Davita Delaware Valley Dialysis Center

“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: 19122 Based on review of facility policy/procedure and documentation and based on interview with the chief technician (Employee #6) and the Administrator (Employee #5), the facility failed to ensure total chlorine testing had been conducted in accordance with facility policy/procedure for 44 of 75 in-center hemodialysis (HD) treatment dates between June 1 and August 27, 2025. Findings include: On August 27, 2025 at approximately 1:35 PM, review of facility policy 1-18-10, titled “CM130 Total Chlorine Online Monitor Daily Start-Up and End of Day Procedures”, revealed the following: Notes: The CM130 Total Chlorine comparison is done on a daily basis prior to the use of dialysis quality water for any process and the start of dialysis treatment(s) and then the device will automatically check the chlorine level every five (5) minutes until all activities that require use of dialysis quality water are completed. Procedure: 5. Perform a manual total chlorine test utilizing the approved method of total chlorine test for the facility... 6. Compare the CMS130 reading to the total chlorine test device measurement...Document manual results in IT Clinical System and verify CMS130 results are automatically transferring... Between August 27, 2025 at approximately 9:28 AM and August 28, 2025 at approximately 12:30 PM, review of “Routine Total Chlorine Testing Log 1-18-02A” and “Water Monitoring Log” documentation failed to reveal that HD staff performed manual verification of the CM130 total chlorine result prior to the initiation of HD treatments for 44 of 75 treatment days between June 1 and August 27, 2025. During interview conducted on August 27, 2025 at approximately 2:03 PM, the Chief Technician confirmed manual verification of the CM130 total chlorine result is to be completed prior to the initiation of HD treatments. During interview conducted on August 28, 2025 at approximately 9:15 AM, the Administrator confirmed manual verification of the CM130 total chlorine result prior to the initiation of HD treatments had not been conducted in accordance with facility policy/procedure between June 1 and August 27, 2025.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 19122 Based on review of facility policy/procedure and medical records and based on interview with the Administrator (Employee 5), the facility failed to ensure a plan of care was completed monthly for one (1) of three (3) unstable hemodialysis (HD) patients. (Patient #5) Findings include: On August 29, 2025 at approximately 12:53 PM, review of facility policy 1-14-01, titled Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, revealed the following on page 8: Monthly (unstable patients)...Monthly until the patient is determined by the interdisciplinary team to be stable... Patient #5 (Discharge): On August 29, 2025 at approximately 9:05 AM, September 2, 2025 at approximately 10:30 AM and September 3, 2025 at approximately 3:45 PM, review of the clinical record revealed the patient stability status was determined to be unstable effective 07/30/2024 as documented on the patient plan of care. Review of the patient plan of care documentation revealed the following: -04/30/2025: The patient’s stability status was unstable due to psychosocial issues. -06/10/2025: The patient’s stability status was unstable due to deterioration of health status. There was no documentation in the medical record which provided evidence a patient plan of care had been completed by the IDT in May 2025. During interview conducted on August 29, 2025 at approximately 2:15 PM, the Administrator confirmed a patient plan of care had not been completed by the IDT in May 2025 for patient #5.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 19122 Based on review of facility policy/procedure, documentation and medical records and based on interview with the Medical Director (Employee #8) and the Administrator (Employee 5), the facility failed to ensure hemodialysis staff notified the Medical Director of abnormal pre-treatment weight findings for one (1) of one (1) unstable hemodialysis patient for whom the pre-dialysis weight was below the prescribed target weight. (Patient #5) Findings include: On August 29, 2025 at approximately 1:03 PM, review of facility policy 1-03-08, titled Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, revealed the following: Pre-Treatment Data Collection/Assessment...7. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated. Abnormal Findings: Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the medical record. Within each category, definitions may be adjusted by a patient specific order... Fluid Status...Pre-Treatment: Any weight less from the last post treatment... On August 26, 2025 at approximately 12:54 PM, review of patient complaint documentation revealed that on 02/18/2025, patient #5 reported being dehydrated by the hemodialysis (HD) treatment. Patient #5 (Discharge): On August 29, 2025 at approximately 9:05 AM, September 2, 2025 at approximately 10:30 AM and September 3, 2025 at approximately 3:45 PM, review of the clinical record revealed the patient stability status was determined to be unstable effective 07/30/2024 and the reasons for identifying the patient as being unstable included concurrent conditions, deterioration in health status (06/10/2025) and psychosocial status (07/09/2025) as documented on the plan of care. Review of hemodialysis treatment orders revealed the prescribed target weight was 90 kilograms as evidenced by the physician order provided by the Medical Director on 06/22/2025. Review of hemodialysis (HD) treatment sheet documentation revealed the following: -07/05/2025: The post-treatment weight was 87.7 kilograms (kg.) -07/12/2025 (First treatment after the 07/05/2025 HD treatment): The pre-treatment weight was 86.1 kg which was a 1.6 kg weight loss since the 07/05/2025 treatment and 3.9 kg below the prescribed target weight. Review of post-treatment assessment findings revealed the post-treatment weight was 85.9 kg and that the registered nurse obtained a physician order to decrease the target weight to 86.5 kg after completion of the HD treatment. -07/15/2025: The pre-treatment weight was 85.1 kg which was a 0.8 kg weight loss since the 07/12/2025 HD treatment and 1.4 kg below the prescribed target weight. The post-treatment weight was 84.9 kg. -07/17/2025: The pre-treatment weight was 84.2 kg which was a 0.7 kg weight loss since the 07/15/2025 HD treatment and 2.3 kg below the prescribed target weight. The post-treatment weight was 84.3 kg. There was no documentation in the medical record which provided evidence that a licensed nurse notified the Medical Director of the abnormal pre-treatment weight findings on 07/12, 07/15 and 07/17/2025. During interview conducted on August 29, 2025 at approximately 2:15 PM, the Medical Director and the Administrator confirmed abnormal pre-treatment weight findings were not reported to the Medical Director prior to the above referenced HD treatments for patient #5.”