Davita Merced East Dialysis

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 49230 Based on interview and record review, the facility failed to ensure that the interdisciplinary team implemented the patient’s plan of care and provided dialysis (medical treatment that essentially acts as an artificial kidney to clean the blood and remove extra fluid and waste products when a person’s own kidneys can’t do the job properly) treatment in accordance with facility standards and policy for one of three sampled patients ( Pt 1), when the facility nursing staff did not complete a pre-dialysis assessment prior to initiation of treatment, as required by facility policy and the nursing staff failed to verify and clarify the Heparin (special medicine that helps make sure blood does not form clots) dose with the physician when the prescribed volume exceeded the patient’s catheter port size. These failures resulted in noncompliance with Patient 1’s plan of care and physician orders, placing Patient 1 at increased risk for adverse outcomes such a hypotension (low blood pressure), inadequate treatment, reduce tolerance during the treatment and bleeding complications risk after dialysis treatment. Findings: During a review of Pt 1’s “ History and Physical (H&P),” dated 8/12/24 from [Hospital A], the “H&P” indicated Pt 1 was a 55 year old female with a past medical history of End-Stage Renal Disease (ESRD - Final stage of chronic kidney disease, where the kidneys permanently fail and can no longer function well enough to sustain life, requiring dialysis for survival) with Hemodialysis on Tuesday, Thursday, Saturday, Insulin-Dependent Diabetes Mellitus (IDDM - disease where the body stops producing insulin, requiring lifelong insulin injections for survival), high blood pressure, history of Cerebrovascular Accident (CVA - Interruption of blood flow to the brain, causing brain cells to die due to lack of oxygen and nutrients). During an interview on 12/17/25 at 11:10 a.m. with the Facility Administrator (FA), the FA stated he had been working at the facility for two and a half years. The FA stated he was familiar with Pt 1. The FA stated Pt 1 expressed concerns to him [unknown date] regarding the care she received during “the week of Thanksgiving [11/24/25 to 11/28/25]” at the facility. The FA stated Pt 1 was transferred to their dialysis facility from [clinic name]. The FA stated Pt 1 expressed concerns regarding the Heparin that was administered in the port of her dialysis catheter (a soft tube placed in a large vein [neck, chest, or leg] to provide access for a life-sustaining treatment for kidney failure, allowing blood to be drawn for cleaning by a dialysis machine and returned to the body) was not the right dosage for her port size. The FA stated he had reviewed the entire treatment record for Pt 1 dated 11/29/25 and it showed Heparin was administered as ordered. The FA stated Pt 1 came to the facility on 12/12/25 and asked for the facility’s grievance process and expressed her concerns regarding the administration of Heparin. The FA stated Pt 1 felt her Heparin should not have been 2000 units [2 milliliter (ml)] but instead insisted the dose should have been 1600 units (1.6 ml). The FA stated the facility’s grievance process was explained to Pt 1 and her concerns were escalated to the network. The FA stated he had reviewed the treatment records for Pt 1 for Heparin administration and Heparin was administered as ordered by the physician. The FA stated he did identify other issues where care was not aligned with the facility policy and/or physician orders. The FA stated he had identified several abnormalities with Pt 1’s treatment on 11/29/25 and has already provided education and in-services (training) to the staff. During a concurrent interview and record review on 12/17/25 at 11:15 a.m. with the FA, Pt 1’s “ Treatment Details Report,” dated 11/29/25 was reviewed. The “Treatment Details Report” indicated, “ ... Dialysis Prescription Treatment Type ...In-Center Hemodialysis treatment ... Treatment Time ... 3 [hour] 0 [minute] ... Blood Flow Rate ... 350 ml/min ... Dialysate Flow Rate 500 ml/min ... Dialysate Temperature ... 37.0 [ Celsius] ... Nurse prescription verification ... 11/29/25 09:52 ...” The FA stated the “Treatment Details Report” indicated Pt 1’s pretreatment assessment was not completed prior to the start of the treatment as the data showed it was collected after the initiation of the treatment at 9:10 a.m. on 11/29/25 and this was not done in accordance with the facility’s policy. The FA stated he was not a nurse and he expected his staff to follow facility policies for the treatment. During a concurrent interview and record review on 12/17/25 at 11:49 a.m. with Registered Nurse (RN) 1, Pt 1’s “medical record,” dated 11/18 25, 11/20/25, 11/25/25 , 11/29/25 and 12/9/25 were reviewed. RN 1 stated Pt 1’s treatment records indicated Pt 1 received 2000 units or 2 ml of Heparin for the first four visits on 11/18/25, 11/20/25, 11/25/25 and 11/29/25. RN 1 stated the medical record indicated physician order was for 2000 units (2 ml). RN 1 stated the order was changed to 1600 units (1.6 ml) for the treatment date of 12/9/25 and Pt 1 received 1600 units [1.6 ml] on 12/9/25 treatment. RN 1 stated the nurse followed the physician’s orders. RN 1 stated Heparin dose for the port is usually based on the catheter port size, however, the physician order indicated a higher dose and since Pt 1 was an existing patient at another clinic, the facility nurses went by the doctor’s orders which were received and renewed by the nephrologist (MD 1) (kidney doctor) at the facility. RN 1 stated the ports on the catheter are labeled with the size and the nurses should have called the doctor and clarified the order when they realized the port size did not match up with the Heparin order. RN 1 stated Pt 1’s catheter port size was 1.6 ml. RN 1 stated for the treatment date of 12/9/25, the Heparin dose was changed to the correct dose of 1600 units (1.6 ml) . During a phone interview on 12/17/25 at 12:55 p.m. with the MD 1 and the FA, MD 1 stated she was the nephrologist for Pt 1. MD 1 stated she was familiar with Pt 1. MD 1 stated Pt 1 reached out to her office and she had called Pt 1 back. MD 1 stated she was unable to recall the exact date and time when she had spoken with Pt 1. MD 1 stated Pt 1 had concerns regarding her Heparin dose and it was adjusted. MD 1 stated Pt 1 was transferred to their facility and she had resumed previous treatment orders for Heparin from the transferring facility for Pt 1. MD 1 stated she had identified and agreed that Pt 1 was getting a “slightly higher” dose of Heparin in her ports but Pt 1’s lab results were “acceptable” indicating patient was okay after receiving the higher dose of Heparin. MD 1 stated administering the higher dose of Heparin had the potential to harm Pt 1. MD 1 stated she had seen Pt 1 on 11/18/25 and 11/25/25, however, Pt 1 did not express any concerns regarding her dialysis treatment. MD 1 stated she expected patient assessment to be completed prior to the start of the patient’s dialysis treatment. MD 1 stated the importance of completing the patient assessment was to ensure the patient was stable and it was safe to do the dialysis treatment. During an interview on 12/17/25 at 1:10 p.m. with the FA, the FA stated he reviewed Pt 1’s treatment record for 11/29/25 and Pt 1’s dialysis treatment was not completed in accordance with the facility’s policy. The FA stated it was not acceptable to not complete pre-assessment prior to treatment initiation. The FA stated these failures had the potential to cause harm to the patient during and after the treatment. During a review of the facility’s policy and procedure (P&P) titled, “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT,” dated April 2024, the P&P indicated, “ ... PURPOSE: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge ... The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN) ... Verification of prescription including machine parameters ... Verification that the patient access is visible and face is not covered ... Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to ... Blood flow rate ... Dialysate flow rate ... The assessment is a nursing responsibility. The nurse will assess the patient pretreatment as warranted by the patient’s condition ... The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. ... If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed ... Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary ... The licensed nurse notifies the physician (or NPP if applicable) as needed of changes inpatient status ... All findings, interventions and patient response will be documented in the patient’s medical record.””

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 49230 Based on interview and record review, the facility failed to ensure staff achieved and sustained the prescribed dose (specific parameters ordered by the physician) of dialysis ( a process used to purify the blood of persons whose kidneys are not working normally) for one of the three sampled patients, Patient (Pt) 1, when Pt 1’s Dialysis treatment’s dialysate flow rate (DFR-how fast the fluid flows through the machine) was increased above the ordered 500 [milliliters per minute (mL/min-unit of measurement)] to 800 mL/min, and the dialysate (special, sterile cleansing fluid used in dialysis to help remove waste products and extra water from the blood when a person’s kidneys cannot do their job properly) temperature was set lower at 36.5 degree Celsius (unit of measurement ) than the ordered 37 degree Celsius. These failures had the potential to affect the adequacy of dialysis treatments and placed Pt 1 at risk for negative health outcomes. Findings: During a review of Pt 1’s “ History and Physical (H&P),” dated 8/12/24 from [Hospital A], the “H&P” indicated Pt 1 was a 55 year old female with a past medical history of End-Stage Renal Disease (ESRD - Final stage of chronic kidney disease, where the kidneys permanently fail and can no longer function well enough to sustain life, requiring dialysis for survival) with Hemodialysis on Tuesday, Thursday, Saturday, Insulin-Dependent Diabetes Mellitus (IDDM - disease where the body stops producing insulin, requiring lifelong insulin injections for survival), high blood pressure, history of Cerebrovascular Accident (CVA - Interruption of blood flow to the brain, causing brain cells to die due to lack of oxygen and nutrients). During a concurrent interview and record review on 12/17/25 at 11:15 a.m. with the FA, Pt 1’s “Treatment Details Report,” dated 11/29/25 was reviewed. The “Treatment Details Report” indicated, “ ... Dialysis Prescription Treatment Type ...In-Center Hemodialysis treatment ... Treatment Time ... 3 [hour] 0 [minute] ... Blood Flow Rate ... 350 ml/min ... Dialysate Flow Rate 500 ml/min ... Dialysate Temperature ... 37.0 [ Celsius] ... Nurse prescription verification ... 11/29/25 09:52 ...” The FA stated the “Treatment Details Report” indicated that during the treatment Pt 1’s DFR was set higher, (to 800 ml/min) than the prescribed rate of 500 and the temperature set on the machine was lower (36.5 Degrees Celcius) than 37 degrees Celsius which was what the physician ordered. The FA stated he was not a nurse and unable to comment on the reasons for the variance from the physician orders, however, he expected his staff to follow physician orders for the treatment and document in the patients’ medical records any reasons for changes from physician orders along with notification to the ordering physician of the changes made to the prescription for the treatment. The FA stated he was not able to find any nursing notes that explained reasons for the changes made to the prescription for Pt 1’s treatment on 11/29/25. During a concurrent interview and record review on 12/17/25 at 11:49 a.m. with Registered Nurse (RN) 1, Pt 1’s “medical record,” dated 11/18 25, 11/20/25, 11/25/25 , 11/29/25 and 12/9/25 were reviewed. RN 1 stated the DFR was increased to 800 ml which was higher than the physician’s order of 500 ml for the treatment date on 11/29/25. RN 1 stated she was not able to find any documentation in the medical records that indicated the reason for the DFR rate increase and was unable to find any documentation the provider was notified. RN 1 stated she would have expected to see a physician order and/or nursing notes for notification regarding the increase of Pt 1’s DFR. RN 1 stated it was important to keep the DFR as ordered to ensure the effectiveness of treatment and patient safety. RN 1 stated the medical record indicated the temperature for the treatment was 36.5 degrees Celsius and the temperature was set lower than the ordered 37 degrees. RN 1 stated it was not acceptable to not follow temperature orders for the treatment and the DFR was not appropriate for Pt 1’s treatment. RN 1 stated this practice of not following prescription order for dialysis did not align with their facility policy and facility staff were provided education and training after this incident. During a phone interview on 12/17/25 at 12:55 p.m. with the MD 1 and the FA, MD 1 stated she was the nephrologist for Pt 1. MD 1 stated she was familiar with Pt 1. MD 1 stated the DFR should be prescribed and the attending physician should be notified and/or documentation should be present for reasons for changes in the DFR. MD 1 stated changes in the DFR had the “potential to harm “Pt 1. MD 1 stated, “prescription to DFR is unique to each patient and it correlates with the degree of cleaning.” MD 1 stated the DFR may be adjusted as “it correlates with the adequacy of cleaning”. MD 1 stated the DFR was ordered at “500” ml and any changes to that would require a reason for change. MD 1 stated the temperature for dialysis treatment was prescribed to ensure patient safety and hemodynamic (relates to how blood moves through vessels, influenced by pressure, vessel size, and friction) stability. MD 1 stated running a lower temperature than the prescribed temperature for the dialysis treatment had the potential to cause harm to Pt 1. During an interview on 12/17/25 at 1:10 p.m. with the FA, the FA stated he reviewed Pt 1’s treatment record for 11/29/25 and Pt 1’s dialysis treatment was not completed in accordance with the facility’s policy. The FA stated it was not acceptable to not follow physician prescriptions for dialysate flow rate or temperature setting. The FA stated these failures had the potential to cause harm to the patient during and after the treatment. During a review of the facility’s policy and procedure (P&P) titled, “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT,” dated April 2024, the P&P indicated, “ ... PURPOSE: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment ... Verification of prescription including machine parameters ... Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to ... Blood flow rate ... Dialysate flow rate ... The assessment is a nursing responsibility. The nurse will assess the patient pretreatment as warranted by the patient’s condition ... The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. ... If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed ... Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary ... The licensed nurse notifies the physician (or NPP if applicable) as needed of changes inpatient status ... All findings, interventions and patient response will be documented in the patient’s medical record.””

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 50446 Based on observation, interview, and record review, the facility failed to ensure the patient or patient’s designee was included in the plan of care meeting held by the interdisciplinary team for one of four sampled patients (Patient (Pt) 1). This failure resulted in Pt 1 or Pt 1’s designee to not be given an opportunity to contribute to Pt 1’s individualized treatment plan and expectations of care on 5/28/25. Findings: During a telephone interview on 7/16/25 at 7:39 a.m. with Pt 1, Pt 1 stated on 5/28/25 at 12:00 p.m. she was at the facility for a scheduled plan of care meeting as indicated in the appointment letter received on 5/21/25. Pt 1 stated the Facility Administrator/ Assessment Manager (FA/AM) cancelled the meeting without explanation while Pt 1 and her Case Manager (CM) were in the lobby. Pt 1 stated the required attendees for Plan of care (POC) meetings should have included the registered nurse (RN), dietician, nephrologist (a medical doctor who specializes in diagnosing and treating kidney diseases), social worker (SW), Pt 1 and Pt 1’s designee; the CM who helped manage Pt 1’s care coordination. Pt 1 stated during previous meetings she was not informed of any restrictions regarding the CM’s attendance. Pt 1 stated she was informed at the 5/28/25 cancelled meeting that the CM could not be present at meetings. Pt 1 stated she was told that another CM wanted to represent her but was also denied entry to another meeting as well. Pt 1 stated she requested a formal letter from the FA/AM documenting the CM could not be present at meetings but was declined. Pt 1 stated “I am fighting for my life and need consistent quality dialysis care to maintain my health and stay eligible for transplant.” Pt 1 stated, “There is no respect for me as a patient, they are supposed to help me but instead, I am constantly dealing with preventable medical emergencies.” Pt 1 stated, “I need immediate attention to these matters and proper plan of care meetings with all the necessary people present including my case managers who help coordinate my care.” Pt 1 stated, “I should have been informed about any changes to my care plan or meeting restrictions.” Pt 1 stated, “As the patient, I have the right to know what’s happening with my treatment and to have my case manager present to help advocate for my care.” During a review of Pt 1’s “Patient Summary of Information Sheet (PSIS-a summary of important information regarding a patient which includes patient identification, clinical information, insurance status, provider information, emergency contact information and other pertinent information),” undated, the “PSIS” indicated Pt 1 started treatment at the facility on 05/07/2021 with diagnoses which included: “end stage renal disease [ESRD- a severe condition where the kidneys have permanently failed, requiring dialysis(a treatment that filters and cleanses the blood when the kidneys are unable to do so) or a kidney transplant to sustain life].” During a review of Pt 1’s “Patient Note (PN),” dated 5/28/25, the “PN” indicated, “ ...POC meeting held without the patient. Patient triggered unstable.” During a concurrent observation and interview on 7/16/25 at 1:37 p.m. with Pt 2 in the treatment room, Pt 2 was sitting in a recliner chair receiving dialysis. Pt 2 stated she does not believe she has ever attended a POC meeting. During a concurrent observation and interview on 7/16/25 at 1:40 p.m. with Pt 3 in the treatment room, Pt 3 was sitting in a recliner chair receiving dialysis. Pt 3 stated he does not know if a POC meeting was conducted. During an interview on 7/16/25 at 2:03 p.m. with the RN, the RN stated POC meetings are done frequently. The RN stated the Nephrologist, SW, RN, and sometimes the Dietician, all sit in on the POC meeting. The RN stated Patient’s CMs are allowed to attend the POC meetings. During a concurrent interview and record review on 7/16/25 at 2:24 p.m. with the Licensed Clinical Social Worker Supervisor (LCSW), Pt 1’s “Comprehensive assessment (CA),” dated 5/5/25 and Pt 1’s “POC Records,” dated 5/10/24-8/28/24, 9/25/24-3/11/25, and 3/11/25-3/26/25 were reviewed. The LCSW stated POCs are done annually, as needed or as requested by patients. The LCSW stated once the assessment was completed, the facility would follow up with a POC meeting. The LCSW stated attendees in the POC meeting included the patient and the patient’s representatives, the nephrologist, the FA/AM, dietician, SW and the RN. During an interview on 7/16/25 at 2:28 p.m. with the Medical Social Worker (MSW), the MSW stated a POC meeting should be done as soon as possible. The MSW stated it was also important to complete the POC meeting to ensure all responsible parties were on the same page for Pt 1’s needs, and appropriate and timely care could be provided to Pt 1. The MSW stated the failure of completing the POC meeting with Pt 1 had the potential for delay of interventions for Pt 1. During a concurrent interview and record review on 7/16/25 at 4:09 p.m. with the FA/AM, Pt 1’s Clinical record titled, “Stability Status and Plan of Care History (SSPOCH),” dated 4/3/25, “CA ,” dated 5/5/25 and “ PN,” dated 5/28/25 were reviewed. The “SSPOCH” indicated Pt 1 had previous Unstable- psychosocial assessments (a comprehensive evaluation of how a person’s mental health, relationships, social support, and environment interact and influence their overall well-being). The “SSPOCH” also indicated the FA/AM triggered a needs assessment -Psychosocial on 4/3/25. The “CA” indicated the triggered needs assessment was completed on 5/5/25 at 8:52 a.m. The “PN” indicated, “ ...POC meeting held without the patient. Patient triggered unstable.” The FA/AM stated unstable patients should have monthly meetings according to their policy. The FA/AM stated the importance of conducting the POC meeting was that “we get a better understanding of how the patient is feeling and address all of their concerns. If we wait too long, the patient will have a hard time adjusting and that puts them at risk.” The FA/AM stated Pt 1’s CM represented Pt 1 in a previous meeting held on 3/7/25. The FA/AM stated after that meeting the facility followed up with the CM and informed CM not to come to meetings. The FA/AM stated Pt 1 was unaware of the incident that involved the CM not coming back to the facility. The FA/AM stated the facility failed to conduct the POC meeting scheduled for 5/28/25 because the CM was present. The FA/AM stated the assessment triggered as an unstable psychosocial assessment. The FA/AM stated the facility did not want the particular CM to attend meetings, but the Pt 1 wanted the CM to represent her . The FA/AM stated, “I didn’t appreciate her tone, so I asked her not to come back.” The FA/AM stated the meeting was held without Pt 1 and the CM. The FA/AM stated the outcome of the meeting was not discussed with Pt 1. During an interview on 7/16/25 at 4:19 p.m. with the FA/AM, the FA/AM stated Pt 1 requested a legal document stating the CM was not allowed to attend meetings. The FA/AM stated, “I cannot provide any legal documentation because it would need to go through my legal team.” The FA/AM stated Pt 1 did not have to participate in her POC meetings. The FA/AM stated the facility had a policy that stated Pt 1 did not have to participate in her POC meeting. The FA/AM was unable to provide the policy which stated Pt 1 did not have to participate in her POC meeting. The FA/AM stated, “It is written in the policy that I have a right to choose who can come to the facility.” The FA/AM was unable to provide the policy which stated the FA/AM had a right to choose who could come to the facility. The FA/AM stated Pt 1 had a right to have her CM in the meeting, but the FA/AM also had the right to refuse visitors. The FA/AM stated Pt 1 requested assessments to be conducted monthly, but the facility was able to provide them when possible. The FA/AM stated, “I think this patient’s needs cannot be met; we have done our best to meet all of this patient’s needs, but she is unsatisfied .” The FA/AM stated he was unsure how not meeting Pt 1’s psychosocial need (the emotional, social, and psychological aspects of a person’s well-being that are essential for healthy development and functioning) would affect her. The FA/AM stated, “I think she has undiagnosed mental illness that is not managed, and I don’t know that we could ever meet her psychosocial needs.” During a review of the facility’s policy and procedure (P&P) titled, “Interdisciplinary Team (IDT) patient Assessment and Plan of Care- Policy 1-14-01,” dated 2007-2024, the P&P indicated, “Purpose: To provide guidance for the development of patient assessment and plan of care for IDT teammates. Policy: ASSESSMENT: 1. The facility’s interdisciplinary team (IDT) consists of, at a minimum, the patient or the patient’s personal representative, a registered nurse, a physician or non-physician Practitioner (NPP), if allowed by the state ESRD licensure regulation, treating the patient for ESRD, a social worker and a qualified renal dietitian per CMS. 2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/ her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations for care ....7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: ... At least monthly for unstable patients including, but not limited to, patients with the following: ... significant changes in psychosocial needs...PLAN OF CARE: ...9. The plan of care will address but not limited to the following: ...psychosocial status which addresses necessary monitoring and social work intervention....14. The patients plan of care will be completed by the facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’s personal representative. If the patient chooses not to sign the plan of care this choice will be documented on the plan of care, along with the reason the signature was not provided...21. Implementation of assessments and plan of cares are detailed in table below: [in grid]- Monthly (unstable patients), Monthly until patient is determined by interdisciplinary team to be stable, complete patient plan of care meeting within 15 days of the completion of the reassessment and POC ....” During a review of the facility’s P&P titled, “Patient Rights and Patient’s standard of Conduct, responsibilities, and facility Rules- Policy 3-01-07,” dated 2008-2021, the P&P indicated, “PURPOSE: To fully inform and educate patients regarding the rights to which they are entitled as well as the responsibility incumbent upon them as patients within all [named company] facilities .... The patient’s right is attachment A of this policy. Patient’s standards of conduct, responsibilities and facility rules is attachment B of this policy.” During a review of the facility’s P&P titled, “Patient Rights- Policy 3-01-07A,” dated 2008-2025, the P&P indicated, “Your rights as a patient: ...5. To be treated with (i) respect, dignity, and recognition of my individuality, choices, ...; and (ii) sensitivity to my psychological needs and ability to cope with ESRD... 9. To receive all information in a way that I can understand. 10. To receive assistance from a family member, representative or other individual in understanding, protecting and/ or exercising my rights ....30. To freely express comments, complaints or grievances verbally or in writing personally, anonymously or through a representative of my choosing. My comments, complaints and grievances may be expressed to the facility administrator (FA) at your facility who is the civil rights coordinator (CRC), ... All comments, complaints and grievances will be resolved in a timely manner ...32. To be informed about and participate, if desired in all aspects of my individualized plan of care ....” During a review of the facility’s P&P titled, “Patient’s standard of Conduct, responsibilities, and facility Rules - Policy 3-01-07B,” dated 2008-2021, the P&P indicated, “PURPOSE: the purpose of this form is to acknowledge that as a [named company] patient. I must comply with the following responsibility to myself ... Patient standard of conduct and responsibilities: ... 13. As an integral part of my healthcare team, I am responsible for participating in the care planning process to the extent I’m reasonably able ....””

“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: 50446 Based on interview and record review, the facility failed to follow their policy and procedure (P&P) titled, “Interdisciplinary Team (IDT) patient Assessment and Plan of Care,” when one of four sampled patients (Patient (Pt) 1), who met the facility’s unstable (could have a rapid change in vital signs or physical condition) patient criteria did not have a complete comprehensive reassessment within a month and the plan of care (POC) revision was not completed within 15 days. This failure had the potential for Pt 1 to experience a delay in necessary interventions to address Pt 1’s care needs. Findings: During a telephone interview on 7/16/25 at 7:39 a.m. with Pt 1, Pt 1 stated on 5/28/25 at 12:00 p.m. she was in the facility with her Case Manager (CM) for a scheduled POC meeting as indicated in the appointment letter she received on 5/21/25. Pt 1 stated the POC meeting was cancelled without an explanation. Pt 1 stated the last POC meeting was held on 3/18/25. Pt 1 stated she was unaware why the monthly POC meetings were not held. Pt 1 stated, “These meetings are supposed to happen monthly, especially since I have ongoing issues.” During a review of Pt 1’s “Patient Summary of Information Sheet (PSIS-a summary of important information regarding a patient which include patient identification, clinical information, insurance status, provider information, emergency contact information and other pertinent information),” undated, the “PSIS” indicated Pt 1 started treatment at the facility on 05/07/2021 with diagnoses which included: “end stage renal disease [ESRD- a severe condition where the kidneys have permanently failed, requiring dialysis (a treatment that filters and cleanses the blood when the kidneys are unable to do so) or a kidney transplant to sustain life].” During a concurrent interview and record review on 7/16/25 at 2:24 p.m. with the Licensed Clinical Social Worker Supervisor (LCSW), Pt 1’s “Comprehensive Assessment (CA)” dated 5/5/25, “POC records” dated 5/10/24-8/28/24, 9/25/24-3/11/25, and 3/11/25-3/26/25, and the facility’s P&P titled, “Interdisciplinary Team (IDT) patient Assessment and Plan of Care (IPP)” dated 2007-2024 were reviewed. The “CA” indicated the triggered needs assessment was completed on 5/5/25. The “IPP” indicated, “Unstable patients should meet monthly.” The LCSW stated POC meetings were done annually, as needed or as requested by patients. The LCSW stated if a patient requested a POC meeting, the facility would arrange for a meeting. The LCSW stated the request for a POC meeting would trigger an unstable assessment also called a needs assessment, and all relevant parties would conduct their assessment before the POC meeting. The LCSW stated the patient would be informed of the meeting. The LCSW stated once the assessment was completed, the facility would follow up with a POC meeting. The LCSW stated if the meeting could not be held, the patient would be informed, and the meeting would be rescheduled. The LCSW stated once an unstable assessment was triggered, a POC meeting should have been completed within 30 days. The LCSW stated Pt 1 triggered as Unstable- psychosocial. The LCSW stated it was the responsibility of the Facility Administrator/ Assessment Manager (FA/AM) to ensure the different responsible disciplines were completing their assessments in a timely manner. The LCSW stated the Social Worker’s (SW) responsibilities included advocating for Pt 1. The LCSW stated she met with Pt 1 on 7/15/25 and Pt 1 wanted to know when her POC meeting would be held. The LCSW stated she was unaware of when the meeting would be held and did not have the information about why the POC had not been arranged. The LCSW validated the Assessment was triggered on 4/3/25. The LCSW stated the POC meeting should have been completed. The LCSW stated It was important that the POC be completed because the concerns of the patient were being discussed. The LCSW stated the failure to complete the POC meeting had the potential outcome of the patient being dissatisfied. The LCSW stated the failure added to Pt 1’s frustration. During an interview on 7/16/25 at 2:28 p.m. with the Medical Social Worker (MSW), the MSW stated a POC meeting should be done as soon as possible. The MSW stated she was unaware if there was any specific guideline as to when the POC meeting should be completed. The MSW stated when assessments were triggered, the POC should be completed within 30 days. The MSW stated the importance of completing the POC meeting was a requirement of their policy. The MSW stated it was also important to complete the POC meeting to ensure all responsible parties were on the same page for Pt 1’s needs, and appropriate and timely care could be provided to Pt 1. The MSW stated the failure to complete Pt 1’s POC meeting had the potential for delay of interventions for Pt 1. During a concurrent interview and record review on 7/16/25 at 4:09 p.m. with the Facility Administrator/ Assessment Manager (FA/AM), Pt 1’s clinical record titled, “Stability Status and Plan of Care History (SSPOCH),” dated 4/3/25, “CA,” dated 5/5/25 and “Patient Note (PN),” dated 5/28/25 were reviewed. The “SSPOCH” indicated Pt 1 had previous Unstable- psychosocial assessments completed with finalized POC dated 5/10/24-8/28/24, 9/25/24-3/11/25, and 3/11/25-3/26/25. The FA/AM stated the “SSPOCH” triggered a needs assessment -Psychosocial on 4/3/25. The “CA” indicated the triggered needs assessment was completed on 5/5/25 at 8:52 a.m. The “PN” indicated, “ ...Patient triggered unstable.” The FA/AM stated every time an assessment was triggered, the assessments should be completed within 30 days and a POC meeting should be completed within 30days. The FA/AM stated the importance of completing the assessment and the POC meeting was to ensure patients’ needs were assessed. The FA/AM stated, “We get a better understanding of how the patient is feeling and address all of their concerns. If we wait too long, the patient will have a hard time adjusting and that puts them at risk.” The FA/AM stated Pt 1’s assessment triggered as an unstable psychosocial assessment. The FA/AM stated no POC meeting was rescheduled until 7/30/25. The FA/AM stated Pt 1’s POC meeting should have been rescheduled within 30 days. The FA/AM stated the facility failed to reschedule the POC meeting within 30 days according to their policy. The FA/AM stated the POC indicated since 5/28/25, there had been no other assessments completed for Pt 1. The FA/AM stated the potential outcome of a delayed and incomplete assessment, was that there was a risk of Pt 1’s needs not being met and worsening of Pt 1’s illness. During a review of the facility’s P&P titled, “Interdisciplinary Team (IDT) patient Assessment and Plan of Care- Policy 1-14-01,” dated 2007-2024, the P&P indicated, “Purpose: To provide guidance for the development of patient assessment and plan of care for IDT teammates. Policy: ASSESSMENT: ...2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/ her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations for care ....7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: ... At least monthly for unstable patients including, but not limited to, patients with the following:... significant changes in psychosocial needs...PLAN OF CARE: 8. The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition,...9. The plan of care will address but not limited to the following: ...psychosocial status which addresses necessary monitoring and social work interventions ...12. Subsequent interdisciplinary re-assessment should be completed within the 30 days following the initiation of the re-assessment. The plan of care following re-assessments must be completed within 15 days of completing the reassessment. The process would occur monthly for unstable patients...13. In addition, if the expected outcome is not achieved, the interdisciplinary team (or individual IDT member) will adjust the patient’s plan of care to achieve the specified goal....14. The patients plan of care will be completed by the facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’s personal representative. If the patient chooses not to sign the plan of care this choice will be documented on the plan of care, along with the reason the signature was not provided...21. Implementation of assessments and plan of cares are detailed in table below: [in grid]- Monthly (unstable patients), Monthly until patient is determined by interdisciplinary team to be stable, complete patient plan of care meeting within 15 days of the completion of the reassessment and POC ...””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47205 Based on interview and record review, the facility failed to ensure staff adhered to facility policy and procedure (P&P) when the Registered Nurse (RN) did not close the clamp on the normal saline (NS-a mixture of sodium chloride (salt) and water) infusion (a method of putting fluids, including drugs, into the bloodstream) tubing before attaching it to Patient (Pt) 1 at the start of Pt 1’s dialysis (a process used to purify the blood of persons whose kidneys are not working normally) treatment. This failure resulted in Pt 1 receiving an unintended amount of fluid which required extended treatment session and had the potential to result in harmful side effects of fluid overload (in dialysis patients, occurs when too much water builds up in the body. It can cause swelling, high blood pressure, breathing problems, and heart issues). Findings: During a review of complaint dated 6/20/24, the complaint alleged Pt 1 received an unintended amount of NS during dialysis treatment on 6/12/24 that caused Pt 1 discomfort, and required the treatment session to be forty-seven (47) minutes longer than planned. Complaint also indicated the RN was not aware of the unintended infusion until the patient brought it up. During a review of Pt 1’s “Patient Summary Report (PSR)” dated 7/5/24, the PSR indicated Pt 1 was “ ...Forty-nine (49) years old, [with history of] end-stage-renal disease (ESRD- a permanent condition where the kidneys stop functioning, requiring dialysis or a kidney transplant to survive), hypertension (high blood pressure), on hemodialysis (a life-saving treatment for kidney failure that removes waste and extra fluids from the blood and regulates blood pressure) congestive heart failure (CHF- when the heart is unable to pump enough blood to meet the body’s needs.) and fluid overload ...” During an interview on 7/5/24 at 10:25 a.m., with Dialysis Patient Care Technician (PCT- provides care for renal dialysis patients, following specific protocols, under the supervision of a Registered Staff Nurse) 1, PCT 1 stated she worked on the day of the event but was on a break. PCT 1 stated another PCT told her Pt 1 was upset, “I guess the saline bag was left open and she got a little bit of saline, not the whole bag.” PCT 1 stated she was not sure who set up the machine. PCT 1 stated “usually the PCT will hand the RN the lines to be hooked up, but this day the RN grabbed the lines herself to start the treatment.” PCT explained that once the dialysis machine is set up, the last step in set up is the PCT clamps the lines (tubing) and hands them to the RN, that was not done. During a concurrent interview and record review on 7/5/24 at 11:03 a.m., of Pt 1’s “Treatment Details Report (TDR) dated 6/12/24, with RN 1, the TDR indicated “ ...pre-treatment ...sitting blood pressure ...162/99 ...pre-treatment fluid calculation ...machine set to remove 2000 mL ...post-treatment total volume removed 2503 mL ...” RN 1 stated once she found out the unplanned fluid infused into the Pt 1, she quickly assessed Pt 1, did not assess a change in Pt 1’s condition so she called the doctor to notify him and to get new orders for how much fluid to remove to make Pt 1’s fluid level balanced. RN 1 stated the process of attaching the dialysis machine tubing to the patient can be done by the RN or a Patient Care Technician or both, depending on the patient’s access( a way to reach the blood placed by a minor surgery; the access allows blood to travel through soft tubes for collection). Once the tubing is ready to be attached, often the PCT hands the RN the tubing and the RN hooks the patient up. RN 1 stated during Pt 1’s treatment initiation, the PCT was on break and she was the only RN on the floor so she grabbed the prepared tubing off the dialysis machine and hooked Pt 1 up. RN 1 stated later, Pt 1 told her that the IV bag was empty. RN 1 stated she assessed the IV bag and determined approximately 400 mL of fluid had infused. RN 1 stated she provide Pt 1 with this information and it was decided and Pt 1 agreed to extend the treatment session to remove the extra fluid. RN 1 stated she did not think this error would have been made if she had not been in a hurry and so she did not check the clamps first, and/or if the PCT had been available to hand her the lines. During a concurrent observation and interview on 7/5/24 at 11:57 a.m., with PCT 2, PCT 2 stated “I don’t believe I was there that day. I heard about it when I came back.. PCT 2 stated she heard about the saline bag, “ it had been left open.” PCT 2 stated she was not sure what facility P&P’s say about who is responsible for making sure the tubing is clamped. During an interview on 7/5/24 at 12:37 p.m., with the facility Administrator (ADM), the ADM stated his expectation of staff, is if the PCT has the time and capacity should be there with the nurse to help with the lines, but there isn’t always a PCT to help. ADM stated an in-service for staff was held on 6/17/24 that addressed expectations. ADM stated one of the expectations discussed was staff hooking patients up to dialysis. ADM stated to lessen confusion and possible harmful outcomes, the staff member hooking the patient up is responsible to make sure the NS tubing is clamped/closed. During a concurrent observation and interview on 7/5/24 at 1:13 p.m., with PCT 3, on the dialysis floor, . PCT 3 stated once the machine is set up it is expected the PCT hands the readied lines to the RN and they work together to get the patient on the dialysis machine; the PCT hands the ready lines “clamped” to the RN. During a review of policy titled, “Medication Policy” dated 11/23, the policy indicated, “ ...Purpose: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications ...Policy: ...8. Medications are administered as prescribed and then documented in the patient’s medical record. No medications are given without an order from the physician ...” According to the National Kidney Foundation, undated, retrieved on 9/5/2024 from https://www.kidney.org/kidney-topics/fluid-overload-dialysis-patient indicated “...Fluid overload in dialysis patients occurs when too much water builds up in the body. It can cause swelling, high blood pressure, breathing problems, and heart issues. Having too much water in your body is called fluid overload or hypervolemia. One of the main functions of the kidneys is to balance fluid in the body. If too much fluid builds up in your body, it can have harmful effects on your health, such as difficulty breathing and swelling. When you are on dialysis, your kidneys are no longer able to keep the right balance of fluid in your body. They cannot remove enough. That’s why it’s so important to limit how much sodium (salt) and fluid you have between dialysis treatments. This helps your body maintain the right amount of fluid, and it makes it easier for your dialysis treatment to remove extra water ...””