Davita White Bluff Dialysis

“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: 30952 Based on observation, facility policy, and interview, it was determined the facility failed to ensure staff followed the facility policy for food and drink on the treatment floor. This had the potential to negatively affect the 37 patients who dialyze at the facility and staff. Findings include: Facility Policy Title: Infection Control for Dialysis Facilities Policy: 1-05-01 Revision Date: April 2023 ...Policy: ...Facility Hygiene ...17. Food and drinks in the treatment area will be limited to patients... 1. During observations on the treatment floor on 8/27/24 at 9:45 AM, the surveyor observed a staff drink cup and peanut bar on the nurse counter across from station four. An interview was conducted on 8/27/24 at 10:45 AM with Employee Identifier # 1, Facility Administrator, who verified the observation and confirmed staff should not have food and drinks in the treatment area.”

“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: 30952 Based on review of the Centers for Medicare and Medicaid Services (CMS) ESRD (End Stage Renal Disease) Core Survey Observations of Hemodialysis Care and Infection Control (IC) Practices, facility policy and procedure, observations, and interviews, it was determined the facility failed to ensure: 1. Patients performed hand hygiene upon entering the treatment area, in one of two arteriovenous fistula/graft (AVF/AVG) dialysis initiations and upon exiting the treatment area, in two of two observations of discontinuation of dialysis with an AVF/AVG, and an unsampled patient. 2. Staff changed gloves and performed hand hygiene after cleaning the access and after evaluating the access in one of two AVF/AVG access for initiation of dialysis. 3. Staff followed the facility policy for hand hygiene including use of alcohol-based hand rub. 4. Staff removed gloves and performed hand hygiene before exiting the private treatment room after contact with potentially contaminated supplies during one of two discontinuations of dialysis with a central venous catheter (CVC). 5. Staff performed hand hygiene before donning clean gloves during one of one initiation of dialysis with a CVC. This did affect Patient Identifier (PI) # 11, an unsampled patient, PI # 12, PI # 2, PI # 9, PI # 1, PI # 10, and had the potential to negatively affect the 37 patients dialyzing at the facility. Findings include: Facility Policy Title: Infection Control for Dialysis Facilities Policy: 1-05-01 Revision Date: April 2023 ...Policy: The...CDC (Centers for Disease) recommendations... will be followed... Hand Hygiene 1. All teammate...perform hand hygiene ...b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient care and dialysis delivery system contact, ...g. before touching clean areas such as supplies...and chairside keyboard/mouse... 2. Patients and caregivers will be encouraged to: a. Wash their hands and access extremity upon entering the treatment area prior to initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area. 7. Disposable gloves will be worn when...touching...equipment at the dialysis station... a. Gloves should be changed when: ...ii.... going from a dirty area or task to a clean area or task... ...PPE (Personal Protective Equipment) ...gloves 5. Appropriate PPE will be worn whenever there is a potential for contact with body fluids... “...7. Disposable gloves will be worn when...touching the patient’s equipment at the dialysis station... End Stage Renal Disease (ESRD) Core Survey Version 1.6 Access of AVF or Graft for Initiation of Dialysis... ...Action ...Wash skin over access with soap and water or antibacterial soap and water... (patient or staff may do this-patients should be instructed to wash their access upon entering facility and staff verbally confirm with patient this was done... Evaluate access: Locate/palpate... Hand Hygiene (remove gloves, if worn); don clean gloves... Facility Procedure Title: AV (Arteriovenous) Fistula or Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose. Procedure Number: 1-04-01E Revision Date: April 2022 ...Materials required: Liquid soap or other skin cleansing agent 70 % alcohol preps ...Skin antiseptic... Notes: ...1. Have patient wash access site with...antibacterial soap...If unable...teammate will clean access...with skin cleansing agent and pat dry. 2. Perform hand hygiene. Put on PPE. ...10. While maintain (ing) aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site... Facility Procedure Title: Use of Alcohol-Based Hand Rubs Procedure: 1-05-01A Revision Date: April 2023 ...Procedure 1. Follow the manufacturer’s recommendations... 2. Apply product in palm of...hand. 3. Rub hands together...all surfaces of hands and fingers until hand rub has evaporated and hands are dry. 1. An observation of Access of AVF/AVG for Initiation of Dialysis for PI # 11 was conducted on 8/27/24 at 9:18 AM with Employee Identifier (EI) # 5, Patient Care Technician, at station five. The surveyor observed PI # 11 enter the treatment room, ambulate to the scales, then station. PI # 11 failed to perform hand hygiene upon entering the treatment area. With gloves on, EI # 5 evaluated the access site using palpation, but failed to perform hand hygiene and don clean gloves after access evaluation. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, Facility Administrator, and EI # 2, Manager of Clinical Services, who confirmed the facility failed to ensure patients and staff followed the facility policy for hand hygiene, and CMS IC Practices. 2. On 8/27/24 at 9:55 AM, an unsampled patient at station six held the access sites with a gloved hand. At 10:10 AM, the patient exited the treatment area without performing hand hygiene. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, and EI # 2, who confirmed staff failed to ensure the patient performed hand hygiene before exiting the treatment area. 3. An observation of Access of AVF/AVG for Initiation of Dialysis for PI # 12 was conducted on 8/27/24 at 10:20 AM with EI # 6, Certified Clinical Hemodialysis Technician at station eight. With gloves on, EI # 6 cleaned the access with soap and water, evaluated the access site using palpation, then cleaned the access site with alcohol and cannulated the access sites. EI # 6 failed to perform hand hygiene and don clean gloves after cleaning the access, and before access antisepsis. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1 and EI # 2, who confirmed staff failed to follow the facility procedure for access of an AVF/AVG for dialysis initiation. 4. On 8/27/24 at 10:35 AM at station eight, EI # 6, ungloved was documenting at the keyboard. EI # 6 retrieved a glove from the clean glove supply, held the glove in his/her left hand and touched the dialysis machine two times with the left hand and glove, and documented at the keyboard with his/her right hand. EI # 6 failed to perform hand hygiene before accessing the clean glove supplies and failed to wear gloves correctly during contact with the dialysis machine. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1 and EI # 2, who confirmed staff failed to follow the facility policy for hand hygiene and glove use. 5. An observation of care was conducted on 8/27/24 at 11:45 AM at station one to discontinue dialysis with an AVF/AVG with EI # 5. The surveyor observed PI # 9 with a gloved hand, holding the access sites. At 12:01 PM, PI # 9 removed the glove, exited the station to the scale, then exited the treatment floor without performing hand hygiene per facility policy. During the procedure EI # 5 removed gloves and sanitized hands for 2-3 seconds, not allowing the sanitizer to dry before accessing the clean glove supply and donning clean gloves. Staff failed to ensure patients performed hand hygiene after holding access sites, glove removal, and prior to leaving the treatment floor and failed to follow the procedure for use of hand rub. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, and EI # 2 who confirmed staff failed to ensure patients performed hand hygiene per facility policy. 6. An observation of care was conducted on 8/27/24 at 11:55 AM at station three to discontinue dialysis with an AVF/AVG with EI # 5. PI # 2, with a gloved hand, held the access sites. At 12:14 PM, EI # 5 removed PI # 2’s glove. PI # 2 exited the station to the scale, then exited the treatment area without performing hand hygiene. During the procedure EI # 5 removed his/her gloves and sanitized hands for 2-4 seconds on multiple occasions, not allowing the sanitizer to dry before accessing the clean glove supply and donning clean gloves. Staff failed to ensure patients performed hand hygiene prior to leaving the treatment floor. Staff failed to follow the procedure for use of hand rub. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1 and EI # 2 who confirmed staff failed to follow the facility hand hygiene policy. 7. An observation was conducted on the treatment floor on 8/27/24 at 12:55 PM in the private treatment room, station ten, with EI # 4, Registered Nurse (RN), to discontinue dialysis with a CVC for PI # 1. Following discontinuation of dialysis, EI # 4, wearing gloves, removed the used dialyzer, bloodlines, and saline solution bag and exited the private treatment room touching the door handle with the glove and holding contaminated supplies. EI # 4 discarded the contaminated supplies into the sharp’s container on the treatment floor. EI # 4 contaminated the private treatment door/handle upon exit and re-entry. EI # 4 failed to remove gloves and perform hand hygiene before re-entry to the private station. EI # 4 assisted PI # 1 to exit the private treatment room in a wheelchair and returned to the treatment room with same gloves on. EI # 4 gathered the used supplies from the tabletop, exited the treatment area with the supplies in hand, touched the private treatment door handle upon exiting. EI # 4 discarded the supplies in the trash on the treatment floor. EI # 4 failed to follow facility policy for hand hygiene and glove use while working with contaminated supplies. An interview was conducted on 8/29/24 at 11:00 AM, with EI # 1, who confirmed staff failed to follow the facility infection control policy and procedure for hand hygiene and glove use after contact with dirty/contaminated supplies. 8. An observation of Initiation of Dialysis with a CVC for PI # 10 was conducted on 8/28/24 at 10:03 AM at station nine. EI # 3, RN, administered heparin, completed the pretreatment patient assessment, sanitized hands, and documented at the chairside keyboard. EI # 3 donned gloves and initiated treatment but failed to perform hand hygiene prior to accessing the clean glove supply. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, who confirmed staff should perform hand hygiene before accessing the clean glove supply and before donning gloves.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 30952 Based on observation, review of facility policy, and interviews, it was determined the facility failed to ensure the staff cleaned and disinfected non disposable equipment before returning it to a common clean area or use on another patient. This had the potential to negatively affect the 37 patients served by this facility. Findings Include: Policy Title: Infection Control for Dialysis Facilities Policy Number: 1-05-01 Revision Date: April 2023 ...Disinfection ...14. Non-disposable items are to be disinfected after each patient use... 1. During observations of care on 8/28/24 at 9:25 AM, the surveyor observed Employee Identifier (EI) # 7, Certified Clinical Hemodialysis Technician, retrieve the electronic thermometer from the clean counter, take the electronic thermometer to station three and check the unsampled patient’s temperature. EI # 7 placed the thermometer on the keyboard cart. EI # 7 failed to disinfect the thermometer and return it to the clean common area. At 10:20 AM, EI # 7 retrieved the dirty thermometer, took the thermometer to station two, checked an unsampled patient’s temperature, and returned the thermometer to the keyboard cart. EI # 7 failed to disinfect the thermometer after use and before using it on another patient. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, Facility Administrator, and EI # 2, Manager of Clinical Services, who confirmed staff failed to disinfect non-disposable equipment after use per policy. 2. Observations of care were conducted on 8/28/24 at 9:38 AM with EI # 3, Registered Nurse, who performed final dialysate conductivity and pH testing with a phoenix meter at station nine. EI # 3 retrieved the meter from the clean sink counter across from station nine. EI # 3 retrieved the meter from the clean sink counter, took the phoenix meter to the station, tested the final dialysate pH and conductivity, and returned the meter to the clean sink counter. EI # 3 failed to disinfect the phoenix meter after use. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1 and EI # 2, who confirmed staff failed to follow the policy and clean non-disposable equipment after use.”

“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: 30952 Based on observations, facility policy, and interview, it was determined the facility failed to ensure staff cleaned and disinfected the dialysis station between patients. This affected two of two observations of dialysis station disinfection and had the potential to negatively affect all 37 patients who dialyze at this facility. Findings include: Facility Policy Title: Infection Control for Dialysis Facilities Policy Number: 1-05-01 Revision Date: April 2023 Purpose: To minimize the spread of infections or blood borne pathogens in the dialysis facility environment. ...Disinfection 12...b. Use an appropriate disinfectant such as 1:100 routine bleach solution for routine disinfection of environmental surfaces... ...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 ...and frequently contacted by healthcare personnel ...front and sides of the dialysis machine...countertops... 15. The chairside cart, terminals mounted on the counter, monitor and keyboards are considered clean areas. a. Wipe-able...covers are to be utilized. b. The chair side cart components will be cleaned at the end of each treatment day... 1. An observation for cleaning and disinfection of the dialysis station was conducted on 8/27/24 at 12:30 PM at station three with Employee Identifier (EI) # 5, Patient Care Technician. EI # 5 failed to clean inside the wire basket on the dialysis machine before placing the clean blood pressure cuff in the basket. EI # 5 failed to disinfect the vinyl beneath the left chair table top and failed to disinfect the television. EI # 5 failed to remove clamp from the intravenous pole and disinfect the clamp. EI # 5 failed to remove the pillow and blue blood pressure cuff from the counter behind the station, and disinfect the pillow, blue blood pressure, and the counter. EI # 5 failed to clean the keyboard on the cart at the end of the treatment day. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, Facility Administrator, and EI # 2, Manager of Clinical Services, who confirmed the staff failed to disinfect the station per facility policy. 2. An observation for cleaning and disinfection of the dialysis station was conducted on 8/27/24 at 12:45 PM at station ten with EI # 4, Registered Nurse. EI # 4 failed to clean inside the wire basket before placing the clean blood pressure cuff in the basket. EI # 4 failed to disinfect the vinyl beneath the right chairside table top and failed to disinfect the counter and the wall box. EI # 4 failed to clean the keyboard on the cart at the end of the treatment day. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1 and EI # 2, who confirmed staff failed to disinfect the dialysis station per facility policy.”

“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: 30952 Based on observations, review of facility policy and procedure, Potter - Perry Fundamentals of Nursing, and interviews, it was determined the facility staff failed to ensure all intravenous (IV) medications were secure and stored according to facility policy. This affected Patient Identifier (PI) # 13, in one of two IV medication preparation and administration observations, and had the potential to negatively affect all 37 patients served by this facility. Findings include: Facility Policy: Medication Policy Policy Number: 1-06-01 Revision Date: October 2023 Policy: ...11...non-refrigerated medications are to be stored in cabinet(s)... Facility Procedure Title: Preparation and Administration of Parental Medications (NON-ESA, NON-PARSABIV) Procedure: 1-06-01A Revision Date: April 2023 ...Procedure ...17. Distribute the medication to the patient station in an aseptic manner...place patient’s syringe(s) in a recloseable plastic bag if medication is not administered immediately... Potter - Perry Fundamentals of Nursing 6th edition copyright date 2001 Chapter 34 Unit VI Medication Administration page 907 Bullets 11 and 12 The six rights of medication administration are the right medication, right dose, right client, right route, right time, and right documentation. Nurses administer only medications they prepare, and prepared medications are never left unattended... 1. An observation was conducted on 8/28/24 at 9:12 AM with EI (Employee Identifier) # 3, RN (Registered Nurse) during IV Heparin preparation and administration for PI # 13. EI # 3 prepared one syringe with 2000 units heparin and one syringe with 2400 units heparin. At 9:22 AM, EI # 3 exited the medication counter with the two syringes in hand to station six where EI # 3 observed PI # 13 had not yet been cannulated. EI # 3 placed the two heparin syringes on the treatment chair table and exited the station. The two heparin syringes were left at the dialysis station until 9:37 AM when EI # 3 returned and administered the Heparin. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, Facility Administrator, and EI # 2, Manager of Clinical Services, and who confirmed staff failed to ensure the IV medications were secure after preparation and stored in a clean environment until administration.”

“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: 30952 Based on observations, facility procedure, medical record (MR) review, and interview, it was determined the facility failed to ensure staff: 1. Disinfected the central venous catheter (CVC) hubs with alcohol for at least 15 seconds after disconnecting the blood lines. 2. Wore the surgical mask above the level of the nose during discontinuation of dialysis with a CVC. 3. Documented the CVC exit site care performed and dialysis treatment initiation with a CVC. This affected Patient Identifier (PI) # 1, in one of two discontinuations of dialysis with a CVC, and one unsampled patient, and one of one MRs with a CVC. This had the potential to affect all patients with a CVC who dialyze at the facility. Findings include: Facility Procedure: Central Venous Catheter (CVC) with Clearguard HD (Hemodialysis) Antimicrobial End Caps Procedure Procedure: 1-04-02B Revised Date: October 2023 ...Materials required: ...1 Germicidal/antiseptic solution or swab ...2 Face masks... Notes: ...first choice for CVC care is 2% Chlorhexidine/70% Alcohol swab...if...contraindicated...physician will prescribe an agent... Use Dialysis Precautions...throughout the procedure. ...Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines... Device Disinfectant and Skin Antiseptic ...70 % Alcohol Pad-Effective for: CVC Hubs; Effective Volume- 1 large pad per hub, Effective Contact Time -15 second’s scrub... Procedure 1...Teammate...wear masks covering the nose and mouth during this procedure... ...23. Attach heparin loading dose...flush... 24. After...3-4 minutes...attach each bloodline... 25. Secure connections and initiate treatment... Upon Completion of Dialysis ...37. Document findings and procedure in electronic health record. 1. An observation was conducted on 8/27/24 at 12:55 PM in the private treatment room, station ten, with Employee Identifier (EI) # 4, Registered Nurse (RN), to observe discontinuation of dialysis with a CVC on PI # 1. After the treatment was discontinued, the extracorporeal circuit was reinfused, and the bloodlines were disconnected, EI # 4 wiped the arterial and venous hubs with alcohol for three wipes before flushing with saline and heparin. EI # 4 failed to perform a 15 second hub scrub with an alcohol pad. An interview was conducted on 8/29/24 at 11:00 AM, with EI # 1, Facility Administrator, who confirmed staff failed to follow the facility procedure treatment termination with a CVC. 2. During observations of care on 8/28/24 at 9:05 AM, the surveyor observed EI # 3, RN, in the private treatment room during discontinuation of dialysis with a CVC with an unsampled patient. EI # 3’s surgical mask was below the nose. An interview was conducted on 8/28/24 at 9:07 AM with EI # 1, Facility Administrator, who verified the observation and confirmed EI # 3 failed to wear the mask above the nose during care of the CVC per facility procedure. 3. PI # 1 was admitted to the facility on 2/10/24 with a diagnosis of End Stage Renal Disease. Review of the Treatment Details Reports (TDR) dated 8/10/24 and 8/15/24 revealed no documentation of the CVC technique and antiseptic solution the nurse used during CVC exit site care. Further review of the 8/10/24 and 8/15/24 TDR revealed no documentation the nurse initiated the dialysis treatment with the CVC. An interview was conducted on 8/28/24 at 10:10 AM with EI # 1, Facility Administrator, who confirmed staff failed to provide and document CVC care per facility procedure.”

“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: 30952 Based on one of one observation for Total Chlorine testing, review of facility procedure, and interviews, it was determined the facility failed to ensure staff followed the procedure for total chlorine testing using the Serim Hisense Ultra 0.1 Test Strip. This had the potential to affect all 37 patients who dialyze at the facility. Findings include: Facility Procedure Title: Serim Hisense Ultra 0.1 Test for Total Chlorine in Feed or Rinse Water Procedure: 1-18-04 Revision Date: October 2021 ...Procedure: 1. Using the sample cup provided fill the sample cup with 20 ml (milliliter) water to be tested. Discard contents and refill before testing. 2. Immerse the indicator pad in the sample solution and swish test strip back and forth vigorously for 30 seconds. ...4. Remove test strip from the test water and shake to remove excess sample. Immediately compare reacted test strip to the color chart on Serim Hisense Ultra 0.1 test bottle... 1. An observation of Total Chlorine testing was conducted on 8/29/24 at 8:52 AM with Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician. From the primary carbon water sample port, EI # 6 filled the sample cup with the dialysis quality water sample and tested the initial water sample. EI # 6 failed to discard the contents of the sample cup and refill the cup before immersing the test strip in the sample solution. EI # 6 swished the test strip back and forth for 60 seconds, and not 30 seconds. EI # 6 removed the test strip from the solution but failed to shake off excess sample before comparing the strip indicator pad to the bottle. After the procedure was complete, the surveyor reviewed the directions on the Serim Hisense Ultra 0.1 Test bottle with EI # 6. EI # 6 confirmed he/she failed to follow the manufacturer’s directions for use. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, Facility Administrator, who verified the staff failed to perform the Total Chlorine test per the facility procedure.”

“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: 30952 Based on observation, review of the facility policy and procedure and interviews, it was determined the facility failed to ensure staff tested the manual conductivity and pH (potential of hydrogen) testing prior to the initiation of dialysis. This affected Patient Identifier (PI) # 10, in one of three observations for hemodialysis preparation and had the potential to negatively affect all 37 patients who dialyze at this facility. Findings include: Facility Policy Title: Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate Policy: 1-03-02 Revision Date: April 2020 ...Notes: Manual pH testing must be performed prior to each patient treatment...independent conductivity testing is determined by manufacturer’s guidelines... Facility Procedure Title: Measuring Conductivity, Temperature and/or pH Using the Phoenix Conductivity Meter. Procedure: 1-21-06 Revision Date: April 2022 Materials required: Phoenix meter Dialysis delivery system in conductivity and without conductivity alarms Dialysis quality water... Procedure ...2. Insert...Phoenix meter into the sampled port on the dialysis machine. 3. Pull the syringe plunger and draw solution...observe the readings on the meter display. ...7. If result is not within acceptable range, perform...level 1 calibration and retest. If results ...outside acceptable range, do not use delivery system for patient treatment...notify Biomed... 8. When you are finished with the Phoenix meter, RINSE interior thoroughly with dialysis quality water. Disinfect...meter with...bleach solution before taking to a common area or used in another station. 9. Document acceptable final dialysate results... During the facility flash tour conducted on 8/27/24 at 9:12 AM, the surveyor located two phoenix meters at the clean sink across from station nine. An observation of care was conducted on 8/27/24 at 10:02 AM at station eight with Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician. EI # 6 set up the dialysis machine at 10:02 AM for PI # 10. All machine alarm tests had been completed and passed and EI # 6 initiated treatment. EI # 6 failed to test independent conductivity or pH of the dialysate prior to beginning the dialysis treatment. An interview was conducted on 8/27/24 at 10:38 AM with EI # 6 who confirmed he/she did not check the dialysate conductivity and pH, but “went off what the other staff had said”. The surveyor conducted interviews with all direct care staff working on the treatment floor on 8/27/24. At 10:39 AM, EI # 4, Registered Nurse, and at 11:00 AM, EI # 5, Patient Care Technician, reported they had not tested the final dialysate conductivity and pH at station eight. EI # 6 failed to ensure the manual conductivity and pH was within acceptable range prior to treatment initiation. An interview was conducted on 8/28/24 at 10:33 AM with EI # 8, Biomedical Service Specialist, who confirmed staff must perform conductivity and pH testing on the final dialysate prior to treatment initiation.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30952 Based on observations, review of the manufacturer’s directions for use (DFU), Occupational Safety and Health Administration (OSHA): Compressed Gas Safety General Safety Guidelines, facility policies and procedure, Fresenius Medical Care 2008K2 Preventive Maintenance guidelines, and interviews, it was determined the facility failed to ensure: 1. Staff followed the Nipro bloodline manufacturer’s DFU during dialysis treatments and maintained the arterial drip chamber (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at the required fill level. 2. Supplies available for patient use were not expired. 3. Oxygen (O2) cylinders were secured and stored per OSHA guidelines. 4. Rinsed the phoenix meter with dialysis quality water after use. 5. All Hemodialysis (HD) machines received preventative maintenance (PM) per facility policy and the Manufacturer’s Recommendations for the dialysis machines. This had the potential to negatively affect all 37 patients who dialyze at this facility. Findings include: NIPRO Instructions for use...Nipro Set Blood Tubing Set ...General Warnings and Precautions ...10. Maintain drip chamber at 3/4 (75 %) full to help prevent drip chamber evacuation, causing possible air embolus... Dialysis Treatment Precautions: ...3... During dialysis treatment: ...b. Periodically check fluid level in drip chamber and adjust if required. ExSept Plus Skin Cleansing Agent Manufacturer: Angelini Pharma Description ...30 months shelf life, 180 days once opened OSHA: Compressed Gas Safety General Safety Guidelines 2. Cylinder Storage Gas cylinders must be secured at all times to prevent tipping. Use appropriate material, such as chain, plastic coated wire cable, commercial straps ... to secure cylinders. ... Cylinders must be stored where they are protected from the ground to prevent rusting... Facility Procedure Title: Measuring Conductivity, Temperature and/or pH Using the Phoenix Conductivity Meter. Procedure: 1-21-06 Revision Date: April 2022 Materials required: Phoenix meter Dialysis delivery system in conductivity and without conductivity alarms Dialysis quality water... Procedure ...2. Insert...Phoenix meter into the sampled port on the dialysis machine. 3. Pull the syringe plunger and draw solution...observe the readings on the meter display. ...7. If result is not within acceptable range, perform...level 1 calibration and retest. If results ...outside acceptable range, do not use delivery system for patient treatment...notify Biomed... 8. When you are finished with the Phoenix meter, RINSE interior thoroughly with dialysis quality water... Facility Policy Title: Preventive Maintenance Schedules for Equipment Policy: 2-01-09 Revision Date: October 2023 ...Policy: 1. Preventive maintenance schedules must be made in accordance with the manufacturer’s recommendation for all equipment used to perform a patient treatment... Fresenius Medical Care 2008K2 Preventive Maintenance Procedures Page 1. 1.0 Introduction Preventive Maintenance for Fresenius 2008K2 Hemodialysis System is simple and straightforward. Maintenance is performed in only two intervals: six (6) months, and annually or after 4000 hours of operation. The Maintenance procedures have been devised to require minimum of time while ensuring that the machine is maintained in optimum operating condition... 1. During observations of care on 8/27/24 and 8/28/24 the following was observed: On 8/27/24 at station three at 9:16 AM, the arterial drip chamber fluid level was less than 30 % full, at 9:36 AM less than 25 % full, at 10:00 AM and 10:15 AM less than 20 % full, and at 11:00 AM less than 50 % full. At station one at 11:25 AM, the arterial drip chamber fluid level was less than 60 % full. On 8/28/24 at 9:26 AM at station four, the arterial drip chamber fluid level was less than 25 % full, and at 9:26 AM the arterial drip chamber fluid level was less than 10 % full. An interview was conducted on 8/28/24 at 9:28 AM with Employee Identifier (EI) # 3, Registered Nurse, who confirmed the arterial drip chamber fluid level was not at the required fill line at station four. An interview was conducted on 8/29/24 at 11:00 AM, with EI # 1, Facility Administrator, and EI # 2, Clinical Service Manager, who confirmed the arterial fluid levels were not maintained at an acceptable level according to the Nipro Set Blood Tubing DFU. 2. On 8/27/24 at 9:35 AM on the clean counter in the treatment area, was one open bottle of ExSept, skin cleansing agent, with an opened date 2/24/24, which is greater than 180 days. The staff failed to follow the DFU and discard the ExSept after 180 days. 3. Observations on the treatment area on 8/28/24 at 9:57 AM revealed three oxygen cylinders, one of the three was secured in a wheeled cart, and two cylinders were upright, free-standing next to the emergency cart on the floor. The two O2 cylinders were not secured to prevent from tipping and were not secured per OSHA guidelines. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1 who confirmed two O2 cylinders were not secured. 4. Observations of care on 8/28/24 at 9:57 AM revealed ten syringes, ten cubic centimeters, expired 7/31/24, in a plastic bag found inside the emergency cart. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, and EI # 2, who confirmed the expired supplies were available for use. 5. Observations of care were conducted on 8/28/24 at 9:24 AM with EI # 7, Certified Clinical Hemodialysis Technician, to test final dialysate conductivity and pH with a phoenix meter at station two. EI # 7 retrieved the meter from the clean sink counter across from station three. EI # 7 took the phoenix meter to station two, tested the pH and conductivity, returned the meter to the clean sink counter, and disinfected the meter with a bleach cloth. EI # 7 disinfected the meter, but failed to rinse the phoenix meter with dialysis quality water after use. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1 and EI # 2 who confirmed staff failed to follow the instructions for use and rinse the phoenix meter after use. 6. Observations of care were conducted on 8/28/24 at 9:38 AM with EI # 3, during testing of final dialysate conductivity and pH with a phoenix meter at station nine. EI # 3 retrieved the meter from the clean sink counter adjacent to the Tri-Station across from station nine. EI # 3 took the phoenix meter to station nine, tested the final dialysate pH and conductivity, and returned the meter to the clean sink counter. EI # 3 failed to rinse the phoenix meter after use. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1 and EI # 2 who confirmed staff failed to follow the instructions for use and rinse the phoenix meter after use. 7. Review of the electronic PM documentation for HD machine number nine, one of five PM document reviews, revealed an annual/4000-hour PM was completed 6/9/23. The next PM documentation for machine number nine was dated 4/30/24, an annual/4000-hour PM. This was ten months later and not at least every six months per the manufacturer’s instructions for PM. An interview was conducted on 8/28/24 at 1:00 PM with EI # 8, Biomed Service Specialist, who confirmed the PM on 4/30/24 was greater than every six months.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 30952 Based on review of medical records (MR), facility policy, and interviews, it was determined the facility failed to ensure staff documented prime and post rinse amounts admininistered during dialysis treatments. This affected four of five MRs reviewed including Patient Identifier (PI) 4, PI # 3, PI # 2, PI # 5 and had the potential to affect the 37 patients who dialyze at the facility. Findings include: Facility Policy: Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment Policy Number: 1-03-08 Date Revised: April 2024 Purpose: To obtain and document baseline and ongoing information... Policy: ...Intradialytic Data Collection/ Assessment ...9. Intradialytic treatment monitoring and data collection which may be performed by the PCT (Patient Care Technician), or licensed nurse includes: ...b. At a minimum, obtain and document the following: ...iv. Fluid removal and/or replacement... 1. PI # 4 was admitted to the facility on 6/28/22 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Detail Reports (TDR) dated 8/13/24, 8/17/24, 8/20/24, 8/24/24 revealed no documentation of the amount of prime and/or post rinse administered. An interview was conducted on 8/28/24 at 10:38 AM with Employee Identifier (EI) # 1, Facility Administered who confirmed staff failed to document the amount of fluid replacement administered. 2. PI # 3 was admitted to the facility on 9/18/15 with a diagnosis of ESRD. Review of the TDR dated 7/24/24, 7/26/24, and 8/2/24 revealed no documentation of the amount of post rinse administered. An interview was conducted on 8/28/24 at 10:54 AM with EI # 1, who confirmed staff failed to document the amount of fluid replacement administered during post treatment rinse. 3. PI # 2 was admitted to the facility on 6/20/23 with a diagnosis of ESRD. Review of the TDR’s dated 8/17/2, 8/20/24, and 8/24/24 revealed no documentation of the amount of prime and/or post rinse administered. An interview was conducted on 8/28/24 at 10:49 AM with EI # 1 who confirmed staff failed to document the amount of fluid replacement administered during prime and post treatment rinse. 4. PI # 5 was admitted to the facility on 6/17/19 with a diagnosis of ESRD. Review of the TDR dated 8/19/24 revealed no documentation of the amount of post rinse administered. An interview was conducted on 8/28/24 at 10:31 AM with EI # 1, who confirmed staff failed to document the amount of post treatment fluid replacement administered on 8/19/24.”

“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: 30952 Based on medical record (MR) reviews, facility policy, and interviews, it was determined the facility failed to ensure staff followed physician orders for Blood Flow Rate (BFR). This affected four of five MR’s reviewed including Patient Identifier (PI) # 1, PI # 2, PI # 5, PI # 4 and had the potential to affect the 37 patients who dialyze at the facility. Findings include: Facility Policy: Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment Policy Number: 1-03-08 Revision Date: April 2024 ...Purpose: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment... Policy: ...3. Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment with the exception of BFR which is verified and documented when the ordered rate is obtained after onset of treatment... Intradialytic Data Collection/Assessment: ...9. ...b. At a minimum, obtain and document the following: ...iii. Blood and dialysate flows... ...10. If the dialysis prescription is not being met (including....inability to obtain prescribed BFR) the reason will be documented... 1. PI # 1 was admitted to the facility on 6/20/23 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Detail Reports (TDR) dated 8/15/24, 8/17/24, and 8/24/24 revealed the ordered BFR was 350 and the BFR was not administered or maintained at 350. There was no documentation why the BFR was not administered at the physician ordered rate. An interview was conducted on 8/28/24 at 10:10 AM with EI # 1, Facility Administrator, who confirmed staff failed to follow the physician orders for BFR administration in three of six treatments. 2. PI # 2 was admitted to the facility on 6/20/23 with a diagnosis of ESRD. Review of the TDR’s dated 8/20/24, 8/22/24, and 8/24/24 revealed the ordered BFR was 350 and the BFR was not administered or maintained at 350. There was no documentation why the BFR was not administered at the physician ordered rate. An interview was conducted on 8/28/24 at 10:49 AM with EI # 1 who confirmed staff failed to follow the physician orders for BFR administration in three of six treatments. 3. PI # 5 was admitted to the facility on 6/17/19 with a diagnosis of ESRD. Review of the TDR’s dated 8/14/24, and 8/16/24 revealed the ordered BFR was 400 and the BFR was not administered or maintained at 400. There was no documentation why the BFR was not administered at the physician ordered rate. An interview was conducted on 8/28/24 at 10:31 AM with EI # 1 who confirmed staff failed to follow the physician orders for BFR administration in two of six treatments. 4. PI # 4 was admitted to the facility on 6/28/22 with a diagnosis of ESRD. Review of the TDR dated 8/15/24 revealed the ordered BFR was 350 and the BFR was not administered or maintained at 350. There was no documentation why the BFR was not administered at the physician ordered rate. An interview was conducted on 8/28/24 at 10:38 AM with EI # 1 who confirmed staff failed to follow the physician orders for BFR administration.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 30952 Based on observations, review of facility procedure and interviews, it was determined the facility failed to ensure staff followed the facility procedure for access of arteriovenous fistula/graft (AVF/AVG) for dialysis initiation. This affected two of two observations conducted with an AVF/AVG for dialysis initiation including Patient Identifier (PI) #11, PI # 12, and had the potential to negatively affect all facility patients who dialyze with an AVF/AVG. Findings include: Facility Procedure Title: AV (Arteriovenous) Fistula or Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose. Procedure Number: 1-04-01E Revision Date: April 2022 ...Materials required: Liquid soap or other skin cleansing agent 70 % alcohol preps Tourniquet, if applicable ...Skin antiseptic... Notes: ...Use Isopropyl Alcohol 70 % as the single antiseptic/skin disinfectant ONLY when the patient has documented allergies to other skin antiseptics. ...Skin Antiseptic ...Isopropyl Alcohol 70 %. Effective Volume-At least 4 prep pads per site. Effective Contact Time 60 seconds, Air Drying Time 15 seconds ...Procedure: 1. Have patient wash access site with...antibacterial soap...If unable...teammate will clean access...with skin cleansing agent and pat dry. 2. Perform hand hygiene. Put on PPE (personal protective equipment). ...4. Prior to auscultating a bruit with a stethoscope... 5. Perform inspection, auscultation...on...access... ...10. While maintain aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site... 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic... 15. Apply a new tourniquet for...AVF or graft...remove...post cannulation... 1. An observation of Access of AVF/AVG for Initiation of Dialysis for PI # 11 was conducted on 8/27/24 at 9:18 AM with Employee Identifier (EI) # 5, Patient Care Technician (PCT) at station five. The surveyor observed PI # 11 enter the treatment room, walk to scales and to station five. PI # 11 failed to wash the access upon entering the treatment area. With gloves on, EI # 5 evaluated the access site using palpation, cleaned access site one for five seconds with one alcohol pad and cannulated the site. EI # 5 cleaned the access site two with one alcohol pad for five seconds, and immediately cannulated the access. PI # 11 failed to wash the access site with soap and water, and EI # 5 failed to verbally confirm and/or wash the access before proceeding with antisepsis. EI # 5 failed to apply the alcohol antiseptic disinfectant, the sole antiseptic, for 60 seconds, and clean each access site with four alcohol pads per access. EI # 5 failed to allow the second access site to dry before cannulation and failed to apply a tourniquet before cannulation. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1, Facility Administrator, and EI # 2, Manager of Clinical Services, who confirmed staff failed to ensure patients and staff followed the facility procedure for AVF/AVG cannulation. 2. An observation of Access of AVF/AVG for Initiation of Dialysis for PI # 12 was conducted on 8/27/24 at 10:20 AM with EI # 6, Certified Clinical Hemodialysis Technician at station eight. With gloves on, EI # 6 evaluated the access site using palpation, cleaned access site one for five seconds using one alcohol pad, and cannulated the access site. EI # 6 cleaned the second access site with one alcohol pad for ten seconds then cannulated the site. EI # 6 failed to perform hand hygiene after access evaluation, failed to clean each access site with at least four alcohol pads per site with a 60 second contact time, and failed to apply a tourniquet before cannulating. An interview was conducted on 8/29/24 at 11:00 AM with EI # 1 and EI # 2, confirmed staff failed to follow the facility procedure for access of an AVF or graft for dialysis initiation.”