Regency Dialysis Center

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 30177 Based on observation, staff interview, review of the facility’s documents, medical record review, manufacturers’ instructions for use and policy review, the facility failed to meet the Condition for Coverage (CfC) for Water and dialysate quality when it; 1) failed to take action on the laboratory’s feedback regarding specimens exceeding the 24-hour holding time for nine months V179); 2) failed to replace cartridge filters (Filters used to remove impurities and particles) every six months according to the manufacturer’s instructions (V189); 3) failed to ensure two of two staff members responsible for conducting the total chlorine testing in hemodialysis water adhered to the MDFU (V196); 4) failed to ensure the Biomedical Technician (BMT) changed the vent air filter located on the water storage tank on a regular schedule according to the manufacturer’s instructions. In addition, there was no documented evidence that the water storage tank was drained and disinfected (V209); 5) failed to implement safety procedures and controls for storage of acid concentrate after delivery, protect stored acid drums from tampering and contamination, store acid per manufacturer’s instructions and ensure staff responsible for transferring acid were trained in acid concentrate transfers (V222); 6) facility failed to ensure Biomedical Technician (BMT) 2, who was assigned responsibility for in-servicing employees on the proper operation and utilization of dialysis equipment and systems, including preventative maintenance of these systems, demonstrated competency in following the manufacturer’s instruction for use (IFU) for the Bicarbonate system (V226); 7) failed to label the acid concentrate storage and dispensing tank to identify the chemical composition or formulation of its contents correctly. The failure to permit identification of the bulk storage and dispensing tanks’ contents had the potential to lead to inadvertently mismatching dialysate components (V228); 8) failed to ensure written policies and procedures indicating adherence to equipment manufacturers’ instructions for use (IFU) were developed and implemented (V259); 9) facility failed to implement an ongoing training program designed to evaluate staff’s proficiency and maintain the operator’s knowledge, which includes periodic observation of skills for five of five staff members (Certified Clinical Hemodialysis Technician (CCHT) 1, CCHT2, CCHT3, CCHT4, and Patient Care Technician (PCT)) who were assigned the responsibility for Acid Concentrate (V260). The cumulative effects of multiple and pervasive deficient practices in water and dialysate quality, as well as the facility’s non-compliance with adherence to the manufacturer’s instruction for use and the facility’s policy regarding verification of potential hydrogen (pH), has resulted in a significant risk of harm and injury to all 66 in-center hemodialysis patients currently receiving in-center hemodialysis treatment in this facility. The facility was notified of the Immediate Jeopardy (IJ) on 9/17/24 at 6:05 PM. In concurrence with New York State’s survey agency review, the removal plan was approved on 09/19/24 at 5:36 PM. Upon exit, 09/20/24, the IJ was ongoing. Findings include: 1. The facility failed to take action on the laboratory’s feedback regarding specimens exceeding the 24-hour holding time for nine months. Refer to 179. 2. The facility failed to replace cartridge filters (Filters used to remove impurities and particles) every six months according to the manufacturer’s instructions. Refer to 189. 3. The Facility failed to ensure two of two staff members responsible for conducting the total chlorine testing in hemodialysis water adhered to the MDFU. Refer to V196. 4. The facility failed to ensure the Biomedical Technician (BMT) changed the vent air filter located on the water storage tank on a regular schedule according to the manufacturer’s instructions. In addition, there was no documented evidence that the water storage tank was drained and disinfected. Refer to V209. 5. The facility failed to implement safety procedures and controls for storage of acid concentrate after delivery, protect stored acid drums from tampering and contamination, store acid per manufacturer’s instructions and ensure staff responsible for transferring acid were trained in acid concentrate transfers. Refer to V222). 6. The facility failed to ensure Biomedical Technician (BMT) 2, who was assigned responsibility for in-servicing employees on the proper operation and utilization of dialysis equipment and systems, including preventative maintenance of these systems, demonstrated competency in following the manufacturer’s instruction for use (IFU) for the Bicarbonate system. Refer to V226. 7. The facility failed to label the acid concentrate storage and dispensing tank to identify the chemical composition or formulation of its contents correctly. The failure to permit identification of the bulk storage and dispensing tanks’ contents had the potential to lead to inadvertently mismatching dialysate components. Refer to V228. 8. The facility failed to ensure written policies and procedures indicating adherence to equipment manufacturers’ instructions for use (IFU) were developed and implemented. Refer to V259. 9. The facility failed to implement an ongoing training program designed to evaluate staff’s proficiency and maintain the operator’s knowledge, which includes periodic observation of skills for five of five staff members (Certified Clinical Hemodialysis Technician (CCHT) 1, CCHT2, CCHT3, CCHT4, and Patient Care Technician (PCT)) who were assigned the responsibility for Acid Concentrate. Refer to V260.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 30177 Based on observation, interview, review of the facility’s documents, and review of Manufacturer’s Instructions for Use and review of facility policies, the facility failed to meet the Condition for Coverage (CfC) for Physical Environment when it: 1.Failed to maintain the integrity of surfaces and maintain equipment in good repair in the water treatment area, patient treatment area, and clean supply storage area. 2. Failed to maintain and provide a safe environment for dialysis patients and staff. 3. Failed to ensure preventive maintenance and repair of all equipment was completed in accordance with the equipment manufacturer’s instructions. The cumulative effects of non-compliance, multiple and pervasive deficient practices in the maintenance of the physical environment, and/or equipment created environmental concerns likely to impact the health and safety of patients and staff. Failure to meet the CfC for Physical Environment created a patient safety hazard and had the potential to negatively affect all 66 in-center hemodialysis patients receiving care in this facility. Findings include: 1. The facility failed to provide a safe environment for dialysis patients and staff when the entrance door was propped open with a rock, potentially allowing unauthorized individuals, insects, or animals to enter the facility and create a hazard for three (09/16/24, 09/17/24, and 09/18/24) of the five treatment days. Refer to V401. 2. The facility failed to maintain the integrity of surfaces and equipment in good repair in critical areas such as the water treatment area, patient treatment area, and clean supply storage area. Refer to V402. 3. The facility failed to maintain the hemodialysis machines per the manufacturer’s Instruction for Use (IFU) by failing to replace 12 of 14 hemodialysis machines’ “Diasafe Plus” filters every 12 weeks. Refer to V403.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 30177 Based on observation and interviews, the facility failed to meet the Conditions for Coverage (CfC) for Governance. The facility failed to provide proper oversight of its operations, and there were concerns with patient safety, water and dialysate quality, physical environment, and staff training. This failed practice led to non-compliance with multiple CFCs, which had the potential to harm all 66 patients receiving in-center treatments at this facility. Findings include: 1. The facility failed to meet the CfC for Water and Dialysate Quality. It failed to implement safety procedures and controls for storing acid concentrate (acidic concentrate used for dialysis) after delivery, protect stored acid drums from tampering and contamination, store acid per manufacturer’s instructions, and ensure staff responsible for transferring acid were trained in acid concentrate transfers (Refer to V175). 2. The facility failed to meet the Condition for Coverage (CfC) 494.30 for Physical Environment when it failed to maintain the integrity of surfaces and maintain equipment in good repair in the water treatment area, patient treatment area, and clean supply storage area, failed to maintain and provide a safe environment for dialysis patients and staff, and failed to ensure preventive maintenance and repair of all equipment was completed in accordance with the equipment manufacturer’s instructions. (Refer to V400). 3. The facility failed to establish an identifiable governing body to ensure oversight of the facility operations. (Refer to 751).”

“BACT OF H20-MEDICAL DIRECTOR RESPONSIBLE CFR(s): 494.40(a) 4.1.2 Bacteriology of water: med dir resp The facility medical director is responsible to ensure the manufacturer or supplier of a complete water treatment and distribution system demonstrates that the complete water treatment, storage, and distribution system is capable of meeting these requirements at the time of installation Following installation of a water treatment, storage, and distribution system, the user is responsible for continued monitoring of the water bacteriology of the system and for complying with the requirements of this standard, including those requirements related to action levels. This Standard is not met as evidenced by: 30177 Based on interview and review of the facility’s documents, the facility failed to take action on the laboratory’s feedback regarding specimens exceeding the 24-hour holding time for nine months (January - September 2024). This oversight had the potential to skew the accuracy of the lab results, posing a potential risk to all 66 in-center hemodialysis patients under the facility’s care. Findings include: Review of water chemical analysis and microbial testing from January to September 2024 revealed that monthly specimen results contained an alert from the laboratory indicating “Specimen has exceeded holding time of 24 hours.” In an interview on 09/17/24 at 11:30 AM, Biomedical Technician (BMT) 2 was shown the chemical analysis and microbial testing from January - September 2024 and asked to define the lab’s comment, “Specimen has exceeded holding time of 24 hours.” BMT2 stated that the lab likely received the specimen after 24 hours of the collection time. A request was made for a policy on collecting and packaging water samples. BMT2 stated that the facility did not have a policy for collecting and packaging water samples. A request was made for BMT2 to contact the laboratory for clarification on the laboratory’s feedback. During a phone conversation with the laboratory, the laboratory analyst stated due to the specimen exceeding 24 hours, they could not guarantee the results. In an interview with Dialysis Consultant 1 on 09/17/24 at 1:00 PM, they were asked about policies related to collecting water samples. Dialysis Consultant 1 stated that the facility had not developed or implemented policies related to collecting water samples. When asked who was responsible for developing and ensuring the policies and procedures were implemented, Dialysis Consultant 1 stated that they were responsible. In an interview with the Clinical Manager on 09/17/24 at 1:30 PM, he/she was shown the water sample laboratory results from January - September 2024 and confirmed the comments for each month. They were asked if the laboratory’s warnings about specimens surpassing the 24-hour holding time for nine months were addressed by the Medical Director. The Clinical Manager replied, “No.” The Clinical Manager agreed that the feedback from the laboratory should have been addressed by the BMT and the Medical Director and reported to Quality assessment and performance improvement (QAPI).”

“CARTRIDGE FILTERS-CONFIG & MONITORING CFR(s): 494.40(a) 5.2.3 Cartridge filters: config and monitoring The cartridge is contained within an opaque filter housing with seals to separate the feed and product water streams. When the maximum [pressure drop] ?P recommended by the filter manufacturer is reached, the cartridge should be replaced according to the manufacturer ’ s instructions. 6.2.3 Cartridge filters Cartridge filters should be monitored on a periodic .... basis for a [pressure drop] ?P across the filter [that] can be used to determine when the filter is retaining particulate matter to the point that the filter will no longer allow the required water flow without an excessive reduction in pressure at the outlet of the filter. A marked decrease in ?P without a corresponding decrease in flow rate may indicate a loss of filter integrity. Follow the manufacturer ’ s recommendations concerning when to replace cartridge filters. Replacement of the cartridge will usually be indicated by an increase in ?P to some specified value. A log sheet should be developed to record the pressure drop measurements. This Standard is not met as evidenced by: 30177 Based on observation, staff interview, and review of manufacturer instructions for use (IFU), the facility failed to replace cartridge filters (Filters used to remove impurities and particles) every six months according to the manufacturer’s instructions. Failure to change the filters as per the manufacturer’s recommendations may result in decreased protection for patients against harmful microbiological contaminants such as bacteria, viruses, and endotoxins which can pose significant health risks. The failure to follow the manufacturer’s guidance had the potential to adversely affect all 66 in-center hemodialysis patients receiving care at this facility. Findings include: Observation and interview during a tour of the water room with Biomedical Technician (BMT) 2 on 09/17/24 at 10:45 AM revealed a cartridge filter and three endotoxin filters (These filters are used to retain harmful microbiological contaminants, such as bacteria, viruses, and endotoxins) in use in the water treatment system. In an interview with BMT2 on 09/17/24 at 10:55 AM, when asked how often the filters should be replaced, he/she stated the filters should be replaced every six months. When asked if there was documentation to validate that the filters have been changed every six months, BMT 2 stated, “No.” BMT2 was asked to validate when the filters were last changed. BMT2 stated that the filter housing did not contain a label on the outside with the filter change date. Therefore, he/she could not determine. Review of the manufacturer IFU, “Cartridge Ultrafilter Replacement,” revealed, “This procedure should be performed every six months...””

“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: 30177 Based on observation, staff interview, review of manufacturer instruction for use (IFU), and review of the facility’s policy, the facility failed to ensure two of two staff members (Certified Clinical Hemodialysis Technician (CCHT) 3 and CCHT 4) responsible for conducting the total chlorine testing in hemodialysis water adhered to the manufacturer IFU. The failure to complete the test correctly placed 66 patients receiving in-center hemodialysis at this center at risk of receiving water with total chlorine levels greater than 0.1 parts per million (ppm), which could cause red blood cell hemolysis (destruction of red blood cells). Findings include: Observation of the total chlorine testing with the Clinical Manager and CCHT3, who verified responsibility for testing dialysis water for total chlorine was completed on 09/18/24 at 3:15 PM After collecting a 100-milliliter (ml) sample of water from the test port, CCHT3 removed a test strip from the foil package without checking the expiration date of the strip. He/she then swished the strip in the water sample, removed the strip, and briskly shook the test strip multiple times to remove excess water. CCHT3 then immediately held the test strip up to the color chart to compare the colors, not allowing the 20-second wait period for the test strip color to develop. When asked if the strip should be read immediately, CCHT3 replied, “Yes.” When asked if they should have checked the test strip’s expiration date, CCHT3 replied, “No.” During an interview immediately after the observations, CCHT3 agreed the chlorine test had not been conducted according to manufacturer IFU. A second total chlorine testing observation was conducted on 09/18/24 at 3:20 PM with the Clinical Manager and CCHT4. After collecting a 100 ml sample of water, CCHT4 removed a test strip from the foil package without checking the expiration date. CCHT4 swished the strip in the water sample, and after removing the strip from the sample, CCHT4 immediately compared the color on the strip to the color chart to read the results. CCHT4 failed to wait 20 seconds for the test strip color to develop. When asked if the strip required a specific wait period for the color to develop, CCHT4 replied, “I am not sure.” No reply was received when asked how would CCHT4 determined the test strip’s expiration date. Interview at the time of observations of CCHT4 agreed the chlorine tests had not been conducted correctly according to manufacturer IFU. Review of the “RPC Ultra-Low Total Chlorine Test Strips Instructions for Use,” the brand of test strips used by the facility, revealed, “Collect a fresh 100 ml sample of water. . .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. . .Remove the strip and shake once, briskly, to remove excess water. Wait 20 seconds (in bold print) for the test strip color to develop. . .After the 20 second wait period (in bold print), immediately compare the strip color to the (brand name) color chart to determine the Total Chlorine level in the sample. Do not use a test strip after the expiration date. . .” Review of the facility’s policy titled, “Total Chlorine Testing Using RPC Ultra Low Total Chlorine Test Strip,” effective 04/2021, revealed, “. . .Collect 100 ml of sample water. . .Remove one test strip from its foil package and swish it in the sample for 20 seconds or follow the manufacturer’s temperature chart [Which depends on the temperature of the water]. . .Remove the strip and shake once, briskly, to remove excess water. Wait 20 seconds or (follow manufacturer temperature chart). . .After the 20 second wait or (follow manufacturer chart) for the test strip color to develop. . .immediately compare the strip color to the (brand name) color chart to determine the Total Chlorine level in the sample. . .” The policy failed to include the need to check the expiration date as per the manufacturer’s IFU. The facility representatives were given an opportunity to present additional information for the findings discussed. No additional information was presented.”

“H20 TANK-SHAPE/VENT/DISINFECT/FILTER P CFR(s): 494.40(a) 5.3.2 Water storage tank: shape/vent/disinfected/filter post When used, storage tanks should have a conical or bowl-shaped base and should drain from the lowest point of the base. Storage tanks should have a tight-fitting lid and be vented through a hydrophobic 0.2 µm air filter. The filter should be changed on a regular schedule according to the manufacturer’s instructions. A means shall be provided to effectively disinfect any storage tank installed in a water distribution system. 7.1 General strategies for bacterial control [in storage tanks]: An ultrafilter, distal to the storage tank, or some other form of bacterial control device is recommended. Storage tanks are therefore not recommended for use in dialysis systems unless they are frequently drained and adequately disinfected. This Standard is not met as evidenced by: 30177 Based on observation, staff interview, review of manufacturer instructions for use (IFU), and review of the facility’s policy, the facility failed to ensure the Biomedical Technician (BMT) changed the vent air filter located on the water storage tank on a regular schedule according to the manufacturer’s instructions. In addition, there was no documented evidence that the water storage tank was drained and disinfected. The failure to follow the manufacturer’s guidance had the potential to adversely affect all 66 in-center hemodialysis patients receiving care at this facility. Findings include: Observation and interview during a tour of the water room with BMT2 on 09/17/24 at 10:45 AM revealed that the water storage tank vent filter housing included an attached sticker with documentation that it was last changed on 04/14/20. BMT2 confirmed that the date on the filter housing indicated 04/14/20. When asked how often the filter should be changed, BMT 2 stated, “Let me check the manufacturer’s instructions.” In an interview with BMT1 on 09/16/24 at 1:45 PM, he/she stated that the water storage tank is drained to a certain level each month, and then disinfectant is added. BMT1 was asked to provide documentation supporting the steps of the procedure and documentation supporting that the procedure was completed each month. Review of a facility document titled “Water System Disinfection Log” from February 2024 through September 2024 revealed that the log failed to contain information indicating that the water storage tank was drained and disinfected per the manufacturer’s recommendations. In an interview with BMT2 on 09/17/24 at 10:55 AM, he/she stated the vent filter on the storage tank should be changed every six months. When asked if there was documentation to validate that the vent filter has been changed every six months, BMT2 stated, “No.” Review of the manufacturer IFU, Storage Tank System- Chapter four: Routine Maintenance, “Check the vent filter daily. If the vent filter has become wet, the filter must be replaced. Wet vent filters will not vent the tank properly ...Vent filter replacement should take place every six months or if the vent filter becomes wet, whichever occurs first. Monthly requirements: Disinfect the storage tank and loop piping. The disinfection procedure should be performed at least monthly for good bacteria control practices.”

“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: 30177 Based on observation, interview, review of the facility’s documents, and review of Manufacturer’s Instructions for Use, the facility failed to implement safety procedures and controls for storage of acid concentrate (acidic dialysis solution) after delivery, protect stored acid drums from tampering and contamination, store acid per manufacturer’s instructions and ensure staff responsible for transferring acid were trained in acid concentrate transfers. This failure created a hazardous situation, exposing the 66 in-center hemodialysis patients at risk of serious harm, illness, or death from exposure to contaminated acid concentrate. Findings include: Review of the Manufacturer’s Instructions for Use for “Naturalyte- Liquid Acid Concentrate for Bicarbonate Hemodialysis,” revealed, “Store between 5° Celsius (C) (41° Fahrenheit (F) and 30°C 86°F). The product can withstand exposure to temperatures down to 0°C (32°F) and up to 40°C (104°F) for a period of up to 72 hrs.” Observation with the Clinical Manager on 09/16/24 at 2:30 PM, revealed fourteen (14) 55-gallon containers made of sturdy plastic that are labeled as acid concentrate were stored outside on the parking lot adjacent to the dialysis facility. Access to the content is to be kept sealed until transfer. Of the 14 acid concentrate containers, 10 were observed with a manufacturer’s plastic seal which covered the access cap, two did not contain the seal or cap and were open to air and one drum’s manufacturer’s seal was missing, exposing the acid concentrate to tampering and contamination by weather elements, insects, animals, and unauthorized access. It was also observed that the inlet connection port was open to air and insects. This connection port was used to transfer acid concentrate from the 55-gallon drum stored outside to the acid concentrate storage system located inside of the facility. The inlet connection port used to transfer acid to the acid concentrate storage tank was unprotected and open to air. There were no protection and security measures noted. The Clinical Manager confirmed that fourteen drums were present in the parking lot of the dialysis facility. The Clinical Manager could not confirm how long each of the drums had been there. In an interview on 09/16/24 at 3:10 PM, when asked, how do they ensure the acid concentrate was stored within the manufacturer’s specific storage temperatures to maintain stability, prevent degradation, and reduce the risk of chemical reactions during extreme weather elements, the Clinical Manager said, “We can’t.” The Clinical Manager was then asked, how does the facility ensure the acid concentrate was protected from tampering and contamination by insects, animals, and unauthorized access. The Clinical Manager stated, “I can’t.” The Clinical Manager confirmed that this practice posed a significant risk to the patients as it did not allow for proper safety controls to prevent inadvertent mix-ups, tampering, or contamination. Review of the “End-Stage Renal Disease (ESRD) CORE Survey Facility Worksheet: Personnel File,” there was no was no documentation supporting that CCHT1, CCHT2, CCHT3, CCHT4, and Patient Care Technician (PCT) had been trained and were deemed competent in the safe storage and transfer of acid concentrate. In an additional interview with the Clinical Manager on 09/17/24 at 1:00 PM, he/she revealed the acid concentrate was transferred from the drums stored in the parking lot to the storage tank yesterday (09/16/24); however, staff members failed to complete the “Acid Pumping Sign-In Sheet.” The Clinical Manager revealed in the past staff had reported acid concentrate drums open with missing caps and seals. The Clinical Manager was not able to give specific dates. The Clinical Manager further stated that the facility cannot ensure the acid drums stored in the parking lot had not been contaminated or tampered with. A policy was requested for the handling, storing, transferring, neutralization of acid concentrate safely. The Clinical Manager stated that the facility does not have a security, storage, and safe transfer of acid policy. The Clinical Manger was then asked how does the facility ensure no insects had entered the inlet connection port located outside and open to the air. The Clinical Manager stated, “I am not sure; maybe there is a filter in place.” The Clinical Manager was asked how does the facility ensure that rain, mist, or dew have not penetrated the seal and contaminated the acid. The Clinical Manager stated, “I am not sure.” Interview with the Clinical Manager on 09/17/24 at 1:15 PM, confirmed it was the facility practice to store the 55-gallon acid concentrate drums outside. The Clinical Manager was asked if the 55-gallon acid drums were rotated to ensure the drums received last were used first. The Clinical Manager stated, “No, the drums are too heavy to rotate.” Review of a document titled, “Acid Pumping Sign in Sheet,” indicated acid concentrate was documented as pumped on 09/05/24 and 09/12/24, which exceeded 72 hours of storage as instructed by the Manufacturers instruction for use. Review of the “Packing List” for receipt of acid concentrate 55-gallon drums revealed that the facility received four drums per delivery on 08/13/24, 08/20/24, 09/03/24, and 09/10/24, which indicated that acid concentrate drums were stored for more than 72 hours. In an interview on 09/17/24 at 2:15 PM, PCT was asked if he/she noticed that the drums had been tampered with, meaning no caps or seals; he/she stated, “Yes.” PCT was asked if he/she had noticed any insects on the acid containers, and he/she stated, “Yes.” When asked if they transfer acid when the seal was comprised, or the caps were missing, PCT stated, “No.” In an interview with the Dialysis Consultants on 09/17/24 at 3:30 PM, a policy was requested on how to handle, store, transfer, and neutralize acid concentrate. Dialysis Consultant 1 stated that the facility did not have a security, storage, transfer, and neutralization of acid policy.”

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 30177 Based on interview and document review, the facility failed to ensure Biomedical Technician (BMT) 1, who was assigned responsibility for in-servicing employees on the proper operation and utilization of dialysis equipment and systems, including preventative maintenance of these systems, demonstrated competency in following the manufacturer’s instruction for use (IFU) for the Bicarbonate system. In addition, the facility failed to have records available of the manufacturer’s instructions for sanitizing, maintaining, and monitoring the Bicarbonate mixing system. The failure to ensure BMT1 demonstrated competency in following the manufacturer’s IFU and ensuring the manufacturer’s IFU was available for sanitizing, maintenance, and monitoring of the mixing system had the potential to adversely affect all 66 in-center hemodialysis patients receiving care at this facility. Findings include: Review of BMT1’s “Evaluation and Competency Skills Checklist” revealed no documented evidence that he/she was trained and demonstrated competency in following the manufacturer’s IFU for the Bicarbonate system, including disinfection of the system. In an interview with BMT2 on 09/17/24 at 11:30 AM, a request was made for the manufacturer’s IFU for the Bicarbonate mixing system and the handling and storage of acid concentrate. BMT2 stated that the manufacturer’s IFU records are not readily available in the facility. BMT2 was then asked what references staff members have access to as essential references for adherence to the manufacturer’s IFU. BMT 2 stated, “I’m not sure.” BMT2 was asked if they were responsible for training staff. They stated “Yes.” BMT1 was not available for interview. In an interview with Dialysis Consultant 1 on 09/17/24 at 1:00 PM, he/she was asked about policies related to the handling and storing of acid concentrate and the preparation and testing of Bicarbonate. Dialysis Consultant 1 stated that the facility had not developed or implemented policies related to the handling and storing acid concentrate and preparing and testing Bicarbonate. When asked who was responsible for developing and ensuring the policies and procedures were implemented, Dialysis Consultant 1 stated that he/she was responsible.”

“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: 30177 Based on staff interviews and observations, the facility failed to label the acid concentrate storage and dispensing tank to identify the chemical composition or formulation of its contents correctly. The failure to permit identification of the bulk storage and dispensing tanks’ contents had the potential to lead to inadvertently mismatching dialysate components. The failed practice had the potential to negatively affect the 66 in-center hemodialysis patients at this facility. Findings Include: During a tour of the Water Treatment/Dialysis Preparation Area with the Clinical Manager on 09/16/24 at 1:55 PM, the acid bulk storage and dispensing tanks were observed without proper identification of their contents. The label affixed to the tank displayed a brand and composition that the facility did not use. In an interview on 09/16/24 at 2:00 PM, the Clinical Manager confirmed the acid bulk storage and dispensing tank were incorrectly labeled and failed to identify the chemical composition or formulation of its contents. The Clinical Manager stated he/she was aware that the tank should be labeled to identify the contents but failed to do so. A policy indicating the need to label the bulk storage/dispensing tanks was requested. The facility failed to provide a policy by the survey’s exit date.”

“PERSONNEL-P&P CFR(s): 494.40(a) 9 Personnel: P & P Policies and procedures that are understandable and accessible are mandatory. This Standard is not met as evidenced by: 30177 Based on interview and document review, the facility failed to ensure written policies and procedures indicating adherence to equipment manufacturers’ instructions for use (IFU) were developed and implemented. The failure to develop and implement policies and procedures had the potential to inhibit safe care delivery for the 66 in-center hemodialysis patients, Findings include: In a joint interview with Dialysis Consultant 1, Dialysis Consultant 2, Biomedical Technician 2, and the Clinical Manager on 09/17/24 at 3:45 PM, policies were requested for Neutralization and Disposal of Acid Concentrate, Storing and Safety Controls of 55-gallon Acid Concentrates Drums, Disinfection of Water Storage Tank, Labeling Acid Concentrate Storage Tank, Endotoxins Filters Replacement, Vent Filter Replacement, Collecting Bacteria Colony Forming Units (CFU), and Collecting Endotoxins Limulus Amebocyte Lysate (LAL) Assays. Dialysis Consultant 1 stated the facility does not have the above policies. When asked if policies and procedures were needed as an essential reference for staff and should reflect current practice at the facility, the Clinical Manager stated, “Yes.” Dialysis Consultant 1 was asked if policies and procedures are needed as an essential reference for staff and should reflect current practice at the facility. The Clinical Manager stated, “Yes.” Dialysis Consultant 2 was asked if policies and procedures are needed as an essential reference for staff and should reflect current practice at the facility. The Clinical Manager stated, “Yes.” Biomedical Technician 2 was asked if policies are needed to provide staff with information and instructions regarding equipment installation, operation, maintenance, and troubleshooting. He/she replied, “Yes.” By the exit date, three policies were developed with an effective date of 09/2024 titled, “Neutralization and Disposal of a Batch of Residual Acid Concentrate; Staff Orientation and Training for Transfer of Acid from Drum to Acid Tank; and Acid Drum Policy.” No other policies were provided by the exit date of 09/20/24. The Clinical Manager agreed that the facility must develop and implement clear policies and procedures that match current practices to provide quality, safe, and effective care.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 30177 Based on interview, document review, and personnel file review, the facility failed to implement an ongoing training program designed to evaluate staff’s proficiency and maintain the operator’s knowledge, which includes periodic observation of skills for five of five staff members (Certified Clinical Hemodialysis Technician (CCHT) 1, CCHT2, CCHT3, CCHT4, and Patient Care Technician (PCT)) who were assigned the responsibility for Acid Concentrate. The failure to train staff and implement an ongoing training program did not allow the facility to evaluate staff competency and procedural compliance periodically. This failed practice did not ensure staff had the knowledge and maintained their knowledge and skills to care for the complex needs of the 66 in-center hemodialysis patients receiving care at this facility and placed the patients at risk for severe injury or harm. Findings include: Review of an undated facility document titled, “Acid Pump Days and Staff,” revealed that CCHT1, CCHT2, CCHT3, CCHT4, and PCT were responsible for transferring acid concentrate for September and had transferred acid concentrate from 55-gallon drums to the acid concentrate storage tank within the last month. Review of the “End-Stage Renal Disease (ESRD) CORE Survey Facility Worksheet: Personnel File,” revealed the absence of competencies (hemodialysis, water, and machine training) for CCHT1, CCHT2, CCHT3. In an interview with the Clinical Manager on 09/16/24 at 11:35 AM, he/she was asked who trained the staff members on the Bicarbonate mixing system and storage and transfer of acid concentrate. The Clinical Manager stated, “That is a function of the Biomedical Technician (BMT).” A request was made for documentation supporting that CCHT1, CCHT2, CCHT3, CCHT4, and PCT, who were responsible for transferring acid concentrated and had transferred acid from 55-gallon drums to the acid concentrate storage tank within the last month, had been trained on proper storage, use, and transfer or acid concentrate. The Clinical Manager stated that the facility did not have evidence of training and confirmed there was no documented evidence to support the training and competency for the acid concentrate in use. In an interview with CCHT 1, CCHT2, and CCHT3 on 09/16/24 at 2:55 PM, they denied having training on ensuring the 55-gallon drums of acid concentrate were stored to prevent unauthorized access, tampering, and contamination by weather elements, insects, and animals. In a joint interview on 09/16/24 at 12:30 PM with the Clinical Manager and Dialysis Consultant 1, the Clinical Manager confirmed there was no documentation supporting that CCHT1, CCHT2, CCHT3, CCHT4, and PCT had been trained and were deemed competent in the safe storage and transfer of acid concentrate. The Clinical Manager also confirmed that the facility failed to implement an ongoing training program to evaluate staff proficiency and maintain the operator’s knowledge.”

“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: 30177 Based on observation and staff interview, the facility failed to provide a safe environment for dialysis patients and staff. On three (09/16/24, 09/17/24, and 09/18/24) of the five treatment days, it was observed that the entrance door to the facility was propped open with a rock, potentially posing a security and safety concern for the facility by allowing unauthorized individuals and insects to enter. This failure had the potential to negatively affect all 66 incenter hemodialysis patients at this facility and the staff who provided care. Findings Include: During the tour of the Dialysis Facility on 09/16/24 at 11:30 AM, 09/17/24 at 10:30 AM, and 09/18/24 at 9:50 AM, the entrance door was found propped open, allowing unauthorized individuals and insects to enter. In an interview with the Clinical Manager on 09/18/24 at 1:30 PM, it was confirmed that the door remains propped open with a rock so patients can easily access it.”

“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: 30177 Based on observation and staff interviews, the facility failed to maintain the integrity of surfaces and equipment in good repair in the water treatment area, patient treatment area, and clean supply storage area. This failure created a patient safety hazard and had the potential to affect all 66 in-center hemodialysis patients at this facility negatively. Findings Include: Observation of the “ Water Treatment/Dialysis Preparation Area,” on 09/16/24 at 3:30 PM with the Biomedical Technician (BMT) 1 and Clinical Manager, the following observations were made and confirmed: 1. A thick build-up of dirt and grime was noted on the floor throughout. 2. Dirt and grime were noted on the rectangle metal drain cover (floor drainage system). 3. The floor around the drain had large, noticeable missing pieces and cracks. 4. Trash was noted strewn on the floor. 5. An accumulation of standing water was noted on the floor. 6. The door threshold had a noticeable accumulation of dirt and grime. 7. A thick brownish substance was found in and on the outer surface of two drains. 8. The floor behind the brine tanks had a brown, thick, tenacious accumulation of an unknown substance and a white powdery substance. 9. The bicarb tank spout was observed to have a thick, powdery substance that had also accumulated on the floor under the spout. 10. The expansion tank had an accumulation of dust and a blue-greenish substance on the floor under the tank. 11. The distribution pump was observed to have rust. The floor near the distribution pump had extensive scale rust. 12. A white crystal substance was noted on the piping, and valves were shut off. 13. One of the ceiling tiles had a noticeable brown stain on its surface, and a section did not have a ceiling tile. 14. A build-up of green substance was noted on the floor, brackets, polyvinyl chloride (PVC) piping, and copper piping. 15. The floor displayed signs of rust, dirt, grime, white powdery substance, and water build-up. 16. Multiple metal pipe holders on the wall and floor were noted to have extensive rust. 17. Substantial and widespread rust accumulation was observed on multiple brackets and screws that held the water treatment piping. 18. Extensive accumulation of rust was detected on two metal shelves and a cart with wheels. 19. A cart that held the bags of bicarb had a build-up of rust and white residue. 20. The booster pump had an accumulation of rust and dust. 21. Multiple shut-off valves throughout the water room were heavily rusted or stained. 22. A build-up of grime and rust was noted on the metal wrench used to open a 55-gallon drum. 23. A pallet used to store the brine tank had a build-up of white powdery substance and an extensive accumulation of dirt, grime, and trash. 24. The backflow preventer had a severe build-up of a bluish-greenish substance. 25. A wall section displayed a streak of brown substance trailing from a rusty metal pipe bracket. 26. The metal bracket holding a filter housing was noted to have a build-up of rust. 27. The brine tank had spatters of a white powdery substance on the exterior surface. Observation of the “Patient Treatment Area,” on 09/16/24 at 4:30 PM with the Facility Administrator, the following observations were made and confirmed: 1. The floor was noted to have a considerable accumulation of dirt, grime, and a white substance throughout the treatment area. 2. The wall displayed areas stained with spatters of a white substance and missing sheetrock, which created a disheveled and unkempt appearance. 3. Twelve of the patients’ recliners were ripped, torn, or depressed in the head or buttocks area. The metal frame of the chairs had a considerable accumulation of dirt, grime, and rust. 4. The stone countertops were missing the facing. Multiple pieces of tape were noted to hold the countertop in place, which creates a safety hazard. 5. The curtains had visible splats of a brown substance. 6. Multiple cords were taped in sockets on the wall. 7. The wheels on the Hoyer Lift were rusty. 8. The countertop formica ledge had visible areas where the formica was torn or missing. 9. The formica-facing walls behind the hemodialysis machines were cracked and coming apart from the walls. The formica baseboards were missing and left torn exposed walls, which comprised the surface of the walls. 10. The outer surface of the walls was missing formica strips. 11. The clean handwashing sink had an accumulation of dirt and grime. 12. The floor drain had a thick rust, dirt, and grime build-up. 13. 12 of 12 hemodialysis machines displayed a streak of brown substance trailing from the acetate port. The Clinical Manager confirmed them to be rusty. All machines had a thick, tenacious build-up of tape on the top. An anonymous source stated that the tape held the data transfer cord in place for years. The screws used to hold the prime buckets had a considerable amount of rust which allotted a streak of brown substance trailing from rusty screws in the prime bucket. The bottom portion of the machine’s outer surface was compromised. 14. All 12 of the hemodialysis wall boxes (Framed recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive concentrates, treated water, and dispose of waste products.) were observed to have various types of stains, dirt, grime, and a white substance accumulated on them. 15. A section of the baseboard was loose, coming away from the wall, and there was damage to the wall above the baseboard. 16. The exterior surfaces of 12 hemodialysis machines had an accumulation of dirt, grime, and dust, and their integrity was not maintained in good repair. The outer sealant had been removed, resulting in a porous surface. 17. Four biohazard containers had an accumulation of rust, dirt, and dust. 18. The outer surface of the wall beneath the hemodialysis stations was damaged. 19. The four rolling stools displayed noticeable wear and tear, with multiple rips and tears indicating disrepair. 20. The wingback chairs on the treatment floor had noticeable rips and tears. 21. The wall had areas with an accumulation of a dark, brown, grimy substance. 22. The two carts used to store clean supplies showed a conspicuous dust accumulation. 23. The outer protective housing that encases the diasafe filter appeared to have accumulated a significant amount of dust in six of the six hemodialysis machines. 24. The power circuit on the back of six hemodialysis machines had accumulated significant dust. 25. The dialysis arterial and venous Hansen connectors were observed to have a build-up of white substance. Observation of the “Clean Supply Area,” on 09/16/24 at 4:15 PM with the Clinical Manager revealed an extensive accumulation of rust was detected on the metal shelving with wheels. A follow-up joint interview on 09/16/24 at 5:00 PM was held with the Biomedical Technician (BMT)2, Clinical Manager, and Dialysis Consultants 1 and 2 to discuss the environmental concerns. BMT2 was asked if he/she does environmental rounds regularly. He/she stated, “I do monthly rounds. When asked for a copy of the rounds for the last six months, he/she said he does not document the findings in Quality Assessment and Performance Improvement (QAPI). A policy on the physical environment was requested. The facility failed to provide a policy by the survey exit date.”

“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: 30177 Based on observation, interview, review of the facility’s documents, policy review, and review of the Manufacturer’s Instructions for Use (IFU), the facility failed to maintain the hemodialysis per the manufacturer’s IFU in that the facility failed to replace 12 of 14 hemodialysis machine’s “Diasafe Plus” filter (filter to remove harmful substances) every 12 weeks. Failure to follow the manufacturer’s IFU had the potential to negatively impact the safety and well-being of the 66 patients receiving in-center hemodialysis treatments at this facility. Findings include: Observation of the hemodialysis treatment area on 09/16/24 at 2:34 PM with Biomedical (BMT) Technician 1 revealed that the “Diasafe Plus” filters on hemodialysis machines 1 - 10, 12, and 14 contained a label dated 04/04/24. In an interview with BMT1 on 09/16/24 at 2:54 PM, they confirmed the “Diasafe Plus” filters had been replaced on 04/04/24. BMT1 was asked how frequently the filters should be replaced. BMT1 stated the filters are changed each quarter. Review of a document titled, “Quarterly Diasafe Replacement Log,” revealed that Machine 14’s “Diasafe Plus” filter was last exchanged on 05/24. Review of the facility’s policy titled, “Preventative Maintenance of Fresenius Machine,” effective 04/21, revealed, “The preventative maintenance schedule on the Fresenius machine will be as per manufacturer recommendations. Review of the “Diasafe Plus Dialysis Fluid Filter” IFU revealed that the filter must be exchanged after 12 weeks or 100 treatments.”

“PQ-DIETITIAN-RD CFR(s): 494.140(c)(1) The facility must have a dietitian who must- (1) Be a registered dietitian with the Commission on Dietetic Registration; This Standard is not met as evidenced by: 30177 Based on interview and document review, the facility failed to employ a Registered Dietitian who is registered with The Commission on Dietetic Registration as well as failed to ensure the contracted Registered Dietitian had an active license. This failed practice placed all 66 in-center hemodialysis patients received dietary nutrition support and education. receiving care at this facility at risk for n not receiving adequate nutrition support and education, Findings include: In an interview with the Clinical Manager on 09/18/24 at 2:15 PM, a request was made to interview the Registered Dietitian concerning the patient’s renal labs, dietary, and nutritional status. The Clinical Manager stated the facility has a contract with an agency that supplies a Registered Dietitian remotely. The Clinical Manager was asked how does the facility ensure that the Registered Dietitian is knowledgeable and competent to provide dietary and nutritional care for the complex needs of the in-center hemodialysis patients. The Clinical Manager stated that it’s the agency’s responsibility. The Clinical Manager was asked if the Registered Dietitian had attended Interdisciplinary Team (IDT) and Quality Assessment and Performance Improvement (QAPI) meetings. The Clinical Manager replied, “No.” When asked how the facility communicates and collaborates with the Registered Dietitian to provide each patient with an individualized and comprehensive assessment of his or her needs and plan of care, the Clinical Manager stated it’s a challenge. A request was then made for the personnel file, contract, and current license. Review of the Registered Dietitian’s license revealed the license expired on 08/31/24. The Clinical Manager was asked in an interview on 09/18/24 at 2:25 PM if the facility had a current copy of the Registered Dietitian’s license. They replied, “No.” The Clinical Manager confirmed the Registered Dietitian’s license had expired. Review of the facility’s “Dietetic Consultation Contract,” dated 06/05/24, revealed, “[Name of Contract Company] shall provide the services of a qualified Registered Dietitian, who is Licensed/Certified as applicable per State dietetic by-laws. [Name of Contract Company] shall provide the facility, prior to Services being rendered, with a copy of a current license to practice in the State and a current certificate of insurance that has been obtained and is in full force and effect.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 30177 Based on review of the facility documents and staff interview, the facility failed to provide evidence that the Medical Director (MD) participated in developing, reviewing, and approving patient care policies and procedures and equipment manufacturer adherence. The failure to ensure the Medical Director’s active involvement in developing and approving patient care policies resulted in staff not having access to current practices and manufacturer recommendations. This failure had the potential to harm all 66 patients receiving care at this facility. Findings include: During an interview with the Facility Administrator on 09/18/24 at 2:45 PM, the Facility Administrator stated that the facility had no policies related to acid mixing, transferring, safety controls, and acid neutralization. During an interview with the MD on 09/18/24 at 11:15 PM, the MD was asked if he/she had participated in developing policies related to dialysis equipment and clinical practice. The MD stated, “I’m sure I have.” When asked if he/she participated in the development of policies for safety procedures and controls for storage of acid concentrate (define) after delivery, protect stored acid drums from tampering and contamination, store acid per manufacturer’s instructions and ensure staff responsible for transferring acid were trained in acid concentrate transfers, the Medical Director stated, “No.””

“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: 30177 Based on observation and interview, the facility failed to ensure hard copies of medical records were stored in a secure location & protected from casual access when not in use. This failure prohibited safeguarding patient medical records against loss, destruction, or unauthorized use. The failed practice did not ensure the medical records of the 66 patients receiving in-center hemodialysis treatments at this facility were stored in a safe manner to protect unauthorized access, privacy, and confidentiality. Findings include: Observation on 09/17/24 at 10:07 AM, accompanied by the Clinical Manager, revealed boxes containing hard copies of the patient’s medical records were stored in the staff/visitor’s restroom. The bathroom door was noted ajar, rendering the hard copies of the medical records unsecure and accessible to all staff and visitors, potentially enabling unauthorized access to the patient’s medical records. During an interview on 09/17/24 at 10:15 AM, the Clinical Manager confirmed that the boxes contained the patient’s medical records and the entrance door to the restroom was open and unsecure. When asked if all staff and visitors had access to the “bathroom,” the Clinical Manager replied, “Yes.” He/she was then asked how the facility safeguards patients’ health information in the restroom against loss, destruction, or unauthorized use. The Clinical Manager stated, “The medical records would have to be removed from the restroom.” In an interview with Dialysis Consultant 1 and Dialysis Consultant 2 on 09/17/24 at 1:15 PM, a facility policy for confidentiality and storage of medical records was requested. The facility failed to provide a policy by the survey exit date of 09/20/24.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 30177 Based on observation and interview, the facility failed to establish an identifiable governing body to ensure oversight of the facility operations relative to patient safety and effective care. The failure to identify and implement a functioning governing body to adopt and enforce rules and provide oversight of the operations could negatively affect the health and safety of patients. The cumulative effects of multiple and pervasive deficient practices had the potential to jeopardize the health and safety of all 66 patients who received treatment at this dialysis center. Findings include: In an interview with the Clinical Manager on 09/18/24 at 1:24 PM, they were asked who the facility appointed as the dialysis facility’s Chief Executive Officer (CEO) or administrator who exercises responsibility for managing the facility and ensuring all dialysis services are provided. The Clinical Manager replied, “I’m not sure, but we have the Nursing Home Administrator and a Consultant Group. When asked how often the dialysis facility governing body meets, the Clinical Manager stated that the dialysis governing body has not met and that there are no meeting minutes for the governing body. A request was made for governing body bylaws, an organizational chart, minutes, and a policy that identifies who constitutes the governing body and who has the legal authority and responsibility for the governance and operation of the dialysis facility. At the conclusion of the survey, it was noted that no official governing body bylaws, organizational chart, meeting minutes, or policies clearly identifying the governing body members were made available to the surveyor.”