1 of 2 staff observed (Certified Clinical Hemodialysis Technician [CCHT] #4). Findings Include: Review of the facility policy, titled Dialyzing Patients with Positive Hepatitis B (HBsAg+), dated 11/6/23, indicated the following: *Caring for HBsAg positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infectious because of the concentration of virus particles in the blood is very high and the hepatitis B virus can live outside the body on surfaces for at least 7 (seven) days. During observation of the termination of dialysis treatment for Patient #14, known to be positive for the Hepatitis B virus, on 1/6/25 at 9:35 AM, in the isolation room, the surveyor observed CCHT #4 as she entered the isolation room, donned her personal protective equipment (PPE) and began to terminate treatment for Patient #14. After completing termination, CCHT #4 removed her gloves, washed her hands in a sink designated as “clean”, and without donning new gloves she opened the cabinet drawer (which is considered a “surface’ within the isolation room) and took gauze pads out of the drawer and placed the supplies on the chair tray table. CCHT #4 then donned new gloves without performing hand hygiene. During an interview on 1/6/25 at 11:16 A.M., CCHT #4 said she should have put on gloves before touching the drawer. During an interview on 1/8/25 at 9:00 A.M., the Clinic Manager said staff should be wearing gloves when touching surfaces in the isolation room.”

“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: 44223 Based on observation, staff interview, and policy review, the facility failed to ensure that there was separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to 1.) ensure staff removed potentially contaminated personal protective equipment (PPE) before entering a clean area for preparation of intravenous (IV) medications for 2 of 2 staff (Certified Clinical Hemodialysis Technician [CCHT] #6, and #7) observed, and 2.) ensure contaminated PPE did not come into contact with “clean” and “dirty” surfaces. Findings Include: 1. The facility failed to ensure staff removed potentially contaminated PPE before entering and preparing heparin in the heparin medication preparation area, a clean area. Review of the facility policy, titled Medication Preparation and Administration, dated 2/6/23, indicated the following: Infection Control *Aseptic technique will be used to prepare and administer IV medications *Medications shall be prepared in a clean work area away from dialysis patient stations and delivered separately to each patient. a. During an observation on 1/6/25 at 10:32 A.M., the surveyor observed CCHT #7 enter the clean heparin medication preparation area without removing her PPE gown, causing concern for cross contamination. CCHT #7 proceeded to prepare the heparin medication without disinfecting the medication preparation area prior to preparing the medication. b. During an observation on 1/6/25 at 10:50 A.M., the surveyor observed CCHT #6 enter the clean heparin medication area without removing her PPE gown, causing concern for cross contamination. CCHT #6 proceeded to prepare the heparin medication without disinfecting the medication preparation area prior to preparing the medication. During an interview on 1/8/25 at 9:00 A.M., the Clinic Manager (CM) said the heparin preparation area is considered clean and staff should be removing their gowns before entering the area, and should disinfect the counter. 2. The facility failed to ensure contaminated PPE did not come into contact with clean surfaces. a. On 1/6/25 at 9:35 A.M., an observation of the treatment area revealed 3 shields and 1 pair of goggles stacked on top of each other, hanging on a hook outside of the isolation room, causing concern for cross contamination. b. On 1/6/25 at 11:55 A.M., an observation of the treatment area revealed a PPE gown hanging on a hook, with the bottom of the PPE gown touching a supply cart where a bleach container for disinfection was located, causing concern for cross contamination. During an interview on 1/8/25 at 9:00 A.M., the CM said the gown should not have been touching the bleach containers, and faceshields should not be stacked on top of each other.”

“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: 44223 Based on observation, policy review, and staff interview, the facility failed to 1.) ensure 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #4) observed, adequately cleaned and disinfected contaminated surfaces within the dialysis station in the isolation room, increasing the risk of cross contamination of blood borne pathogens; and 2.) ensure 10 of 27 blood pressure (BP) cuffs observed were free from lint and debris to allow for proper disinfection. Findings Include: Review of the facility policy, titled Cleaning and Disinfecting the Dialysis Station, dated 9/5/23, indicated the following: Definition: *Dialysis Station - Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during the dialysis treatment, patient training, and/or patient clinic visits. *Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments such as IV pole, BP cuff and hand sanitizer/holder, organizer, chair/bed, Pureflow SL, and individual television and remote. *All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. 1. The facility failed to ensure CCHT #4 adequately cleaned and disinfected contaminated surfaces in the isolation room. On 1/6/25 at 10:15 A.M., the surveyor observed CCHT #4 disinfect the isolation room for the next patient. She was observed to disinfect the hemodialysis machine and hemodialysis chair using 1:100 bleach soaked pads. CCHT #4 failed to disinfect the television, and the arm of the television. She also failed to disinfect the supply cart, and the counter tops. During an interview on 1/6/25 at 10:30 A.M., CCHT #4 said she did not clean the television or counters, but she should have. 2. On 1/6/25 at 9:00 A.M., during an observation of the treatment floor, the surveyor observed 10 of 27 BP cuffs, including those at stations #1, 3, 6, 12, 13, 14, 15, 23, 25, and the isolation room, were laden with lint embedded in the Velcro portion of the BP cuff, making it difficult to adequately disinfect between patients. During an interview on 1/8/25 at 9:00 A.M., the Clinic Manager said the BP cuffs could not be disinfected adequately.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 44223 Based on observation, interview, and policy review, the facility failed to ensure that 2 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT]#4 and Registered Nurse [RN] #5) observed, removed personal protective equipment (PPE) before exiting the isolation room. Findings Include: Review of the facility policy, titled Dialyzing Patients with Positive Hepatitis B Antigen (HBsAG+), dated 11/6/23, indicated the following: *Personal protective equipment (PPE) must be removed and discarded or left in the isolation room/area if not soiled. 1. On 1/6/25 at 9:53 A.M., the surveyor observed CCHT #4 in the isolation room assisting the patient and documenting on the computer. She was wearing a gown, faceshield, mask, and gloves. After assisting the patient, CCHT #4 removed her gown, faceshield, and gloves. She performed hand hygiene, and exited the isolation room. CCHT #4 did not remove her mask prior to exiting the isolation room. She then proceeded to care for other patients while wearing the same contaminated mask. During an interview on 1/6/25 at 11:16 A.M., CCHT #4 said she did not remove her mask before leaving the isolation room. 2. On 1/6/25 at 11:05 A.M., the surveyor observed RN #5 enter the isolation room wearing a mask. She then proceeded to put on a gown, gloves, and faceshield. RN #5 assisted the patient and completed documentation on the computer. She then proceeded to remove her gown, faceshield, and gloves. She performed hand hygiene and then exited the isolation room wearing the same mask. RN #5 proceeded to treat other patients while wearing the same contaminated mask. During an interview on 1/6/25 at 11:15 A.M., RN #5 said thanks for letting me know, they go back and forth with the policy. During an interview on 1/8/25 at 9:00 A.M., the Clinic Manager said staff should be removing their mask when leaving the isolation room.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 10249 Based on observation, interview, and policy review, the facility failed to ensure that 2 of 2 staff members observed (Certified Clinical Hemodialysis Technician [CCHT] #1 and Registered Nurse [RN] #7), implemented adequate infection control practices during initiation of dialysis treatment for 2 of 2 patients (#11 and #12) with an arteriovenous fistula or graft (AVF/G), out of a total sample of 14 patients. Findings include: Review of the facility policy titled, Access Assessment and Cannulation, dated 5/6/24, included the following: *Skin Disinfection *Disinfect cannulation site as follows using any of the disinfectants below: *70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating. Perform skin antiseptic on one site at a time, allow to dry and then cannulate. Do not touch cannulation site after skin disinfection. 1. For Patient #11, staff failed to ensure adequate disinfection to both the upper and lower needle access sites of the AVF prior to cannulation, per facility policy. On 1/6/25 at 9:50 A.M., the surveyor observed CCHT #1 as he prepared to cannulate Patient #11’s fistula access for dialysis. CCHT #1 was observed to open an alcohol prep pad and disinfect the upper access site for 10 seconds. CCHT #1 was observed to remove his gloves and exit station 10 to prepare heparin for the the patient’s treatment. CCHT #1 performed hand hygiene and returned to station 10. He opened an alcohol prep pad and disinfected the same upper access for 8 seconds, inserted the needle, then taped the needle in place. CCHT #1 then opened an alcohol prep pad and disinfected the lower access site for 10 seconds, inserted the needle, then taped the needle in place. CCHT #1 failed to disinfect each access site for 30 seconds before cannulation, per facility policy. During an interview on 1/6/25 at 10:40 A.M., CCHT #1 said he cleaned the areas for 15 seconds each and counted in his head. During a follow-up interview on 1/6/25 at 3:00 P.M., CCHT #1 said, after reviewing the policy, he thought cleaning the sites were 15 seconds each, not 30 seconds. 44223 2. For Patient #12, the facility failed to ensure adequate disinfection to both the upper and lower needle access sites of the AVF prior to cannulation, per facility policy. On 1/6/25 at 10:50 A.M., the surveyor observed RN #7 as she prepared to cannulate Patient #12’s fistula access for dialysis treatment. RN #7 disinfected the lower access site with an alcohol prep pad in a circular motion for a total of 8 seconds. She then cannulated the lower access site. RN #7 then disinfected the upper access site with an alcohol prep pad in a circular motion for 10 seconds. She then cannulated the upper access site. RN #7 failed to disinfect each access site for 30 seconds prior to cannulation, per facility policy. During an interview on 1/6/25 at 11:20 A.M., RN #7 said disinfection should be for 30 seconds. She said she thought she had disinfected for 30 seconds, but she counted in her head and may have counted to fast.”

“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: 44223 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff members (Registered Nurse [RN] #5) observed, implemented adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 patients (#6) observed with a Central Venous Catheter (CVC), out of a total sample of 14 patients. Findings Include: Review of the facility policy, titled Initiation of Treatment Using Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer, dated 5/6/24, indicated the following: Preparing the Catheter: Dressing Change *The catheter exit site must be examined for signs and symptoms of infection, dislodgement of catheter or other problems and the catheter exit site care and dressing replacement must be completed prior to accessing the bloodstream. *Preparing the Catheter: Disinfection of the Catheter Connections, heparin removal, flushing the catheter and heparin administration: *Check to make sure catheter clamps are closed. *Using a sterile alcohol pad scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue. *Using the same sterile alcohol pad applying friction to remove any blood or residue, move from the hub at least several centimeters towards the body of the catheter. On 1/6/25 at 11:30 A.M., the surveyor observed RN #5 as she prepared Patient #6 for initiation of his/her dialysis treatment via a CVC. RN #5 disinfected the exit site and the catheter hubs. She then applied a clean dressing to the catheter site. RN #5 did not disinfect the sides (threads) of the catheter per the facility policy. During an interview on 1/6/25 at 11:45 A.M. RN #5 said that she disinfects the catheter lines when she sees dried blood or residue on them. She said she did not realize she did not clean them today.”

“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: 10249 Based on observation, interview, and Manufacturer’s Recommendations for Use, the facility failed to ensure that 1 of 2 staff observed (Certified Clinical Hemodialysis Technician [CCHT] #6) waited 20 seconds before reading the results of chlorine test to ensure an accurate result was obtained. Findings include: Review of the Manufacturer’s Total Chlorine Test Strips Instruction for Use indicated the following: *Collect a fresh 100 milliliter (ml) sample of water in a clean plastic sample cup. *Remove one test strip from its foil package and swish it in the sample for the amount of time indicated according to the temperature range. *Remove the strip and shake once, briskly, to remove the excess water. *Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it provides a consistent viewing background. *After 20 second wait period, immediately compare the color strip color to the color chart to determine the total chlorine level in the sample. During an observation on 1/6/25 at 8:27 A.M., in the water room, the surveyor observed CCHT #6 obtain a fresh 100 ml sample of water in a clean sample cup. She opened a test strip and submerged the strip into the sample and moved the test strip in a back-and-forth motion for 60 seconds, then briskly removed the excess water, waited 15 seconds, then read the results. CCHT #6 failed to wait the 20 seconds to ensure the test strip color was fully developed. During an interview on 1/6/25 at 8:30 A.M., CCHT #6 said she waited 15 seconds before reading the test strip.”

“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: 10249 Based on record review, interview, and policy review, the facility failed to ensure staff documented the theoretical conductivity (TCD), which is the expected conductivity of the dialysate calculated by the machine based on the dialysate composition, sodium, and bicarbonate setting, prior to initiating treatment for 1 of 8 applicable patient records (#1) reviewed, out of a total sample of 14 patients. Findings Include: Review of the facility policy titled, Checking Conductivity and pH of Final Dialysate, published 5/6/24, included the following: *Purpose: The purpose of this policy is to provide guidance to verify final dialysate conductivity and pH prior to initiating hemodialysis treatments and during treatments if required. *The theoretical conductivity (TCD) is calculated by the machine based on the concentrate formula selected, and the sodium and bicarbonate values entered in the dialysate composition screen. To ensure delivery of safe dialysate, the conductivity alarm limits must be maintained at +/- 0.5 mS/cm of the TCD. Check TCD on all dialysis machines. Ensure alarm limits are +/- 0.5 mS/cm of the TCD of the dialysate concentrate ordered by the attending physician. Staff/care partners must maintain limits at +/-0.5 mS/cm of the TCD. If limits are found not to be set appropriately, staff should adjust them to +/- 0.5 mS/cm of the TCD. Staff/care partners May Not Adjust them to any other position than +/- 0.5 mS/cm of the TCD. *Documentation: Record conductivity and pH readings in the facility treatment record. For Patient #1, the facility failed to ensure that staff documented the TCD in the treatment record. Patient #1 was admitted to the facility in December 2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of 10 treatment sheets, dated 11/18/24 through 1/3/25, indicated that staff failed to document the TCD for 3 of 10 treatments including 11/18/24, 12/2/24, and 12/27/24. During an interview on 1/7/25 at 1:30 P.M., the Clinic Manager said the TCD should be documented on the treatment sheets for each treatment.”

“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: 10249 Based on observation and staff interview, the facility failed to provide dialysis staff a functional and comfortable environment including the Home Program storage room floor and double doors of the storage area/water room that lead to the outside. Findings Include: On 1/6/25 at 8:30 A.M., during the initial flash tour of the Home Program storage room, the surveyor observed the following: -The Home Program storage area floor was a cement and gray in color. The floor was noted to be cracked and broken in various shapes and sizes. These missing pieces caused divots in the flooring causing potential risk for tripping. Also on the floor there was a 12 inch by 12 inch square with wood exposed through the cement. During an interview on 1/6/25 at 1:00 P.M., the Area Technical Operational Manager (ATOM) said he had identified the uneven floor in May 2024 during his physical plant audit on 5/31/24, however did not discuss with clinic manager at the time. During an interview on 1/6/25 at 1:30 P.M., the Clinic Manager said the ATOM did identify the storage room floor in his annual environmental audit, but nothing was done. On 1/6/25 at 1:15 P.M., during a tour of the dialysis storage area and water room, the surveyor observed the following: -The surveyor observed a space under the bottom of the exterior double doors that may allow pests to enter. There was also a space between the two doors, approximately 4 inches long, by the door handle, where light was visible from the outside. The storage room contained sterile items to be used for patient care including, but not limited to dialyzers, blood tubing sets with priming set, dressing supplies, and syringes. During an interview on 1/6/25 at 1:20 P.M., the ATOM said no one, including pest control, had ever identified the space between or at the bottom of the door.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 10249 Based on record review, staff interview, and policy review, the facility failed to ensure that staff monitored and documented intradialytic blood pressure and pulse, per facility policy, for 3 of 10 applicable patients (#1, #3, and #5), out of a total sample of 14 patients. Findings include: Review of the facility policy titled, Patient Assessment and Monitoring, dated 5/1/2023, included the following: *Monitoring 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. *Document machine parameters and safety checks every 30 minutes or more often as needed, but not to exceed 45 minutes or per state regulations. *Patient monitoring includes changes in the patient’s status, blood pressure, pulse, respirations and temperature. 1. Review of Patient #1’s 10 treatments sheets, dated 11/18/24 through 1/3/25, included the following: *On 12/9/24 at 10:37 A.M., the patient’s blood pressure and pulse was 170/79 and 61. The next recorded blood pressure and pulse was 191/87 and 69 and was not documented until 11:31 A.M., greater than 30 minutes, exceeding 45 minutes. * On 12/27/24 the patient’s treatment began at 10:21 A.M., with no documented blood pressure or pulse. The first documented blood pressure and pulse was 171/83 and 61 and was not documented until 11:41 A.M., greater than 30 minutes, exceeding 45 minutes. * On 1/3/25 at 10:54 P.M., the patient’s blood pressure and pulse was 144/56 and 54. The next recorded blood pressure and pulse was 176/79 and 62 and not documented until 12:03 P.M., greater than 30 minutes, exceeding 45 minutes. 2. Review of Patient #3’s 9 treatments sheets, dated 12/18/24 through 1/6/25, included the following: * On 12/20/24 at 8:03 A.M., the patient’s blood pressure and pulse was 95/61 and 71. The next recorded blood pressure and pulse was 105/62 and 66 and was not documented until 9:04 A.M., greater than 30 minutes, exceeding 45 minutes. * On 12/29/24 at 9:30 A.M., the patient’s blood pressure and pulse was 99/69 and 68. The next recorded blood pressure and pulse was 107/66 and 55 and was not documented until 10:30 A.M., greater than 30 minutes, exceeding 45 minutes. * On 12/31/24 at 9:03 A.M., the patient’s blood pressure and pulse was 99/56 and 68. The next recorded blood pressure and pulse was 100/63 and 68 and was not documented until 10:01 A.M., greater than 30 minutes, exceeding 45 minutes. * On 1/3/25 at 9:01 A.M., the patient’s blood pressure and pulse was 110/68 and 69. The patient’s treatment ended at 11:03 A.M., with no documented blood pressure or pulse recorded after 9:01 A.M.. 3. Review of Patient #5’s 10 treatments sheets, dated 12/17/24 through 1/4/25, included the following: * On 12/17/24 at 10:03 A.M., the patient’s blood pressure and pulse was 115/61 and 77. The next recorded blood pressure and pulse was 119/65 and 75 and was not documented until 11:02 A.M., greater than 30 minutes, exceeding 45 minutes. * On 12/26/24 at 11:36 A.M., the patient’s blood pressure and pulse was 147/73 and 83. The next recorded blood pressure and pulse was 139/58 and 81 and was not documented until 12:31 P.M., greater than 30 minutes, exceeding 45 minutes. * On 12/28/24 at 10:00 A.M., the patient’s blood pressure and pulse was 142/61 and 81. The next recorded blood pressure and pulse was 171/72 and 90 and was not documented until 11:04 A.M., greater than 30 minutes, exceeding 45 minutes. During an interview on 1/7/25 at 1:30 P.M., The Clinic Manager said staff need to monitor and document blood pressure and pulse every 30 minutes.”

“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: 10249 Based on observation, interview, and record review, the facility failed to ensure the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate (BFR-speed measured in milliliters per minute [ml/min]) in which the patient’s blood is pushed through the dialyzer and back into the body) and Dialysate Flow Rate (DFR-the measurement of how fast the dialysate solution flows in ml/min to draw toxins from the patient’s blood) for 1 of 4 patient prescriptions (#5) observed; and for 2 of 8 applicable patient (#1, #2) records reviewed, out of total sample of 14 patients. Findings include: 1. For Patient #5, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the DFR. Patient #5 was admitted to the facility in February 2016 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 11/23/24, indicated the DFR was to be delivered at a rate of 500. During an observation of the treatment floor on 1/7/25 at 10:15 A.M., the surveyor observed Patient #5 receiving dialysis treatment, and the machine was set at a DFR rate of 800, and not 500 as ordered. During an interview on 1/7/25 at 10:20 A.M., Registered Nurse [RN] #7 reviewed the physician’s order and said it should be running at 500, not 800. RN #7 said Certified Clinical Hemodialysis Technician [CCHT] #6 was caring for the patient and set up the machine. During an interview on 1/7/25 at 10:30 A.M., CCHT #6 said she had to move the patient to another station, and did not change the DFR to 500 at the start of the treatment. 2. For Patient #1, and #2, the facility failed to ensure that the dialysis prescription was delivered as prescribed relative to BFR and/or DFR. a. Patient #1 was admitted to the facility in December 2023 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 8/16/24, indicated the dialysis order included a BFR to be delivered at a rate of 450 ml/min, and a DFR to be delivered at a rate of 800 ml/min. Review of the 10 hemodialysis flowsheets, dated 11/18/24 through 1/3/25, indicated the BFR and/or DFR had not been delivered as prescribed for 4 of 10 treatments, including the following: *11/18/24 - The DFR was delivered at a rate of 700 ml/min for 2 hours, not the 800 ml/min as ordered, and there was no documentation to indicate why the physician’s orders was not followed. *11/20/24 - The BFR was delivered at a rate of 400 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s orders was not followed. *12/9/24 - The DFR was delivered at a rate of 500 ml/min, not the 800 ml/min as ordered, and there was no documentation to indicate why the physician’s orders was not followed. *12/16/24 - The BFR was delivered at a rate of 300 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s orders was not followed. During an interview on 1/7/25 at 1:30 P.M., the Clinic Manager said her expectation is that if staff need to change the BFR/DFR there should be documentation in the comment section of the treatment sheets. 44223 b. Patient #2 was admitted to the facility in October 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 12/14/24, indicated the dialysis order included a BFR to be delivered at a rate of 400 ml/min. Review of 9 hemodialysis flowsheets, dated 12/17/24-1/4/25, indicated the BFR had not been delivered as prescribed for 5 of 9 treatments, including the following: *12/21/24 - The BFR was delivered at a rate of 300 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *12/23/24 - The BFR was delivered at a rate of 300 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *12/26/24 - The BFR was delivered at a rate of 375 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *1/2/25 - The BFR was delivered at a rate of 350 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicated why the physician’s order was not followed. *1/4/25 - The BFR was delivered at a rate of 350 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 1/8/25 at 9:00 A.M., the Clinic Manager said the expectation is that staff documents on the treatment sheets why there was a change in the BFR.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 10249 Based on record review, staff interview, and policy review, the Medical Director failed to 1.) ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration of heparin (blood thinning medication) bolus to initiate dialysis treatment for 6 of 10 patients (#3, #5, #2, #4, #6, #7), and 2.) ensure 1 staff followed the policy related to reversal of Central Venous Catheter (CVC) lines for 1 of 10 patients (#2), out of a total sample of 14 patients. Findings Include: Review of the facility’s policy titled, Heparinization, published 8/3/2020, indicated the following: * Heparin Administration * Heparin must be given at least 3-5 minutes prior to dialysis. This allows time for the full anticoagulation at the start of treatment. Administer into the second inserted access needle or catheter 3-5 minutes prior to hemodialysis treatment initiation. 1. For Patient #3, #5, #2, #4, #6, and #7, the Medical Director failed to ensure staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after heparin bolus to initiate dialysis treatments. a. Patient #3 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 12/18/24 through 1/6/25, indicated for 6 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 12/18/24 treatment started at 7:04 A.M., heparin was documented as administered at 7:05 A.M., 1 minute after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 12/20/24 treatment started at 7:14 A.M., heparin was documented as administered at 7:16 A.M., 2 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 12/24/24 treatment started at 6:46 A.M., heparin was documented as administered at 6:49 A.M., 3 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 12/31/24 treatment started at 6:55 A.M., heparin was documented as administered at 7:00 A.M., 5 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/3/25 treatment started at 7:09 A.M., heparin was documented as administered at 7:14 A.M., 5 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/6/25 treatment started at 6:56 A.M., heparin was documented as administered at 6:57 A.M., 1 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. b. Patient #5 had a physician’s order to administer heparin bolus 3000 units intravenously (IV) push, every dialysis treatment. Review of 10 treatment sheets, dated 12/17/24 through 1/4/25, indicated for 4 of 10 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 12/17/24 treatment started at 8:59 A.M., heparin was documented as administered at 9:03 A.M., 4 minute after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 12/23/24 treatment started at 8:30 A.M., heparin was documented as administered at 8:31 A.M., 1 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/2/25 treatment started at 8:57 A.M., heparin was documented as administered at 8:57 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/7/25 treatment started at 8:49 A.M., heparin was documented as administered at 10:35 A.M., 1 hour and 46 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. During an interview on 1/7/25 at 1:30 P.M., the Clinic Manager said staff should be documenting when they administer the bolus dose of heparin and should wait the 3-5 minutes to start treatment after they administer the heparin bolus. 44223 c. Patient #2 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 12/17/24 through 1/4/25, indicated for 2 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 12/23/24 treatment started at 6:59 A.M., heparin was documented as administered at 6:57 A.M., 2 minutes prior to initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 12/26/24 treatment started at 6:33 A.M., heparin was documented as administered at 6:33 A.M., the same time as initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. d. Patient #4 had a physician’s order to administer heparin bolus 5000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 12/18/24 through 1/6/25, indicated for 3 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 12/18/24 treatment started at 11:05 A.M., heparin was documented as administered at 11:45 A.M., 40 minutes after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. *On 12/22/24 treatment started at 10:47 A.M., heparin was documented as administered at 10:48 A.M., 1 minute after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. *On 12/27/24 treatment started at 11:20 A.M., heparin was documented as administered at 11:25 A.M., 5 minutes after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. e. Patient #6 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 12/18/24 through 1/6/25, indicated for 4 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 12/20/24 treatment started at 11:00 A.M., heparin was documented as administered at 11:04 A.M., 4 minutes after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. *On 12/24/24 treatment started at 9:00 A.M., heparin was documented as administered at 9:06 A.M., 6 minutes after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. *On 12/27/24 treatment started at 11:05 A.M., heparin was documented as administered at 11:18 A.M., 13 minutes after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. *On 12/29/24 treatment started at 10:49 A.M., heparin was documented as administered at 10:50 A.M., 1 minute after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. f. Patient #7 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 12/18/24 through 1/6/25, indicated for 4 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 12/24/24 treatment started at 7:13 A.M., heparin was documented as administered at 7:14 A.M., 1 minute after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. *On 12/27/24 treatment started at 7:21 A.M., heparin was documented as administered at 7:25 A.M., 4 minutes after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. *On 12/29/24 treatment started at 6:28 A.M., heparin was documented as administered at 6:30 A.M., 2 minutes after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility policy. *On 1/3/25 treatment started at 7:30 A.M., heparin was documented as administered at 7:33 A.M., 3 minutes after the initiation of treatment, not the 3-5 minutes prior to dialysis, per the facility. During an interview on 1/8/24 at 9:00 A.M., the Clinic Manager said the expectation is that heparin is given 3-5 minutes prior to the initiation of dialysis treatment. 2. The Medical Director failed to ensure staff followed the facility policy related to notifying the physician and obtaining an order when reversing treatment lines. Review of the facility policy, titled Reversal of Central Venous Catheter Lines, dated 2/5/24, indicated the following: *Reversal of CVC lines requires the following documentation in the patient’s medical record: *Provider order with frequency (each treatment, x1 etc) entered in the patient medical record. *Reason for line reversal. *Action of line reversal in the treatment record. *Evaluation of catheter function and future need for vascular referral. Patient #2 was admitted to the facility in October 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis three times a week. Review of the hemodialysis flowsheets, dated 12/17/24-1/4/25, indicated for 1 of 9 treatments the CVC lines were reversed, including 12/26/24. There was no documentation indicating nursing had notified the physician, and obtained an order to reverse the lines. Further review of the medical record did not indicate any documentation for why the CVC lines were reversed. During an interview on 1/8/25 at 9:00 A.M., the Clinic Manager said staff should have an order from the physician to reverse lines, and should document on the flowsheet why the lines were reversed.”