Commerce Kidney Center

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 50523 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), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. On 8/6/25 at 11:55 a.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) finding with the likelihood to cause harm to seven of seven hemodialysis patients who were receiving hemodialysis treatment at Station (S) 1 , S2, S3, S4, S7, S10, and S11 who were undergoing hemodialysis treatment at the time of this observation, when one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality, failed to perform the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). The Facility Administrator was informed of the IJ finding on 8/6/25 at 11:55 a.m. The noncompliance related to the IJ was identified to have existed on 8/6/25 at 11:55 a.m. The IJ situation was abated on 8/6/25 at 3:03 p.m., when the facility implemented their “IJ Abatement Plan” that included inservice on daily chlorine testing, staff training, return demonstration, and conducted a Governing Body meeting. The facility also failed to ensure that the reverse osmosis (RO) system (used to purify water for dialysis) was maintained and free from water leakage that can mean internal failure (allowing feed water to bypass the membranes, leading to unfiltered water entering the product water), or housing, or O-ring failure (which can compromise pressure and system safety), which means the water is no longer reliably purified. A determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the likelihood to cause harm to 17 in-center hemodialysis patients. The Facility Administrator and Medical Director were informed of the IJ finding on 8/7/25 at 5:30 p.m. The noncompliance related to the IJ was identified to have existed on 8/7/25 at 5:30 p.m. The IJ situation was abated on 8/7/25 at 6:39 p.m., when the facility implemented their “IJ Abatement Plan” that included but not limited to: a Governing Body meeting was held, a Deionization (DI - used for water purification) system was ordered for immediate delivery, an inservice with the Direct Patient Care (DPC) staff (nurses and patient care technicians) was conducted, and all patients were scheduled to be dialyzed at a sister facility from 8/8/25 until the DI water purification system is installed or the RO system is repaired and disinfected per facility policy. Findings include: Cross References: V 196 - Failure of the facility to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. V199 - Failure of the facility to ensure that the MRORX04AX Reverse Osmosis System was free of membrane leakage and cracks.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on observations, a review of records, staff interviews, review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedures (P & P), 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 17 patients who dialyzed at this facility. Findings include: Cross References: V 196 - Failure of the facility to ensure that one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality, performed the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. V199 - Failure of the facility to ensure that the MRORX04AX Reverse Osmosis System was free of membrane leakage and cracks. V757 - Failure of the Facility Administrator to ensure that the facility had an adequate number of qualified Patient Care Technicians (PCTs) as dialysis caregivers to meet the needs of all patients, to provide safe patient care and to be in compliance with the minimum state required staff-to-patient ratio of one dialysis caregiver to four patients.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 50523 Based on record review and staff interview, it was determined that the facility failed to ensure the facility’s Emergency Preparedness Plan (EPP) was evaluated and updated at least every two years. Failure to review and update the EPP risked reliance on outdated or incomplete procedures that may not reflect current risks, staffing changes, or lessons learned from prior drills or real events such as a natural disaster, power outage, or supply chain (normal flow of goods, supplies, or services that a facility depends on to operate) disruption. This deficient practice had the potential to negatively affect the health and safety of all 17 hemodialysis patients who were under the care of this facility. Findings include: A review of the facility’s EPP and Governing Body Meeting minutes revealed that there was no documented review and evaluation of the EPP since 2022. During an interview on 8/5/25 at 10:42 a.m., the Facility Administrator confirmed that the EPP was not evaluated and updated since 2022.”

“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: 50523 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), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. On 8/6/25 at 11:55 a.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) finding with the likelihood to cause harm to seven of seven hemodialysis patients who were receiving hemodialysis treatment at Station (S) 1 , S2, S3, S4, S7, S10, and S11, who were undergoing hemodialysis treatment at the time of this observation, when one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality, failed to perform the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). The Facility Administrator was informed of the IJ finding on 8/6/25 at 11:55 a.m. The noncompliance related to the IJ was identified to have existed on 8/6/25 at 11:55 a.m. The IJ situation was abated on 8/6/25 at 3:03 p.m., when the facility implemented their “IJ Abatement Plan” that included inservice on daily chlorine testing, staff training, return demonstration, and a Governing Body meeting. The facility census was 17. Findings include: During observation of PCT AA’s performance of the Total Chlorine test on 8/6/25 between 10:00 a.m. and 10:10 a.m., the following was observed: - PCT AA performed the Total Chlorine Test using RPC Ultra Low Total Chlorine Test strip (K100-0118F). PCT AA proceeded to collect the sample water in a 100 milliliter (mL) cup, swished the test strip for 25 seconds and immediately compared the test strip to the color chart. When asked how many seconds she was supposed to swish the test strip, PCT AA stated 15 seconds, based on the temperature of the collected sample water. When asked how many seconds she was supposed to wait before comparing the test strip to the color chart, PCT AA stated she was not sure. - A review of the manufacturer’s DFU showed the following: Test Procedure 4) Wait 20 seconds for the test strip color to develop. 5) After the 20 second wait period, immediately compare the strip color to the K100-0118 or K100-0118F color chart to determine the Total Chlorine level in the sample. - A review of Procedure titled, “Daily Chlorine Testing of Dialysis Water” with latest revision date of July 2021 showed the following: 1. Fill the sample cup to the line marked 100 mL with the sample. 2. Remove one test strip from the foil package and swish it in the sample for the amount of time indicated according to the following temperature ranges: Water sample temperature from 42F to 61F (6C to 16C), swish time = 60 seconds. Water sample temperature from 62F to 74F (17C to 23C), swish time = 32 seconds. Water sample temperature from 75F to 88F (24C to 31C), swish time = 20 seconds. Water sample temperature from 89F to 93F (32C to 34C), swish time = 15 seconds. A. Move the strip back and forth at a constant gentle rate... 3. Remove the test strip and shake once, briskly, to remove excess water. 4. Wait 20 seconds for the test strip color to develop... 5. After the 20 second wait period, immediately compare strip. The IJ was abated on 8/6/25 at 3:03 p.m. upon completion of the following: - The Facility Administrator immediately began conducting re-education/staff in-service with all Direct Patient Care Staff with a return demonstration on 8/6/25 at 1:00 p.m. - PCT AA as well as Registered Nurse (RN AA), and Facility Administrator demonstrated/performed the correct procedure for testing the water for Total Chlorine using RPC Ultra-Low Total Chlorine Test Strip K100-0118F according to the manufacturer’s DFU and facility P&P specifically, test strip swished according to water sample temperature swish time and waiting 20 seconds for the color to develop before comparing the test strip to the color chart and obtained results of 0.1ppm (parts per million) total chlorine in water used for dialysis. Thus, the water was determined to be safe for dialysis. - A Governing Body meeting was conducted and approved by the Facility Administrator, the assistant Facility Administrator and the Medical Director. - Audits of staff performing chlorine testing were conducted and will be ongoing.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 50523 Based on observations, interviews, and a review of the Med-Reverse Osmosis System Operation and Maintenance Manual, it was determined that the facility failed to ensure that the reverse osmosis (RO) system (used to purify water for dialysis) was maintained and free from water leakage. A leaking membrane can mean internal failure (allowing feed water to bypass the membranes, leading to unfiltered water entering the product water), or housing, or O-ring failure (which can compromise pressure and system safety), which means the water is no longer reliably purified, posing a high risk to patients on dialysis. A determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the likelihood to cause harm to 17 in-center hemodialysis patients. The Facility Administrator and Medical Director were informed of the IJ finding on 8/7/25 at 5:30 p.m. The noncompliance related to the IJ was identified to have existed on 8/7/25 at 5:30 p.m. The IJ situation was abated on 8/7/25 at 6:39 p.m., when the facility implemented their “IJ Abatement Plan” that included but not limited to: a Governing Body meeting was held, a Deionization (DI - used for water purification) system was ordered for immediate delivery, an inservice with the Direct Patient Care (DPC) staff (nurses and patient care technicians) was conducted, and all patients were scheduled to be dialyzed at a sister facility from 8/8/25 until the DI water purification system is installed or the RO system is repaired and disinfected per facility policy. Findings include: During a tour of the facility on 8/4/25 at 1:48 p.m., it was observed that the US Filter Reverse Osmosis System, MRORX04AX, was leaking water from the first membrane housing. During an interview on 8/4/25 at 2:00 p.m., the Biomedical Technician (BMT) stated that the RO System has been leaking for a while due to a crack causing a leak from the cap of the RO membrane. On 8/6/25 at 11:25 a.m., the Medical Director (MD) stated that he wasn’t aware of the RO system leak but would get the first membrane housing repaired immediately. During a telephonic interview on 8/7/25 at 9:21 a.m., the Mar Cor (Vendor of water purification products and support services for hemodialysis) Engineer Support Technician II (EST) stated that the RO system should not leak or be cracked. The EST also stated that the water pressure entering the membrane could cause unfiltered water to mix with the filtered or product water, thereby compromising the overall water quality. On 8/7/25 at 3:30 p.m., it was observed that water was still leaking from the first membrane housing of the RO water purification system. During an interview on 8/7/25 at 4:45 p.m., the Facility Administrator confirmed that the RO system was still leaking and had been leaking for some time. A review of the “Med-RO Series Reverse Osmosis Systems Operation and Maintenance Manual” stated: The RO membranes must be maintained in an operational or standby state to retain full effectiveness. A leaking membrane could mean that there is an internal failure (allowing feed water to bypass the membrane leading to unfiltered water entering the product water), or housing or O-ring failure (which can compromise pressure and system safety). The IJ was abated on 8/7/25 at 6:39 p.m., upon completion of the following: - A Governing Body meeting was held and was approved by the Medical Director. - All patients were scheduled to be dialyzed at a sister facility from 8/8/25 until the DI water purification system is installed or the RO system is repaired and disinfected per facility policy. - A DI system was ordered for immediate delivery. - The Facility Administrator conducted staff in-service with all Direct Patient Care Staff.”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 50523 Based on a review of Fiscal Year 2025 Quarterly Dialysis Facility Report (QDFR: A report prepared by Centers for Medicare and Medicaid Services [CMS] to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.), a review of facility records , and staff interview, it was determined that the facility failed to effectively manage patients’ anemia outcome by identifying root causes and commonalities, and opportunities to improve care among patients who did not reach the minimum expected target goal for anemia management, measured by Hemoglobin (Hgb: protein in red blood cells that carries oxygen) in six of six months of Quality Assessment and Performance Improvement (QAPI) meeting minutes reviewed (January 2025 - June 2025). The outcome goal based on current professionally accepted clinical practice standards for dialysis patients is between 10 g/dl and 12 g/dl (grams per deciLiter). Low Hgb levels, or anemia, in dialysis patients can lead to various adverse health consequences. These included increased fatigue, weakness, and shortness of breath due to reduced oxygen delivery to tissues. Severe anemia can also cause chest pain, cognitive impairment, and a higher risk of hospitalization and death. The facility census was 17. Findings include: - A review of Fiscal Year 2025 QDFR revealed that 51.0 % of hemodialysis patients at this facility had Hgb levels of less than (<) 10 g/dL. The U.S. average was 23.0 %. A review of facility’s QAPI meeting minutes for the past six months (January 2025 - June 2025) revealed the following: - In January 2025, 59.0% of patients had Hgb levels of <10.0 g/dL. - In February 2025, 57.0% of patients had Hgb levels of <10.0 g/dL. - In March 2025, 42.0% of patients had Hgb levels of <10.0 g/dL. - In April 2025, 44.0% of patients had Hgb levels of <10.0 g/dL. - In May 2025, 66.0% of patients had Hgb levels of <10.0 g/dL; and - In June 2025, 68.0% of patients had Hgb levels of <10.0 g/dL. - There was a lack of documentary evidence that the QAPI team conducted a comprehensive review of the facility’s anemia management. Although the facility data was collected monthly, there was no documented evidence that a root cause analysis was conducted. The plan for the last six months was to repeat Hgb and Hematocrit (the percentage by volume of red cells in blood) lab draws at the hospital prior to any referral for a blood transfusion. There was a lack of documented evidence that the interdisciplinary team modified or adjusted any part of the plan, intervened in actionable factors, or identified opportunities to improve care and anemia outcome. - During the exit interview on 8/6/25 at 3:25 p.m., the Facility Administrator acknowledged the above findings and did not produce the missing documents.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 50523 Based on observation, staff interviews, a review of facility records, and a review of the minimum state required staffing ratios. it was determined that the Governing Body failed to ensure the facility had an adequate number of qualified dialysis care givers, to meet the needs of all patients and provide safe patient care as evidenced by one of two Patient Care Technician (PCT) was assigned to care for five patients on the first shift. This deficient practice had the potential to cause a delay in monitoring patients for issues such as changes in vital signs, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, delayed adjustments, or missed complications including but not limited to intradialytic hypotension (sudden drops in blood pressure which can occur when fluid is removed too rapidly), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility census was 17. Findings include: - A review of “Patient and Teammate Schedule” (schedule of the number of patients each shift and assigned dialysis care givers: PCT AA, PCT BB, and Registered Nurse (RN) AA) from May 2025 to August 6, 2025, revealed the following: - The Patient Treatment Room had three Pods (sections) with four patient Stations (S) in each Pod. - The facility was open on Mondays, Wednesdays, and Fridays (MWF) with two shifts. There were nine patients who dialyzed on the first shift and eight patients on the second shift. - On the first shift, PCT AA and PCT BB alternated between being assigned to four patients in Pod 1 and five patients in Pod 3. - When assigned to Pod 1, PCT AA or PCT BB cared for the patients at S1, S3, S4, and S6. - When assigned to Pod 3, PCT AA or PCT BB cared for five patients at S8, S9, S10, S11, and S12. - During an interview with PCT AA on 8/6/25 at 9:36 a.m., she confirmed that she has been assigned to care for five patients on the first shift in Pod 3, alternating with PCT BB every other week in Pod 1. She stated that each PCT has been responsible for setting up the machine, initiating their patients’ treatments, monitoring their patients, discontinuing treatments, disinfecting patient stations, and performing other related tasks. PCT AA explained that the nurse’s responsibility was to initiate patient’s treatment of all patients with CVC (Central Venous Catheter - a thin, flexible tube inserted into a large vein in the neck, chest, or groin, to allow easy access to the bloodstream for dialysis treatments), as primary hemodialysis access. PCT AA further explained that nurses initiated treatments only for patients with CVC, but the PCTs were responsible for monitoring the patients and returning their blood after treatment. - On 8/6/25 at 11:23 a.m., the Facility Administrator (an RN) confirmed what PCT AA stated above regarding the PCTs’ schedule and responsibilities. The Facility Administrator also stated that PCT BB called out on 8/4/25 and 8/6/25. As a result, she was assigned to Pod 1 with four patients on the first shift, while PCT AA was assigned to Pod 3 and cared for five patients on the first shift on 8/4/25 and 8/6/25.”