Davita Cleveland Dialysis Center

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 29191 Based on observation, record review, and staff interview; A. the facility’s staff failed to ensure that the total chlorine tests were performed were within the 4-hour parameter. The facility staff failed to follow the facility’s “Daily Water System Total Chlorine Monitoring” policy. Cross-reference Tag V 196 B. the facility’s staff failed to ensure the Minncare HD disinfectant solution was not expired before disinfecting the CWP (COR Water Purification) monthly per the recommended manufacturer’s instructions. It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. Cross-reference Tag V 219 C. the facility’s biomedical staff failed to identify and promptly correct an acid leak present in the facility’s water treatment room. Also, the facility staff failed to follow the policy, “Responsibilities of the Biomed Department”. Cross-reference Tag V 222 D. the facility staff failed to ensure caps were being used on the 2.5-gallon jugs when stored The jugs were stored with wands instead of a closed system to prevent contamination. Also, the facility staff failed to follow the policy, “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS.” Cross-reference Tag V 228 E. the staff failed to perform a rinse cycle before preparing a new batch of acid concentrate. Also, the facility staff failed to follow the facility’s “Granuflo Concentrate Dissolution Unit (132 Gallon) Mixing Procedure” policy. Cross-reference Tag V 230”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 29191 Based on observation, record review, and staff interviews; A. the facility staff failed to ensure the emergency pull cord (a call light strategically placed throughout the facility to provide a user with a means of summoning help in an emergency) was accessible for the facility’s patients in the event of an emergency. Cross-refer to Tag V 402 B. the facility’s biomedical technician failed to ensure that the “Dummy” drip chamber was secure and not available for staff to use when preparing a dialysis machine. It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. Cross-refer to Tag V 403”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 48749 Based on observation and staff interview, the facility staff failed to ensure that 1 of 1 oxygen E-Cylinder was stored in a secure oxygen tank rack. This deficient practice had the likelihood to cause harm to the facility’s dialysis patients if the oxygen E-Cylinder fell over. If an oxygen E-Cylinder falls over, it can pose a serious safety threat due to the potential of it becoming a projectile and fire hazard from the pressurized oxygen rapidly escaping the cylinder. Findings include: During a tour of the facility on 06/09/2025 at 11:50 AM, the surveyor observed that one (1) oxygen E-Cylinder was free-standing and not secured in the designated oxygen tank rack on the treatment floor. An interview was conducted with Staff #2 on 06/10/2025 at 1:30 PM. Staff #2 acknowledged the surveyor’s findings that an oxygen E-Cylinder was not secured in the oxygen tank rack on the in-center treatment floor.”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within 5 (Medication Preparation Area, Laboratory, In-Center Treatment Area, Storage Room, and Water Room) of 5 areas in the dialysis center. Also, the facility staff failed to follow the facility’s “Infection Control for Dialysis Facilities” policy. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. Findings include: During a tour of the facility on 06/09/2025 at 11:50 AM, the surveyor observed the following infection control issues; Medication Preparation Area: * There was an accumulation of dust and debris on the bottom of the medication refrigerator and nutrition refrigerator. * There were (42) 21-gauge needles with an expiration date of 04/30/2025 in a cabinet above the medication preparation counter. The needles were available for use on patients. Laboratory: * There was an accumulation of dust and debris in the drawers next to the laboratory refrigerator. * There was an accumulation of dust and debris on the bottom of the laboratory refrigerator. In-Center Treatment Area: * Station #4-There was an accumulation of lint on the blood pressure cuff. * Station #10- There was an accumulation of lint on the blood pressure cuff and there was an accumulation of rust on the chairside table bolts, securing the table to the chair. Also, there was a crack with a piece missing off of the blood pump face plate on the dialysis machine. * Station #20- There was an unknown dried white crystal substance on the pipe and valve in the wall chase. * There was an accumulation of dust and clutter on top of the emergency crash cart (code cart). * There was an accumulation of dust on the supplies stored on top of the emergency evacuation cart. * There was a box of (50) 2 X 2 all-purpose sponges with an expiration date of 08/01/2024 located in a drawer of the evacuation cart. The sponges were available for use on patients. * There was a box of 50 4 x 4 all-purpose sponges with an expiration date of 03/01/2025 located in a drawer of the evacuation cart. The sponges were available for use on patients. * There was an accumulation of dust on the frames of the patient privacy screens. Storage Room: * There was an accumulation of an unknown brown substance inside a storage tote with sterile intravenous lines. * There was an accumulation of dust on the lids of the plastic storage bins containing sterile supplies. * There was a plastic storage bin containing 13 Cellentia Dialyzer Filters with an expiration date of 04/30/2024. The dialyzers were available for use on patients. Water Room: * There was an accumulation of a dried white crystallized substance on the pipe connected to the filter of the acid mixing tank. * There was a CM 130 machine (used to check chlorine) mounted on the wall in the water room. The solution inside the CM 130 machine had an expiration date of 01/18/2023 on the label. * The Minncare HD Disinfection solution was attached to the Central Water Purification (CWP) system with an expiration date of 03/04/2025 on the label. A review of the facility’s “Infection Control for Dialysis Facilities” dated April 2023 revealed the following; “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. SUPPLIES 8. Supplies will be stored in a manner that maintains their integrity. a. Patient and visitors should not access the supplies. b. Expiration date and package integrity will be verified prior to use. c. Supplies will not be opened until time of use. d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet, or contaminated, the package and its contents must be disposed of and not used. DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to the clean/designated area or removal from the treatment area. 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 (e.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 dialysis delivery system. 15. The chair side cart, terminals mounted on the counter, monitor and keyboard are considered clean areas. a. Wipe-able keyboard covers or medical grade keyboards are to be utilized. b. The chair side cart components will be cleaned at the end of each treatment day. c. Sharps containers are not stored on the chair side cart. d. Disposable gloves and alcohol based hand rub containers may be stored on the chair side cart shelves but not stored on counters where terminals are mounted. e. The monitor screen is cleaned as needed and daily at end of each treatment day using a disposable wipe moistened with 65 - 70% isopropyl alcohol solution. FACILITY HYGIENE 16. 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.” An interview was conducted with Staff #2 and Staff #14 on 06/10/2025 at 11:30 AM. Staff #2 and Staff #17 acknowledged the infection control and safety issues found by the surveyor during the tour of the facility.”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to perform disinfection on 1 (machine # 13) of 1 dialysis machines put back in service after maintenance. The facility staff failed to follow the facility’s policy “Fresenius Dialysis Delivery System Cleaning and Disinfection.” This deficient practice had the likelihood to place all patients being dialyzed on this machine at risk for potential harm, due to the use of bicarbonate during the dialysis process. Bicarbonate has a high potential for bacterial growth. Findings Include: A review of the April 2025 Machine Disinfect log revealed the following: * On 04/14/2025, dialysis machine #13 was documented as out of service. * On 04/15/2025, dialysis machine #13 was documented as out of service. * On 04/16/2025, dialysis machine #13 was documented back in service and ready for patient use. There was no documentation provided to support that dialysis machine #13 received disinfection prior to being placed back in service for patient use. A review of the facility’s “Fresenius Dialysis Delivery System Cleaning and Disinfection” policy dated April 2019 revealed the following; “Purpose: To promote patient safety by cleaning and disinfection of Fresenius dialysis delivery systems. NOTES: All dialysis delivery systems, including backup dialysis delivery systems intended for patient use, are required to be disinfected at no more than the 72-hour interval. A dialysis delivery system that has not been disinfected within the 72-hour interval must be disinfected prior to patient use. 14. Dialysis delivery systems that have been offline for repairs are disinfected once repairs are completed. After disinfection, they are rotated into service as needed. NOTE: Supporting documentation is also maintained to show dialysis delivery systems that are out of service and exempt from cleaning and disinfection procedures.” An interview with Staff #22 (Bio-Medical Manager) and Staff #23 (Area Bio-Medical) was conducted on 06/10/2021 at 10:00 AM. Staff #22 and Staff #23 confirmed the findings of dialysis machine #13 not receiving disinfection prior to being placed back in service for patient use.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 48749 Based on record review and staff interview, the facility staff failed to ensure that the total chlorine tests were performed within the 4-hour parameter. The facility staff failed to follow the facility’s policy, “Daily Water System Total Chlorine Monitoring.” Findings include: A review of the facility’s “Routine Total Chlorine Testing” log for 04/18/2025 revealed the following; *The initial chlorine check for the start of treatment was documented at 4:01 AM. *The second chlorine check was documented at 5:00 AM. *The third chlorine check was documented at 10:10 AM (70 minutes late) *The fourth chlorine check was documented at 1:44 PM. *The final chlorine check was documented at 5:15 PM. There was no documentation found or provided to support why the third chlorine check was not performed within the required 4-hour parameter on 04/18/2025. A review of the facility’s “Daily Water System Total Chlorine Monitoring” policy dated October 2024 revealed the following; “PURPOSE: To establish that total chlorine testing is regularly performed and within limits specified by International Organization of Standardization (ISO)/Association for the Advancement of Medical Instrumentation (AAMI) and DaVita standards. 3. Total Chlorine testing is done on a daily basis prior to the use of dialysis quality water for any process and the start of dialysis treatment(s) and within every four (4) hours until all activities that require the use of dialysis quality water are completed. All samples are to be drawn only after the water system has been operating for at least 15 minutes. Document results on either the Routine Total Chlorine Testing Log or Daily Water Treatment Log (with CM130) and in IT Clinical System.” An interview was conducted with Staff #2 on the afternoon of 06/10/2025. Staff #2 confirmed the findings of the late chlorine check performed on 04/18/2025.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 29191 Based on observation, record review, and interview, the facility’s staff failed to ensure the Minncare HD disinfectant solution was not expired before disinfecting the CWP (Cor Water Purification) system monthly per the recommended manufacturer’s instructions. It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. This deficient practice had the likelihood to expose patients to chemical disinfectants and cause harm to all patients receiving dialysis at the facility. Findings include: The staff had been performing the disinfectant tests monthly. During a tour of the water room observed that the Minncare HD disinfectant solution had expired 03/04/2025. The facility staff had started using the container of Minncare HD disinfectant solution on 04/29/2025, and the container remained as the disinfectant until the surveyor pointed out that Minncare HD disinfectant solution had expired. A review of the CWP water purification system instruction manual 3.2.1 stated, “Disinfection must be performed on a regular basis to ensure consistent microbiological quality of the product water. Required frequency depends on factors such as inlet water quality and operation schedule and should therefore be determined by regular microbiological testing. Once a week should, however, be the minimum.” A review of the facility policy titled, “ WATER TREATMENT SYSTEM DISINFECTION” dated April 2025 revealed the followed: “PURPOSE: To disinfect Reverse Osmosis (RO) devices and the distribution system on a regular basis and in response to elevated bacteria and/or endotoxin test results. POLICY: 1. Water system disinfection is performed when the treatment area is patient-free and when no other processes are using dialysis-quality water. 2. These processes include but are not limited to bicarb mixing, concentrate mixing, etc. Prior to starting disinfection, teammate is to verify that no other processes are using dialysis quality water. Notification of the type of chemical used for disinfection is prominently displayed on the system to indicate the presence of disinfectant in the system. Notification is visibly displayed to indicate the presence and type of disinfectant in the water treatment system, bicarb mixer, or concentrate mixer. Disinfection processes will vary based on whether water system configuration is direct feed (systems that do not utilize a holding tank), indirect feed (systems utilizing a holding tank), and whether disinfection is accomplished using chemicals or hot water. Frequency of disinfection will be based on manufacturer guidance and additional disinfection may be required based on microbial results. Additionally, the RO and distribution system are disinfected when bacterial cultures and/or endotoxin results indicate the need for disinfection. The type of chemical disinfectant used, its concentration and dwell time will be consistent with manufacturer guidance for RO device and distribution system. Chemically-disinfected RO devices and/or distribution systems: Direct feed systems are disinfected monthly and include both the reverse osmosis (RO) machine and the distribution system. Indirect feed storage tanks and distribution systems are disinfected at least monthly. RO systems connected to storage tanks are disinfected at least quarterly or per manufacturer instructions for use. The distribution system includes all components that come in contact with dialysis quality water. Deionizers and any attached equipment incompatible with the disinfectant utilized are excluded from disinfection.” An interview with Staff #17 on 06/9/2025 at 12:55 PM confirmed that the Minncare HD disinfectant solution being used by staff had expired.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 29191 Based on observation, record review, and staff interviews, the facility’s biomedical staff failed to identify and promptly correct an acid leak present in the facility’s water treatment room. Also, the facility staff failed to follow the policy, “Responsibilities of the Biomed Department”. During a tour of the facility’s water treatment room on 06/09/2025 at 12:55 PM, the surveyor observed a large build-up of dried white crystals on the piping located on the acid mixer before the acid filter. The surveyor observed an acid leak in the wall chase behind station #20. A review of the facility policy titled “Responsibilities of the Biomed Department” with a revision date of October 2021 revealed the following: “PURPOSE: To provide guidance for the responsibilities of the DaVita Biomed department. POLICY: 1. The responsibilities of the Biomed Department include: Repair and maintain, with support documentation, all dialysis delivery machines, RO water treatment systems, ancillary equipment, and related equipment used in the provision of care to patients as recommended by the equipment manufacturer’s specifications and DaVita policies and procedures ....” An interview with Staff #5 on 06/09/2025 at 1:00 PM acknowledged the acid leak on the piping located on the acid mixer before the acid filter.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 29191 Based on observation and staff interview, the facility staff failed to ensure caps were used on the 2.5-gallon acid concentrate jugs when stored. The jugs were stored with wands instead of a closed system to prevent contamination. Also, the facility staff failed to follow the policy, “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS” Findings Include: The surveyor observed that there were three (3) 2.5-gallon acid concentrate jugs on the bottom shelf of the black cart in the storage area. Each jug had a different solution and date on a handwritten label. Also, the surveyor observed that all 3 jugs were stored with an open-ended wand, which presented a risk for contamination. There was no way to determine if the jugs were clean or dirty. The acid jugs were labeled 2K-2.5CA with a date of 12/20/2024, 3K-2.5CA with a date of 09/30/2024, and 2K-2.5CA with a date of 04/04/2025, with a handwritten label on the jugs. Acid concentrate is not susceptible to bacterial contamination, but every effort should be made to keep the system closed to prevent nonbacterial contamination and evaporation per the ANSI/AAMI standards. A review of the facility’s policy titled, “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS” dated April 2019, revealed the following: “PURPOSE: To provide guidance for acid concentrate distribution and documenting receipt and pump off, where applicable, of acid concentrates. To provide guidance for the use and disposal of acid concentrate containers. ACID GALLON CONCENTRATE CONTAINERS 17. Acid concentrate is to be stored at room temperature in a secure designated area. 18. Upon opening an acid gallon concentrate container, label container with date opened and initials of teammate. 19. The entire solution volume in the acid gallon concentrate containers should be used prior to opening another acid gallon container of the same concentrate. NOTE: Open, unused acid concentrate solutions remain in the original container, are not to be combined, and should be capped when not in use. 20. Unopened and opened standardized acid concentrate containers must be used prior to the manufacturer’s expiration date on the label, if applicable.” An interview with Staff #2 on 06/09/2025 at 12:48 AM confirmed the 2.5-gallon jugs had no caps, only stored with open-ended wands, and Staff #2 was unable to verify if the 2.5-gallon jugs were clean or dirty.”

“MIXING SYSTEMS-CLEANING CFR(s): 494.40(a) 6.4.1 Mixing systems: cleaning Concentrate mixing equipment should be either: (1) completely emptied, cleaned, and disinfected according to the manufacturer’s instructions; or (2) cleaned and disinfected using a procedure demonstrated by the facility to be effective in routinely producing concentrate meeting [these regulations related to allowable bacterial and endotoxin levels]. The disinfection data should be recorded for each ...disinfection cycle using a dedicated log. This Standard is not met as evidenced by: 48749 Based on record review and staff interview, the facility staff failed to perform a rinse cycle before preparing a batch of acid concentrate. Also, the facility staff failed to follow the facility’s “Granuflo Concentrate Dissolution Unit (132 Gallon) Mixing Procedure” policy. Findings include: A review of the facility’s “Granuflo (132 Gallon) Batch Production Record” dated 04/04/2025 revealed the following; There was no rinse cycle performed prior to preparing the acid batch. There was no documentation found or provided to support an explanation as to why a rinse cycle was not completed. A review of the facility’s “Granuflo Concentrate Dissolution Unit (132 Gallon) Mixing Procedure” policy dated October 2024 revealed the following; “A Rinse Cycle must be performed: *Following any Disinfection Cycle (Disinfection Cycle is described in a separate procedure). *Immediately before preparing a batch of acid concentrate. To avoid bacterial growth in the Granuflo and 1 micron filter, a Dissolution Cycle will immediately follow a Rinse Cycle.” An interview was conducted with Staff #2 on the afternoon of 06/10/2025. Staff #2 confirmed the findings of the missed rinse cycle.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 48749 Based on observation and staff interview, the facility staff failed to ensure the emergency pull cord (a call light strategically placed throughout the facility to provide a user with a means of summoning help in an emergency) was accessible for the facility’s patients in the event of an emergency. This deficient practice had the likelihood of causing harm and delay of care to patients in the event of an emergency. Findings include: Upon entering the facility’s lobby on 06/09/2025 at 11:15 AM, the surveyor observed the emergency pull cord wrapped around the handrail in the patient’s unisex bathroom and not easily accessible for the facility’s patients in the event of an emergency. The emergency pull cord should be within 6 inches of the floor, hanging freely, and accessible to patients. An interview was conducted with Staff #2 on the afternoon of 06/10/2025. Staff #2 acknowledged the surveyor’s findings of the emergency pull cord wrapped around the handrail in the facility’s lobby bathroom.”

“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: 29191 Based on a review of records, observations, and staff interview, the facility’s biomedical technician failed to ensure that the “Dummy” drip chamber was secure and not available for staff to use when preparing a dialysis machine. It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. This deficient practice has the likelihood of being hazardous to patient safety and risks the undetected infusion of air into a patient if the “dummy” drip chamber if not removed at the initiation of dialysis. Findings include: During a tour of the facility on 06/09/2025 at 1:05 PM, the surveyor entered the Bio-medical room, which is directly off the in-center treatment floor. There were 3 dialysis machines labeled “Ready for Use.” These are backup machines available for the staff if one of the dialysis machines malfunctions during a patient’s treatment. On one of three machines, there was a “Dummy” drip chamber in the air detection chamber. “Dummy” drip chambers are fluid-filled chambers that are used to bypass the dialysis machine’s air detectors. The practice of using a “dummy” drip chamber to prepare a dialysis machine for patient use is hazardous to patient safety and risks the undetected infusion of air into a patient if the “dummy” drip chamber is not removed at the initiation of dialysis. A review of the facility policy titled, “USE OF DUMMY VENOUS DRIP CHAMBER WITH FRESENIUS 2008 SERIES DIALYSIS DELIVERY SYSTEMS” dated October 2023, revealed the following: “PURPOSE: To provide guidance for Biomed teammates only on the use of dummy venous chambers to test and calibrate level detector Fresenius 2008 series dialysis delivery systems POLICY: 1. If applicable to dialysis delivery system manufacturer guidance, the use of Venous Drip Chamber Test Devices (“dummy chambers”) is acceptable only for machine maintenance purposes and only for use outside the patient treatment areas. a. Only a trained Biomed teammate will utilize Venous Drip Chamber Test Devices (“Dummy Chambers”) for calibration and verification purposes only. b. Venous Drip Chamber Test Devices will only be utilized for testing and calibration purposes of dialysis equipment in an area designated for equipment maintenance and repair. c. Venous Drip Chamber Test Devices will be accessible to Biomed teammate only. They will be stored in a secured locked area or carried in the Biomed Teammate’s tool box. d. A bright colored label will be placed on the Venous Drip Chamber Test Device stating “For Biomed Use only, Not for Patient Use”... An interview with Staff #5 was conducted on 06/09/2025 at 1:05 PM. The surveyor asked Staff #5 why there was a “Dummy” drip chamber left in the machine, labeled with a tag, and locked up. Staff #5 stated, “I forgot and left the “Dummy” drip chamber in the dialysis machine. “Dummy” drip chamber was not locked up cause the lock is broken. There was writing on the chamber in black, but it was faded so that the chamber was not tagged, preventing staff from knowing to remove it from the machine. An interview with Staff #22 (Biomedical manager ) on 06/09/2025 at 1:30 PM confirmed the “Dummy” drip chamber should be locked up and labeled with “For Biomedical Use Only” and “Not for Patient Use.””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 48749 Based on record review and staff interview, the facility staff failed to follow the physician’s prescribed orders for the blood flow rate (BFR) and the dialysis flow rate (DFR) for 2 (Patient #1 and #5) of 5 medical records reviewed. The facility staff failed to follow the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” policy. This deficient practice had the likelihood to harm patients by not following the physician’s dialysis orders, which could negatively impact the effectiveness and adequacy of the dialysis treatment for all 49 in-center hemodialysis patients receiving care at the facility. Findings include: Patient # 1 A review of the treatment sheet dated 06/04/2025 revealed the following, “Dialysis Prescription: BFR (blood flow rate): 400 ml/min DFR (dialysis flow rate): 500 ml/min (milliliters per minute)” The patient’s set BFR (blood flow rate) throughout treatment was “350 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed blood flow rate. There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 5 A review of the treatment sheet dated 05/30/2025 revealed the following, “Dialysis Prescription: BFR: 400 ml/min DFR: 800 ml/min “ The patient’s set BFR throughout treatment was “350 ml/min”. The patient’s set DFR throughout treatment was “500 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed blood flow rate. There was no documented order from the physician to adjust the BFR and DFR for this treatment date. A review of the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” policy dated April 2024 revealed the following; “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. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge. 3. Patient identity, prescription, and machine settings are verified by a teammate prior to initiation of treatment, with the exception of blood flow rate, which is verified and documented when the ordered rate is obtained after onset of treatment. 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. Prescription components include, but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium, and bicarb) and settings j. Heparinization (intradialytic infusion setting)” An interview was conducted with Staff #2 on 06/10/2025 at 11:00 AM. Staff #2 confirmed that the facility staff was not consistently following the physician’s order for blood flow rate and dialysis flow rate.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48749 Based on observation, record review, and staff interview, the facility’s staff failed to: A. monitor and provide a sanitary environment to minimize the transmission of infectious agents within the dialysis center. Also, the facility staff failed to follow the facility policy, “Infection Control For Dialysis Facilities”. (Cross Refer to Tag V 0111) B. ensure 3 of the 3 sinks in the in-center treatment area had warm water available and that the faucet tip was working properly. Also, the facility staff failed to follow the facility policy titled, “Infection Control For Dialysis Facilities”. (Cross Refer to Tag V 0114) C. ensure medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to ensure that patient nutritional supplies were not stored in the same refrigerator as medications. In addition, the facility failed to store vaccines according to CDC (Centers for Disease Control) guidelines. (Cross Refer to Tag V 0117) D. ensure that staff and the bio-medical technician followed the facility’s policy for bleach disinfection of 4 (#9, #14, #20, and #23) of 23 patients’ dialysis machines for the months of April and May 2024. E. follow the correct procedure for cleaning and disinfecting contaminated dialysis surfaces in the in-center treatment area. The staff failed to follow the facility’s policy, “Infection Control For Dialysis Facilities”. (Cross Refer to Tag V 0122)”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within the dialysis center. Also, the facility staff failed to follow the facility policy, “Infection Control For Dialysis Facilities”. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. During a tour of the facility on 06/10/2024 at 11:30 AM, the surveyor observed the following infection control issues in the supply room, water room, and in-center treatment area. Findings Include: IN-CENTER TREATMENT AREA: * Observed a cart with 10 vinegar jugs with open connector ports/wands on the top rack. On the bottom rack, there were 9 unlabeled acid jugs without secured lids. There was an unknown clear liquid substance in one of the jugs. The staff members could speak to how long the jugs had been there. *Observed an unknown dried white liquid substance spilled on the wall and on the floor of the back hallway leading to the water room. The facility had a bicarbonate leak in the loop over 2 weeks ago and the floor had not been cleaned. *Observed the metal door frame of the emergency exit at the in-treatment area which had rust, peeling/chipping paint, and missing a piece of the wall border. The metal was cracked and corroded. * Observed in the corner of the in-center treatment area was dead bugs, dust and dirt particles. *Observed an unknown brown dried liquid and dead insects on the bottom of the lab refrigerator. Also, there was a build-up of ice inside the lab freezer. *Observed an unknown brown liquid substance dried in the cabinet behind the nurse’s station. There were liquid medications stored on the shelf above the patient nutrition bars. There was an open cardboard box on the shelf with the patient’s nutrition bars. *Observed a build-up of dust on the counter of a nurse’s station. There were dust and debris inside the patient sterile supply drawers. *Observed an open bottle of RO (a reverse osmosis system is the primary method for purifying water for dialysis treatment) water sitting on the counter next to the sink. There was no cap found for the bottle. There was a bottle of conductivity solution (a solution of inorganic salts that are dissociated in electrically charged ions) without a date of opening, staff initials, or a date of discard written on the label. The surveyor was unable to determine when the bottle was opened and if it had expired. *Observed a build-up of dust on the base of the patient Hoyer lift (equipment that allows a person to be lifted and transferred with a minimum of physical effort). There was an unknown dried white liquid and a build-up of dust on the bases of the intravenous poles (a medical device designed as a slender portable pole with adjustable heights that provide a secure place to hang bags of fluid and/or medications). *Observed a used PH test strip bottle tapedto the foot of the privacy curtain base; due to the wheel of the privacy curtain was missing. *Observed an accumulation of an unknown dried white substance on the faucets of the eye wash station. Also, there was a build-up of dust in the eye wash sink bowl. On the exposed drain pipe attached to the sink bowl, the surveyor was able to wipe away a half inch of dust. *Observed an unknown dried white liquid substance and what appeared to be intravenous fluid caps inside the sink at a treatment station. *Observed an open bottle of PH test strips on the counter of a treatment station, without a date of opening, staff initials, or a date of discard written on the label. The surveyor was unable to determine when the bottle was opened, by which staff member, and if it had expired. *Observed an unknown dried white liquid on the floor near a wall box and dialysis machine at Station #11. *Observed an unknown dried white liquid below the hansen connectors (connectors for connecting a dialysate port of a dialyzer to a dialysate-delivery line on the dialysis machine) at Station #3. *Observed a build-up of dust on the backs and bases of multiple dialysis machines being used in the treatment area. Also, there was an accumulation of dust on the hose connectors. *Observed a missing turn plate on the front of dialysis machine #18. *Observed inside a drawer at the hand washing station with an open package of gowns stored with wheelchair legs. Also, there was hair and dust particles in the drawer. *Observed a cardboard box of normal saline solution stored on top of the emergency transport cart in the in-center treatment area. *Observed an unknown dried white liquid substance and dust on the bases of the biohazard containers. *Observed an unknown dried white substance on the floor under the wall chase box in the isolation room. WATER ROOM: *Observed on a shelf by the door, there was an expired open bottle of conductivity solution labeled with an opening date of 04/01/2024. There was an expired open bottle of PH test strips labeled with an opening date of 04/16/2024. Also, there was a build-up of dust on the shelf. STORAGE ROOM: * Observed cardboard boxes were mixed in with sterile supplies. There were cardboard boxes stored on top of sterile patient supplies. The sterile supplies were stored in clear plastic bins. The clear plastic bins had an accumulation of dust on the lids. there was no barrier on the bottom shelf to prevent splatter from when staff were sweeping and mopping. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items). *Observed an open package of gowns sitting on the shelf below open cardboard boxes. *The floor of the supply area was dirty with dust and dirt debris. A review of the facility’s policy titled, “Infection Control For Dialysis Facilities” policy dated April 2023 revealed the following: “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. Additional precautions recommended by the CDC are to be observed for patients with infectious hepatitis B and are included in the policy: Infection Control and Isolation Measures for Known or Suspected Hepatitis B Antigen Positive Patients. SUPPLIES 8. Supplies will be stored in a manner that maintains their integrity. a. Patient and visitors should not access the supplies. b. Expiration date and package integrity will be verified prior to use. c. Supplies will not be opened until the time of use. d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet, or contaminated, the package and its contents must be disposed of and not used. 9. If a common supply cart is used to store clean supplies in the patient treatment area, this cart is to remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. The cart will not be moved between stations to distribute supplies. 10. Unused supplies (syringes, alcohol swabs, tape, etc.) or medications (including multiple dose vials containing diluents) taken into the station should be used only for that patient and should not be returned to a common clean area or used on other patients. 11. Measures will be taken to prevent cross-contamination between patients. a. Medication vials, syringes, tape, alcohol swabs, gloves, or other supplies will not be carried in pockets. b. Electronic thermometers and/or blood glucose meters should not be placed on potentially contaminated equipment such as the dialysis delivery system. DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e., used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. a. Prior to routine disinfection, remove all visible blood. * For visible blood or gross blood spills, a 1:10 (one to ten) bleach solution must be utilized. * After all visible blood is cleaned with the 1:10 (one to ten) bleach solution, teammates are to use a new disposable towel soaked with 1:10 (one to ten) bleach solution and clean area a second time. * Cleaning of visible blood should be performed when first observed. b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. * Disinfection should be completed by using a wiping motion with friction. * Sufficient disinfectant should be applied so that surfaces are visibly wet. * Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time. * Items disinfected via submersion will be fully submerged. c. Spray bottles containing cleaning solutions are single-use and cannot be reused or refilled. This practice does not include contracted housekeeping services. 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 (e.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). * The Wall box, Drain and Water supply lines are considered part of the dialysis 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. * Priming containers are to be emptied prior to disinfection. Drain line and water supply line should not be placed with ends in prime containers or in a position where they can drip into or contaminate the prime bucket. FACILITY HYGIENE 16. 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. 17. Food and drinks in the treatment area will be limited to patients. Sharing and storage in the treatment area are not allowed. 18. Dressing changes should not be performed in the treatment area with the exception of vascular access care. 19. Sinks should be easily accessible and readily available in the treatment area and in other appropriate areas such as the medication area, home training room, and isolation area/room. a. Sinks must be plumbed with both hot and cold water. b. Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place. c. Soap and a supply of paper towels protected from contamination must be available at each clean sink. 20. Use of battery-operated, electrical, or ceiling-mounted fans are not allowed in patient treatment areas. 21. Patient charts are not to be placed on top of dialysis delivery systems.” An interview with Staff #2 and Staff #4 on 06/11/2024 at 8:30 AM confirmed the infection control and safety issues found in the in-center treatment area, storage room, and water room.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to ensure 3 of the 3 sinks in the in-center treatment area had warm water available. Also, the facility staff failed to follow the facility policy titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES”. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. During a tour of the in-center treatment area with Staff # 2 on 06/10/2024 at 11:30 AM, the surveyor observed the following: The 3 clean sinks located on the in-center treatment floor did not have warm water. The surveyor washed hands for 30 seconds and the water remained cold for the duration. Also, the water from the faucets sprayed water on the surveyor’s clothes due to the tip was not properly working. According to the CDC (Centers for Disease Control), “Healthcare facilities should ensure that supplies necessary for adherence to hand hygiene are readily accessible in all areas where patient care is being delivered. Hand Hygiene means cleaning your hands by using either handwashing (washing hands with soap and hot water), antiseptic hand wash, antiseptic hand rub (i.e., alcohol-based hand sanitizer including foam or gel), or surgical hand antisepsis.” A review of facility policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” with a revision date of October 2023 revealed, “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. POLICY: The Centers for Disease Control (CDC) Recommendations for preventing transmission of infections among Chronic Hemodialysis Patients will be followed when caring for all patients ... 39. Sinks should be easily accessible and readily available in the treatment area and in other appropriate areas such as the medication area, home training room, and isolation area/room. Sinks must be plumbed with both hot and cold water. Clean sinks should be dedicated to clean activities such as hand washing and remain clean... The facility should have a sink available for patients to wash their access sites prior to treatment and their hands after treatment. The sink may also be used by teammates for handwashing. Soap and a supply of paper towels protected from contamination must be available at each clean sink...” In an interview with Staff # 2 on 06/10/2024 at 11:46 AM confirmed that the 3 sinks in the center treatment area did not have hot water available and water was spraying and staff clothes would become wet.”

“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: 48749 Based on observation, record review, and interview the facility staff failed to ensure medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to ensure that patient nutritional supplies were not stored in the same refrigerator as medications. In addition, the facility failed to store vaccines according to CDC (Centers for Disease Control) guidelines. These deficient practices had the likelihood to cause harm to all patients who receive care at the facility by using vaccines that were not stored according to CDC guidelines. Findings include: During a tour of the facility on 06/11/2024 at 8:30 AM with Staff # 2, the surveyor observed: A. There were three open medication cups holding unknown medication pills, a syringe of Venofer 50 mg, and a syringe of Mircera 75 mcg. The medications were not labeled with a staff member’s initials. The surveyor was not able to determine what staff member prepared the medication. Also, the drawer was unlocked with the keys inserted into the lock on the drawer. B. Inside the medication refrigerator, the Pneumococcal, Hepatitis B, and Tuberculin vaccines were stored on the top shelf, next to the walls of the refrigerator. Also, there were three bottles of Novasource Renal oral nutrition stored on the top shelf of the refrigerator, next to the vaccines. C. There were cardboard boxes of injectable Sodium Thiosulfate stored on the shelf above patient nutrition bars. D. There were two syringes of Heparin inside a plastic bag, lying unsecured on the counter in the patient treatment area. A review of the facility’s policy “Medication Requiring Refrigeration” dated 04/2017 revealed the following: “PURPOSE: To provide guidance for the storage of medications requiring refrigeration. POLICY: 1. Medications that require refrigeration are stored in the facility refrigerator designated for medications only. 2. The refrigerator is checked twice daily, during facility normal operating hours, for cleanliness and to verify that the temperature remains between 36° F and 46° F. The refrigerator temperature is to be checked by a licensed nurse teammate or designee at the beginning and end of the day. 3. The temperature is documented on the Refrigerator Temperature Log. 4. A separate temperature log is maintained for each medication refrigerator present in the facility. 5. Refrigerators that do not maintain temperatures in the stated range will be repaired or replaced as soon as possible. 6. Per Centers for Disease Control (CDC). place vaccines in center refrigerator space, contained in original packaging, inside designated storage trays positioned 2 - 3 inches from refrigerator walls.” According to CDC guidelines for the storage of immunizations: www.cdc.gov/vaccines “Store between 35 and 46 degrees. Place the vaccine in bins with open airflow or leave the top off. Make sure the door is shut. Remove crisper bins and place water bottles labeled ‘Do Not Drink in the bottom.’ Leave 2-3 inches between all vaccine containers and refrigerator walls. Post do not unplug on the refrigerator. Don’t use a dormitory-style refrigerator. Don’t store vaccines on top shelf Don’t put food and beverages in the refrigerator. Don’t put vaccines or diluents in the door or floor of the refrigerator. Don’t drink or remove water bottles.” A review of the facility’s policy “Medication Policy” dated 11/2023 revealed the following: “PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. 11. All refrigerated medications, for example, erythropoietin stimulating agents (ESA) and vaccines are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. 13. All open or unopened medication packages (i.e., vials, ampules, etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired.” An interview conducted on the morning of 06/11/2024 with Staff #2 at 9:00 AM confirmed that medication was left unsecured and that vaccines were stored against the wall of the refrigerator.”

“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: 29191 Based on observation, record review, and interview, the facility failed to: A. ensure that staff and the bio-medical technician followed the facility’s policy for bleach disinfection of 4 (#9, #14, #20, and #23) of 23 patients’ dialysis machines. The clean and disinfect logs for April and May 2024 were reviewed. B. follow the correct procedure for cleaning and disinfecting contaminated dialysis surfaces in the in-center treatment area. The staff failed to follow the facility’s policy, “Infection Control For Dialysis Facilities”. A. This deficient practice had the likelihood of placing all patients being dialyzed on these machines at risk for potential harm due to the machines using bicarbonate during the dialysis process having a high potential for bacterial growth. Findings include: A review of the April 2024 daily disinfection log revealed the following: A review of the log titled, “Machine Disinfect Log” Staff #5 failed to document on April 9, 2024, that bleach disinfection had been performed on dialysis machines #9 and #23. The machines were out of service and placed back in service without being disinfected by the bio-medical technician. A review of the log titled, “Machine Disinfect Log” Staff #5 failed to document on April 30, 2024, that bleach disinfection had been performed on dialysis machines #14 and #20. The machines were out of service and placed back in service without being disinfected by the bio-medical technician. A review of the May 2024 daily disinfection log revealed the following: A review of the log titled, “Machine Disinfect Log” Staff #5 failed to document on May 28, 2024, that bleach disinfection had been performed on dialysis machine #20. The machine was out of service and placed back in service without being disinfected by the bio-medical technician. A review of the facility’s policy titled, “FRESENIUS DIALYSIS DELIVERY SYSTEM CLEANING AND DISINFECTION POLICY “ dated 10/2017 revealed the following: “EXAMPLES OF CLEANING/DISINFECTION PROCEDURES AND INTERVALS Weekly Bleach or Peracetic Acid Disinfection Operator Instructions for Use manuals for dialysis delivery systems currently in use are to be readily available to teammates performing cleaning and disinfection procedures. Refer to manufacturers’ procedures for the dialysis delivery system utilized.” Internally disinfect the dialysis machine as outlined below or per manufacturer guidelines: “* Heat disinfect after the last treatment each day the machine is used. * Bleach disinfects each week (at least every seven (7) days). Bleach disinfection can replace heat disinfection.” An interview with Staff #5 (Bio-Medical) on 06/11/2024 at 9:00 AM confirmed dialysis machines (#9, #14, #20, and #23) had not been bleach disinfected weekly as required by manufacturer guidelines. B. These findings had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by allowing supplies and equipment to be used that had been exposed to microbial contamination and unclean surfaces. Findings include: During a tour of the facility’s in-center treatment area on 06/10/2024 at 2:30 PM, the surveyor observed 3 dialysis patients complete dialysis treatment and walk to the scale for post-treatment weight. All 3 of the patients touched the handrail and scale buttons without a staff member disinfecting the contaminated surfaces between each patient contact. Also, there were no disinfecting wipes located near the weight station for the patients or staff members to use. A review of the facility’s policy titled, “Infection Control For Dialysis Facilities” with a revision date of April 2023, revealed the following: “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. Additional precautions recommended by the CDC are to be observed for patients with infectious hepatitis B and are included in the policy: Infection Control and Isolation Measures for Known or Suspected Hepatitis B Antigen Positive Patients ... DISINFECTION: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. i. Disinfection should be completed by using a wiping motion with friction. ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time. iv. Items disinfected via submersion will be fully submerged.” In an interview with Staff # 4 on 06/10/2024 at 2:45 PM, Staff # 4 confirmed the facility staff were not disinfecting the surfaces at the patient scale and there were no disinfecting wipes in the vicinity of the scale to be utilized by facility staff. Staff # 4 had to get disinfecting wipes from the supply to put near the patient scale for use.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to check and maintain the salt pellets no lower than the water halfway mark in the brine tank. This deficient practice had the likelihood to cause the water to become hard, failure to ensure adequate salt levels in the brine tank can lead to water hardness in the system at levels unacceptable for dialysis being performed on patients. Findings include: During a tour of the facility’s water room on 06/10/2024 at 12:45 PM observed the salt pellets were below the water level in the brine tank. An interview with Staff #8 on 06/10/2024 at 12:45 PM confirmed Staff #8 visualized the salt pellets in the brine tank below the water line halfway mark.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility failed to ensure that the acid storage tank did not contain contaminated acid solution from the acid connection outlet valve leak at the bottom of the acid storage tank and the acid tubing and connections running along the wall up to the loop. Observed dried acid (a white crystal substance) on the connections below the acid storage tank and connections next to the acid storage tank. This deficient practice had the likelihood to cause harm to all patients receiving exposed contaminated acid through the loop at the chairside through the dialysis machine at the facility. Findings include: On a tour of the water room on 06/10/2024 at 12:46 PM, observed there was a white crystal substance build-up around the acid housing connection tubing underneath the acid storage tank. Observed drippings of white substance from beneath the acid storage tank and the connections. Also, observed dried acid (a white substance) on the wall connections next to the acid storage tank. There was dried crystal acid build-up on all the connections around both acid storage tanks. An interview with Staff #8 on 06/10/2024 at 12:46 PM confirmed there was a large amount of acid (white substance) build-up drippings from beneath the acid storage tank housing and the connection valve outlets.”

“ACID CONC DIST-CONC LABELED & COLOR-CODED RED CFR(s): 494.40(a) 5.5.3 Acid concentrate distribution systems: labeled & color-coded red Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary. More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility’s staff failed to ensure that the dialysis stations’ wall boxes (acid dispensing outlets) had no leaks and were properly cleaned. Also, the facility’s staff did not follow the policy “Infection Control for the Dialysis Facilities” for cleaning the wall boxes. This deficient practice has the likelihood to cause nonbacterial contamination and evaporation in the wall boxes and infect the patients receiving in-center hemodialysis at the facility. Findings include: A tour of the in-center treatment area on 06/10/2024 at 11:59 AM observed that wall boxes had dried crusted white sediment in the outlet boxes and around the acid outlets. Also, there large amount of dried crystal white substance on the floor under the wall box at station #2. Observed at station #14 the acid outlets had large amount of dried brown colored substance around both the 2K# and 3K# outlets. The bottom of the wall box had a orange-brown rusted discoloered appearance. A tour of the in-center treatment area on 06/11/2024 at 8:36 AM with Staff #2 and #4 observed the acid outlets and wall boxes had dried crusted white sediment. The surveyor opened the door on the wall chase to view the inside of the plumbing of acid connecting tubing. Twelve (#1, 2, 8, 9, 10, 12, 13, 14, 15, 16, 17, and 18) out of 20 wall boxes had large crystal balls of dried acid around the connectors. Chase boxes #2, 16, and 17 had cracked fittings. The surveyor asked who was responsible for cleaning the wall boxes. Staff #4 stated, “The staff is responsible for cleaning the wall boxes, but Bio-Medical technician was responsible for the leaks and cracks”. A review of the CDC guidelines related to dialysis wall boxes revealed the following: “Dialysis wall boxes are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water and dispose of waste products. There are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections.” A review of the facility policy titled; “Infection Control for the Dialysis Facilities” revealed the following: “WALL BOX AND DRAIN/WATER LINE CARE AND MAINTENANCE: 58. The Wall box, Drain, and Water supply lines are considered part of the dialysis delivery system and should be cleaned with 1:100 (one to one hundred) bleach as part of routine station disinfection between each patient treatment. This process will also be completed for the wall boxes in the biomedical repair area once daily. This process of cleaning the drain and water supply lines will also be completed prior to bringing a machine to the treatment floor. NOTE: Do not wipe wall boxes during any active disinfection process in order to avoid chemical reactions (i.e., bleach and citric acid).” An interview with Staff #4 on 06/11/2024 at 9:00 AM confirmed the acid outlets and wall boxes had dried crusted white sediment in all the in-center stations’ wall boxes and 12 had leaks in the wall chase.”

“BICARB CONC DIST-COLOR CODED BLUE & SEALED CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: color coded blue & sealed Bicarbonate concentrate delivery piping should be color-coded blue at the point of use (at the jug filling station or dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility failed to ensure that wall boxes #1 through #20 (Bicarbonate dispensing outlets) at the dialysis stations had no leaks and were properly cleaned. This deficient practice had the likelihood of causing bacterial growth in the wall boxes and infecting the patients who were receiving in-center hemodialysis at the facility. Findings include: Observation of the wall boxes at each dialysis station on 06/11/2024 at 8:36 AM revealed that the stations had been leaking bicarbonate solution around the seals’ outlets. The boxes were noted to have crusted white sediment down the chase wall and along the connecting hoses. A review of the CDC guidelines related to dialysis wall boxes revealed the following: “Dialysis wall boxes are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water and dispose of waste products. There are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections.” An interview with Staff #4 on 06/11/2024 at 9:00 AM confirmed there was white-crusted sediment on the wall boxes down the chase wall and along the connecting hoses.”

“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: 48749 Based on observation and interview, the facility staff failed to ensure the conductivity solution bottle located in the treatment area had a secure cap. Also, the facility Biomedical ( technicians who ensure that medical equipment is well maintained and safetyly functional) staff failed to ensure the conductivity solution bottle was within parameters for use in the facility’s water room. In addition, the facility staff failed to consistently perform conductivity on the dialysis machines prior to use on their patients. These findings had the likelihood to cause harm to all patients if the conductivity solution to verify the conductivity of the dialysis machines was not being performed before each use. An unsecured conductivity bottle would allow contaminants to enter the conductivity solution. Findings include: The manufacturer’s instructions for the conductivity standard solution state “Discard solution 30 days after opening. Discard solution if the cap is loose, the bottle has been left open, or the solution has been frozen.” During a tour of the treatment floor on 06/10/2024 at 11:30 AM revealed the following: Observation of the facility staff revealed that 5 of 6 staff observed did not perform consistent conductivity on the dialysis machines before each use. Also, a conductivity solution bottle at the in-center treatment area did not have a secure lid. During a tour of the water room on 06/11/2024 at 12:40 PM revealed the following: A bottle of conductivity standard solution was labeled with an opening date of 04/01/2024. There was no discard date listed. The manufacturer’s label on the bottle reads discard solution 30 days after opening. An interview with Staff #4 on 06/11/2024 at 12:30 PM acknowledged that the conductivity solution located in the treatment area did not have a secure lid and the conductivity solution located in the water room was expired per the manufacturer’s guidelines.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 29191 Based on observation and staff interviews, the facility failed to ensure the emergency pull cord was accessible for a patient in the event they fell on the floor in the lobby. The emergency pull cord should be within 6 inches of the floor. This deficient practice has the likelihood of causing harm to patients in an emergency. Findings include: Upon entering the facility’s lobby on 06/10/2024 at 11:15 AM, the emergency pull cord was blocked by a lobby chair and was not accessible for a patient to call for help in the event the patient fell on the floor. The chair remained in front of the call cord for two days until the surveyor moved the lobby chair. An interview with Staff # 4 on 06/11/2024 at 5:00 PM confirmed the pull cord was blocked by a lobby chair and was not accessible for a patient to call for help in the event the patient fell on the floor.”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to ensure quality control solutions (a liquid made up of water, glucose, and buffers used to test the function of the meter and test strips) and test strips (a band, piece, or strip of material used for biological testing) for the glucometers (a small device that measures how much sugar is in a blood sample) were dated when opened. The facility staff failed to follow the “EmbracePro Blood Glucose Monitor: Quality Control (QC)” policy. Findings include: During a tour of the facility treatment floor on the morning of 06/10/2024, the surveyor observed an open bottle of glucose test strips. The bottle was not labeled with a date of opening or the staff member’s initials that opened the test strip bottle. Also, a box of quality control solutions were expired with an expiration date of 06/06/2024. A review of the facility’s “EmbracePro Blood Glucose Monitor: Quality Control (QC)” policy dated 09/2020 revealed the following: “3. Do not use control solutions past expiration date. Discard control solutions 90 days after opening or on the expiration date printed on the bottle, whichever comes first. When opening a new control solution, write the open and discard dates on the side of the bottle along with teammate initials. 4. Do not use test strips past expiration date. Discard test strips four (4) months after opening or on the expiration date printed on the bottle, whichever comes first. When opening new test strips, write the open and discard dates on the side of the bottle along with teammate’s initials.” An interview was conducted with Staff #2 on the morning of 06/11/2024. Staff #2 confirmed that the glucose test strips were not labeled with a date of opening or with the staff member’s initials and that the quality control solutions were expired.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48749 Based on record review and interview, the Registered Nurse failed to complete the pre-treatment and post-treatment nursing assessments within one hour of treatment on 2 (# 1, # 4) of 5 patient medical records reviewed. Also, the facility staff failed to notify the Physician of abnormal vital signs on 1(#1) of 5 patient medical records reviewed. The facility staff failed to follow the “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. Findings Include: Patient # 1 A review of 1 of 6 treatment sheets for Patient # 1 revealed that a post-treatment nursing assessment was not completed within 1 hour of the patient’s treatment termination. A review of the treatment sheet dated 05/27/24 revealed Staff # 2 did not complete the post-treatment nursing assessment (documented on 05/27/24 at 11:39 AM) within 1 hour of the termination of treatment. Treatment ended on 05/27/24 at 9:56 AM. Further review of the treatment sheet dated 05/27/2024 revealed Staff # 22 charted the following vital signs: “7:03 AM: Blood Pressure (BP)- 215/82 7:05 AM: BP- 205/75 7:08 AM: BP- 209/83 7:33 AM: BP- 204/76 8:04 AM: BP- 218/86 8:05 AM: BP- 217/79 8:33 AM: BP- 203/68 9:56 AM: BP- 202/78 (Treatment termination)” Staff # 2 completed a post-treatment assessment and documented at 11:39 AM a BP of “190/71.” There was no documentation from Staff # 2 to support the Physician being made aware of the abnormal findings. The patient was discharged home with a blood pressure of “190/71” by Staff # 2. In addition, a review of the pre-treatment fluid calculation for the treatment sheet dated 05/27/2024 revealed the maximum ordered ultra-filtration rate was 13.0 milliliter(mL)/kilogram(kg)/hour(hr). The actual ultra-filtration rate post-treatment was 13.4mL/kg/hr. There was no documentation to support that a Physician was notified to obtain an order to change the ultra- filtration rate. Patient # 4 A review of 1 of 6 treatment sheets for Patient # 4 revealed that a pre-treatment nursing assessment was not completed within 1 hour of initiating the patient’s treatment. A review of the treatment sheet dated 05/20/2024 revealed Staff # 18 did not complete the pre-treatment nursing assessment (documented on 05/20/2024 at 12:43 PM) within 1 hour of the initiation of treatment. Treatment started on 05/20/2024 at 10:10 AM. Further review of the treatment sheet dated 05/20/2024 revealed that Staff # 18 did not verify the patient’s prescription (documented on 05/20/2024 at 12:43 PM) within 1 hour of the initiation of treatment. Treatment started on 05/20/2024 at 10:10 AM. A review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” dated 04/2024 revealed the following: “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. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge. 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law. 11. Abnormal findings or findings outside of any patient-specific physician-ordered parameters will be reported to the licensed nurse immediately (refer to the “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions, and patient response will be documented in the patient’s medical record. ABNORMAL FINDINGS: Unless other abnormal parameters are established by the facility’s Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient-specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Fluid Status: Pre-treatment: * Any weight loss from last post-weight * If unable to obtain patient weight, the nurse is to contact physician for orders * Removal goal not to exceed maximum ordered by physician Post-treatment: *If patient is above or below 1 kg from the target weight Blood pressure: Pre-dialysis: * Systolic greater than 180 mm/Hg or less than 90 mm/Hg * Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic: * Systolic greater than 180 mm/Hg or less than 90 mm/Hg * Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg * Signs/symptoms of hypotension may include: * Nausea and vomiting * Cold and clammy skin * Restlessness * Rapid, shallow respirations * Excessive yawning * Diaphoretic Blood Pressure Post Treatment: * If the patient can stand: * Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg * Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg * If patient is not able to stand, document reason and sitting BP * Sitting BP for patient’s that cannot stand: * Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg * Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg * Signs/symptoms of hypotension may include: * Nausea and vomiting * Cold and clammy skin * Restlessness * Rapid, shallow respirations * Excessive yawning * Diaphoretic * Dizziness * Feeling faint” An interview with Staff # 2 on 06/11/2024 at 3:00 PM confirmed the facility staff had not documented pre-nursing and post-nursing assessment times within the required time frame. Also Staff # 2 confirmed the facility staff did not notify the Physician for a patient with abnormal vital signs.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 29191 Based on observation and interviews, the facility staff failed to ensure that patient medical records information was properly safeguarded. Findings include: During a tour of the facility on 06/10/2024 at 12:04 PM, the surveyor observed two rolling metal racks of patient medical records. There were two 3-shelf rolling carts containing patient medical records. One of the metal doors was off the cart and propped against the glass of the isolation room. An interview with Staff #2 on 06/11/2024 at 12:30 PM was asked if the carts were left on the floor and unlocked. Staff #2 stated, “Yes”. Also, the surveyor pointed out that if the carts don’t lock due to observing a door was propped against the glass of the isolation; doesn’t that mean housekeeping has access to the patient’s medical records? Staff #2 stated, “Yes”. An interview with Staff #2 on 06/11/2024 at 12:30 PM confirmed the patient’s medical records were not safeguarded from the housekeeping staff that works in the facility after the staff had left for the evening.”