Putnam Dialysis LLC

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 03383 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis) using the RPC Ultra-Low Total Chlorine Test Strips, and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT BB) and one of one Licensed Practical Nurse (LPN DD) observed, who was assigned the task of testing the water quality, performed and validated, the Total Chlorine Test according to the manufacturer’s DFU. Residual levels of Total Chlorine in the water used for dialysis may result in hemolysis (destruction of patient’s red blood cells). The facility also failed to ensure solutions used to calibrate the Phoenix XL meter and the Myron L meter [Devices used to measure pH (acidity) and conductivity (ability to conduct electricity) of dialysis solution] were not expired, to ensure accuracy of tests for pH and conductivity to ensure that the dialysis solution is safe for use. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, and chest pain) could result if dialysate composition is incorrect. And if conductivity is off, the effectiveness of the treatment is reduced, and patient electrolyte balance could be altered. This failure could affect the health and safety of 32 in-center hemodialysis patients who dialyzed at this facility. Findings include: Cross References: V196 - Failure of the facility to ensure testing for chlorine was done according to manufacturer’s recommendations and per facility policy. V 250 - Failure of the facility to ensure solutions used to calibrate the Phoenix XL meter and the Myron L meter were not expired to ensure accuracy of test for pH and conductivity to ensure that the dialysis solution is safe for use.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 03383 Based on observations, facility record review, staff interviews, a review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedure, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 32 in-center hemodialysis patients who received dialysis at this facility. Findings include: Cross References: V196 - Failure of the facility to ensure testing for chlorine was done according to manufacturer’s recommendations and per facility policy. V 250 - Failure of the facility to ensure solutions used to calibrate the Phoenix XL meter and the Myron L meter were not expired to ensure accuracy of test for pH and test for conductivity to ensure that the dialysis solution is safe for use. V403: Failure of the facility to ensure that two of two pHoenix XL meters [Devices used to measure pH (acidity) and conductivity (ability of the dialysate to conduct electricity)] were maintained and operated in accordance with the manufacturer’s recommendations; and three of three out-of-order back-up dialysis machines were maintained in safe and functional working condition.”

“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: 03383 Based on observation, staff interview, and a review of facility policy, it was determined that the Infection Control Committee failed to ensure that Direct Patient Care Staff cleaned and disinfected one of one dialysis chair [in Station (S) 1] that had visible blood, immediately or as soon as possible. This breach in infection control could lead to transmission of bloodborne pathogens (such as hepatitis B virus) and other infections from one patient to another in hemodialysis units. The facility had 32 in-center hemodialysis patients. Findings include: During observation in the patient treatment area on 10/16/24 at 1:15 p.m., the following was revealed: - The dialysis chair at S9 had brownish red substance/drips that appeared to be dried blood on the left side panel (leather) of the chair. - The station had been cleaned, set-up and ready for use for the next shift patient. This surveyor informed Patient Care Technician (PCT) DD of the above findings on 10/16/24 at 1:17 p.m. PCT DD stated that stains could be blood or Betadine (iodine). PCT DD cleansed the side of chair with bleach solution and the reddish-brown substance wiped clean. (Dried Betadine cannot be removed from leather because iodine affects the hide of leather and cannot be removed). A review of Policy 01-700 titled, “Disinfection” dated 5/18/202 showed: - The bleach solution will have at least a five (5) minute contact time as per manufacturer’s recommendation for external disinfection of non-disposable items, dialysis machines, dialysis chairs and related surfaces. - Complete surface disinfection at the end of each dialysis treatment after the patient has vacated the station. - 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... - Clean chair by placing in the reclining position and swing arms out (if applicable) to clean seat, footrest, backrest and sides, armrest, inside of chair arms and chair frame and side tray tables. Return chair to its upright position when cleaning is complete. - Visible blood: Utilize a two-step process to clean and disinfect.”

“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: 03383 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis) using the RPC Ultra-Low Total Chlorine Test Strips, and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT BB) and one of one Licensed Practical Nurse (LPN DD) observed, who were assigned the task of testing the water quality, performed and validated, the Total Chlorine Test according to the manufacturer’s DFU. Residual levels of Total Chlorine in the water used for dialysis may result in hemolysis (destruction of patient’s red blood cells) and had the potential to cause harm to 32 in-center hemodialysis patients who dialyzed at this facility. Findings include: During observation of the chlorine testing on 10/16/24 at 1:30 p.m. and on 10/17/24 at 4:38 p.m., the following was revealed: - PCT DD was observed performing chlorine testing of RO (Reverse Osmosis) water on 10/16/24 at 1:30 p.m. The feed water temperature was 76° F. PCT DD informed this surveyor that she would need to swish the test strip for 20 seconds. However, PCT DD did not use a clock or a timer to count out the seconds. PCT DD compared the strip to the color chart immediately and did not wait for 20 seconds per manufacturer’s instructions. On 10/16/24 at approximately 1:35 p.m., PCT DD stated that she was counting in her head. - On 10/17/24 at 4:38 a.m., LPN AA was observed while she tested the RO water for chlorine. The feed water temperature was 80° F. LPN AA informed this surveyor that she would need to swish the test strip for 30 seconds. However, the manufacturer’s DFU showed that swish time should be 20 seconds. LPN AA used her watch and swished for 30 seconds. LPN AA compared the strip to the color chart immediately and did not wait for 20 seconds per manufacturer’s DFU with result of 0.02 mg/L (milligrams per liter). LPN AA allowed the RO system to run for approximately 10 minutes and rechecked the chlorine at 4:51 a.m. using the exact same method as described at 4:38 a.m. with result of 0.02 mg/L. LPN AA rechecked the water for chlorine from a different site which she indicated that Biomed told her to check (from TP10) using the same technique as described at 4:38 a.m. At this time, LPN AA obtained a result of 0.0 mg/L. The Facility Administrator was informed on 10/18/24 at 11:30 a.m., that PCT DD and LPN AA did not follow the manufacturer’s DFU when testing the water for chlorine. A review of the “RPC Manufacturer’s Instructions for Ultra-Low Total Chlorine Test Strips” showed the following: Test Procedure: - Collect a fresh I00 ml (milliliter) sample of water in a clean plastic sample cup. A. The sample cup should be known to be free of chlorine or, prior to collecting the sample, rinse the clean sample cup with the water to be tested. B. Be sure to collect the sample just prior to performing the test as Chlorine tends to volatilize out of the sample quickly. Remove one test strip from its foil package and swish it in the sample for the amount of time indicated according to the following temperature ranges: - Water sample temperature from 42° F (Fahrenheit) to 61° F (6° C [Celsius] to 16° C), swish time = 60 seconds. - Water sample temperature from 62° F to 74° F (17° C to 23° C), swish time = 32 seconds. - Water sample temperature from 75° F to 88° F (24° C to 31° C), swish time = 20 seconds. - Water sample temperature from 89” F to 93° F (32° C to 34° C), swish time = 15 seconds. Move the strip back and forth at a constant gentle rate of approximately two, 1-2 inch wide strokes (one forward - one backward) per second. Remove the strip and shake once, briskly, to remove excess water. Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it provides a consistent viewing background. After the 20 second wait period, immediately compare the strip color to the KI00-0118 or Kl 00-0 I l8F color chart to determine the Total Chlorine level in the sample. A review of policy titled, “Chlorine/Chloramine Testing and Breakthrough” dated 4/1/18 showed the following: Tests for total chlorine, which include both free and combined forms of chlorine, may be used as a single analysis with the maximum allowable concentration of 0.1 mg/liter. Test results of greater than 0.5 parts per million (ppm) for chlorine or 0.1 ppm for chloramine from the port between the initial tank(s) and final tank(s) shall require testing to be performed at the final exit and replacement of the initial tank(s). Testing equipment, supplies and procedures shall be used in accordance with the manufacturer’s directions for use.”

“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: 03383 Based on observation, staff interviews, and a review of Policy and Procedures, it was determined that the facility failed to ensure solutions used to calibrate the pHoenix XL meter and the Myron L meter [Devices used to measure pH (acidity) and conductivity (ability to conduct electricity) of dialysis solution] were not expired, to ensure accuracy of test for pH and test for conductivity and ensure that the dialysis solution was safe for use. Conductivity and pH of dialysate are measurements used to verify proper proportioning of acid concentrate, bicarbonate concentrate and treated water. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, and chest pain) could result if dialysate composition is incorrect. And if conductivity is off, the effectiveness of the treatment is reduced, and patient electrolyte balance could be altered. This failure could affect the health and safety of 32 patients who dialyzed at this facility. Findings include: During a tour of the facility with the Administrative Assistant (AA) on 10/16/24 between 9:00 a.m. and 9:45 a.m., the following expired supplies were discovered: In the Water Treatment Room: - One bottle of CalRite QC Standard Solution 7.00 pH Standard Buffer Solution had a piece of tape with dates written on it by a staff and was applied to the side of bottle above the label that showed an opening/first use date of 5/20/24 and an expiration date of 8/20/24. - One bottle of CalRite QC Standard Solution 14.0 mS/cm Conductivity Solution with a written opened date of 6/10/24 and an expiration date of 9/10/24. - One ProbeRite Sensor Cleaning Solution with a written opened date of 7/20/24 and an expiration date of 9/20/24. Upon further inspection, when the AA lifted the bottles, it was revealed that the expiration date on the bottle of CalRite QC Standard Solution 7.00 pH Standard Buffer Solution was 2/28/24; the expiration date on the bottle of CalRite QC Standard Solution 14.0 mS/cm Conductivity Solution was 1/28/24; and the expiration date of ProbeRite Sensor Cleaning Solution was 2/28/27. A review of the manufacturer’s directions for use on the bottles revealed that the solution used for conductivity should be discarded 30 days after opening or expiration date - whichever comes first; and the pH Buffer Solutions must be discarded 90 days after opening or expiration date - whichever comes first. Thus, the solutions were not only expired, but they were used after the 30-day shelf life after opening. The AA stated on 10/16/24 at approximately 9:15 a.m., that the solutions were used to calibrate the pHoenix XL Meter. - One bottle of CalRite QC Standard Solutions 15 ppm 23.8 uS/cm Fresh Water TDS Solution “442” was found next to Myron L meter with an expiration date of 9/28/24. - One bottle of CalRite QC Standard Solution 14.0 mS/cm Conductivity Solution with tape applied above label with a written opening/first use date of 6/9/24 and an expiration date of 9/9/24. However, the expiration date on the bottle was 8/28/24. The solution was not only expired, but it was being used beyond the 30-day shelf life after it was opened. These solutions were used to calibrate the Myron L meter. In the Biomed Room: - One bottle of Myron L Company NIST Traceable TDS/Conductivity Standard Solution 442-1500 that expired 6/2/23. - One bottle of CalRite QC Standard Solution 14.0 mS/cm Conductivity Solution with tape applied above label with a written opening/first use date of 6/9/24 and an expiration date of 9/9/24. However, an expiration date on the bottle was 8/28/24. Again, this solution was not only expired, but it was being used beyond the 30-day shelf life after it was opened. - CalRite QC Standard Solution 150 ppm and 228 u/S Fresh Water TDS Solution “442” that expired 9/28/24. - Five bottles of CalRite QC Standard Solution 7.00 pH Standard Buffer Solution that expired 2/28/24. - Six bottles of CalRite QC Standard Solution 14.0 mS/cm Conductivity Solution that expired 1/28/24. - Two bottles of CalRite QC Standard Solution 15 ppm 23.8 uS/cm Fresh Water TDS Solution “442” that expired 2/28/24. - Three bottles of CalRite QC Standard Solutions 30 ppm 46.7 uS/cm Fresh Water TDS Solution “442 that expired 7/28/24. - Two bottles of CalRite QC Standard Solution 10.00 pH Standard Buffer Solution that expired 7/28/24. - Two bottles of CalRite QC Standard Solution 4.00 pH Standard Buffer Solution that expired 9/28/24. - Five bottles of CalRite QC Standard Solution 1.0 mS/cm Conductivity Solution that expired 7/28/24. In the Patient Treatment Room: - One bottle of CalRite QC Standard Solutions 15 ppm 23.8 uS/cm Fresh Water TDS Solution “442” with an expiration date of 9/28/24 was found on a counter in the treatment area. The AA confirmed the discovery of all of the expired solutions listed above during the tour of the facility on 10/16/24 between 9:15 a.m. and 9:45 a.m. The AA stated that these solutions must have arrived at the facility expired because they have not had them for very long. The Facility Administrator was informed about the expired solutions on 10/16/24 at 9:50 a.m. and stated that all expired solutions would be discarded. During observation in the Water Treatment Room on 10/17/24 at 5:39 a.m., with Licensed Practical Nurse (LPN) AA, the following was revealed: The bottle of CalRite QC Standard Solution 7.00 pH Standard Buffer Solution with an expiration date of 2/28/24 and the bottle of CalRite QC Standard Solution 14.0 mS/cm Conductivity Solution with an expiration date of 1/28/24 that were discovered in the Water Treatment Room on 10/16/24, had not been discarded and was still available for use. LPN AA acknowledged that the solutions were expired based on the tape that indicated an opening date of 5/20/24 and an expiration date of 8/20/24 for the pH solution; and an opening date of 6/10/24 and an expiration date of 9/10/24 for the conductivity solution. The bottles of expired solution were not discarded as the Facility Administrator stated they would be on 10/16/24 at 9:50 a.m. LPN AA searched around and found bottles of pH and conductivity solutions. The expired solutions were discarded and were replaced with solutions that expire 1/13/25. On 10/17/24 at 8:10 a.m., the Facility Administrator was informed about the expired solutions found in the Water Treatment Room on 10/16/24 that were not discarded. The Facility Administrator stated they stayed late discarding the expired solutions found and must have missed those solutions. A review of Policy 05.500 titled, “Discard/Expiration Date Information” dated 4/1/18 showed the following: Phoenix Meter Solutions: Shelf Life of Opened Bottles: - Conductivity: 30 days after opening or expiration date-whichever comes first; - pH Buffer Solutions: 90 days after opening or expiration date-whichever comes first. Myron L conductivity solution: 30 days after opening or expiration date-whichever comes first.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 03383 Based on observation and staff interview, it was determined that the facility failed to ensure that there was a safe environment for all patients and staff, as evidenced by failure of the facility to ensure that one of one door (double doors) in the Supply Room, was maintained to prevent entry of insects and vermin. Findings were: During a tour of the facility with the Administrative Assistant (AA) on 10/16/24 at 9:00 a.m., the following was observed: The double doors in the Supply Room that led to the outside had approximately 1/4 inch - 1/2 inch gap between the double doors and the floor (24 inches width across the left door, 1/2 inch in the middle, and 12 inches across the right door) that could allow insects and vermin to enter the building. The AA confirmed the above findings on 10/16/24 at 9:15 a.m. A re-inspection of the double doors on 10/17/23 at 1:00 p.m. showed unrepaired gap between the doors and 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: 03383 Based on observation, staff interviews, a review of pHoenix XL User’s Guide and Policy and Procedures, it was determined that the facility failed to ensure that two of two pHoenix XL meters [Devices used to measure pH (acidity) and conductivity (ability of dialysate solution to conduct electricity) were maintained and operated in accordance with the manufacturer’s recommendations. This failure resulted in delayed treatments as patients could not be dialyzed until pH and conductivity were verified to be safe for dialysis. The facility also failed to ensure that three of three back-up dialysis machines were maintained in safe and functional working condition. The lack of back-up dialysis machines that were readily available for use had the potential to cause more treatment delays that could negatively affect the health and safety of 32 in-center hemodialysis patients who dialyzed at this facility. During a tour of the facility on 10/16/24 at 9:00 a.m., the Administrative Assistant stated that the facility had a part time Biomed Technician (BMT) and was in the process of hiring a BMT. During observation in the Patient Treatment Room on 10/17/24 at 5:06 a.m., LPN AA obtained a pHhoenix XL meter to check the machine at Station 6. LPN AA did not find the calibration solution in the treatment area and carried the pHoenix meter to the Bicarb (Bicarbonate) Room. LPN AA hooked up the meter to expired CalRite QC Standard Solution 7.00 pH and experienced problems with calibration. The pH registered at 7.6 and then stopped working (did not show further readings for pH). Another pHoenix XL meter was found in a holder in the Bicarb Room. LPN AA stated the second meter was broken; the handle was frozen and did not work. LPN AA stated that the current BMT said the pHoenix meter was out of date. The label in the back of both meters showed annual preventive maintenance expiration date of 4/12/23. LPN AA voiced frustration with non-functioning equipment and the inability to get supplies. LPN AA stated she was not sure if the meters had been calibrated prior to use since she was having problems with calibrating for pH. LPN AA also stated the BMT from home office informed them during his last visit in September 2024, that the pHoenix meters were outdated but stated that staff could continue to use them. LPN AA also stated that the second pHoenix meter was already broken when the BMT visited this facility in September. On 10/17/24 at 5:27 a.m., PCT JJ joined LPN AA in the Bicarb Room and assisted with the calibration of both pHoenix meters without success. LPN AA stated that the BMT used to come to this facility two days a week but has stopped coming to this facility. Stated that the prior BMT passed about six months ago, and they also started having problems with getting supplies. The Facility Administrator was contacted by the charge nurse at 5:54 a.m. on 10/17/24. PCT JJ left the facility and picked up Phoenix meters from another facility in a city that was approximately 30 minutes away. PCT JJ returned to this facility with two Phoenix meters at 7:05 a.m. The meters were calibrated without issues and the final dialysate was checked at each station. Treatments were delayed as patients could not be dialyzed until pH and conductivity were checked. The current BMT traveled to this facility from home office located in Florida and was interviewed on 10/17/24 at 8:33 a.m. The BMT stated that the facility lost their BMT two months ago along with the previous Administrator (both were deceased), and they were in the process of finding another BMT. Stated he has only been at this facility once (in September 2024). When this surveyor asked about the three back-up machines that were out-of-service and in need of repairs, the BMT stated that a BMT who resides locally but works for multiple companies was asked to come in to repair the machines but has not made it to the facility. The BMT also revealed that he was aware of the outdated pHoenix meters. However, there was a lack of documented evidence that the BMT addressed the issues to resolve the problems. On 10/17/24 at 1:20 p.m., the Facility Administrator was notified of the three out-of-service back-up dialysis machines that were in need of repairs and two pHoenix meters that were outdated and non-functional. The Facility Administrator indicated they would see if they could keep the meters obtained from another facility, or at least hold on to one of them. She also stated that she would ask the current BMT if he could repair the back-up machines. During the exit interview on 10/18/24 at 1:15 p.m., the Facility Administrator asked the BMT if he could repair the back-up machines, but the BMT did not say he would definitively. A review of the “pHoenix XL User’s Guide” showed the following: Under normal meter usage and storage conditions, the pH component is expected to last for 12 months. The length of time can be greater than 12 months or it can be shorter than 12 months if the measurement module is not rinsed and stored as directed after use. The pH function of the pHoenix XL relies upon a component in the measurement module which contains undissolved potassium chloride. As the measurement module is used during daily verifications, the amount of this salt will decline overtime. When the potassium chloride in the measurement module component is depleted, the result is an unstable pH reading and inability to properly calibrate and/or verify pH with the meter. This result indicates a replacement measurement module should be installed on the pHoenix XL handle. A review of Policy 01.600 titled, “Routine Maintenance on Dialysis Equipment” dated 1/1/17 showed the following: Proper machine maintenance done by qualified dialysis biomed technicians will help to ensure patient safety and to ensure all equipment has an accurate account of all preventive maintenance and repairs performed on it ... 3. All repairs and calibration of dialysis equipment will be performed in accordance with the manufacturer’s recommendations and specifications.”

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 03383 Based on a review of medical records, staff interviews, and review of facility policy, it was determined that the social worker failed to complete the KDQOL-36 (Kidney Disease Quality of Life 36-item survey: a patient-reported outcome measure for patients on dialysis) which were directed toward supporting the patient’s psychosocial needs in two of five patients (P) (P#5 and P#3) sampled. This failure could hinder the development of an effective treatment plans to support the psychosocial needs of P#5 and P#3. The facility census was 33. Findings include: This surveyor requested KDQOL-36 for P#5 on 10/18/24 at approximately 9:15 a.m. and the Administrative Assistant stated she could not find one for this patient. P#5’s medical record was reviewed with the Facility Administrator and Regional Director of Nursing on 10/18/24 at 9:59 a.m. The Facility Administrator made a telephone call to the Social Worker (SW) and discussed the missing KDQOL for P#5. The SW confirmed that KDQOL was not completed for this patient. P#5 was admitted to the facility on 10/23/23. A review of P#3’s medical record showed that P#3 was admitted to this facility on 2/10/24. There was a blank KDQOL and an entry made by the SW dated 10/16/24 that showed KDQOL was offered to the patient on 8/20/24 (over six months after first treatment). A review of the “Progress Notes” lacked documentary evidence that the SW followed up on completion of KDQOL or offered assistance with completion of KDQOL per facility policy. During a telephonic interview on 10/18/24 at 9:59 a.m., the SW stated that she did not realize she could assist patients with KDQOL but would begin doing this. A review of Policy 02.110 titled “Quality of Life KDQOL 36” dated 4/1/18 showed the following: Questionnaires should be administered initially and annually for all patients or more frequently as determined by the facility or as needed by the patient. All new patients shall complete the SF-36 survey at regular intervals which means that the assessment survey is administered by the time of the first patient reassessment (within 4 months of initiating treatment) and repeated at least annually. Questionnaires are to be completed by the patient whenever possible with assistance from the Management Team, legal guardian, family member, or significant other if necessary. Completed questionnaires are to be forwarded to the Facility.”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 03383 Based on a review of facility records, staff interviews, and review of Policy and Procedures, it was determined that the facility failed to monitor indicators or performance measures that included safe machine maintenance and repairs, in six of six months (March 2024 - August 2024) of Continuous Quality Assessment and Performance Improvement Plan (CQAPI) meeting minutes reviewed. This deficient practice resulted in unrepaired three of three back up dialysis machines; and a lack of annual preventive maintenance for two of two non-functioning pHoenix XL meters (Devices used to measure pH (acidity) and conductivity (ability of the dialysate to conduct electricity). Findings include: A review of the CQAPI meeting minutes from March 2024 to August 2024 revealed a lack of data that monitored equipment preventive maintenance and repairs. It was also revealed that a Biomed Technician (BMT) has not attended the CQAPI meeting since December 2023. During an interview on 10/18/24 at 9:10 a.m., the Facility Administrator stated the interdisciplinary team will work toward including machine maintenance and repairs in CQAPI. The Facility Administrator indicated that the previous BMT passed in June 2024 and the facility was in the process of recruiting a BMT to fill the position. The facility had issues with dialysis equipment as well as securing supplies. A review of policy 02-300 titled, “Continuous Quality Assessment and Performance Improvement Plan (CQAPI)” dated 4/1/18 showed the following: The scope of the CQAPI program may include monitoring of: Equipment preventive maintenance and repair Cross reference: V403 - Failure of the facility to implement and maintain a program to ensure that all equipment including dialysis machines and pHoenix meters were maintained and operated in accordance with the manufacturer’s recommendations.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 03383 Based on a review of records, staff interview, and a review of policy, it was determined that the facility failed to conduct and include patient satisfaction surveys in six of six months (March 2024 - August 2024) of Continuous Quality Assessment and Performance Improvement Plan (CQAPI) meeting minutes reviewed. This deficient practice did not allow for identification of opportunities to improve the care for 32 in-center hemodialysis patients and one peritoneal dialysis patient who received dialysis services at this facility. Findings include: A review of the CQAPI meeting minutes from March 2024 to August 2024 revealed a lack of patient satisfaction surveys. During an interview with the Facility Administrator on 10/18/24 at 9:10 a.m., it was revealed that the facility has never conducted patient satisfaction surveys. The Facility Administrator stated the interdisciplinary team will work toward including patient satisfaction surveys in CQAPI. A review of policy 02-300 titled, “Continuous Quality Assessment and Performance Improvement Plan (CQAPI)” dated 4/1/18 showed the following: RESPONSIBILITY: Medical Director, All Facility Personnel, Director of Nursing, Dietician, Home Training Nurse, Biomed Technician, Social Worker The scope of the CQAPI program includes monitoring of clinical performance measures as well as patient satisfaction, patient quality of life (Facility Specific), and other quality indicators as per the CQAPI Indicators as developed by the facility. The scope of the CQAPI program may include monitoring of: Patient Satisfaction and Grievances”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 03383 Based on a review of the facility’s Fiscal Year (FY) 2025 Dialysis Facility Report (DFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients), a review of facility records, and staff interview, it was determined that the Continuous Quality Assessment and Performance Improvement (CQAPI) Committee failed to track, trend, analyze, and develop plans of action to improve and sustain the facility’s Dialysis Adequacy, Anemia Management, Mineral Metabolism and Bone Disorder, and Vascular Access Management for six of six months (March 2024 - August 2024) of CQAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the patient outcomes for 32 in-center hemodialysis (ICHD) patients and one peritoneal dialysis (PD) patient who were receiving dialysis services at this facility. Findings include: A review of the FY2025 Quarterly DFR, (third quarter 2023), revealed that the facility was above the United States (US) threshold in: 1. Dialysis Adequacy - Kt/V (a number used to quantify hemodialysis treatments) less than (<) 1.2) - this facility was 5.3 % whereas, US was 2.1 %. 2. Mineral Metabolism and Bone Disorder - (Phosphorus greater than (>) 7.0) - facility was 21.9 % whereas US was 12.6 %. 3. Anemia [Hemoglobin (a protein containing iron that facilitates the transport of oxygen in red blood cells) < 10.0] - facility was 40.9 % for ICHD and 35.7 for PD whereas, US was 26.2 %. 4. Vascular Access (Long-Term Catheter Rate) - facility was 82.8 % whereas, US was 10.7 %. In Comparison, a review of the facility’s last six months of CQAPI meeting minutes from December 2023 - June 2024, (the Facility Administrator explained that the January and February CQAPI meeting was combined) revealed the following outcomes that were greater than the US threshold: Specifically, 1. Dialysis Adequacy (The effectiveness of dialysis prescriptions to avoid symptoms of uremia measured by Kt/V) - The percentage of patients with Kt/V < 1.2 ranged between 7.14% (August) and 30% (in June). 2. Mineral Metabolism and Bone Disorder - The percentage of patients with Phosphorus >7.0 ranged could not be determined since the facility did not monitor Phosphorus >7.0. This facility was monitoring Phosphorus <3.4 and >5.6. 3. Anemia - The percentage of patients with Hemoglobin < 10.0 ranged between 21.21 % (lowest in April) and the highest at 56.25 % in June, fluctuated down to 25.81 % in July, and increased to 55.17 % in August. 4. Vascular Access - Long Term Catheter Rate, equal to or greater than (=/>) 90 days. The percentage of patients using a Central Venous Catheter (CVC) =/> 90 days ranged could not be determined since the facility was not monitoring (CVC) =/> 90 days. This quality indicator was not included in QAPI. In addition, the facility was not monitoring albumin < 4; the facility was monitoring albumin < 3.4 and >4; the facility no longer monitored uncorrected calcium >10 since April 2024; and the UFR (Ultrafiltration - fluid removal) > 13 ml/Kg/hr (milliliter per kilogram per hour) was not monitored. The plans of correction for the outcomes that were addressed in CQAPI meetings were formulated but were not evaluated nor updated or revised, when they were not effective for the outcomes to improve and be sustained. The Facility Administrator stated on 10/18/24 at approximately 9:10 a.m., that the IDT will work toward improvement of these outcomes. A review of policy 02-300 titled, “Continuous Quality Assessment and Performance Improvement Plan (CQAPI)” dated 4/1/18 showed the following: RESPONSIBILITY: Medical Director, All Facility Personnel, Director of Nursing, Dietician, Home Training Nurse, Biomed Technician, Social Worker. - The Facility will compare their specific data to network or national data to assess, identify, analyze, correct, and monitor real or potential problems and/or trends. - The Facility Committee meet monthly under the supervision of the Facility GB (Governing Body). At this meeting, the Quality Indicators identified by Facility are measured. Results of these measurements are reviewed at the facility with comparison to optimal standards set by the National and Network pre-determined goals. - The scope of the CQAPI program includes monitoring of clinical performance measures as well as patient satisfaction, patient quality of life (Facility Specific), and other quality indicators as per the CQAPI Indicators as developed by the facility.”