Davita Pdi Worcester

“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: 37349 Based on observation, interview and record review, the Medical Director failed to ensure that staff were educated and trained on the manufacturer’s instructions for use when measuring the pH of the dialysate solution with an independent method before starting the treatment for the next patient. Findings include: Review of the facility policy titled, Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate, revised April 2020, included the following: * Trained teammates will test pH and conductivity of final dialysate utilizing appropriate test strips and/or meters prior to each patient treatment. *The acceptable range for the final dialysate pH is 6.9-7.6. Check independent pH with approved test method for final dialysate. Review of the pH manufacturer’s test strip guidance, E-Z Chek 6.8-8.5 pH Test Strips, included the following: *Dip the strip into the solution to be tested. *Start the timer as the strip is being pulled from the solution. *Remove the strip and shake off excess liquid. *To determine closest match for bicarbonate/citrate dialysate, compare color reaction on the strip to the color chart on bottle immediately at 10 seconds. The facility failed to ensure that 3 staff members (CCHT #4, CCHT #1 and CCHT #5) shook off excess liquid and waited 10 seconds before reading the pH test strip results, per the manufacturer’s instructions. A. On 12/21/23 at 9:58 A.M., the surveyor observed CCHT #4 test the pH of the dialysate solution from station #6. While at the dirty sink, he obtained a test strip, dipped it into the cup of dialysate solution, removed the strip, and without shaking off excess liquid, immediately read the strip using the color guidance on the test strip container (CCHT #4 did not shake off the excess solution or wait 10 seconds to read the result per the MDFU). He said the pH was 7.4 which was acceptable and the process of testing and result reading was how they were trained to do it. B. On 12/21/23 at 10:22 A.M., the surveyor observed CCHT #1 test the pH of the dialysate solution from station #4. While at the dirty sink, she obtained a test strip, dipped it into the cup of dialysate solution, removed the strip and without shaking off excess liquid, immediately read the strip using the color guidance of the test strip container (CCHT #1 did not shake off the excess solution or wait 10 seconds to read the result per the MDFU). She said the pH was high at 8, then immediately repeated the same process using a second test strip. She said the pH was too high, and she then reported the findings to Registered Nurse Clinical Manager. The hemodialysis machine was taken out of service. C. On 12/21/23 at 9:24 A.M., the surveyor observed CCHT #5 test the pH of the dialysate solution from station #24. While at the dirty sink, she obtained a test strip, dipped it into the cup of dialysate solution, removed the strip, and without shaking off excess liquid, immediately read the strip using the color guidance on the test strip container (CCHT #5 did not shake off the excess solution or wait 10 seconds to read the result per the MDFU). She said the result was to be read immediately or the pH results keeps going higher. She read the result immediately as 7.6 and said it was an acceptable reading. During an interview on 12/21/23 at 1:58 P.M., the Manager of Clinical Services said that when staff are testing the pH of the dialysate solution, they should have waited for 10 seconds before reading the pH results, as indicated on the test strip bottle instructions. Review of the facility training/inservice documentation form, dated 11/13/23, indicated that staff, including CCHT #1, CCHT #4 and CCHT #5 had received training on the facility policy for pH and conductivity testing with a focus on making sure Teammates check pH prior to each patient treatment. The training failed to include review of the manufacturer’s instructions for the test strips used by the facility. During an interview on 12/21/23 at 2:30 P.M., the Director of Clinical Services said staff should have been trained on the proper use of the test strips.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 37349 Based on observation, interview and record review, the facility failed to maintain a complete and accurate medical record for 2 patients (#14 and #7), out of a total sample of 10 patients. Findings include: 1. For Patient #14, admitted to the facility in 3/2023 with a diagnosis of end stage renal disease, requiring dialysis via a central venous catheter, the facility failed to ensure that staff a.) accurately documented that treatment was run with hemodialysis lines reversed; b.) accurately documented care they provided under their own name and c.) accurately documented the administration of heparin. a.) The facility failed to ensure that staff (Clinic Manager (CM)) accurately documented that he resumed treatment for Patient #14 with the hemodialysis lines reversed. On 12/21/23 at 9:35 A.M., the surveyor observed Certified Clinical Hemodialysis Technician (CCHT) #3 discontinue dialysis treatment for Patient #14 via his/her central venous catheter. The surveyor noted that the hemodialysis lines had been reversed. Review of Patient #14’s treatment flow sheet for 12/21/23 failed to indicate that the hemodialysis treatment had been run with the hemodialysis lines reversed. During an interview on 12/21/23 at 10:55 A.M., the Clinic Manager (CM) said that the treatment for Patient #14 had been paused and he restarted the treatment with the hemodialysis lines reversed because Patient #14 had told him the treatment had been running with the hemodialysis lines reversed. He said he did not document the hemodialysis lines were reversed because he assumed the patient was correct and it had already been documented. During an interview on 12/21/23 at 10:50 A.M., the Director of Clinical Services said that the reversed lines should have been documented on the flow sheet. b.) The facility failed to ensure that staff (CM and Certified Clinical Hemodialysis Technician (CCHT) #3) documented care they provided under their own name. On 12/21/23 at 9:35 A.M., the surveyor observed Certified Clinical Hemodialysis Technician (CCHT) #3 discontinue the dialysis treatment for Patient #14 via his/her central venous catheter. Review of Patient #14’s treatment flow sheet for 12/21/23 indicated that CCHT #4 had discontinued treatment, not CCHT #3 as observed. Further review indicated that CCHT #4 had resumed treatment for Patient #14, after a pause, at 8:26 A.M. During an interview on 12/21/23 at 10:50 A.M., CCHT #4 said that he had paused the hemodialysis treatment for Patient #14, but did not resume the treatment as documented. During an interview on 12/21/23 at 10:55 A.M., the Clinic Manager (CM) said that the hemodialysis treatment for Patient #14 had been paused and he restarted the treatment. He said the computer may have been open and he may have inadvertently documented under CCHT #4’s name. During an interview on 12/21/23 at 10:50 A.M., the Director of Clinical Services said that the computer system may allow staff to be logged in at multiple computers, but staff should be documenting under their own names. c.) The facility failed to accurately document the administration of heparin for Patient #14. Review of Patient #14’s treatment sheet for 12/21/23 indicated there was a physicians order for heparin (blood thinner) 600 units per hour via intravenous infusion every dialysis treatment. Treatment started at 6:16 A.M., the infusion started at 6:16 A.M.. Treatment ended at 9:27 A.M., but the infusion was documented as ending at 9:39 A.M., 12 minutes after the treatment had ended. During an interview on 12/21/23 at 11:10 A.M., the Director of Clinical Services said that heparin is something they continue to audit. 10249 2. For Patient #7, admitted to the facility in December 2021 with a diagnosis of end stage renal disease and used an AV fistula (left upper arm) for hemodialysis, staff failed to accurately document the administration of heparin. Patient #7 had a physician’s order, dated 9/18/22, for a heparin pump, 600 units per hour, for three hours, and stop time for hourly dose 60 minutes before the end of treatment, for a total of 1800 units per treatment. Review of Patient #7’s treatment flow sheet for 12/20/23 indicated that dialysis treatment was initiated at 6:22 A.M. and the heparin infusion was documented as starting at 5:43 A.M., 39 minutes before treatment began. During an interview on 12/21/23 at 1:17 P.M., the Manager of Clinical Services said what you see on the treatment sheet is the correct time, but could not explain why the infusion pump of heparin started prior to the treatment. During an interview on 12/21/23 at 1:51 P.M., the Clinic Manager said the infusion pump can not be turned on until the treatment begins.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 37349 Based on observations, policy review and interviews, the facility failed to ensure seven staff members (Registered Nurse 4, #5 and #6, Certified Clinical Hemodialysis Technician (CCHT) #2, #5 and #6 and Patient Care Technician (PCT) #1) consistently implemented infection control standards to prevent infection within the dialysis unit to meet the condition of infection control. Findings include: 1. The facility failed to ensure a sanitary environment to minimize the transmission of infectious agents within the treatment center. Please see V111 2. The facility failed to ensure that one staff member RN (#5) performed adequate infection control practices, related to proper glove use, while providing care within the hemodialysis area. Please see V113 3. The facility failed to ensure there was a separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to ensure 2 of 2 staff (Registered Nurse [RN] #4 and RN #6) observed, failed to remove potentially contaminated personal protective equipment (PPE) gowns before preparing intravenous medication. Please see V117 4. The facility failed to 1.) ensure 2 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #2, and CCHT #6) observed, adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the hemodialysis station, increasing the risk for cross contamination of blood borne pathogens, and 2.) failed to ensure the hemodialysis chair tray tables were free of tape debris to allow for proper disinfection to reduce the risk of spread of infection, and 3.) ensure bleach was stored in a covered container to prevent disintegration of the chemical when exposed to sunlight and air. Please see V122 5. The facility failed to ensure that 1 of 2 facility staff (Patient Care Technician (PCT) #1) provided adequate infection control measures regarding fistula cannulation for 1 of 2 patients (#8) with fistulas/grafts observed, out of a total sample of 10 patients. Please see V142 6. The facility failed to ensure that 2 of 2 staff members (Registered Nurse (RN) #6 and Certified Clinical Hemodialysis Technician (CCHT) #5) observed provided appropriate care of the central venous catheter (CVC) as follows; 1.) RN #6 failed to provide exit site care of CVC to ensure it was safe to initiate treatment, per facility policy, failed to provide adequate infection control measures during exit site care and failed to provide adequate infection control measures during initiation of treatment with a CVC; and 2.) CCHT #5 failed to provide adequate infection control measures during termination of treatment with a CVC. Please see V147”

“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: 44223 Based on observation and staff interview, the facility failed to ensure a sanitary environment to minimize the transmission of infectious agents within the treatment center. Findings Include: The Centers for Disease Control and Prevention (CDC) defines a “sanitary environment” as an environment that meets “Standard Precautions” for an in-patient hospital setting plus the more stringent precautions which are recommended for hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms. On 11/7/23 at 10:25 A.M., during a tour of the dialysis treatment area, the surveyor observed that the laminate on the counter, behind the patient hemodialysis machine and hemodialysis chair, was cracked and torn away from the counter, exposing the wood underneath at stations 1, 2, 3, 6, 20, 21, 24, and 25. This would make attempts to disinfect ineffective and create the risk of spreading infection. During an interview on 11/9/23 at 11:25 A.M., both the Facility Administrator and the Corporate Nurse said that it would be difficult to ensure that the areas are being effectively disinfected.”

“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: 38141 Based on observation, interview, and policy review, the facility failed to ensure that one staff member (Registered Nurse (RN) #5) performed adequate infection control practices, related to proper glove use, while providing care within the hemodialysis area. Findings include: Review of the facility policy, titled Infection Control for Dialysis Facilities, revised April 2023, indicated the following: * Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station. During an observation of the treatment area (station #12) on 11/8/23 at 12:10 P.M., the surveyor observed RN #5 assess the patient’s lung sounds using a stethoscope and then touched the patient’s bilateral lower extremities to assess for edema without wearing gloves. RN #5 disinfected the stethoscope, performed hand hygiene and then administered medication to the patient without wearing gloves and then performed hand hygiene after. During an observation on the treatment area (station #13) on 11/8/23 at 12:20 P.M., the surveyor observed RN #5 assess the patient’s lung sounds using a stethoscope and then touched the patient’s bilateral lower extremities to assess for edema without wearing gloves. RN #5 disinfected the stethoscope, performed hand hygiene, and then administered medication to the patient without wearing gloves and then performed hand hygiene after. During an observation on the treatment area (station #14) on 11/8/23 at 12:28 P.M., the surveyor observed RN #5 assess the patient’s lung sounds using a stethoscope and then touched the patient’s bilateral lower extremities to assess for edema without wearing gloves. RN #5 disinfected the stethoscope, performed hand hygiene and then administered medication to the patient without wearing gloves and then performed hand hygiene after. During an observation on the treatment area (station #15) on 11/8/23 at 12:42 P.M., the surveyor observed RN #5 assess the patient’s lung sounds using a stethoscope and then touched the patient’s bilateral lower extremities to assess for edema without wearing gloves. RN #5 disinfected the stethoscope, performed hand hygiene and then administered medication to the patient without wearing gloves and then performed hand hygiene after. During an interview on 11/8/23 at 12: 50 P.M., RN #5 said that she thought it was okay to not wear gloves when assessing the patient if there are not any visible body fluids or any open areas on the skin. She said that she will check the facility policy for use of gloves. During an interview on 11/8/23 at 2:15 P.M., the Corporate Nurse said that staff members should wear gloves when assessing the patient, especially in the treatment areas.”

“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 observations and staff interview the facility failed to ensure there was a separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to ensure 2 of 2 staff (Registered Nurse [RN] #4 and RN #6) observed, failed to remove potentially contaminated personal protective equipment (PPE) gowns before preparing intravenous medication. Findings Include: Review of the Centers for Disease Control (CDC) Infection Control Requirements for Dialysis Facilities and Clarification Regarding Guidance on Parenteral Medication Vials, dated 8/15/08, included the following: CDC recommends that all parenteral medications should be prepared in a clean area separate from potentially contaminated items and surfaces. In hemodialysis settings where environmental surfaces and medical supplies are subjected to frequent blood contamination, medication preparation should occur in a clean area removed from the patient treatment area. Proper infection control practices must be followed during the preparation and administration of injected medications. This is consistent with official CDC recommendations for infection control precautions in hemodialysis. 1. On 11/7/23 at 11:50 A.M., during observation of medication preparation and administration, the surveyor observed RN #4 enter the medication preparation area (labeled clean) wearing a gown that had been worn in and out of patient stations to care for patients. At no time did RN #4 remove the gown prior to entering the medication preparation area. He aseptically removed two pre-filled syringes of Micera 30 mcg (used to treat anemia associated with chronic kidney disease), he prepared 60 mcg and then proceeded to administer the medication to Patient #10 at station #24. On 11/9/23 at 3:00 P.M., the Facility Administrator and Cooperate Nurse #1 said that staff do not change their gowns when they go into the medication preparation area and have not been doing that and have never been told otherwise. 37349 2. On 11/7/23 at 12:27 P.M., during observation of medication preparation and administration, the surveyor observed RN #6 enter the medication preparation area (labeled clean) wearing a gown that had been worn in and out of patient stations to care for patients. At no time did RN #6 remove the gown prior to entering the medication preparation area. He aseptically prepared Micera, and then proceeded to administer the medication to a patient in station #17. On 11/9/23 at 3:00 P.M., the Facility Administrator and Cooperate Nurse #1 said that staff do not change their gowns when they go into the medication preparation area and have not been doing that and have never been told otherwise.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to 1.) ensure 2 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #2, and CCHT #6) observed, adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the hemodialysis station, increasing the risk for cross contamination of blood borne pathogens, and 2.) ensure the hemodialysis chair tray tables were free of tape debris to allow for proper disinfection to reduce the risk of spread of infection, and 3.) ensure bleach was stored in a covered container to prevent disintegration of the chemical when exposed to sunlight and air. Findings Include: 1. The facility failed to ensure CCHT #2 and CCHT #6 adequately cleaned and disinfected the hemodialysis station between patients. Review of the facility policy titled, Infection Control for Dialysis Facilities, revised April 2023, included the following: 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (i.g. dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens;countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysate delivery system. Pressurized washers, spray bottles, or sprayers for cleaning purposes will not be used on wall boxes or the adjoining area. Teammates will monitor and address wall box residue/build up and patency issues. A. On 11/7/23 at 10:05 A.M., the surveyor observed CCHT #2 cleaning the dialysis machine/treatment area at station #18 for the next patient. She was observed to clean the treatment area with 1:100 bleach soaked pads. CCHT #2 failed to disinfect the countertops behind the hemodialysis chair/dialysis machine. She also failed to disinfect the wall water box. B. On 11/7/23 at 10:20 A.M., the surveyor observed CCHT #6 cleaning the dialysis machine/treatment area at station #17 for the next patient. She cleaned the treatment area with 1:100 bleach soaked pads. CCHT #6 failed to disinfect the countertops behind the hemodialysis chair/dialysis machine. She also failed to disinfect the wall water box. During an interview on 11/7/23 at 10:30 A.M., CCHT #6 said the countertop and wall box should be disinfected between patients. During an interview on 11/9/23 at 11:30 A.M., Cooperate Nurse #1 said the countertops and wall boxes should be cleaned during the disinfection of the station. 2. The facility failed to ensure the hemodialysis chair tray tables were free of tape debris to allow for proper disinfection to reduce the risk of spread of infection. On 11/7/23 at 10:25 A.M., during observation of the treatment area, the surveyor observed paper tape debris on the hemodialysis chair tray tables at stations # 1, 2, 9, 12, 13, 15, 16, 22, 23, 24, 25, and 26. On 11/7/23 at 8:05 A.M., during the flash tour of the home program area, the surveyor observed paper tape on the hemodialysis chair tray tables in treatment room 1 and treatment room 2. During an interview on 11/9/23 at 10:25 A.M., the Home Program RN said that paper tape cannot be properly disinfected and it needed to be removed. During an interview on 11/9/23 at 11:55 A.M., Cooperate Nurse #1 agreed that paper tape cannot be disinfected and should not be left on the tray tables. 3. The facility failed to ensure bleach was stored in a covered container to prevent disintegration of the chemical when exposed to sunlight and air. Review of the facility policy, titled Preparation of 1:100 Bleach Solution, revised October 2023, included the following: * When the solution is not being used, place a lid on the bleach solution container. Bleach solution open to air causes the solution to degrade over time and becomes less effective. The policy failed to indicate the effect of light on the solution. On 11/7/23 from 10:35 A.M. to 12:40 P.M., the surveyor observed the container of 1:100 bleach solution stored in a clear plastic container across from the Clinic Manager Office, uncovered. During an interview on 11/9/23 at 9:30 A.M., the Corporate Nurse said bleach should be covered when not in use.”

“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: 37349 Based on observation, policy review, and interview, the facility failed to ensure that 1 of 2 facility staff (Patient Care Technician (PCT) #1) provided adequate infection control measures regarding arterio-venous fistula (AVF) cannulation for 1 of 2 patients (#8) with fistulas/grafts observed, out of a total sample of 10 patients. Findings include: Review of the facility’s policy/procedure titled, AV Fistula or Graft Cannulation with NIPRO or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose, revised October 2022, included the following: 10. While maintain (sic) aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out. 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allowing to dry. 12. For patients who have a documented allergy to povidone iodine or ExSept Plus, necessitating alcohol alone, apply alcohol using a circular rubbing motion, center out for 60 seconds and allow to dry for 15 seconds prior to cannulation. Alcohol can be very drying to the skin and less effective than other skin antiseptics. Teammates will need to use a minimum of 4 prep pads per site for at lease 60 seconds total contact time to adequately prep cannulation site. 13. Do not palpate insertion site once area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. 1. For Patient #8, PCT #1 failed to ensure adequate disinfection to both the upper and lower needle access sites of the AV fistula, in accordance with facility policy and failed to disinfect the upper access site after palpating. On 11/7/23 at 11:30 A.M., the surveyor observed PCT #1 initiate treatment for Patient #8 via an AVF. PCT #1 access the AVF and chose his/her upper and lower access sites. She disinfected the lower access site with 4 alcohol prep pads in a circular motion for a total of 60 seconds. She then disinfected the upper access site with 3 alcohol prep pads in a circular motion, with the 4th alcohol prep pad she wiped back and forth between the upper and lower access site, not per the policy of circular rubbing motion on the access site. She then proceeded to cannulate the lower access site. She then palpated the upper access site (recontaminating the area) and without disinfecting the site cannulated the upper access site. During an interview on 11/7/23 at 11:40 A.M., PCT #1 said that she should not have gone back and forth between the two access site with the alcohol prep pad and she thought she had touched the site above where she accessed it.”

“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: 37349 Based on observation, interview and policy review, the facility failed to ensure that 2 of 2 staff members (Registered Nurse (RN) #6 and Certified Clinical Hemodialysis Technician (CCHT) #5) observed provided appropriate care of the central venous catheter (CVC) as follows; 1.) RN #6 failed to provide exit site care of CVC to ensure it was safe to initiate treatment, per facility policy, failed to provide adequate infection control measures during exit site care and failed to provide adequate infection control measures during initiation of treatment with a CVC; and 2.) CCHT #5 failed to provide adequate infection control measures during termination of treatment with a CVC. Findings include: 1a. For Patient #9, RN #6 failed to provide exit site care prior to initiating treatment, failed to provide adequate infection control measures during exit site care. and failed to provide adequate infection control measures during initiation of treatment with a CVC. Review of the facility policy titled, Central Venous Catheter with Clearguard HD Antimicrobial End Caps Procedure, revised October 2023, included the following: * Remove old dressing and discard. * Observe site for signs and symptoms of infection such as redness, drainage, swelling or tenderness. If present report to RN/physician. If drainage is present, obtain order for exit site culture. Observe CVC at exit site for evidence of migration, cracks, or leaks in the catheter limbs. If present, do not initiate dialysis. Report to RN/physician for further follow up. On 11/7/23 at 10:50 A.M., the surveyor observed RN #6 initiate treatment for Patient #9 with a CVC in station #13. He did not remove the old CVC dressing to observe the site for signs of infection, migration, cracks, or leaks. During an interview on 11/7/23 at 11:10 A.M., RN #6 said he would change the exit site dressing before the treatment was completed. During an interview on 11/7/23 at 12:50 P.M., the Clinic Manager said the exit site dressing should be completed before treatment is initiated, and he would send RN #6 over to do it right away. During an interview on 11/7/23 at 1:05 P.M., RN #6 said he should have provided exit site care before he started the treatment. 1b. Review of the facility policy titled, Central Venous Catheter with Clearguard HD Antimicrobial End Caps Procedure, revised October 2023, included the following: *Device Disinfectant and Skin Antiseptic 2% Chlorhexidine Effective Contact Time 30 seconds. On 11/7/23 at 12:55 P.M., the surveyor observed RN #6 provide exit site care to Patient #9 in station #13. He removed the old dressing and discarded it. After changing his gloves and performing hand hygiene, he disinfected the area with a Chlorhexidine swab for 15 seconds, not 30 seconds per policy. During an interview on 11/7/23 at 1:05 P.M., RN #6 said he thought the policy was to disinfect with Chlorhexidine for 15 seconds. 1c. Review of the facility policy titled, Central Venous Catheter with Clearguard HD Antimicrobial End Caps Procedure, revised October 2023, included the following: * Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason. *70% alcohol CVC Hubs 15 second scrub. * Holding catheter with non dominant hand, use other hand to place sterile 4 x 4 under catheter limbs. Minimize contact with the 4 x 4 gauze by holding only a corner. * Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad, Scrub each CVC hub for 15 seconds including the sides, threads and ends of hub thoroughly with friction making sure to remove any residue, for example blood. Hold the limbs until the antiseptic has dried. * Attach sterile 10 milliliter (ml) syringe to the arterial and venous limbs. * Aspirate an amount greater than the catheter limb lumen, generally about 5 ml from each limb. Proceed to step 20 if both limbs are patent. * Draw lab specimens if applicable. * Aseptically discard syringe containing indwelling solution from arterial limb and attach a saline filled syringe. Repeat step for venous limb. * Unclamp and flush each limb with saline and re-clamp. * Attach heparin loading dose to venous line, as applicable. * After a minimum of 3-5 minutes, remove syringe from each access port one at a time, then attach each blood line carefully, as not to contaminate blood line tips or catheter limbs. * Secure connections and initiate dialysis per procedure. On 11/7/23 at 10:50 A.M., the surveyor observed RN #6 initiate treatment for Patient #9 with a CVC in station 13. He removed the old dressing over the limbs, disinfected the outside of the limbs, and placed them down on a 4 x 4. He removed the cap to the venous limb and disinfected it for 10 seconds, not 15 seconds, and placed it down on the 4 x 4, when he picked it up to attach an empty syringe his gloved fingertip came in contact with the tip of the catheter, he attached the syringe and aspirated about 5 ml. He did the same for the arterial limb. He then removed and discarded the syringes. As he was priming the machines lines over the prime waste bucket, the lines came in contact with his gloved hand before securing the connections. During an interview on 11/7/23 at 1:00 P.M., RN #6 said he should have disinfected the hubs for 15 seconds. He said he didn’t realize he touched the hubs or the machine lines. He said he should have disinfected the lines again. 2. For Patient #1, CCHT #5 failed to provide adequate infection control measures during termination of treatment with a central venous catheter. Review of the facility policy titled, Central Venous Catheter with Clearguard HD Antimicrobial End Caps Procedure, revised October 2023, included the following: * Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason. 70% alcohol CVC Hubs 15 second scrub * Clamp arterial catheter limb and blood line. Aseptically disconnect arterial blood line from arterial CVC limb. Attach a 10 ml syringe filled with normal saline to arterial catheter limb. Unclamp arterial catheter limb and push normal saline into arterial port and quickly clamp arterial catheter limb. Attach arterial blood line to saline infusion. * Clamp venous catheter limb and blood line. Aseptically disconnect venous blood line and connect 10 ml syringe with normal saline to the venous catheter limb. Unclamp venous catheter limb and push normal saline into venous port and quickly clamp venous catheter limb. * If a CC locking solution is prescribed, remove normal saline syringes and connect syringe appropriate for catheter lumen volume with prescribed locking solution to each catheter limb one at a time, unclamp and instill solution then re-clamp both catheter limbs. * Remove syringes and disinfect the CVC hubs wit new alcohol prep pad for each CVC hub. Scrub the sides, threads and end of hub thoroughly with friction for 15 seconds, making sure to remove any residue, for example blood. Hold the catheter until the antiseptic has dried. * While holding the shield and catheter hub in one hand, remove the single Clearguard HD cap by rotating the lock ring counterclockwise, taking care to only handle the lock ring, do not touch the rod. Carefully insert the rod into the catheter into catheter hub and using a simultaneous push and twist motion, tighten by rotating clockwise. On 11/7/23 at 10:00 A.M., the surveyor observed CCHT #5 terminate treatment for Patient #1 in station 6. He clamped the arterial limb and disconnected the blood line. He disinfected the hub with an alcohol swab for 5 seconds, and then attached a 10 ml syringe of normal saline. He did the same for the venous line. He then removed the syringe from the arterial port and disinfected with an alcohol pad for 5 seconds, before putting the cap in place. He did the same for the venous line. During an interview on 11/7/23 at 10:00 A.M., CCHT #5 said he needed to review the policy to verify how long he should disinfect the hub of a CVC. During an interview on 11/7/23 at 10:10 A.M., the Corporate Nurse said teammates should scrub the hubs of a CVC for 15 seconds during discontinuation of treatment.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff members observed (Certified Clinical Hemodialysis Technician (CCHT) #2), performed water testing for Total Chlorine per facility policy. Findings include: Review of the Total Chlorine Test using RPC Ultra Low Total Chlorine Test Strip policy and procedure, revision date October 2023, included the following: 1. Rinse the sample collection cup thoroughly with the water to be tested. Fill the sample cup to the line marked 100 milliliters (ml) with the sample. 2. Remove one test strip from the foil package and dip it in the water sample for 60 seconds. While dipping the strip, move it back and forth at a constant gentle rate of approximately two, 1-2 inch wide strokes per second. 3. Remove the strip and shake once, briskly, to remove excess water. 4. Wait 20 seconds for the test strip color to develop. While waiting fold the white plastic handle of the test strip under the test pad area so that it provides a consistent viewing background. 5. After waiting the 20 second wait period, immediately compare the strip color to the color chart to determine the Total Chlorine level in the sample. 6. Document test results on Routine Total Testing Log and in IT Clinical System then take any necessary actions per the policy. On 11/8/23 at 9:00 A.M., the surveyor observed CCHT #2 perform a Total Chlorine Test. She rinsed the collection cup thoroughly 5 times and obtained a 100 ml sample. She opened a test strip and dipped it in the sample and moved it back and forth for 60 seconds. When she removed the strip she shook it once, folded the handle and compared the strip color to the chart without waiting 20 seconds. During an interview on 11/8/23 at 9:05 A.M., CCHT #2 said that it took about 15 seconds for the strip color to develop and she figured by the time she took the strip out of the sample, shook the water off, folded the strip and compared it to the chart that was about 15 seconds.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to ensure that 2 staff members (Registered Nurse (RN) #6 and RN #4 ) observed, measured the pH of the dialysate prior to starting treatment of the next patient. Findings include: Review of the facility policy titled, Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate, revised April 2020, included the following: * Trained teammates will test pH and conductivity of final dialysate utilizing appropriate test strips and/or meters prior to each patient treatment. 1. On 11/7/23 at 10:50 A.M., the surveyor observed RN #6 initiate dialysis treatment for a patient in station #13 without measuring the pH of the final dialysate. During an interview on 11/7/23 at 11:00 A.M., RN #6 said they have new machines and there is no need to measure the pH, the new machine does it for them. During an interview on 11/7/23 at 11:25 A.M., the Clinical Manager said that staff still need to measure pH and should be using test strips to measure the pH of the dialysate before initiating a patient’s treatment. 44223 2. On 11/7/23 at 11:30 A.M., the surveyor observed RN #4 initiate dialysis treatment for a patient at station #24 without measuring the pH of the final dialysate. During an interview on 11/7/23 at 11:40 A.M., RN #4 said that the facility no longer uses test strips to check the pH because the machine does it automatically. He further said that there has been some confusion over whether or not staff should be checking it. During an interview on 11/9/23 at 11:55 A.M., the Cooperate Nurse said that staff still need to measure pH and should be using test strips to measure the pH of the dialysate before initiating a patient’s treatment.”

“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: 44223 Based on record review, staff interview, and policy review, the facility failed to ensure staff conducted Pre-Dialysis Nursing Assessments within one hour of dialysis treatment for 3 of 7 applicable patients (#2,#3,#7), out of a total sample of 10 patients. Findings Include: Review of the facility policy, titled Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, revised October 2021, indicated but is not limited to: *Purpose: to obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. *The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. 1. For Patient #2, the facility failed to conduct the Dialysis Nursing Assessment within the first hour of dialysis per the facility policy. Patient #2 was admitted to the facility in 3/2023 with a diagnosis of End Stage Renal Disease requiring hemodialysis. Review of 9 dialysis treatment sheets, dated 9/23/23-11/1/23, indicated that for 3 of 9 treatments the nursing assessment was not completed within the first hour including the following: *On 9/26/23, the patient’s dialysis treatment began at 6:30 A.M., the nursing assessment was not completed until 1:38 P.M., exceeding the one hour requirement. *On 9/28/23, the patient’s dialysis treatment began at 6:28 A.M., the nursing assessment was not completed until 7:58 A.M., exceeding the one hour requirement. *On 10/7/23, the patient’s dialysis treatment began at 6:28 A.M., the nursing assessment was not completed until 11:26 A.M., exceeding the one hour requirement. During an interview on 11/8/23 at 10:35 A.M., Cooperate Nurse #1 said that pre-assessment nursing assessments should be done within one hour of the start of treatment. 2. For Patient #3, the facility failed to conduct the Dialysis Nursing Assessment within the first hour of dialysis per the facility policy. Patient #3 was admitted to the facility in 7/2023 with a diagnosis of End Stage Renal Disease requiring hemodialysis. Review of 9 dialysis treatment sheets, dated 10/16/23-11/6/23 indicated that for 4 of 9 treatments the nursing assessment was not completed within the first hour including the following: *On 10/16/23 the patient’s dialysis treatment began at 6:17 A.M., the nursing assessment was not completed until 8:41 A.M., exceeding the one hour requirement. *On 10/20/23 the patient’s dialysis treatment began at 6:21 A.M., the nursing assessment was not completed until 8:57 A.M., exceeding the one hour requirement. *On 10/23/23 the patient’s dialysis treatment began at 6:19 A.M., the nursing assessment was not completed until 7:59 A.M., exceeding the one hour requirement. During an interview on 11/8/23 at 10:35 A.M., Cooperate Nurse #1 said that pre-assessment nursing assessments should be done within one hour of the start of treatment. 31240 3. For Patient #7, the facility failed to conduct the Dialysis Nursing Assessment within the first hour of dialysis initiation per the facility policy. Patient #7 was admitted to the facility in August 2016 with a diagnosis of end stage renal disease requiring hemodialysis. Review of 19 treatment sheets, dated 9/25/23 through 11/6/23, indicated that for 8 of 19 treatments the nursing assessment was not completed with the first hour including the following: *On 10/4/23, the patient’s dialysis treatment began at 5:57 A.M., the nursing assessment was not completed until 7:18 A.M., exceeding the one hour requirement. *On 10/9/23, the patient’s dialysis treatment began at 6:01 A.M., the nursing assessment was not completed until 7:51 A.M., exceeding the one hour requirement. *On 10/11/23, the patient’s dialysis treatment began at 6:03 A.M., the nursing assessment was not completed until 8:26 A.M., exceeding the one hour requirement. *On 10/13/23, the patient’s dialysis treatment began at 6:02 A.M., the nursing assessment was not completed until 8:00 A.M., exceeding the one hour requirement. *On 10/20/23, the patient’s dialysis treatment began at 6:12 A.M., the nursing assessment was not completed until 11:46 A.M., exceeding the one hour requirement. *On 10/27/23, the patient’s dialysis treatment began at 6:10 A.M., the nursing assessment was not completed until 7:14 A.M., exceeding the one hour requirement. *On 11/1/23, the patient’s dialysis treatment began at 6:10 A.M., the nursing assessment was not completed until 7:28 A.M., exceeding the one hour requirement. *On 11/3/23, the patient’s dialysis treatment began at 6:08 A.M., the nursing assessment was not completed until 7:26 A.M., exceeding the one hour requirement. During an interview on 11/10/23 at 10:00 A.M., Corporate Nurse #1 said the above nursing assessments were not completed timely, as required, and should have been completed within the first hour of the dialysis treatment as indicated per the policy.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 38141 Based on observation, record review, and interviews, the facility failed to develop a communication plan of care for Patient #8, who resided in a Long-Term Care Facility (LTC), to ensure the LTC facility staff removed a pressure dressing for an arteriovenous Fistula (AVF) access sites after returning from dialysis treatment and prevent it from recurring. Findings include: Patient #8 was admitted to the facility in 1/2022 with a diagnosis of End Stage Renal Disease. Review of the facility policy titled “Interdisciplinary Team Patient Assessment and Plan of Care”, with revision date of July 2023, indicated the following: *The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in patient’s condition, and will include measurable and expected outcomes and estimated timetables to achieve this outcome. On 11/7/23 at 11:30 A.M., prior to the initiation of Patient #8’s AVF access at station #7, the surveyor observed Patient #8’s right arm AVF access with a pressure dressing. Patient Care Technician (PCT) #1 asked Patient #8 if it is the same pressure dressing that was applied to his/her right arm AVF access 3 days ago on 11/4/23 after his/her dialysis treatment. Patient #8 acknowledged that the pressure dressing on his/her right arm AVF access was the same pressure dressing from his/her previous dialysis treatment on 11/4/23. Review of Patient #8’s dialysis treatment sheets and progress notes, dated 11/7/23, failed to indicate that PCT #1 notified the Registered Nurse (RN) that Patient #8 came in for treatment with the same pressure dressing on his/her right arm AVF access from previous dialysis treatment. During an interview on 11/8/23 at 11:40 A.M., RN #6 said that he was not aware that Patient #8 came in yesterday with the same pressure dressing on his/her right arm AVF access from his/her previous dialysis treatment. RN #6 said that PCT #1 did not notify him. He said that Patient #8 had a history of coming in for dialysis treatment with the same pressure dressing on his/her right AVF access. He said the LTC facility staff should remove the pressure dressing to assess the right arm AVF access. RN #6 said a prolonged pressure dressing to an AVF access could cause constrictions. RN #6 said that he did not write any comment in Patient #8’s communication book to the LTC facility staff to ensure the removal of the pressure dressing on his/her right arm AVF access after returning from dialysis treatment because he was not aware of it. During an interview on 11/8/23 at 11:55 P.M., PCT #1 said that he should have notified RN #6 that Patient #8 came in yesterday with the same pressure dressing on his/her right AVF access from previous dialysis treatment. Review of Patient #8’s care plan and record indicated the facility had not developed a plan to ensure a communication process was in place between the facility and the LTC facility staff to ensure that Patient #8’s pressure dressing to his/her right AVF access would be removed after returning from the dialysis treatment. During an interview on 11/8/23 at 2:15 P.M., Corporate Nurse #1 said that the facility’s policy for pressure dressings on a AVF access is that a pressure dressing should be removed 4 hours after the treatment. She said that there should be a care plan for communication to the LTC, and that this should had been discussed during the interdisciplinary meeting, and that someone from the facility should have contacted the LTC facility staff to ensure that Patient #8’s pressure dressing on his/her right AVF access would be removed by LTC staff after returning from the dialysis treatment.”

“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: 37349 Based on observation, staff interview, and policy review, the facility failed to ensure that appropriate care and services were provided by a staff member (Patient Care Technician [PCT] #1), to protect a patient’s access from injury for 1 of 2 applicable patients (#8), in a total sample of 10 patients, during the assessment and needle placement of an arteriovenous fistula (AVF) for dialysis treatment. Findings include: For Patient #8, the facility failed to use a tourniquet when accessing Patient #8’s AVF site. Review of the facility policy and procedure titled, Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care, revised October 2023, included the following: *Purpose: To reduce the risk of infection in the patient to reduce trauma to the fistula or graft while minimizing blood loss and to maximize the lifetime of each access. 10. Fistula requires a tourniquet for cannulation (some patients may prefer to manually simulate a “tourniquet” with their non-accessed hand). Review of the facility’s policy/procedure titled, AV Fistula or Graft Cannulation with NIPRO or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose, revised October 2022, included the following: 15. Apply a new tourniquet for cannulating AV fistula or graft. Apply to the extremity above the fistula or graft firmly enough to impede but not occlude venous flow. Remove the tourniquet post cannulation. A tourniquet should be used to distend the fistula even when vessel does not appear to require it. A tourniquet may also be used to distend and stabilize an easily compressible graft. Patient #8 was admitted to the facility in 1/2022, with a diagnosis of end stage renal disease, requiring hemodialysis. He/she received treatment through an AVF. On 11/7/23 at 11:30 A.M., during treatment room observation, the surveyor observed PCT #1 preparing Patient #8 for his/her dialysis treatment. PCT #1 performed hand hygiene and donned gloves. She disinfected the lower needle site, then disinfected the upper needle site. She then cannulated the lower needle site without using a tourniquet and then proceeded to cannulate the upper needle site without using a tourniquet, per the facility policy. During an interview on 11/7/23 at 11:40 A.M., PCT #1 said she felt comfortable cannulating without the tourniquet so she didn’t use it. During an interview on 11/9/23 at 9:30 A.M., Corporate Nurse #1 said a tourniquet should be used when cannulating a fistula.”

“H-TRAIN CONTENT INCLUDES ER PREP HOME PTS CFR(s): 494.100(a)(3) The training must- (3) Be conducted for each home dialysis patient and address the specific needs of the patient, in the following areas: (i) The nature and management of ESRD. (ii) The full range of techniques associated with the treatment modality selected, including effective use of dialysis supplies and equipment in achieving and delivering the physician’s prescription of Kt/V or URR, and effective administration of erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a target level hemoglobin or hematocrit as written in patient’s plan of care. (iii) How to detect, report, and manage potential dialysis complications, including water treatment problems. (iv) Availability of support resources and how to access and use resources. (v) How to self-monitor health status and record and report health status information. (vi) How to handle medical and non-medical emergencies. (vii) Infection control precautions. (viii) Proper waste storage and disposal procedures. This Standard is not met as evidenced by: 37349 Based on record review, interview, and policy review, the facility failed to ensure that 1 of 2 home hemodialysis patients (#5) received instructions on how to document the administration of heparin (a blood thinning medication to prevent blood clots) on their treatment Flowsheet, out of a total sample of 10 patients. Findings include: Review of the facility policy, Arteriovenous(AV) Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose, revised October 2022, included the following: 28. Attach heparin loading dose to venous fistula needle, as applicable. Unclamp and gently flush heparin back and forth 3-5 times into fistula or graft. 29. Do not initiate dialysis for a minimum of three to five minutes after administering heparin loading dose. Patient #5 was re-admitted to the facility in 9/2023 with a diagnosis of end stage renal disease. Review of the clinical record included a Home Hemodialysis Prescription for 180 minutes 3 times per week NxStage Car 172-C AV Fistula and a prescription for heparin 4000 units loading dose, dated 9/18/23. Review of the last 2 months of treatment sheets indicated that for 17 of 17 treatments (9/19/23, 9/23/23, 9/25/23, 9/27/23, 9/28/23, 10/1/23, 10/4/23, 10/6/23, 10/9/23, 10/11/23, 10/14/23, 10/19/23, 10/21/23, 10/25/23, 10/28/23, 11/1/23, and 11/7/23) indicated a heparin dose of 4000 and a heparin route of access. The flowsheets failed to indicate the time the dose was administered compared to the time the treatment was initiated to determine if Patient #5 followed the policy of waiting 3-5 minutes before starting treatment. During an interview on 11/9/23 at 10:45 A.M., the Home Program Nurse said there is no easy place for the patient to document the administration of heparin on the electronic Flowsheet. She said she observes Patient #5 administer heparin correctly when he/she comes to the center, so feels that it is just a matter of figuring out where to document the information on the Flowsheet.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 44223 Based on interview, policy review, Quality Assessment and Performance Improvement (QAPI) monthly reports, and review of the patient Grievance Reports, the facility failed to 1.) ensure the facility grievance process was followed and QAPI Committee developed a plan to resolve patient grievances, and 2.) failed to implement an opportunity for improvement for the patient’s grievance process. Findings Include: Review of the facility policy titled, Patient Grievance, revised 10/2021, included but is not limited to: * Purpose: To provide guidance on the patient grievance process. * The DaVita teammate should report the grievance to the charge nurse. If a solution to the grievance is not reached through this discussion, the charge nurse is to notify the Facility Administrator (FA) and the Regional Operations Director (ROD) within one business day for follow-up. * The FA (or designee) is to discuss the grievance with the patient, investigate, and take appropriate action towards a solution, if possible. This discussion should occur within 10 days of receipt of grievance. Review of the facility policy titled, Addressing Patient Grievances: DaVita Teammates, revised 10/2021, indicated but is not limited to: * Purpose: To provide guidance to DaVita teammates for receiving and addressing Patient Grievances. * All details of patient grievances and discussions will be documented. This documentation will be maintained in a separate file and kept in a secure and locked locations. * If the grievance is not resolved, the patient should be invited to a grievance conference. The grievance conference should be coordinated to occur within 10 days of receipt of the complaint. Review of the monthly Patient Grievance Logs between May 2023 and September 2023 indicated 7 out of 8 grievances by patients with no documented evidence that grievances had been investigated and resolved. Review of the monthly QAPI minutes indicated that Social Worker (SW) #1 reported grievance to the QAPI meeting. Further review failed to identify that grievances were reviewed for resolutions or that resolutions were brought forward in the QAPI meeting. During an interview on 11/8/23 at 12:20 P.M. SW#1 said that grievances are reviewed at the QAPI meeting monthly but that since they have had multiple Facility Administrators (FA) over the past year it has been difficult to have a good process because each FA wants the process done differently. She said a new form has been put in place over the past couple of months and it seems to be working. During an interview on 11/9/23 at 12:10 P.M., the FA and the Cooperate Nurse said that the SW brings grievances to the QAPI meeting. They said that sometimes the SW takes on to much responsibility of the grievance process and should include more of the interdisciplinary team. They said they do need to make sure that all grievances have a resolution.”

“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: 31240 Based on record review, interview, and policy review, the Medical Director failed to ensure 1.) the staff waited 3-5 minutes after the administration of a heparin (blood thinning medication) bolus and/or failed to administer a heparin bolus before the initiation of hemodialysis treatment (removes excess waste products and water from the blood) for 3 of 3 applicable (#3, #2, and #7) patients, out a total sample of 10 patients; and 2.) that staff administered a heparin infusion as ordered by the Physician, for 1 of 3 applicable (#7) patients, out of a total sample of 10 patients. Findings include: Review of the facility policy, Anticoagulant (medication that decreases the blood’s ability to clot) Policy, revised October 2023, indicated the following: *Heparin is administered per the physician’s order. *It is recommended that the heparin hourly infusion be discontinued 60 minutes prior to the end of treatment for patients with arterio-venous fistulas (AVF-surgical connect between an artery and vein) and/or arterio-venous grafts per the physician order. *To anticoagulate the patient, the initial loading dose of heparin is administered through the venous fistula needle or the venous port of the central venous catheter (CVC-thin, flexible tube that is placed into a large vein above the heart) at least three to five minutes prior to the initiation of the hemodialysis treatment. 1 a. For Patient #7 who receives his/her dialysis treatment via an AVF, the Medical Director failed to ensure staff waited to initiate dialysis until 3-5 minutes after a heparin bolus dose was administered, and/or failed to administer a heparin bolus prior to the initiation of dialysis. Patient #7 was admitted to the facility in August 2016 with a diagnosis of End Stage Renal Disease (ESRD), and required hemodialysis treatments three times a week. Review of a Physician’s order, dated 8/21/23, indicated to administer 2600 unit bolus of heparin every dialysis treatment. Review of 19 treatment sheets, between 9/25/23 and 11/10/23, indicated that for 9 of 19 treatments, staff failed to administer the heparin bolus prior to the initiation of dialysis, and for 1 of 19 treatments staff failed to wait to initiate dialysis until 3-5 minutes after a heparin bolus dose was administered, including the following: *Review of a treatment sheet, dated 9/27/23, indicated that the patient’s dialysis treatment began at 5:55 A.M., and a bolus dose of heparin 2600 units was documented as administered at 6:16 A.M. after the treatment began (not 3-5 minutes prior to the start of treatment per policy). *Review of a treatment sheet, dated 10/2/23, indicated that the patient’s dialysis treatment began at 6:12 A.M., and a bolus dose of heparin 2600 units was documented as administered at 6:12 A.M. as the treatment began (not 3-5 minutes prior to the start of treatment per policy). *Review of a treatment sheet, dated 10/4/23, indicated the patient’s dialysis treatment began at 5:57 A.M., and a bolus dose of heparin 2600 units was documented as administered at 6:00 A.M. after the treatment began (not 3-5 minutes prior to the start of treatment per policy). *Review of a treatment sheet, dated 10/6/23, indicated the patient’s dialysis treatment began at 6:10 A.M., and a bolus dose of heparin 2600 units was documented as administered at 7:40 A.M. after the treatment began (not 3-5 minutes prior to the start of treatment per policy). *Review of a treatment sheet, dated 10/9/23, indicated the patient’s dialysis treatment began at 6:01 A.M., and a bolus dose of heparin 2600 units was documented as administered at 6:03 A.M. after the treatment began (not 3-5 minutes prior to the start of treatment per policy). *Review of a treatment sheet, dated 10/16/23, indicated the patient’s dialysis treatment began at 6:20 A.M., and a bolus dose of heparin 2600 units was documented as administered at 6:26 A.M. after the treatment began (not 3-5 minutes prior to the start of treatment per policy). *Review of a treatment sheet, dated 10/20/23, indicated that the patient’s dialysis treatment began at 6:12 A.M., and a bolus dose of heparin 2600 units was documented as administered at 11:44 A.M. after the treatment began (not 3-5 minutes prior to the start of treatment per policy). *Review of a treatment sheet, dated 10/27/23, indicated that the patient’s dialysis treatment began at 6:10 A.M., and a bolus dose of heparin 2600 units was documented as administered at 6:16 A.M. after the treatment began (not 3-5 minutes prior to the start of treatment per policy). *Review of a treatment sheet, dated 10/30/23, indicated that the patient’s dialysis treatment began at 5:55 A.M., and a bolus dose of heparin 2600 units was documented as administered at 6:04 A.M. after the treatment began (not 3-5 minutes prior to the start of treatment per policy). During an interview on 11/10/23 at 10:00 A.M., the Corporate Nurse and Regional Nurse said the heparin bolus should have been administered 3 to 5 minutes prior to the initiation of the dialysis treatments. b. For Patient #7, the Medical Director failed to ensure that staff followed the heparin intravenous (IV) infusion order during dialysis treatments. Review a Physician’s order, dated 8/21/23, indicated; Administer heparin 600 units/hour IV infusion, stop 60 minutes before end of the treatment. Review of 19 treatment sheets, between 9/25/23 and 11/10/23, indicated that for 14 of 19 treatments the order for the heparin IV infusion was not followed as ordered, including the following: *Review of a treatment sheet, dated 9/25/23, indicated that the patient’s dialysis treatment began at 6:16 A.M. and ended at 10:18 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 6:10 A.M. to 10:18 A.M. (not stopped 60 minutes before the end of treatment as ordered). *Review of a treatment sheet, dated 9/29/23, indicated that the patient’s dialysis treatment began at 6:03 A.M. and ended at 10:02 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 10:03 A.M. to 10:06 A.M. (not administered as ordered). *Review of a treatment sheet, dated 10/2/23, indicated that the patient’s dialysis treatment began at 6:12 A.M. and ended at 10:13 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 6:12 A.M. to 10:32 A.M. (not stopped 60 minutes before the end of treatment as ordered). *Review of a treatment sheet, dated 10/4/23, indicated that the patient’s dialysis treatment began at 5:57 A.M. and ended at 9:57 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 7:15 A.M. to 10:05 A.M. (not stopped 60 minutes before the end of treatment as ordered). *Review of a treatment sheet, dated 10/6/23, indicated that the patient’s dialysis treatment began at 6:10 A.M. and ended at 10:21 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 7:40 A.M. to 10:24 A.M. (not stopped 60 minutes before the end of treatment as ordered). *Review of a treatment sheet, dated 10/9/23, indicated that the patient’s dialysis treatment began at 6:01 A.M. and ended at 10:01 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 6:01 A.M. to 10:00 A.M. (not stopped 60 minutes before the end of treatment as ordered). *Review of a treatment sheet, dated 10/11/23, indicated that the patient’s dialysis treatment began at 6:03 A.M. and ended at 10:05 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 8:23 A.M. to 10:18 A.M. (not administered as ordered). *Review of a treatment sheet, dated 10/13/23, indicated that the patient’s dialysis treatment began at 6:02 A.M. and ended at 9:56 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 9:58 A.M. to 9:59 A.M. (not administered as ordered). *Review of a treatment sheet, dated 10/16/23, indicated that the patient’s dialysis treatment began at 6:20 A.M. and ended at 10:25 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 6:25 A.M. to 10:25 A.M. (not stopped 60 minutes before the end treatment as ordered). *Review of a treatment sheet, dated 10/18/23, indicated that the patient’s dialysis treatment began at 6:08 A.M. and ended at 10:15 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 6:08 A.M. to 10:26 A.M. (not stopped 60 minutes before the end of treatment as ordered). *Review of a treatment sheet, dated 10/20/23, indicated that the patient’s dialysis treatment began at 6:12 A.M. and ended at 10:02 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 6:00 A.M. to 11:45 A.M. (not stopped 60 minutes before the end of treatment as ordered). *Review of a treatment sheet, dated 10/27/23, indicated that the patient’s dialysis treatment began at 6:10 A.M. and ended at 10:18 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 6:09 A.M. to 10:38 A.M. (not stopped 60 minutes before the end of treatment as ordered). *Review of a treatment sheet, dated 10/30/23, indicated that the patient’s dialysis treatment began at 5:55 A.M. and ended at 9:57 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 6:05 A.M. to 9:59 A.M. (not stopped 60 minutes before the end of treatment as ordered). *Review of a treatment sheet, dated 11/3/23, indicated that the patient’s dialysis treatment began at 6:08 A.M. and ended at 10:03 A.M., and the 600 units/hour IV heparin infusion was documented as administered from 6:04 A.M. to 10:08 A.M. (not stopped 60 minutes before the end of treatment as ordered). During an interview on 11/10/23 at 2:20 P.M., the Corporate Nurse said the facility staff failed to follow the physician order, and failed to follow the policy for IV infusion of heparin. 44223 2.) For Patient #2, the Medical Director failed to ensure that staff adhered to the heparin administration policy and administered the heparin within the appropriate time frame of 3-5 minutes prior to initiation of dialysis treatment. Patient #2 was admitted to the facility in 7/2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated Patient #2 had a physician order to administer heparin bolus 2000 units IV every dialysis treatment. Review of 9 treatment sheets dated 9/23/23-11/1/23, indicated 5 of 9 treatments staff did not wait 3-5 minutes after administration of heparin to begin treatment including the following: *On 9/23/23 treatment started at 6:12 A.M., heparin documented as administered at 6:13 A.M., 1 minute after dialysis treatment was initiated not the 3-5 minutes per the facility policy. *On 9/26/23 treatment started at 6:30 A.M., heparin documented as administered at 6:30 A.M., staff did not wait the 3-5 minutes per the facility policy. *On 9/28/23 treatment started at 6:28 A.M., heparin documented as administered at 6:38 A.M., 10 minutes after dialysis treatment was initiated, not the 3-5 minutes per the facility policy. *On 9/30/23 treatment started at 6:28 A.M., heparin documented as administered at 6:26 A.M., staff did not wait the 3-5 minutes per the facility policy. * On 10/27/23 treatment started at 4:00 P.M., heparin documented as administered at 4:27 P.M., 27 minutes after dialysis treatment was initiated not the 3-5 minutes prior to initiation per the facility policy. During an interview on 11/10/23 at 10:00 AM., Cooperate Nurse #1 and Regional Nurse #1 said the heparin bolus should have been administered 3-5 minutes prior to the initiation of dialysis treatment. 3.) For Patient #3, the Medical Director failed to ensure that staff adhered to the heparin administration policy and administered the heparin within the appropriate time frame of 3-5 minutes prior to initiation of dialysis treatment. Patient #3 was admitted to the facility in 7/2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated Patient #3 had a physician order to administer heparin bolus 2000 units IV every dialysis treatment. Review of 9 treatment sheets, dated 10/16/23-11/6/23, indicated 2 of 9 treatments staff did not wait 3-5 minutes after administration of heparin to begin treatment including the following: *On 10/18/23 treatment started at 6:10 A.M., heparin documented as administered at 6:27 A.M., 17 minutes after dialysis treatment was initiated, not the 3-5 minutes prior to initiation per the facility policy. *On 10/25/23 treatment started at 6:19 A.M., heparin documented as administered at 6:24 A.M., 5 minutes after dialysis treatment was initiated not the 3-5 minutes prior to initiation per the facility policy. During an interview on 11/10/23 at 10:00 AM., Cooperate Nurse #1 and Regional Nurse #1 said the heparin bolus should have been administered 3-5 minutes prior to the initiation of dialysis treatment.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 44223 Based on record review, interview, and policy review, the facility failed to ensure that staff consistently implemented the internal grievance process in response to grievances received from 5/2023 through 9/2023. Findings Include: Review of the facility policy titled, Patient Grievance, revised 10/2021, included but is not limited to: * Purpose: To provide guidance on the patient grievance process. * The DaVita teammate should report the grievance to the charge nurse. If a solution to the grievance is not reached through this discussion, the charge nurse is to notify the Facility Administrator (FA) and the Regional Operations Director (ROD) within one business day for follow-up. * The FA (or designee) is to discuss the grievance with the patient, investigate, and take appropriate action towards a solution, if possible. This discussion should occur within 10 days of receipt of grievance. Review of the facility policy titled, Addressing Patient Grievances: DaVita Teammates, revised 10/2021, indicated but is not limited to: * Purpose: To provide guidance to DaVita teammates for receiving and addressing Patient Grievances. * All details of patient grievances and discussions will be documented. This documentation will be maintained in a separate file and kept in a secure and locked locations. * If the grievance is not resolved, the patient should be invited to a grievance conference. The grievance conference should be coordinated to occur within 10 days of receipt of the complaint. Review of the Patient Grievance Log Forms, dated May 2023 thorough September 2023, included the following: May 2023 * On 5/2/23 two patients complained about a patient smoking to close to the building. The form indicated the grievance was reported to the CN or the FA on 5/2/23. *On 5/2/23 one patient reported they had concerns that there was no follow up from their previous complaint. There was no specific information documented regarding the details of the grievances, the staff members involved, the actions taken by the facility to investigate the grievances, and any corrective action taken by the facility. There was no documentation to indicate the facility responded to the grievances filed by the patient in accordance with the facility’s grievance policy. June 2023 * On 6/6/23 one patient complained they had concerns in regards to an interaction with a staff member. * On 6/6/23 one patient complained they had concerns regarding the cleanliness of the facility. * On 6/6/23 one patient complained they had concerns over not being in his/her correct chair. * On 6/20/23 one patient complained it was too cold in the facility. There was no specific information documented regarding the details of any of these grievances, the staff members involved, the actions taken by the facility to investigate the grievances, and any corrective action taken by the facility. There was no documentation to indicate the facility responded to the grievances filed by the patient in accordance with the facility’s grievance policy. July 2023 * On 7/2/23 one patient complained about customer service. There was no specific information documented regarding the details of the grievance, the staff members involved, the actions taken by the facility to investigate the grievance, and any corrective action taken by the facility. There was no documentation to indicate the facility responded to the grievance filed by the patient in accordance with the facility’s grievance policy. August 2023 * One documented grievance with investigation and resolution. September 2023 * On 9/7/23 a concern was reported to the facility by Quest Services stating that a patient’s family member had concerns regarding the care of their family member. The form indicated to see attached report. There was not attachment filed with the report. The facility called the family member who stated he/she would give the facility number to the patient. Review of the grievance form indicated there was no call back from the patient. There was no specific information documented regarding the details of the grievance, the staff members involved, the actions taken by the facility to investigate the grievance, and any corrective action taken by the facility. Further review indicated there was no intervention or resolution put in place until 10/31/23, 38 days after the initial complaint was filed, not within 10 days per the facility policy. Further record review indicated that the patient had not been in the facility since 10/27/23. There was no documentation to support the IDT met with her/him at that time. During an interview on 11/8/23 at 12:20 P.M., Social Worker (SW) #1 said the grievance process did not have a good system. She said the facility has had multiple FA’s over the past year and they all wanted the process done differently, which makes it confusing for staff. SW #1 said grievances are supposed to be resolved within two weeks, or 6 treatments from day of grievance. She said she was not aware if there is any documentation for these specific grievances. SW #1 said many times staff discuss the concern and then the grievance is verbally discussed with the patient. SW #1 said it did not look like the grievances have been resolved since there is no documentation available to show resolution.”