Elik Dialysis Home Therapy

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 43999 Based on observation, record review and interview, the facility’s interdisciplinary team (IDT) failed to complete interdisciplinary care plan on patients in 5 out of 10 sampled patients: Patient #s 1, 3, 4, 8 & 9. Based on observation, record review and interview, per the Texas Administrative Code (TAC), Title 26 §117.45(a)(2), the facility’s interdisciplinary team (IDT) failed to complete interdisciplinary care plan on patients in 5 out of 10 sampled patients: Patient #s 1, 3, 4, 8 & 9. Findings: Review of the patient#s 1, 3, 4,8 & 9 most recent IDT plan of care revealed the following: The physician, and social worker had not completed and signed the most recent 2025 IDT plan of care. Patient#s 1, 3, 4,8 &9 IDT plan of care did not provide documentation the patient’s had been invited or involved in the plan of care. During the record review, surveyor requested documentation that the physician participated in the plan of care meeting. There was no documentation provided. In an interview with the Registered Nurse (Staff #3) and the Facility Administrator (staff #1) on 8/20/25 it was revealed that the social worker and physician did not complete and sign the IDT POC for patient#s 1, 3, 4,8 &9 prior to review with the patient. The POC can and should be printed once all IDT members have completed and signed then it should be reviewed with patient signed and filed in the medical record. During this review of patient records, Staff # 3 confirmed the IDT POCs were not completed prior to the patient signing them during the clinic.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 43999 Based on interview and review of documentation, the facility failed to retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and maintain this information in the patient ’ s medical record. Findings: The facility staff were unable to provide Patient #3, 7 & 8’s home monitoring treatment sheets for June 2025 to present. Review of the patient’s medical records revealed documentation by the nurse asking them to bring the information to the facility. There was no documentation that the patients were reeducated on the importance of providing the self-monitoring treatment sheets to the facility and no followup was provided to correct ongoing lack of reporting. On 8/20/25 at 11:30 a.m. the above findings were confirmed by Staff # 1, Facility Administrator.”

“H-MONITOR HOME ADAPT;HOME VISIT=POC CFR(s): 494.100(c)(1)(i) Services include, but are not limited to, the following: (i) Periodic monitoring of the patient’s home adaptation, including visits to the patient’s home by facility personnel in accordance with the patient’s plan of care. This Standard is not met as evidenced by: 43999 Based on facility documentation, observation and interviews, the facility failed to meet periodic monitoring of the patient’s home adaptation, including visits to the patient’s home by facility personnel in accordance with the patient’s plan of care. Findings: Patient’s 3,4,7,& 8 medical record reviewed did not provide a current annual home visits from the RN in 2025. In an interview with the RN (Staff # 3) on 8/20/25, it was confirmed documentation for the patient’s home visits for 2025 were not found in the medical records.”

“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: 43999 Based on observation and interview, the facility Governing Body failed to provide documentation of the Facility’s Governing Body meeting minutes which addressed and enforced rules and regulations relative to health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. Findings: Review of Facility Policy: Titled, “ Governing Body partly stated: POLICY: - The Governing Body is responsible for (not all inclusive): - The operation of the facility - Fiscal management - Staff training and coverage ... The Dialysis Services Medical Director shall ensure that: - All policies and procedures related to patient admission, patient care, infection prevention and control and safety are adhered to by all individuals treating patients, including attending physicians and non-physician providers. Review of facility 2025 Governing Body and QAPI (Quality Assurance and Improvement Program) revealed no documentation of completion of actions plans from the April 2024 refortification survey submitted and accepted. The Statement of Deficiencies (SOD) partly stated, “The Governing Body and Director of Nursing meet on 4/16/2024 to review survey findings. PD RN will educate all patients on the importance of completing self-monitoring documentation, on the required treatment records and review by PD nurse to ensure safe treatment in the home setting. Education acknowledgement form will be used to capture completion by the PDRN. 100% completion by 05/30/2024. “PD Manager will monitor, track and report completion via the Monthly Quality Assessment Performance Improvement meetings until 100 % compliance met. PD Manager will report monthly via the Monthly Quality Assessment Performance Improvement meeting any patients with ongoing non-compliance, root cause analysis and plan of action action, to be evaluated monthly. PD RN will review with IDT ongoing non-compliance with self-monitor, documentation to include the Attending Physician and Social Worker. Non-compliance patient, self-monitoring treatment documentation will be reviewed during, monthly patient conference training 04/26/2024 with IDT. All above steps will be initiated by 04/25/2024, with 100% education with all current PD patients by 05/30/2024. In an interview with the FA the above findings were confirmed, the facility was unable to provide documentation that the actions of the SOD were completed.”

“H-TRAIN CONTENT INCLUDES ER PREP HOME PTS CFR(s): 494.100(a)(3) The training must- (3) Be conducted for each home dialysis patient and address the specific needs of the patient, in the following areas: (i) The nature and management of ESRD. (ii) The full range of techniques associated with the treatment modality selected, including effective use of dialysis supplies and equipment in achieving and delivering the physician’s prescription of Kt/V or URR, and effective administration of erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a target level hemoglobin or hematocrit as written in patient’s plan of care. (iii) How to detect, report, and manage potential dialysis complications, including water treatment problems. (iv) Availability of support resources and how to access and use resources. (v) How to self-monitor health status and record and report health status information. (vi) How to handle medical and non-medical emergencies. (vii) Infection control precautions. (viii) Proper waste storage and disposal procedures. This Standard is not met as evidenced by: 10802 Based on record review and interview, the facility’s registered nurse failed to document/ include in patients’ training for peritoneal home dialysis, the effect and side effect for medication prescribed for anemia management, the importance of managing/ monitoring blood pressure when prescribed this medication, and when medication can be taken or not taken in 2 of 6 sampled patient’s record reviewed. Patient #s 3 and 5 Findings: Patient #3 Review of the facility’s current Policy on Patient Training Guidelines; Policy # 04.101, effective 11/10/2017 directs staff as follows “ during the training sessions, the following topics will be discussed and any associated procedures will be demonstrated: #16 “Self- administering Epogen.” Review of patient #3’s clinical record (medication administration record) revealed documentation the patient was administered Mircera on 0 3/07/ 2024 and 03/2024 based on Mircera algorithm utilized by the facility’s staff. Review of the patient’s educational training for peritoneal dialysis patients revealed documentation that the patient was admitted to the facility on 4/20/2022. Review of the patient’s educational training for peritoneal dialysis revealed documentation that the patient completed training from staff on 5/17/2022 for peritoneal dialysis with training and support from facility’s staff. Review of the patient’s training record revealed no documentation that the patient was educated on medication management of the drug as it relates to the effect and side effect of the medication, how to store medication, the importance of management blood pressure when taking the medication, when medication can be taken or not taken. Patient #5 Review of the patient’s educational training for peritoneal dialysis revealed documentation that the patient was admitted to the facility on 2/17/2023 and completed training from staff on 5/17/2023 for peritoneal dialysis with training and support from facility’s staff. Review of patient #5’s clinical record( medication administration record revealed the patient was administered Mircera on 2/ 07/2024, 2/21/2024 and 3/13/2024 based on Mircera algorithm utilized by the facility’s staff. Review of the patient’s training record revealed no documentation that the patient was educated on medication management of the drug as it relates to the effect and side effect of the medication, how to store medication, the importance of management blood pressure when taking the medication, when medication can be taken or not taken.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 10802 Based on record review and interview the facility failed to ensure patients monitor body temperature and weight before and after peritoneal dialysis treatment in 2 of 6 sampled patients’ records reviewed Patient #s 2 and 3. Findings: Patient #2 Review of patient #2’s clinical record ( home monitoring ) treatment sheet, dated 01/08/2024 - 03/05/2024 revealed no documentation of the patient monitoring body temperature before and after peritoneal dialysis treatment. Review of the patient’s self-monitoring sheet revealed all blank spaces for patient’s temperature. Review of the record revealed no documentation that this was identified by facility’s staff and the patient educated on the importance of self-monitoring body temperature pre and post peritoneal dialysis. Monitoring the body temperature pre and post peritoneal dialysis is an indicator of changes in one’s temperature. Review of the patient’s self-monitoring sheet provides crucial information on treatment adherence and any problem with the peritoneal dialysis treatment namely peritonitis. Patient #3 Review of patient #3’s clinical record ( home monitoring ) treatment sheet dated 01/10/2024 - 03/16/2024 revealed no documentation of patient monitoring body weight before and after peritoneal dialysis treatment. Review of the patient’s self-monitoring sheet revealed all blank spaces for patient’s weight. Review of the record revealed no documentation that this was identified by facility’s staff and the patient educated on the importance of self-monitoring body weight pre and post peritoneal dialysis. Monitoring the body weight pre and post peritoneal dialysis is an indicator of changes in one’s weight. Review of the patient’s self-monitoring sheet provides crucial information on treatment adherence and any problem with the peritoneal dialysis treatment. On 04/04/2024 at 9:30 a.m. The surveyor reviewed the patients’ self-monitoring treatment sheets with the Facility’s Director of Nursing. She confirmed that the patients were not self-monitoring their temperature and body weight and that there was any documentation on educating the patients on the importance of doing so.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 10802 Based on record review and interview facility’s quality assessment performance improvement committee failed to conduct root cause analysis and evaluation of plans to address upward trends in patients with albumin less than 3.5 and phosphorus greater than 5.5. Findings: Review of the facility’s quality assessment performance improvement meeting minutes and data revealed the following outcomes for patients albumin: December 2024 : <3.5 = 25.% January 2024: <3.5 = 9.5% February <3.5 = 19.0 % March <3.5 = 28.6%. Review of the records revealed no root cause analysis done as to the reason why patients are not meeting goal. Review of the records revealed the same documented plan for all 4 months : “Encourage patients to eat protein first at meals. Recommenced nutritional supplements. Suggest to liberalize diet to increase protein intake.” The plans were not reevaluated to improve outcome albumin in patients. Review of the facility’s quality assessment performance improvement meeting minutes and data revealed the following outcomes for patients phosphorus greater than 5.5 : December 2023 : Phosphorus > 5.5 = 62.5% January 2024 : Phosphorus > 5.5 = 57.1% February 2024 : Phosphorus > 5.5 = 76.2% March 2024 : Phosphorus > 5.5 = 71.4% Review of the records revealed no root cause analysis done as to the reason why patients are not meeting goal and that the facility is trending up with its outcome for phosphorous. Review of the records revealed the same documented plan for all 4 months. “ Reviewed high phosphorus foods to limit/ avoid. Reviewed correct phosphate binder regimen. Emphasized relevant potential adverse outcome. Encourage compliance with diet and medications.” The plans were not reevaluated to improve outcome of phosphorous in its patients. On 04/04/2024 at 2:00 p.m. The Surveyor reviewed the data and plan with the facility’s Chief Operating Officer. She concurred that the facility’s quality assessment data were not analyzed, and plan reevaluated to improve outcomes for albumin and phosphorous.”