Sanderling Dialysis of Tehachapi

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 45654 Based on interview and record review the facility failed to ensure the safety of clients when: 1. Client 1 had aggressive behavior towards staff and other clients. This failure resulted in unwanted psychosocial harm of clients. 2. The facility did not follow state and local guidelines, and report Client 1’s aggressive behaviors . This failure resulted in a one of one sampled client (Client 2) having a panic attack. Findings: 1. During a review of Client 1’s “Nursing Note,” dated 6/13/25, 6/16/25 and 6/18/25, the Nursing Notes indicated the following: The Nursing note dated 6/13/25 at 4: 24 p.m. indicated, Client 1,”does not allow me/male staff to participate in his care.” The Nursing Note dated 6/16/25 at 11:29 a.m. indicated, “Patient (Client 1) came at 9:45 a.m. in unit and started shouting that chair not ready but the technician told him his tx time is 1015 timing and he will make it ready now. Patient [Client 1] get more aggressive and started shouting at technician. Patient (Client 2) sitting besides [beside] has panic attack and called the husband [family member] and the husband was mad for having such patients in the unit. Client 1 do not want technician [technician 1] to put him [Client 1] on and he was the only one used to start his treatment. “The other technician [Technician 2], [Technician 3] already had issues with him due his aggressive behaviour [sic].” The Nursing Note dated 6/16/25 at 11:53 a.m. indicated, “PT (Patient -Client 1) arrived about 9:45 a.m. and placed belongings against TX [treatment] chair. He (Client 1) was let known that it is not ready and if he (Client 1) can remove the belongings from the chair so it could be prepared. PT (Client 1) upset. stating he will not remove his things. . . Nurse asked for PT (Client 1) to leave TX floor. PT (Client 1) has been arguing and yelling with nurse getting rather close to her, to prevent any physical assault i [sic] stepped between the PT (Client 1) and nurse and let PT (Client 1) know if he does not leave the floor he will be physically removed.” The Nursing Note dated 6/18/25 at 11:05 a.m. indicated, Client 1 “. . . refused to be cannulated by staff members present. . . patient (Client 1) very loud and aggressive to all the staff members and clients on the unit.” During an interview on 6/24/25 at 10:18 a.m. with Facility Administrator (FA), FA stated on Wednesday she did notify cooperate network office of the incident. FA stated she left a message and finally got a call back on Monday morning dated 6/24/25. FA stated that none of the clients felt safe. 2. During a review of Client 2’s “Incident Report,” dated 6/18/25, the Incident Report indicated, “The environment is not safe when he [Client 1] is around. His speratic [sic] action are making me have panic attacks that will lead me into an ambulance.” The Nursing note dated 6/18/25 at 9:44 a.m. indicated, “Client 2 doesn’t feel safe”. During an interview on 6/18/25 at 2:52 p.m. with Client 2, Client 2 stated Client 1 went off staff on Monday or Wednesday the whole thing caused her anxiety. Client 2 stated Client 1 was upset walking around and getting in staff faces he was aggressive with staff. Client 2 stated the police were called. During an interview on 6/24/25 at 9:15 a.m. with Family Member (FM), FM stated Client 1 harasses a female client and the staff last Wednesday. FM stated he witnessed Client 1 harassing the staff and the staff was trying to get Client 1 out of the clinic. FM stated Client 1 was,”cussing out the staff and screaming at them.” FM stated he stays to make sure Client 1 is settled and comes an hour before her treatment is finished. FM stated Client 2 used to have her anxiety under control but now it is not. During an interview on 6/24/25 at 1:53 p.m. with Patient Services Manager (PSM), PSM stated the process is for her to file a report within 24 hours to the District Office. Policy requested, and not received.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 45654 Based on interview and record review the facility failed to follow its Policy and Procedure (P&P) titled “Clinic Code of Conduct,” for one of five sampled clients (Client 1) when a Client 1 had aggressive behaviors towards staff and clients. This failure resulted in Client 2 having a panic attack. Findings: During an interview on 6/18/25 at 2:52 p.m. with Client 2, Client 2 stated Client 1 went off on staff on Monday or Wednesday, and the whole thing caused her anxiety. Client 2 stated Client 1 was upset walking around and getting in staff faces, he was aggressive with staff. Client 2 stated the police were called. During an interview on 6/24/25 at 9:15 a.m. with Family Member (FM), FM stated Client 1 harassed a female client and the staff last Wednesday. FM stated he witnessed Client 1 harassing the staff and the staff was trying to get Client 1 out of the clinic. FM stated Client 1 was,”cussing out the staff and screaming at them.” FM stated Client 2 used to have her anxiety under control but now it is not. During an interview on 6/24/25 at 9:38 a.m. with Technician 4, Technician 4 stated she was working on 6/16/25 Client 1’s station was not set up. Technician 1 told Client 1 that he needed to wait for his station to be cleaned, and Technician 1 would call Client 1 back. Client 1 started yelling at Technician 1. Technician 4 stated Client 1 started yelling and cussing at Technician 1. Technician 4 stated the nurse told Client 1 to stop cussing. During an interview on 6/24/25 at 9:39 a.m. with Technician 4,Technician 4 stated Client 2 has an increase in her anxiety when Client 1 walks by her, or is too close. Technician 4 stated she (Client 2) gets tense. During an interview on 6/24/25 at 9:42 a.m. with Technician 1, Technician 1 stated, on Monday 6/16/25, Client 1 kept crossing the back sink area then went to his chair, but his chair was not clean. Technician 1 stated he tried to clean it and to have Client 1 return to the lobby, but he (Client 1) started cussing and getting agitated the nurse came over and Client 1 yelled and cussed at the nurse. Technician 1 stated on Wednesday 6/18/25, Client 1 started yelling and cussing at the nurse at the counter. Technician 1 stated Client 1 was being guided out of the treatment area and into the lobby. Client 1 opened the lobby window, and started yelling and shouting obscenities. Technician 1 stated he went to close the window and Client 1 grabbed his hands, and started squeezing them. During an interview on 6/24/25 at 10:10 a.m. with Client 3, Client 3 stated she felt uncomfortable and scared being around Client 1. Client 3 stated she told staff this. During an interview on 6/24/25 at 10:15 a.m. with Client 4, Client 4 stated I already told them [facility] they had issue. During an interview on 6/24/25 at 10:18 a.m. with Facility Administrator (FA), FA stated Client 1 got physically aggressive. FA stated none of the clients or staff felt safe. During a review of Client 1’s “Nursing Note,” dated 6/16/25 and 6/18/25, the Nursing Notes indicated the following: The Nursing Note dated 6/16/25 at 11:29 a.m. indicated, “Patient (Client 1) came at 9:45 a.m. in unit and started shouting that chair not ready but the technician told him his TX time is 1015 timing and he will make it ready now. Patient [Client 1] get more aggressive and started shouting at technician. Patient (Client 2) sitting besides [beside] has panic attack and called the husband [family member] and the husband was mad for having such patients in the unit. Client 1 do not want technician [technician 1] to put him [Client 1] on and he was the only one used to start his treatment. “The other technician [Technician 2], [Technician 3] already had issues with him due his aggressive behaviour [sic].” The Nursing Note dated 6/16/25 at 11:53 a.m. indicated, “PT (Patient -Client 1) arrived about 9:45 a.m. and placed belongings against TX [treatment] chair. He (Client 1) was let known that it is not ready and if he (Client 1) can remove the belongings from the chair so it could be prepared. PT (Client 1) upset. stating he will not remove his things. . . Nurse asked for PT (Client 1) to leave TX floor. PT (Client 1) has been arguing and yelling with nurse getting rather close to her, to prevent any physical assault i [sic] stepped between the PT (Client 1) and nurse and let PT (Client 1) know if he does not leave the floor he will be physically removed.” The Nursing note dated 6/18/25 at 9:44 a.m. indicated, “Client 2 doesn’t feel safe”. The Nursing Note dated 6/18/25 at 11:05 a.m. indicated, Client 1 “. . . refused to be cannulated by staff members present. . . patient (Client 1) very loud and aggressive to all the staff members and clients on the unit.” During a review of Client 1’s “Behavioral Agreement,” dated 6/17/23, the Behavioral Agreement indicated, “I will refrain from yelling or using profanity when addressing any staff member, patient or visitor to this facility. Any such behavior may result in my dialysis treatment being stopped and I will be asked to leave the facility.” During a review of the facility’s P&P titled, “Clinic Code of Conduct,” [undated], the P&P indicated, “Physical violence, or threat of violence towards persons or property will not be tolerated.””

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis center failed to: 1. Ensure Patient Care Technicians (PCT) 1, PCT 4, PCT 5, PCT 6 and Registered Nurse (RN) 1 received education on the facility policy titled “Cleaning Machine and Area Blood Spill.” 2. Ensure PCT 1, PCT 2, PCT 3, PCT 4, PCT 5, PCT 6, RN 1, RN 2, and RN 3 received re-education on wearing appropriate Personal Protective Equipment (PPE- refers to gowns, gloves, masks, face shields, or goggles worn to protect one from injury or infection). 3. Ensure daily audits were conducted regarding facility cleanliness, maintaining sanitary environment, ensuring blood spills were cleaned properly and immediately, PPE was worn during initiation and termination of dialysis, cleaning of dialysis machines, and during centrifugation (spinning blood samples in collection tubes at high speeds) of blood according to the facility’s plan of correction (POC). These failures had the potential to transmit infectious diseases to patients, staff, and visitors. Findings: 1. During a concurrent interview and record review on 1/25/24 at 12 p.m. with Registered Nurse (RN) 2 and Facility Administrator (FA), the POC, approved 11/15/23, was reviewed. RN 2 was unable to provide the facility policy and procedure titled, “Cleaning Machine and Area Blood Spill,” dated 3/14/12 and proof of all staff re-education on the above policy and procedure as written in the facility’s POC. RN 2 stated, “I think I have it in my car and if not, I think I have it at home.” FA verified the findings and stated, “I was not hired then.” 2. During a concurrent interview and record review on 1/25/24 at 12:15 p.m. with RN 2 and FA, the POC, approved 11/15/23, was reviewed. RN 2 was unable to provide all staff re-education on the proper use of PPE as written on the facility’s POC. RN 2 stated, “I don’t have it.” FA stated she was not here then, but that should have been done. 3. During a concurrent interview and record review on 1/25/24 at 12:30 p.m. with RN 2 and FA, the POC, approved 11/15/23, was reviewed. RN 2 was unable to provide daily audits conducted for four weeks on blood spills, or occurrences of not cleaned according to their policy. RN 2 was not able to provide daily infection control audits on the use of PPE. FA stated she did not have those audits as RN 2 was responsible for the POC. During a review of the facility’s policy and procedure (P&P) titled, “Dialysis Infection Control Precautions,” [undated], the P&P indicated, 10. The clinic manager is responsible to implement the policy, and to monitor lapses in infection control.””

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 35649 The dialysis facility failed to meet the regulatory compliance for § 494.62 Condition for Coverage: Emergency Preparedness. (The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area) as evidenced by: 1. Based on interview and record review, the dialysis facility failed to review and update the emergency preparedness/readiness plan at least every two years. This failure had the potential to place patients, staff, and visitors’ safety and well-being at risk for harm in the event of a disaster or emergency. (Refer to E-0004) 2. Based on interview and record review, the dialysis facility failed to conduct an emergency risk assessment (the process of determining what the facility-based disasters care related to equipment failure, interruption in communication, interruptions to normal supply resources, such as water, food, medications, etc.,) annually. This failure had the potential for the dialysis facility’s to be unprepared in the event of an actual emergency or disaster. (Refer to E-0006). 3. Based on interview and record review, the dialysis facility failed to ensure communication and collaboration exists between the dialysis center and the local emergency agency annually. This failure had the potential for the local emergency agency being unaware of the dialysis facility’s needs that could result in the dialysis facility not receiving the support and the emergency supplies and equipment needed for their patients during an actual emergency. (Refer to E-0009). 4. Based on observation, interview, and record review, the dialysis facility failed to follow their emergency policies and procedures when the dialysis facility failed to: A. Ensure one of one crash cart (mobile cart that contains emergency medical equipment, supplies and drugs used in the event of a medical emergency) was checked weekly and failed to ensure the crash cart was locked. This failure had the potential to result in the crash cart not ready for use in the event of an emergency and potential for harm due to unauthorized access by patients or visitors. (Refer to E-0028, item 1) B. Ensure emergency equipment, such as an oxygen tank and suction machine (medical device used to remove mucous, saliva, etc from a person’s airway), were ready and functional; and an Automated External Defibrillator (AED - a medical device designed to analyze the heart rhythm and deliver an electric shock to victims of sudden cardiac arrest) was checked three times a week when the dialysis facility is in operation. This failure had the potential to place patients at risk for harm in the event of a medical emergency. (Refer to E-0028, item 2) C. Ensure four dialysis tubing clamps used for emergency take off were accessible for 31 of 31 in-center hemodialysis patients use in all nine dialysis machines. This failure had the potential for patients to not be able to perform emergency take off in the event of an actual emergency. (Refer to E-0028, item 3) 5. Based on interview and record review, the dialysis facility failed to ensure fire drills were conducted with facility staff quarterly every shift in accordance with the facility’s policy and procedure. This failure had the potential for the staff to not be aware of the emergency procedure in the event of fire. (Refer to E-0038). 6. Based on interview and record review, the dialysis facility failed to ensure emergency patient education and training on emergency take off were provided for nine of nine sampled patients (Patient 2, Patient 4, Patient 9, Patient 11, Patient 22, Patient 24, Patient 25, Patient 26, and Patient 27) quarterly. This failure had the potential for Patient 2, Patient 4, Patient 9, Patient 11, Patient 22, Patient 24, Patient 25, Patient 26, and Patient 27 to be unaware of what to do in the event a disaster or when emergency occurs during dialysis treatment. (Refer to E-0040). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to ensure patients safety in the event of a disaster or emergency in compliance with the Condition for Coverage on Emergency Preparedness.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 35649 The dialysis facility failed to meet the regulatory compliance for § 494.30 Condition for Coverage: Infection Control as evidenced by: 1. Based on observation and interview, the dialysis facility failed to provide a sanitary environment, when multiple metal drain covers for the drainage areas, used to drain dialysis fluid waste from dialysis machines, located at the back of each dialysis stations (Station 2, Station 3, Station 4, Station 5, Station 6, Station 7, Station 8, and Station 9) were rusty. This failure had the potential to result in destruction of metals, blockage of pipes, and contamination. (Refer to V111). 2. Based on observation, interview, and record review, the dialysis facility failed to: A. Ensure three of three Patient Care Technicians (PCT 1, PCT 2, and PCT 3) and one of four Patient Care Technician Orientees (PCTO) 2 performed hand hygiene and changed gloves in between tasks. This failure had the potential to transmit infectious diseases to patients, staff, and visitors. (Refer to V113). B. Ensure five of five dialysis patients (Patient 9, Patient 10, Patient 12, Patient 1, and Patient 17) performed hand hygiene before and after dialysis treatment. This failure had the potential to transmit infectious diseases to patients, staff, and families. (Refer to V113). C. Ensure two of two staff (PCTO 4 and Registered Nurses [RN] 2) removed their gowns and gloves, when they exited the HD treatment area to the lobby and parking area, to assist two in-center HD sampled patients (Patient 15 and Patient 18). This failure had the potential to transmit infectious diseases to patients, staff, and visitors. (Refer to V113). 3. Based on observation, interview, and record review, the dialysis facility failed to: A. Ensure PCT 2 wore face shield during discontinuation of dialysis catheters for Patient 27. This failure had the potential to expose PCT 2 to splashes of blood and body fluids, resulting in transmission of infectious diseases. (Refer to V115). B. Ensure one of one Patient Care Technician (PCT) 2 did not use someone else’s face shield during cannulation (insertion of dialysis needles) of Patient 19’s Arteriovenous Fistula (AV fistula- a connection that’s made by a surgeon between an artery and a vein for dialysis access). This failure had the potential for cross-contamination and transmission of infectious disease. (Refer to V115). 4. Based on observation, interview, and record review, the dialysis facility failed to ensure one of two Registered Nurses (RN) 1 separated the clean from dirty supplies during access and care of Patient 12’s central venous catheter (CVC-a type of access used for hemodialysis, placed under the skin and into a large central vein). This failure had the potential to transmit infectious diseases. (Refer to V117). 5. Based on observation, interview, and record review, the dialysis facility failed to dispose of infectious wastes appropriately for one of 30 in-center HD sampled patients (Patient 1). This failure had the potential for the spread of infectious diseases to patients, visitors, and staff. (Refer to V121). 6. Based on observation, interview, and record review, the dialysis facility failed to ensure two of two staff members, Patient Care Technician (PCT) 1 and Registered Nurse (RN) 2, disinfected their stethoscopes (a medical instrument for listening to someone’s heart or breathing) after patient use. This failure had the potential to transmit infectious diseases. (Refer to V122). 7. Based on interview and record review, the facility failed to: A. Offer two of six susceptible in-center HD sampled patients (Patient 1 and Patient 3) the Hepatitis B vaccination (vaccine used to stimulate the body’s immune response against the contagious hepatitis B virus [HBV] - a liver infection that can spread from person to person via blood and body fluids]) after tests indicated patients had no immunity to HBV. B. Perform laboratory test to determine immunity to two of six sampled staff (Patient Care Technician [PCT] 6 and Registered Nurse [RN] 2). These failures had the potential for the patients and staff to become infected with Hepatitis B infection if exposed to the HBV and spread Hepatitis B infection. (Refer to V126). 8. Based on interview and record review, the dialysis facility failed to provide Infection Control and Prevention Training and Education. This failure had the potential to transmit bacteria and blood-borne viral agents from patient-to-patient or healthcare personnel-to-patient, directly or indirectly through contaminated supplies and equipment, surfaces, or hands. (Refer to V132). 9. Based on interview and record review, the dialysis facility failed to: A. Conduct, analyze, evaluate, act, track, and trend infection control surveillance activities. B. Provide evidence of visual audits of each direct care staff to verify competency for infection control prevention. These failures had the potential for infection control issues to not be addressed, monitored, and acted upon, which could result in the spread and transmission of infectious diseases, directly or indirectly to patients, staff, and visitors. (Refer V142). 10. Based on observation, interview, and record review, the dialysis facility failed to: A. Follow its policy and procedure on Medication Administration. This failure had the potential to transfer microorganisms from one person or object to another during preparation and administration of medications. (Refer to V143). B. Ensure expired medications were not available for use. This failure had the potential for the medication to loss its effectiveness and potency. (Refer to V143). 11. Based on interview and record review, the dialysis facility failed to ensure: A. Five of seven sampled staff (Patient Care Technician [PCT] 6, Registered Nurse [RN] 2, Biomedical Technician [BMT], and Registered Dietitian [RD] 2 and (PCT 5) TB (tuberculosis - an infectious lung disease) screening (TB skin test or TB blood test evaluation or questionnaires) were completed upon hire and annually. B. One of six in-center HD sampled patients (Patient 3) had TB screening (TB skin test or blood test evaluation/questionnaires) on admission. These failures had the potential for patients and staff at risk for contracting TB when exposed and spread TB infection. (Refer to V145). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to prevent transmission of infections, directly or indirectly in compliance with the Condition for Coverage on Infection Control.”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 35649 The dialysis facility failed to meet the regulatory compliance for § 494.80 Condition for Coverage: Patient Assessment as evidenced by: 1. Based on interview and record review, the dialysis facility failed to ensure the Interdisciplinary Team (IDT-a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) conducted IDT meetings, developed comprehensive assessment to formulate a plan of care, and provided evidence IDT discussed the plan of care (POC) for six of 11 in-center hemodialysis sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, and Patient 11). This failure had the potential for patients to not receive the appropriate treatment plan, which could negatively impact patient care. (Refer to V501). 2. Based on observation, interview and record review, the dialysis facility failed to follow prescribed dialysis prescription, document, and notify the physician when prescribed dialysis prescription were adjusted without rationale for change and when the target goals as prescribed were not achieved for five of 11 sampled patients (Patient 6, Patient 7, Patient 9, Patient 10, and Patient 11). This failure had the potential for dialysis patients to not achieve adequate dialysis and meet their target goal. (Refer to V503). 3. Based on interview and record review, the dialysis facility failed to: A. Ensure Registered Nurse (RN) 2 assess and reassess reported elevated blood pressures and intervened appropriately pre (before), intra (during), and post (after) dialysis treatment for four of 11 in-center hemodialysis sampled patients (Patient 2, Patient 3, Patient 5, and Patient 6) with labile blood pressure (when a person’s blood pressure repeatedly or suddenly changes from normal to abnormally high levels) and one of eight sampled Home-Hemodialysis patients (Patient 21). This failure resulted in patients dialyzing with elevated blood pressure and not meeting her target weight post dialysis. (Refer to V504). B. Ensure registered nurses (RN 1 and RN 2) performed intradialytic (during dialysis) assessments and physicians notified when ultrafiltration rate (UFR-mechanical removal of fluid from the patient) was greater than 13 ml/kg/hour (limit of UFR monitored by the Centers for Medicare and Medicaid Services [CMS] to decrease the risk of heart failure symptoms and mortality) for two of 11 in-center hemodialysis sampled patients (Patient 7 and Patient 11). This failure had the potential to place patients at risk for harm during and post-dialysis treatment. (Refer to V504). C. Ensure registered nurses (RN 1 and RN 2) performed reassessment of dry weights for one of 11 in-center hemodialysis sampled patients (Patient 9) to be able to manage fluid and unmet targeted dry weight. This failure resulted in Patient 9’s unmet care needs to achieve targeted dry weight. (Refer to V504). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to provide each patient with an individualized and comprehensive assessment of his or her needs in compliance with the Condition for Coverage on Patient Assessment.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 35649 The dialysis facility failed to meet the regulatory compliance for § 494.90 Condition for Coverage: Patient Plan of Care as evidenced by: 1. Based on interview and record review, the dialysis facility failed to ensure the Interdisciplinary Team (IDT-a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) conducted IDT meetings, developed comprehensive assessment to formulate a plan of care, and provided evidence IDT discussed the plan of care (POC) for six of 11 in-center hemodialysis sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, and Patient 11). This failure had the potential for patients to not receive the appropriate treatment plan, which could negatively impact patient care. (Refer to V542). 2. Based on interview and record review, the dialysis facility failed to ensure one of eight HHD patients (Patient 21) and two of 11 sampled in-center HD Patients (Patient 1 and Patient 4) post-dialysis target weights were reviewed and evaluated with the physician. This failure had the potential to result in poor patient health outcome. (Refer to V543). 3. Based on interview and record review, the dialysis facility failed to ensure the Social Worker (SW) followed up on the transplant referral and update the plan of care for six of six in-center hemodialysis sampled patients (Patient 4, Patient 6, Patient 7, Patient 22, Patient 23, Patient 29). This failure had the potential for unmet care needs. (Refer to V554). 4. Based on interview and record review, the dialysis facility failed to perform a 30-day patient assessment for one of one patient (Patient 10). This failure had the potential for patients’ unmet care needs. (Refer to V557). 5. Based on interview and record review, the dialysis facility failed to ensure four of five nephrologists (kidney doctors- Physician 1, Physician 2, Physician 3, Physician 4) documented monthly physician progress notes for three of three in-center hemodialysis sampled patients (Patient 6, Patient 7, and Patient 8) and one of one Peritoneal Dialysis (PD-a treatment for kidney failure that uses the lining of one’s abdomen or belly to filter blood) patient (Patient 20). This failure had the potential for Patient 6, Patient 7, Patient 8, and Patient 20 to have missed evaluation for medical care, which could be detrimental to their treatment plan and care. (Refer to V560). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to provide each patient with an individualized and comprehensive plan of care necessary to address patients’ needs in compliance with the Condition for Coverage on Patient Plan of Care.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 35649 The dialysis facility failed to meet the regulatory compliance for § 494.110 Condition for Coverage: Quality Assessment and Performance Improvement as evidenced by: A. Based on interview and record review, the dialysis facility failed to maintain an effective Quality Assessment and Performance Improvement (QAPI-a data driven and proactive approach to quality improvement, ensuring services are meeting quality standards) Program as evidenced by: 1. Three staff members, Registered Nurse (RN) 2, Patient Care Technician Orientee (PCTO) 3, Patient Care Technician (PCT) 2 were not aware and knowledgeable about the dialysis facility’s QAPI Program. This failure had the potential for the staff to not be aware of opportunities for improvement, address gaps in processes, develop action plans, and monitor effectiveness of interventions to achieve and improve quality of care. (Refer to V626). 2. The Interdisciplinary Team (IDT-a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) did not act upon areas of concerns discussed in the quarterly QAPI meetings regarding anemia (a condition of not having enough healthy red blood cells to carry oxygen to the body’s tissues) management, high phosphorus (a chemical element that helps filter out waste in the kidneys), etc. This failure had the potential for past and current non-compliance opportunities to not be addressed, which could lead to negative outcomes for the dialysis patients. (Refer to V626). B. Based on interview and record review, the dialysis facility failed to: 1. Conduct, analyze, act, evaluate, track, and trend infection control surveillance (ongoing, systematic collection, analysis, and interpretation of data) activities. 2. Provide evidence of visual audits of each direct care staff to validate competency (knowledge and skills to perform the job) for infection control prevention. These failures had the potential for infection control issues to not be addressed, monitored, and acted upon, which could result in the spread and transmission of infectious diseases, directly or indirectly to patients, staff, and visitors. (Refer to V628). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to demonstrate evidence of an effective data driven QAPI Program to achieve measurable health outcomes and reflect processes of care in compliance with the Condition for Coverage on Quality Assessment and Performance Improvement.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 35649 The dialysis facility failed to meet the regulatory compliance for § 494.180 Condition for Coverage: Governance I. The dialysis facility failed to meet the regulatory compliance for § 494.62 Condition for Coverage: Emergency Preparedness. (The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area) as evidenced by: 1. Based on interview and record review, the dialysis facility failed to review and update the emergency preparedness/readiness plan at least every two years. This failure had the potential to place 40 of 40 patients, staff, and visitors’ safety and well-being at risk for harm in the event of a disaster or emergency. (Refer to V 0004). 2. Based on interview and record review, the dialysis facility failed to conduct an emergency risk assessment (the process of determining what the facility-based disasters care related to equipment failure, interruption in communication, interruptions to normal supply resources, such as water, food, medications, etc.,) annually. This failure had the potential for the facility’s emergency needs to not be appropriated properly, which could be detrimental during a disaster or emergency. (Refer to V 0006). 3. Based on interview and record review, the dialysis facility failed to ensure communication exists between the dialysis center and the local emergency agency annually. This failure had the potential for the local emergency agency to not be aware of the dialysis center’s needs that could result in the dialysis center to not receive the support and the emergency supplies and equipment needed during an emergency. (Refer to V 0009). 4. Based on observation, interview, and record review, the dialysis facility failed to: A. Ensure one of one crash cart (mobile cart that contains emergency medical equipment, supplies and drugs used in the event of a medical emergency) was checked weekly and locked when unattended. This failure had the potential to result in the crash cart not ready for use in the event of an emergency and potential for harm when unlawfully accessed by patients or visitors. (Refer to V 0028). B. Ensure emergency equipment, such as oxygen tank and suction machine, were ready and functional, and Automated External Defibrillator (AED -a medical device designed to analyze the heart rhythm and deliver an electric shock to victims of sudden cardiac arrest) were checked three times a week when the clinic is in operation. This failure had the potential to place patients at risk for harm in the event of a medical emergency. (Refer to V 0028). C. Ensure four dialysis tubing clamps used for emergency take off were accessible for 31 of 31 in-center hemodialysis patients’ use in all nine dialysis machines. This failure had the potential for patients to not be able to perform emergency take off in the event of an emergency. (Refer to V 0028). 5. Based on interview and record review, the dialysis facility failed to ensure fire drills were conducted with the staff quarterly every shift in accordance with the facility’s policy and procedure. This failure had the potential for the staff to not be aware of the emergency procedure in the event of fire. (Refer to V 0038). 6. Based on interview and record review, the dialysis facility failed to ensure emergency patient education and training on emergency take off were provided for nine of nine sampled patients (Patient 2, Patient 4, Patient 9, Patient 11, Patient 22, Patient 24, Patient 25, Patient 26, and Patient 27) quarterly. This failure had the potential for Patient 2, Patient 4, Patient 9, Patient 11, Patient 22, Patient 24, Patient 25, Patient 26, and Patient 27 to be unaware of what to do in the event a disaster or when emergency occurs during dialysis treatment. (Refer to V 0040). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to ensure patients safety in the event of a disaster or emergency in compliance with the Condition for Coverage on Emergency Preparedness. II. The dialysis facility failed to meet the regulatory compliance for § 494.30 Condition for Coverage: Infection Control as evidenced by: 1. Based on observation and interview, the dialysis facility failed to provide a sanitary environment, when multiple metal drain covers for the drainage areas, used to drain dialysis fluid waste from dialysis machines, located at the back of each dialysis stations (Station 2, Station 3, Station 4, Station 5, Station 6, Station 7, Station 8, and Station 9) were rusty. This failure had the potential to result in destruction of metals, blockage of pipes, and contamination. (Refer to V111). 2. Based on observation, interview, and record review, the dialysis facility failed to: A. Ensure three of three Patient Care Technicians (PCT 1, PCT 2, and PCT 3) and one of four Patient Care Technician Orientees (PCTO) 2 performed hand hygiene and changed gloves in between tasks. This failure had the potential to transmit infectious diseases to patients, staff, and visitors. (Refer to V113). B. Ensure five of five dialysis patients (Patient 9, Patient 10, Patient 12, Patient 1, and Patient 17) performed hand hygiene before and after dialysis treatment. This failure had the potential to transmit infectious diseases to patients, staff, and families. (Refer to V113). C. Ensure two of two staff (PCTO 4 and Registered Nurses [RN] 2) removed their gowns and gloves, when they exited the HD treatment area to the lobby and parking area, to assist two in-center HD sampled patients (Patient 15 and Patient 18). This failure had the potential to transmit infectious diseases to patients, staff, and visitors. (Refer to V113). 3. Based on observation, interview, and record review, the dialysis facility failed to: A. Ensure PCT 2 wore face shield during discontinuation of dialysis catheters for Patient 27. This failure had the potential to expose PCT 2 to splashes of blood and body fluids, resulting in transmission of infectious diseases. (Refer to V115). B. Ensure one of one Patient Care Technician (PCT) 2 did not use someone else’s face shield during cannulation (insertion of dialysis needles) of Patient 19’s Arteriovenous Fistula (AV fistula- a connection that’s made by a surgeon between an artery and a vein for dialysis access). This failure had the potential for cross-contamination and transmission of infectious disease. (Refer to V115). 4. Based on observation, interview, and record review, the dialysis facility failed to ensure one of two Registered Nurses (RN) 1 separated the clean from dirty supplies during access and care of Patient 12’s central venous catheter (CVC-a type of access used for hemodialysis, placed under the skin and into a large central vein). This failure had the potential to transmit infectious diseases. (Refer to V117). 5. Based on observation, interview, and record review, the dialysis facility failed to dispose of infectious wastes appropriately for one of 30 in-center HD sampled patients (Patient 1). This failure had the potential for the spread of infectious diseases to patients, visitors, and staff. (Refer to V121). 6. Based on observation, interview, and record review, the dialysis facility failed to ensure two of two staff members, Patient Care Technician (PCT) 1 and Registered Nurse (RN) 2, disinfected their stethoscopes (a medical instrument for listening to someone’s heart or breathing) after patient use. This failure had the potential to transmit infectious diseases. (Refer to V122). 7. Based on interview and record review, the facility failed to: A. Offer two of six susceptible in-center HD sampled patients (Patient 1 and Patient 3) the Hepatitis B vaccination (vaccine used to stimulate the body’s immune response against the contagious hepatitis B virus [HBV] - a liver infection that can spread from person to person via blood and body fluids]) after tests indicated patients had no immunity to HBV. B. Perform laboratory test to determine immunity to two of six sampled staff (Patient Care Technician [PCT] 6 and Registered Nurse [RN] 2). These failures had the potential for the patients and staff to become infected with Hepatitis B infection if exposed to the HBV and spread Hepatitis B infection. (Refer to V126). 8. Based on interview and record review, the dialysis facility failed to provide Infection Control and Prevention Training and Education. This failure had the potential to transmit bacteria and blood-borne viral agents from patient-to-patient or healthcare personnel-to-patient, directly or indirectly through contaminated supplies and equipment, surfaces, or hands. (Refer to V132). 9. Based on interview and record review, the dialysis facility failed to: A. Conduct, analyze, evaluate, act, track, and trend infection control surveillance activities. B. Provide evidence of visual audits of each direct care staff to verify competency for infection control prevention. These failures had the potential for infection control issues to not be addressed, monitored, and acted upon, which could result in the spread and transmission of infectious diseases, directly or indirectly to patients, staff, and visitors. (Refer V142). 10. Based on observation, interview, and record review, the dialysis facility failed to: A. Follow its policy and procedure on Medication Administration. This failure had the potential to transfer microorganisms from one person or object to another during preparation and administration of medications. (Refer to V143). B. Ensure expired medications were not available for use. This failure had the potential for the medication to loss its effectiveness and potency. (Refer to V143). 11. Based on interview and record review, the dialysis facility failed to ensure: A. Five of seven sampled staff (Patient Care Technician [PCT] 6, Registered Nurse [RN] 2, Biomedical Technician [BMT], and Registered Dietitian [RD] 2 and PCT 5) TB (tuberculosis - an infectious lung disease) screening (TB skin test or TB blood test evaluation or questionnaires) were completed upon hire and annually. B. One of six in-center HD sampled patients (Patient 3) had TB screening (TB skin test or blood test evaluation/questionnaires) on admission. These failures had the potential for patients and staff at risk for contracting TB when exposed and spread TB infection. (Refer to V145). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to prevent transmission of infections, directly or indirectly in compliance with the Condition of Participation on Infection Control. III. The dialysis facility failed to meet the regulatory compliance for § 494.80 Condition for Coverage: Patient Assessment as evidenced by: 1. Based on interview and record review, the dialysis facility failed to ensure the Interdisciplinary Team (IDT-a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) conducted IDT meetings, developed comprehensive assessment to formulate a plan of care, and provided evidence IDT discussed the plan of care (POC) for six of 11 in-center hemodialysis sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, and Patient 11). This failure had the potential for patients to not receive the appropriate treatment plan, which could negatively impact patient care. (Refer to V501). 2. Based on observation, interview and record review, the dialysis facility failed to follow prescribed dialysis prescription, document, and notify the physician when prescribed dialysis prescription were adjusted without rationale for change and when the target goals as prescribed were not achieved for five of 11 sampled patients (Patient 6, Patient 7, Patient 9, Patient 10, and Patient 11). This failure had the potential for dialysis patients to not achieve adequate dialysis and meet their target goal. (Refer to V503). 3. Based on interview and record review, the dialysis facility failed to: A. Ensure Registered Nurse (RN) 2 assess and reassess reported elevated blood pressures and intervened appropriately pre (before), intra (during), and post (after) dialysis treatment for four of 11 in-center hemodialysis sampled patients (Patient 2, Patient 3, Patient 5, and Patient 6) with labile blood pressure (when a person’s blood pressure repeatedly or suddenly changes from normal to abnormally high levels) and one of eight sampled Home-Hemodialysis patients (Patient 21). This failure resulted in patients dialyzing with elevated blood pressure and not meeting her target weight post dialysis. (Refer to V504). B. Ensure registered nurses (RN 1 and RN 2) performed intradialytic (during dialysis) assessments and physicians notified when ultrafiltration rate (UFR-mechanical removal of fluid from the patient) was greater than 13 ml/kg/hour (limit of UFR monitored by the Centers for Medicare and Medicaid Services [CMS] to decrease the risk of heart failure symptoms and mortality) for two of 11 in-center hemodialysis sampled patients (Patient 7 and Patient 11). This failure had the potential to place patients at risk for harm during and post-dialysis treatment. (Refer to V504). C. Ensure registered nurses (RN1 and RN 2) performed reassessment of dry weights for one of 11 in-center hemodialysis sampled patients (Patient 9) to be able to manage fluid and unmet targeted dry weight. This failure resulted in Patient 9’s unmet care needs to achieve targeted dry weight. (Refer to V504). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to provide each patient with an individualized and comprehensive assessment of his or her needs in compliance with the Condition for Coverage on Patient Assessment. IV. The dialysis facility failed to meet the regulatory compliance for § 494.90 Condition for Coverage: Patient Plan of Care as evidenced by: 1. Based on interview and record review, the dialysis facility failed to ensure the Interdisciplinary Team (IDT-a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) conducted IDT meetings, developed comprehensive assessment to formulate a plan of care, and provided evidence IDT discussed the plan of care (POC) for six of 11 in-center hemodialysis sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, and Patient 11). This failure had the potential for patients to not receive the appropriate treatment plan, which could negatively impact patient care. (Refer to V542). 2. Based on interview and record review, the dialysis facility failed to ensure one of eight HHD patients (Patient 21) and two of 11 sampled in-center HD Patients (Patient 1 and Patient 4) post-dialysis target weights were reviewed and evaluated with the physician. This failure had the potential to result in poor patient health outcome. (Refer to V543). 3. Based on interview and record review, the dialysis facility failed to ensure the Social Worker (SW) followed up on the transplant referral and update the plan of care for six of six in-center hemodialysis sampled patients (Patient 4, Patient 6, Patient 7, Patient 22, Patient 23, Patient 29). This failure had the potential for unmet care needs. (Refer to V554). 4. Based on interview and record review, the dialysis facility failed to perform a 30-day patient assessment for one of one patient (Patient 10). This failure had the potential for patients’ unmet care needs. (Refer to V557). 5. Based on interview and record review, the dialysis facility failed to ensure four of five nephrologists (kidney doctors- Physician 1, Physician 2, Physician 3, Physician 4) documented monthly physician progress notes for three of three in-center hemodialysis sampled patients (Patient 6, Patient 7, and Patient 8) and one of one Peritoneal Dialysis (PD-a treatment for kidney failure that uses the lining of one’s abdomen or belly to filter blood) patient (Patient 20). This failure had the potential for Patient 6, Patient 7, Patient 8, and Patient 20 to have missed evaluation for medical care, which could be detrimental to their treatment plan and care. (Refer to V560). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to provide each patient with an individualized and comprehensive plan of care necessary to address patients’ needs in compliance with the Condition for Coverage on Patient Plan of Care. V. The dialysis facility failed to meet the regulatory compliance for § 494.110 Condition for Coverage: Quality Assessment and Performance Improvement as evidenced by: 1. Based on interview and record review, the dialysis facility failed to maintain an effective Quality Assessment and Performance Improvement (QAPI-a data driven and proactive approach to quality improvement, ensuring services are meeting quality standards) Program as evidenced by: A. Three staff members, Registered Nurse (RN) 2, Patient Care Technician Orientee (PCTO) 3, Patient Care Technician (PCT) 2 were not aware and knowledgeable about the dialysis facility’s QAPI Program. This failure had the potential for the staff to not be aware of opportunities for improvement, address gaps in processes, develop action plans, and monitor effectiveness of interventions to achieve and improve quality of care. (Refer to V626). 2. The Interdisciplinary Team (IDT-(a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) did not act upon areas of concerns discussed in the quarterly QAPI meetings regarding anemia management, high phosphorus, etc. This failure had the potential for past and current non-compliance opportunities to not be addressed, which could lead to negative outcomes for the dialysis patients. (Refer to V626). 3. Based on interview and record review, the dialysis facility failed to: A. Conduct, analyze, act, evaluate, track and trend infection control surveillance (ongoing, systematic collection, analysis, and interpretation of data) activities. B. Provide evidence of visual audits of each direct care staff to verify competency (knowledge and skills to performa the job) for infection control prevention. These failures had the potential for infection control issues to not be addressed, monitored, and acted upon, which could result in the spread and transmission of infectious diseases, directly or indirectly to patients, staff, and visitors. (Refer to V628). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to demonstrate evidence of an effective data-driven QAPI Program to achieve measurable health outcomes and reflect processes of care in compliance with the Condition for Coverage on Quality Assessment and Performance Improvement. The cumulative effect of these systemic problems resulted in the dialysis facility’s failure to adhere to the Centers for Medicare and Medicaid Services (CMS) applicable rules and regulations that led to noncompliance with the Conditions for Coverage on Governing Body, Emergency Preparedness, Infection Control, Patient Assessment, Plan of Care, and Quality Assessment and Performance Improvement.”

“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: 35649 Based on interview and record review, the dialysis facility failed to review and update the emergency preparedness/readiness plan at least every two years. This failure had the potential to place patients, staff, and visitors’ safety and well-being at risk for harm in the event of a disaster or emergency. Findings: During a concurrent interview and record review on 11/7/23 at 10:13 a.m. with Facility Administrator (FA), the facility’s “Emergency Readiness Plan,” dated 3/1/13, was reviewed. FA stated, “The emergency readiness plan has not been revised and updated since March 2013.” During a review of the Centers for Medicare and Medicaid Services (CMS) End Stage Renal Disease Facilities (ESRDs) Requirements titled, “CMS Emergency Preparedness Final Rule,” dated 3/26/21, the emergency preparedness requirement indicated, “Emergency Preparedness: The ESRD facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to fire, equipment or power failures, emergency care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The ESRD facility must establish and maintain an emergency preparedness program that meets the requirements of this section. (a) Emergency Plan: The ESRD facility must develop and maintain an emergency preparedness plan that must be evaluated and updated at least every two years. . .””

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(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 the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[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. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to conduct a risk assessment (the process of determining what the facility-based disasters care related to equipment failure, interruption in communication, interruptions to normal supply resources, such as water, food, medications, etc.,) annually. This failure had the potential for the dialysis facility’s to be unprepared in the event of an actual emergency or disaster. Findings: During a concurrent interview and record review on 11/7/23 at 9:56 a.m. with Facility Administrator (FA), FA was unable to provide evidence of the current facility’s emergency risk assessment. FA stated she reviewed the facility’s Emergency Preparedness binder and did not find a recent facility emergency risk assessment. FA stated, “The facility’s risk assessment was done in January 2020.” During a review of the facility’s policy and procedure (P&P) titled, “Disaster and Emergency Readiness,” dated 3/1/13, the P&P indicated, “. . .The Clinic Manager of each facility with assistance from the Medical Director are responsible for arranging and providing for emergency preparedness training, demonstration and simulation to facilitate a response that will promote the safety and well-being of all patients and personnel.” During a review of the Centers for Medicare and Medicaid Services (CMS) End Stage Renal Disease Facilities Requirements titled, “CMS Emergency Preparedness Final Rule,” dated 3/26/21, the emergency preparedness final rule indicated, “Emergency Plan: . . .The plan must do all of the following: 1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. 2) Include strategies for addressing emergency events identified by the risk assessment.””

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to ensure communication and collaboration existed between the dialysis facility and the local emergency agency annually. This failure had the potential for the local emergency agency being unaware of the dialysis facility’s needs that could result in the dialysis facility not receiving the support and the emergency supplies and equipment needed for their patients during an actual emergency. Findings: During a concurrent interview and record review on 11/7/23 at 10:30 a.m. with Facility Administrator (FA), FA was unable to find any facility communication with the local emergency agency. FA stated, “There is none.” FA stated there was no policy and procedure that addressed communication and collaboration between the dialysis facility and the local emergency agency. During a review of the Centers for Medicare and Medicaid Services (CMS) End Stage Renal Disease Facilities Requirements titled, “CMS Emergency Preparedness Final Rule,” dated 3/26/21, the emergency preparedness final rule indicated, “Emergency Plan. . .4) Include a process for cooperation and collaboration with local, tribal, regional, State and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency.””

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the dialysis facility failed to follow their emergency policies and procedures when the dialysis facility failed to: 1. Ensure one of one crash cart (mobile cart that contains emergency medical equipment, supplies and drugs used in the event of a medical emergency) was checked weekly and failed to ensure the crash cart was locked. This failure had the potential to result in the crash cart not ready for use in the event of an emergency and potential for harm due to unauthorized access by patients or visitors. 2. Ensure emergency equipment, such as an oxygen tank and suction machine (medical device used to remove mucous, saliva, etc from a person’s airway), were ready and functional; and an Automated External Defibrillator (AED - a medical device designed to analyze the heart rhythm and deliver an electric shock to victims of sudden cardiac arrest) was checked three times a week when the dialysis facility is in operation. This failure had the potential to place patients at risk for harm in the event of a medical emergency. 3. Ensure four dialysis tubing clamps used for emergency take off were accessible for 31 of 31 in-center hemodialysis patients use in all nine dialysis machines. This failure had the potential for patients to not be able to perform emergency take off in the event of an actual emergency. Findings: 1. During a concurrent observation and interview on 11/6/23 at 9:08 a.m. with Registered Nurse (RN) 2 in the dialysis treatment area, just outside of the isolation room, was a crash cart observed unlock. The first drawer of the crash cart was noted to have been pulled out. RN 2 verified the findings and stated, “I meant to check it, but I have not done it today. The last time I checked the cart was last Monday (10/30/23). I was not sure which lock to use to secure it.” RN 2 showed two yellow plastic locks inside the cart. The cart had emergency medications, needles and syringes, and other emergency supplies. During a concurrent interview and record review on 11/7/23, at 11 a.m. with Facility Administrator (FA), the “Weekly Crash Cart Checklists” dated 1/2/23 to 6/19/23 were reviewed. The Weekly Crash Cart Checklist indicated the crash cart was not checked on 4/3/23, 4/10/23, 5/8/23, and 6/26/23. The 2023 submissions provided by RN 1 did not indicate a crash cart weekly check for the months of January, February, March, July, August, September, October, and November 1 through November 7, 2023. FA verified the findings and stated the crash carts should be checked consistently. During a review of the facility’s policy and procedure (P&P) titled, “Emergency Equipment and Medication Checks,” dated 11/15/12, the P&P indicated, “5. Weekly checks will be documented on the Emergency Cart Checklist and recorded on Formstack ‘Weekly Crash Cart Checklist’. . .” 2. During a concurrent observation and interview on 11/6/23 at 9:30 a.m. with RN 1, in the dialysis treatment area where the crash cart was located, a portable oxygen tank was observed in a rack without an oxygen flow meter (equipment used to administer and control the oxygen flow from the tank) and a suction machine on top of the crash cart. RN 1 stated the oxygen flow meter is attached at the time of use and during an emergency. RN 1 pointed to an oxygen concentrator located in Dialysis Station 6 and stated, “that could be used instead.” RN 1 checked the functionality of the suction machine and found the suction machine to be non-functional. RN 1 verified the findings and stated the suction machine did not have enough pressure to be able to suction and work properly. During a concurrent interview and review of the AED Checklist, on 11/7/23, at 11:50 a.m., with Registered Nurse (RN) 1, the AED daily checklist, dated 2023, was reviewed. The AED Checklist indicated missing checks for 1/2023, 2/1/23, 2/3/23, 2/6/23, 2/8/23, 2/10/23, 4/5/23, 4/7/23, 6/30/23, 8/4/23, 9/20,23, 9/22/23, 9/27/23, 10/4/23, 10/9/23, 10/13/23, 10/16/23, 10/18/23, 10/20/23, 10/23/23, and 10/30/23. RN 1 stated the AED was not consistently checked. During a review of the facility’s P&P titled, “Emergency Equipment and Medication Checks,” dated 3/1/13, the P&P indicated, “1. Each clinic will ensure that all emergency equipment and supplies are available and in proper working order each operating day. . .Weekly Checks: b. The suction machine is turned on and negative vacuum pressure is verified.” During a review of the facility’s P&P titled, “Emergency Equipment and Medication Checks,” dated 11/15/12, the P&P indicated, 2. The nurse in charge or designee will check the AED each operating day to ensure equipment is available and functional using Formstack ‘Weekly Crash Cart Checklist’. . .” 3. During a concurrent observation and interview on 11/7/23, at 11:30 a.m. with FA, in dialysis treatment area, the dialysis tubing clamps (device used to seal and stop blood flow) used by patients to clamp the bloodlines in an emergency, were all hanging on nine dialysis machines’ IV (intravenous, with in the vein) poles situated above the patients’ head receiving dialysis treatment. FA stated the clamps were not accessible to the patients to clamp their bloodlines during an emergency. During a review of the patient education titled, “How to Get Off the Machine in An Emergency,” [undated], the patient education indicated, “3. Clamp off all four clamps on your bloodlines. Disconnect lines between the two clamps.””

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to ensure fire drills were conducted with facility staff quarterly every shift in accordance with the facility’s policy and procedure. This failure had the potential for the staff to not be aware of the emergency procedure in the event of fire. Findings: During a concurrent interview and record review on 11/6/23 at 11:50 a.m. with Registered Nurse (RN) 1, the fire drill records, dated 2022 and 2023, were reviewed. The fire drill records for 2022 indicated the following: 5/14/22 at 1:30 p.m. 8/16/22 at 11:30 a.m. 11/16/22 at 12:40 p.m. 11/23/22 at 7 a.m. RN 1 was unable to provide the sign in sheets for the fire drill training conducted with the staff. RN 1 stated the fire drill records did not indicate fire drills were conducted quarterly every shift. The fire drill records for 2023 indicated the following: 2/10/23 at 8:05 a.m. 2/10/23 at 12:30 p.m. 5/12/23 at 8 a.m. 5/24/23 at 12:31 p.m. RN 1 stated the fire drills were given the first and second quarter, but not every shift. RN 1 was unable to provide the sign-in sheet for the fire drill training with the staff. During a review of the facility’s policy and procedure (P&P) titled, “Fire Plan & Drill Procedure,” dated 3/1/13, the P&P indicated, “Emergency Training for Staff including (sic): 1. A fire drill will be conducted on a quarterly basis on each shift. . .2. A Record of In-service will be completed at the time of the fire drill. Documentation on the record will include the date and time of the drill and signatures of all the staff involved.””

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to ensure emergency patient education and training on emergency take off were provided for nine of nine sampled patients (Patient 2, Patient 4, Patient 9, Patient 11, Patient 22, Patient 24, Patient 25, Patient 26, and Patient 27) quarterly. This failure had the potential for these patients to be unaware of what to do in the event a disaster or emergency occurs during dialysis treatment. Findings: During a concurrent interview and record review for Patient 2 on 11/7/23 at 11:10 a.m. with Facility Administrator (FA), the patient education titled, “How to Get Off the Machine in An Emergency,” [undated] was reviewed. FA stated patient education is given quarterly and Patient 2 did not receive emergency patient education for the third quarter (July, August, September). During a concurrent interview and record review for Patient 4 on 11/7/23 at 11:12 a.m. with FA, the patient education titled, “How to Get Off the Machine in An Emergency,” [undated] was reviewed. FA stated patient education is given quarterly and Patient 4 did not receive emergency patient education for the third quarter (July, August, September). During a concurrent interview and record review for Patient 9 on 11/7/23 at 11:14 a.m. with FA, the patient education titled, “How to Get Off the Machine in An Emergency,” [undated] was reviewed. FA stated patient education is given quarterly and Patient 9 did not receive emergency patient education for the third quarter (July, August, September). During a concurrent interview and record review for Patient 11 on 11/7/23 at 11:16 a.m. with FA, the patient education titled, “How to Get Off the Machine in An Emergency,” [undated] was reviewed. FA stated patient education is given quarterly and Patient 11 did not receive emergency patient education for the third quarter (July, August, September). During a concurrent interview and record review for Patient 22 on 11/7/23 at 11:18 a.m. with FA, the patient education titled, “How to Get Off the Machine in An Emergency,” [undated] was reviewed. FA stated patient education is given quarterly and Patient 22 had not been provided emergency patient education in 2020, 2021, 2022, and the first, second, and third quarters in 2023. FA stated, “I did not find any emergency patient education record in the chart.” During a concurrent interview and record review for Patient 24 on 11/7/23 at 11:20 a.m. with FA, the patient education titled, “How to Get Off the Machine in An Emergency,” [undated] was reviewed. FA stated patient education is given quarterly and Patient 24 did not receive emergency patient education for the third quarter (July, August, September). During a concurrent interview and record review for Patient 25 on 11/7/23 at 11:22 a.m. with FA, the patient education titled, “How to Get Off the Machine in An Emergency,” [undated] was reviewed. Patient 25’s patient education indicated the emergency take off was last provided on 4/15/19. FA stated patient education is given quarterly and Patient 25 had not been provided emergency patient education in 2020, 2021, 2022, and the first, second, and third quarters in 2023. FA stated, “I did not find any emergency patient education record in the chart.” During a concurrent interview and record review for Patient 26 on 11/7/23 at 11:24 a.m. with FA, the patient education titled, “How to Get Off the Machine in An Emergency,” [undated] was reviewed. FA stated patient education is given quarterly and Patient 26 did not receive emergency patient education for the third quarter (July, August, September). During a concurrent interview and record review for Patient 27 on 11/7/23 at 11:26 a.m. with FA, the patient education titled, “How to Get Off the Machine in An Emergency,” [undated] was reviewed. FA stated patient education is given quarterly and Patient 27 did not receive emergency patient education for the third quarter (July, August, September). During a review of the facility’s “Patient Education Emergency Procedures,” [undated], the patient education indicated the following questionnaire, “1. Is the patient able to comprehend state of emergency? 2. Is the patient mentally/physically impaired? 3. Can the patient perform emergency blood return procedure? 4. Can the patient perform emergency disconnect procedure? 5. Can Patient identify emergency exit door locations? 6. Could patient leave unattended? 7. Is the patient willing/agreeable to perform these emergency procedures? 8. Was patient given emergency preparedness information? The questions were answerable with a Yes or No answer. Completed, signed, and dated by patient.” During a review of the facility’s policy and procedure (P&P) titled, “Disaster and Emergency Readiness,” dated 3/1/13, the P&P indicated, “Each patient will receive training on a quarterly basis as outlined on the Emergency Procedure Evacuation Training Form. This will include but is not limited to assessment of the patient’s ability to evacuate the building, performance of self-disconnection from the dialysis machine during treatment and identifying and exiting through any of the facility’s designated exits.””

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 32234 Based on observation and interview, the dialysis facility failed to provide a sanitary environment, when multiple metal drain covers for the drainage areas, used to drain dialysis fluid waste from dialysis machines, located at the back of each dialysis stations (Station 2, Station 3, Station 4, Station 5, Station 6, Station 7, Station 8, and Station 9) were rusty. This failure had the potential to result in destruction of metals, blockage of pipes, and contamination. Findings: During a concurrent observation and interview on 11/6/23 at 11:40 a.m. with Registered Nurse (RN) 1, in the dialysis treatment area, the metal drain covers at the back of each dialysis machine in Station 2, Station 3, Station 4, Station 5, Station 6, Station 7, Station 8, and Station 9 were covered with rust. RN 1 stated, the rusty metal drain at the back of each dialysis stations needed to be fixed and repaired. RN 1 stated, “It’s hard to get rid of the rust.” During an interview on 11/6/23 at 11:45 a.m. with Patient 30 in Dialysis Station 3, Patient 30 stated, “That’s nasty (referring to the metal drains). It’s been like that for a long time. Nobody has come to fix it.””

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the dialysis facility failed to: 1. Ensure three of three Patient Care Technicians (PCT 1, PCT 2, and PCT 3) and one of four Patient Care Technician Orientees (PCTO) 2 performed hand hygiene and changed gloves in between tasks. This failure had the potential to transmit infectious diseases to patients, staff, and visitors. 2. Ensure five of five dialysis patients (Patient 9, Patient 10, Patient 12, Patient 1, and Patient 17) performed hand hygiene before and after dialysis treatment. This failure had the potential to transmit infectious diseases to patients, staff, and families. 3. Ensure two of two staff members (PCTO 4 and Registered Nurse [RN] 2) removed their gowns and gloves, when they exited the HD (a process of purifying the blood of a person whose kidneys are not working normally by using an artificial kidney, called the “dialyzer” and a machine) treatment area to the lobby and parking area, to assist and accompany two in-center HD sampled patients (Patient 15 and Patient 18). This failure had the potential to transmit infectious diseases to patients, staff, and visitors. Findings: 1a. During a concurrent observation and interview on 11/6/23 at 9:11 a.m. with PCT 2 in Dialysis Station 7, PCT 2 was discontinuing dialysis treatment and removing blood lines from Patient 27. PCT 2 did not perform hand hygiene before putting on clean gloves and pulling the needles off the Arteriovenous Fistula (AV fistula- a connection that’s made by a surgeon between an artery and a vein for dialysis access). The phone rang and PCT 2 removed his gloves, but did not perform hand hygiene before answering the phone. PCT 2 acknowledged he did not perform hand hygiene before and after his tasks, and stated he should have performed hand hygiene. 1b. During a concurrent observation and interview on 11/6/23 at 1:59 p.m. with PCTO 2 in HD treatment area, PCTO 2 brought a urinal filled with urine to the specimen room. PCTO 2 placed the urinal inside the specimen refrigerator. With the same gloves on, PCTO 2 stepped out of the room, proceeded to the nurses’ station, and made a label for Patient 10’s 24-hour urine collection (a timed urine collection to check for kidney function). PCTO 2 did not change her gloves, and she returned to the specimen room. PCTO 2 stated, “My mistake, I should have washed my hands and changed gloves.” 1c. During a concurrent observation and interview on 11/6/23 at 2:10 p.m. with PCT 1 in Dialysis Station 4, PCT 1 cannulated (insert dialysis needles) Patient 10’s right arm Arteriovenous Fistula. PCT 1 held the two bloodlines in his gloved hands in preparation to connect to Patient 10’s AV fistula. Prior to connection, PCT 1 touched Patient 10’s wheelchair, parked in front of Patient 10’s dialysis chair, to move the wheelchair out of the way. With the same gloves on, PCT 1 connected the bloodlines to the AV fistula without performing hand hygiene and changing gloves. PCT 1 acknowledged he moved the wheelchair and stated, “I had the tubing in my hands to connect the catheters.” 1d. During a concurrent observation and interview on 11/13/23 at 9:11 a.m. with PCT 3 in Dialysis Station 9, PCT 3 discontinued Patient 14’s left arm AV fistula. PCT 3 pulled the arterial needle out and disposed of it in the sharps container, but his gloved hands touched the sharp container. PCT 3 did not perform hand hygiene and changed gloves. PCT 3 continued with the discontinuation of the venous catheter. PCT 3 applied tapes on the exit site and applied the fistula clamp (a device used to apply pressure to prevent bleeding from the exit site) with the same gloves on. PCT 3 acknowledged and stated he had not performed hand hygiene and changed gloves. 2a. During a concurrent observation and interview on 11/6/23 at 2:02 p.m. with PCT 2 in HD treatment area, Patient 9 and PCT 3 walked towards the weighing scale. After Patient 9 was weighed, PCT 3 walked the patient out to the lobby wearing his gown worn in the treatment area. PCT 3 verified the finding and stated, “I should have asked [Patient 9] to wash her hands before leaving the facility.” 2b. During a concurrent observation and interview on 11/6/23 at 2:07 p.m. with Patient 10, in HD treatment area, Patient 10 walked inside the dialysis treatment to Dialysis Station 4 without washing his hands and access site. PCT 2 asked [Patient 10] to wash his hands. Patient 10 stated, “Is this a new thing? Is it because the surveyors are here? No one has ever asked me to wash my hands before dialysis treatment. Patient 10 stated, “No, I never do that (referring to washing his hands and his AV fistula).” 2c. During a concurrent observation and interview on 11/13/23 at 2 p.m. with RN 1 in Dialysis Station 7, Patient 12 did not wash his hands after dialysis treatment. Patient 12 went to weigh himself, returned to RN 1 to report his weight, and proceeded to exit the dialysis center. RN 1 verified the findings and stated we should have asked him to wash his hands after treatment. 32234 2d. During a concurrent observation and interview on 11/13/23 at 2:28 p.m. with Facility Administrator (FA) in the HD treatment area, Patient 1 entered the HD treatment area and proceeded to the weighing scale. Without washing his hands, Patient 1 proceeded to Station 1. FA stated patients needed to wash their hands before proceeding to the dialysis station. 2e. During a concurrent observation and interview on 11/6/23 at 9:30 a.m. with PCT 1 in the HD treatment area, PCT 1 assisted Patient 17 to the weighing station to get weighed post-dialysis treatment. Patient 17 did not perform hand hygiene after he was weighed and left the HD treatment area to go to the lobby. PCT 1 stated patients should wash their hands before leaving the HD treatment area. 3a. During a concurrent observation and interview on 11/6/23 at 2:10 p.m. with PCTO 4 in the HD treatment area, PCTO 4 accompanied Patient 18 out to the parking area post-dialysis treatment. PCTO 4 did not remove her gown and gloves when she exited the HD treatment area to the lobby and parking lot. PCTO 4 acknowledged and stated, she did not remove her gown and gloves when she went out to accompany Patient 18 to the parking lot. 3b. During a concurrent observation and interview on 11/10/23 at 9:35 a.m. with RN 2 in the HD treatment area, RN 2 guided Patient 15 from Station 3 to the weighing scale. Without removing her gown and gloves, RN 2 exited the HD treatment area and walked Patient 15 out to the lobby. RN 2 acknowledged and stated she did not remove her gown and gloves when she went out to the lobby with Patient 15. During a review of the facility’s P&P titled, “Cannulation with Fistula Needle,” dated 11/2/12, the P&P indicated, “1. Perform hand hygiene. 2 Ask patient if they have washed access? If not, encourage patient to wash access.” During a review of the facility’s policy and procedure (P&P) titled, “Dialysis Infection Control Precautions,” [undated], the P&P indicated, “Standard Precautions include A. Hand Hygiene: 1. Perform hand hygiene a. After touching blood, body fluids, secretions, excretions, contaminated items whether gloves are worn. . .d. Anytime to avoid transfer of microorganisms to another patient or the environment. B. Gloves: 3. Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. . .Personal Protective Equipment [PPE- refers to gowns, gloves, masks, eye protection, face shields used to protect the wearer from injuries or infections]: 5. Change gloves and perform hand hygiene between each patient, clean and dirty tasks with the same patient, dirty area to a clean area, and returning and leaving to/from the treatment area to prevent cross-contamination (the physical movement or transfer of harmful bacteria from one person, object, or place to another).””

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the dialysis facility failed to: 1. Ensure PCT 2 wore a face shield during discontinuation of the dialysis catheters for one of one in-center HD sampled patient (Patient 27). This failure had the potential to expose PCT 2 to splashes of blood and body fluids, resulting in transmission of infectious diseases. 2. Ensure one of one Patient Care Technician (PCT) 2 did not use someone else’s face shield during cannulation (insertion of dialysis needles) of Patient 19’s Arteriovenous Fistula (AV fistula- a connection that’s made by a surgeon between an artery and a vein for dialysis access). This failure had the potential for cross-contamination and transmission of infectious disease. Findings: 1. During a concurrent observation and interview on 11/6/23 at 9:11 a.m. with PCT 2 in Dialysis Station 7, Patient 27’s dialysis treatment terminated and PCT 2 removed the arterial catheter and disconnected the bloodline. PCT 2 was not wearing a face shield during the discontinuation of Patient 27’s dialysis access. PCT 2 realized he did not have a face shield and stated, “I forgot.” 2. During a concurrent observation and interview on 11/6/23 at 3:21 p.m. with PCT 2 in Dialysis Station 5, PCT 2 cannulated Patient 19’s AV Fistula. PCT 2 was wearing a face shield with the name of the Patient Care Technician Orientee (PCTO) 2 written on the back of the face shield. PCT 2 was made aware he was using someone else’s face shield. PCT 2 stated he grabbed one of the face shields in the nurses’ station. PCT 2 took the face shield off his face and saw PCTO 2’s name written on the face shield. PCT 2 stated, “I don’t know where mine is.” PCT 2 was unable to articulate how face shields were disinfected and stated, “Are face shields being disinfected?” PCT 2 stated they (referring to facility staff) do not disinfect the face shields. During a review of the facility’s policy and procedure (P&P) titled, “Dialysis Infection Control Precautions,” [undated], the P&P indicated, “Standard Precautions: C. Mask, Eye Protection, and Face Shield: Wear to protect mucous membranes of eyes, nose, and mouth during procedures and other patient care activities that are likely to generate splashes or sprays of blood, body fluids, secretions, and excretions.” During a review of the article from the National Institute for Occupational Safety and Health (NIOSH) titled, “Strategies for Conserving the Supply of Eye Protection,” dated 5/9/23, the article indicated, “If implementing reuse, disposable eye protection should be dedicated to one healthcare professional (HCP) and appropriate cleaning and disinfection should be performed after each use and if it becomes visibly soiled or difficult to see through during use.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the dialysis facility failed to ensure one of two Registered Nurses (RN) 1 separated the clean from dirty supplies during access and care of Patient 12’s central venous catheter (CVC-a type of access used for hemodialysis, placed under the skin and into a large central vein). This failure had the potential to transmit infectious diseases. Findings: During a concurrent observation and interview on 11/13/23 at 2 p.m. with RN 1 in Dialysis Station 7, RN 1 had a clean chair-side paper barrier with the following clean supplies: sterile packages of gauzes, alcohol wipes, syringe with saline flushes, and syringes with heparin (blood thinner) that RN 1 would need during the care of Patient 12’s CVC. RN 1 disposed of the alcohol swabs, syringes with blood aspirate, and used port caps back into the clean area with clean supplies. RN 1 opened a sterile package with two port caps and placed them on the blue chux (paper barrier between the patient and the CVC) on top of Patient 12’s abdomen. RN 1 picked up the two port caps from the blue chux and affixed one to the arterial line and the other to the venous line. RN 1 stated, “That’s how I have always done it.” RN 1 stated he dropped the dirty and contaminated supplies with the clean supplies, and he should not have done it. During a review of the facility’s policy and procedure (P&P) titled, “Maintenance of Aseptic Technique,” dated 6/18/18, the P&P indicated, “Sterility of Packaged Item: 1. Open sterile items just prior to use including dialysis supplies. 2. Avoid letting sterile items touch anything non-sterile (e.g., an object, surface, or person). If an item becomes contaminated, discard it, and open a new sterile item. . .The risk of infection or adverse reactions can be reduced strictly following aseptic technique (the application of preventative measures to reduce the likelihood of introducing microorganisms that may cause infections, particularly in immunocompromised (one’s immune system’s defenses are low, affecting its ability to fight off infections and diseases) patients.””

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 32234 Based on observation, interview, and record review, the dialysis facility failed to dispose of infectious wastes appropriately for one of 30 in-center HD sampled patients (Patient 1). This failure had the potential for the spread of infectious diseases to patients, visitors, and staff. Findings: During an observation on 11/6/23 at 2:20 p.m. with Registered Nurse (RN) 2 in the dialysis treatment area, RN 2 was performing dressing change on Patient 1’s Central Venous Catheter (CVC - a type of access used for hemodialysis, placed under the skin and into a large central vein) to his left upper chest. RN 2 used 10 ml [milliliter - unit of measurement] sterile syringes to each CVC ports (two CVC ports) to remove solutions and/or blood. After aspirating blood from the CVC ports, RN 2 disposed of the two used 10 ml syringes with blood aspirate into the regular trash can. During a concurrent observation and interview on 11/6/23 at 3:30 p.m. with RN 1 in the dialysis treatment area, Patient 1’s regular trash can was found with the two 10 ml syringes with blood aspirate. RN 1 stated the syringes should have been discarded in the biohazard waste (infectious wastes). During a review of the facility’s policy and procedure (P&P) titled, “Biomedical Waste Plan,” dated 9/18/23, the P&P indicated, “Regulated Waste means liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials. Procedure: 1. Separate sharps waste from other biomedical waste.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the dialysis facility failed to ensure two of two staff (Patient Care Technician [PCT] 1 and Registered Nurse [RN] 2) disinfected their stethoscopes (a medical instrument for listening to someone’s heart or breathing) after patient use. This failure had the potential to transmit infectious diseases. Findings: During a concurrent observation and interview on 11/6/23 at 10:10 a.m. with RN 2 in HD treatment area, RN 2 used a stethoscope to listen to Patient 12’s heart and lung sounds. After use, RN 2 placed the stethoscope around her neck and shoulder without disinfecting the stethoscope. RN 2 stated she should have wiped down the stethoscope after patient use. During a concurrent observation and interview on 11/6/23 at 2:10 p.m. with PCT 1, in HD treatment area, PCT 1 evaluated Patient 10’s right upper arm AV Fistula using a stethoscope. After patient use, PCT 1 did not disinfect the stethoscope and put it back around his neck and shoulder. PCT 1 stated he should have disinfected the stethoscope after patient use. During a review of the facility’s policy and procedure (P&P) titled, “Dialysis Infection Control Precautions, [undated], the P&P indicated, “3. Disinfect scissors, stethoscopes, blood pressure cuffs, electronic thermometer, etc. between patients with low-level disinfectant (agent that destroys all vegetative bacteria [except tubercle bacilli] and destroys most viruses - including Hepatitis B virus [HBV], and human immunodeficiency virus [HIV]) such as 1:100 bleach or other appropriate germicide, or as required by state regulations.””

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 32234 Based on interview and record review, the facility failed to: 1. Offer two of six susceptible in-center HD sampled patients (Patient 1 and Patient 3) the Hepatitis B vaccination (vaccine used to stimulate the body’s immune response against the contagious hepatitis B virus [HBV] - a liver infection that can spread from person to person via blood and body fluids]) after tests indicated patients had no immunity to HBV. 2. Performed laboratory test to determine immunity to two of six sampled staff (Patient Care Technician [PCT] 6 and Registered Nurse [RN] 2). These failures had the potential for the patients and staff to become infected with Hepatitis B infection if exposed to the HBV and spread Hepatitis B infection. Findings: 1. During a concurrent interview and record review on 11/15/23, at 9:40 a.m. with RN 1, Patient 1’s laboratory results dated 3/13/23 were reviewed. The laboratory result for Hepatitis B titer (a laboratory test that measures the presence and number of antibodies in blood) was “<4 [less than 4 mlU/ml - milli-International Units/milliliter - a unit of measurement]. RN 1 stated a Hepatitis B titer of <10 had no Hepatitis B immunity. RN 1 stated, Patient 1 needed to receive his Hepatitis B vaccine. Patient 1’s date of admission was on 3/13/23 and RN 1 was unable to find documentation in Patient 1’s immunization record for Hepatitis B vaccine. RN 1 stated, Patient 1 needed to be started on his Hepatitis B vaccine after consent was obtained. During a concurrent interview and record review on 11/15/23 at 9:40 a.m. with RN 1, Patient 3’s immunization record for Hepatitis B was reviewed. RN 1 stated Patient 3’s Hepatitis B titer was less than 10 (no Hepatitis B immunity). RN 1 was unable to provide documentation Patient 3 received her Hepatitis B vaccination since her date of admission on 7/12/23. RN 1 stated Patient 3 needed to have her Hepatitis B vaccination after consent was obtained. 2. During an interview on 11/9/23 at 2 p.m. with Facility Administrator (FA), FA stated if patients and staff had low Hepatitis B titer, the Hepatitis B vaccine would be offered or have the patients or staff signed a declination of Hepatitis B vaccine. During a concurrent interview and record review on 11/15/23 at 10:03 a.m. with FA, the immunization record for PCT 6 was reviewed. FA was unable to find documentation the laboratory test for the Hepatitis B titer was completed and Hepatitis B vaccination was offered to PCT 6 since her hire date on 3/23/22. During a concurrent interview and record review on 11/15/23 at 10:44 a.m. with FA, RN 2’s laboratory test was reviewed. FA was unable to find evidence RN 2 completed her laboratory test to check her Hepatitis B titer since her date of hire on 6/23/23. FA stated, RN 2 needed to complete her laboratory test for Hepatitis B titer and her Hepatitis B vaccination. During a review of the “Staff File Checklist (SFC-requirements for newly hired employee),” [undated], the Staff File Checklist indicated, “Hep (Hepatitis) B titers.””

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to provide Infection Control and Prevention Training and Education for the staff. This failure had the potential to transmit bacteria and blood-borne viral agents from patient-to-patient or healthcare personnel-to-patient, directly or indirectly through contaminated supplies and equipment, surfaces, or hands. Findings: During a concurrent interview and record review on 11/8/23 at 3:38 p.m. with Facility Administrator (FA), FA was unable to provide evidence of staff Infection Control Training. During a concurrent interview and record review on 11/8/23 at 3:50 p.m. with Registered Nurse (RN) 1, RN 1 presented one staff education sign-in sheet for cleaning up blood spills. The staff education on “Cleaning Up Blood Spills,” dated 10/30/23, was reviewed. The sign-in sheet indicated seven out of 16 staff members, equivalent to 43%, had been educated on cleaning up blood spills. RN 1 was unable to show the content/instruction material for the staff education on cleaning up blood spills. RN 1 stated he had given several in-services on infection control, but unable to provide evidence of the infection control staff education. During a review of the facility’s policy and procedure (P&P) titled, “Blood-borne Pathogens Exposure Plan,” dated 11/12/12, the P&P indicated, “Employee-At Risk-Training Required: 1. All employees with occupational exposure will participate in a training program that will be provided at no cost to the employee and during working hours. 2. Training will be provided as follows: i. At the time of initial assignment to tasks where occupational exposure may take place such as upon employment. ii. At least annually thereafter. . .Training Records: 1. Training records shall include the following: i. The dates of the training sessions. ii. The contents or summary of the training sessions. iii. The names and qualifications of the persons conducting the training. iv. The names and job titles of all persons attending the training sessions.””

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to: 1. Conduct, analyze, act, evaluate, track and trend infection control surveillance (ongoing, systematic collection, analysis, and interpretation of data) activities. 2. Provide evidence of visual audits of each direct care staff to verify competency (knowledge and skills to perform a job) for infection control prevention during routine care of dialysis patients. These failures had the potential for infection control issues to not be addressed, monitored, and acted upon, which could result in the spread and transmission of infectious diseases, directly or indirectly to patients, staff, and visitors. Findings: During a concurrent interview and record review on 11/7/23 at 2:46 p.m. with Facility Administrator (FA), FA stated handwashing, glove change, and AV Fistula/AV graft (a looped, plastic tube that connects an artery to a vein) cannulation (insertion of dialysis catheters) are some of the surveillance activities conducted in the facility for infection control. FA was unable to provide evidence of audits conducted for handwashing, glove change, and AV fistula/graft monitoring. FA was unable to articulate the indicators used for the audits. FA was unable to provide evidence of surveillance plan addressing quality improvement on infection control and prevention. FA stated there is nothing. During a concurrent interview and record review on 11/14/23 at 2 p.m. with Chief Nursing Officer (CNO), CNO was unable to provide evidence of infection control audits for each direct care staff to validate their infection control competencies during routine care of dialysis patients. CNO stated they don’t have it. During a review of the facility’s policy and procedure (P&P) titled, “Quality Assessment and Performance Improvement Program (QAPI- systematic, comprehensive, and data-driven approach to maintaining and improving safety and quality),” dated 1/28/23, the P&P indicated, “The scope of the QAPI Program at minimum includes Infection Control: a. Analyze and document the incidence of infections to identify trends and establish baselines on infection incidents. b. Develop recommendations and actions to minimize infection transmission and promote immunizations. c. Take actions to reduce future incidence. 5. Surveillance reviewed but not limited to. . .Infections.” During a review of the facility’s P&P titled, “Vascular Access Monitoring,” dated 11/9/12, the P&P indicated, “3. A member of the clinical staff must review the vascular access monitoring/surveillance documentation on a monthly basis to identify adverse trends and take action if indicated. . .””

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the dialysis facility failed to: 1. Follow its policy and procedure on Medication Administration. This failure had the potential to transfer microorganisms from one person or object to another during preparation and administration of medications. 2. Ensure expired medications were not available for use. This failure had the potential for the medication to lose its effectiveness and potency. Findings: During a concurrent observation and interview on 11/6/23 at 9:25 a.m. with Registered Nurse (RN) 1, in the nurses’ station medication preparation area, two multidose vials were found opened and undated. One vial of Heparin (medication to prevent clotting during dialysis treatment) 30,000 units in 30 ml (milliliter, a unit of measure) was opened and undated. Another vial of Lidocaine (local anesthetic used to treat pain during a procedure) 1% (percent) 200 mg (milligram, a unit of measure) in 20 ml was opened and undated. RN 1 stated the vials must be dated and initialed when first opened. During a concurrent observation and interview on 11/6/23 at 10:03 a.m. with Patient Care Technician Orientee (PTCO) 1, in the nurses’ station medication preparation area, a multidose vial of Heparin 30,000 units in 30 ml was found with an aspirating needle stuck and left inside the rubber cap of the multidose vial. The multidose vial of Heparin 30,000 units in 30 ml was opened and undated. PTCO 1 stated she just opened the vial today, but she did not label it, and she did not remove the needle. PTCO 1 stated, “I was told I could use the same needle to draw medications for multiple patients. I could discard the needle once I am done and leave the medication preparation area.” During a concurrent observation and interview on 11/8/23 at 2:05 p.m. with RN 1 and PCTO 1, in the nurses’ station medication preparation area, another multidose vial of Heparin 30,000 units in 30 ml had an aspirating needle stuck and left again inside the rubber cap of the vial. RN 1 verified the findings and stated, it is not an acceptable practice. PTCO 1 stated, “That’s how I was taught by the nurse.” During a concurrent observation and interview on 11/8/23 at 4:30 p.m. with RN 1 in the nurses’ station medication preparation area, two three ml syringes labeled with heparin were on top of a blue chux (paper barrier between the medication and the surface) in the medication preparation area. The syringes did not have the patients’ names, the dosage of the heparin, the date and time drawn, and the initial of the staff who drew up the medication. RN 1 stated, “I am disposing these medications. These could not be used.” During a concurrent observation and interview on 11/13/23 at 10:30 a.m. with RN 1 in Dialysis Station 9, RN 1 did not wipe the hub of the venous port prior to administration of Patient 12’s intravenous (IV, within the vein) medications Zemplar (medication to prevent bone disorder) 1 mcg (microgram, a unit of measure) IV and Diphenhydramine (medication to treat allergic reaction) 50 mg (milligram, a unit of measure) IV. RN 1 stated the port is clean. I don’t usually wipe the venous port. RN 1 stated it should have been wiped with alcohol wipe, but he did not. During a review of the facility’s policy and procedure (P&P) titled, “Drawing Medications From (sic) an Ampule and a Vial,” dated 12/20/12, the P&P indicated, “3. Aseptic technique will be used to prepare parenteral medications for injection from an ampule /vial. . .Vials should be entered with a new sterile syringe and needle. . .If either vial is multi-use, a different syringe/needle must be used for entry into each vial.” During a review of the facility’s P&P titled, “Heparin,” dated 12/20/22, the P&P indicated, “1. Strict procedures for Aseptic Technique, Universal Precautions, and Infection Control will be used when administering Heparin. . .4. Each bottle of Heparin will be marked with the date it is opened and used. . . 5. Heparin will not be drawn up more than 4 hours prior to administration. . .If not immediately given, the syringe will be labeled with: i. Patient Name ii. Drug name and dosage iii. Date and time drawn iv. Initials of the caregiver drawing up the Heparin.” 32234 2. During a concurrent observation and interview on 11/6/23 at 11:33 a.m. with RN 1 in the Peritoneal Dialysis (PD) training room, one vacutainer safety-lok (used for blood collection and helps protect against needlestick injury) was found inside the cabinet with an expiration date of 9/30/23. RN 1 stated vacutainer safety-lok should have been disposed of. During a concurrent observation and interview on 11/7/23 at 12:05 p.m. with RN 1 in the medication storage cabinet in the dialysis treatment area, one bottle of Nitrostat (medication used to relieve chest pain) tablets had an expiration date of 10/23. RN 1 stated, the expired Nitrostat tablets needed to be disposed of. During a review of the facility’s policy and procedure (P&P) titled, “Discarding Expired or Unused Medications,” dated 12/20/12, the P&P indicated, “All expired or unused medications needing disposed of in the dialysis center will be discarded in the following manner. . .lb. All other types of medications will be discarded in the biohazard trash receptacle.””

“IC-REPORT COMMUNICABLE DISEASES CFR(s): 494.30(c) The facility must report incidences of communicable diseases as required by Federal, State, and local regulations. This Standard is not met as evidenced by: 32234 Based on interview and record review, the dialysis facility failed to ensure: 1. Five of seven sampled staff (Patient Care Technician [PCT] 6, Registered Nurse [RN] 2, Biomedical Technician [BMT], Registered Dietitian [RD] 2, and PCT 5) TB (tuberculosis - an infectious lung disease) screening (TB skin test or TB blood test evaluation or questionnaires) were completed upon hire and annually. 2. One of six in-center HD sampled patients (Patient 3) had TB screening (TB skin test or blood test evaluation/questionnaires) on admission. These failures had the potential for patients and staff at risk for contracting TB when exposed and spread TB infection. Findings: 1. During a concurrent interview and record review on 11/9/23 at 10:40 a.m. with RN 1, the personnel files were reviewed. RN 1 was unable to find the TB test or TB evaluation/questionnaires were completed annually and on hire date for the following staff: a. RN 2 - Date of Hire: 6/23/23. No TB test since the hire date. b. BMT - Date of Hire: 6/6/22. No annual TB test for the year of 2023. c. RD 2 - Date of Hire: 11/1/15. No annual TB test for the year of 2023. Last TB test was done on 10/21/19. RN 1 stated the TB test should have been completed upon hire and annually. During a concurrent interview and record review on 11/15/23 at 10:03 a.m. with Facility Administrator (FA), the personnel files were reviewed. FA was unable to find TB test or TB evaluation/questionnaires were completed annually or upon hire for the following staff: a. PCT 6 - Date of Hire: 523/22. No annual TB test for the year of 2023. b. PCT 5 - Date of Hire: 7/1/22. No TB test since the hire date. FA stated PCT 6’s TB test should have been completed annually and PCT 5’s TB test should have been completed when she was hired on 7/1/22. During a review of the facility’s “Staff File Checklist (SFC-requirements for hiring employees),” [undated], the “SFC” indicated, “TB - within the past 12 months/Chest XRAY.””

“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: 32234 Based on interview and record review, the dialysis facility failed to perform the colorblind test (a color vision test) for four of six sampled staff (Patient Care Technician [PCT] 6, Registered Dietitian [RD] 2, Registered Nurse [RN] 2, and Biomedical Technician [BMT]). This failure had the potential for inaccurate reading of presence of chlorine in water used for HD treatment. Findings: During a concurrent interview and record review on 11/9/23 at 11:50 a.m. with Facility Administrator (FA), the personnel file for the colorblind test records were reviewed. FA was unable to find the colorblind tests for the following staff: PCT 6 -Date of hire: 5/23/22 RD 2 - Date of hire: 11/1/15. RN 2 - Date of hire: 6/23/23 BMT - Date of hire: 6/6/22. FA stated, “No one has received the colorblind test this year except the newly hired staff in October 2023. FA stated [PCT 6] should have her colorblind test done in March 2023 and [BMT] should have his colorblind test done in June 2023. FA stated [RN 2] and [RD 2] should have had their colorblind tests done upon hire. FA stated colorblind tests are done upon hire and annually.”

“UF-EFFECTIVE/OPAQUE HOUSING/MONITOR CFR(s): 494.40(a) 5.2.9 Ultrafiltration: effective/opaque housing/monitoring Refer to RD62:2001, 4.3.12 Ultrafilters: When used in a water purification system for hemodialysis applications, an ultrafilter shall be shown to reduce the concentrations of bacteria and endotoxin in the feed water to the ultrafilter by factors at least as great as those specified in the manufacturer’s labeling. 5.2.9 Ultrafiltration Refer to RD62:2001, 4.3.12 Ultrafilters: Ultrafilters [should] have an opaque housing or that other means be used to inhibit proliferation of algae. 5.2.9 Ultrafiltration Ultrafilters should be included in routine disinfection procedures to prevent uncontrolled proliferation of bacteria in the feed water compartment of the filter. 6.2.9 Ultrafiltration The pressure drop across the ultrafilter (?P) should be measured using simple inlet and outlet pressure gauges. Ultrafilters operated in the cross-flow mode should also be monitored in terms of the flow rate of water being directed to drain (concentrate). Results of pressure measurements and bacteria and endotoxin levels should be recorded in a log. This Standard is not met as evidenced by: 32234 Based on observation, interview, and record review, the dialysis facility failed to ensure four of five portable Reverse Osmosis (RO - a water purification system specifically designed for supplying a single patient hemodialysis system) machines (RO 1 between Stations 1 and 2, RO 2 between Stations 3 and 4, RO 3 between Stations 5 and 6, and RO 4 between Stations 7 and 8) used by the in-center dialysis patients during dialysis treatments, were operated in accordance with the manufacturer’s directions for use (DFU - to use one portable RO machine for one dialysis machine). This failure had the potential for all in-center HD patients using eight of the nine dialysis stations (Station 1, Station 2, Station 3, Station 4, Station 5, Station 6, Station 7, Station 8) to not receive the prescribed physician’s ordered Dialysis Flow rate (DFR - used to increase dialysis efficiency to remove impurities or toxins in the blood) and had the potential to compromise water purity for those in-center HD patients. Findings: During a concurrent observation and interview on 11/6/23 at 2:25 p.m. with Registered Nurse (RN) 2 in the dialysis treatment area, Patient 1’s dialysis machine in Station 1 and Patient 16’s dialysis machine in Station 2 were connected to one portable RO machine. RN 2 stated, Patient 1’s DFR could only be set to 400 (ml [milliliter - a unit of measurement]/minute) due to two machines are sharing with one portable RO. During a review of Patient 1’s “Hemodialysis Flowsheet (HDF),” dated 11/1/23, the “HDF” indicated, “Dialysate Flow [DFR]:500. . . Nursing Notes. . . Dialysate flow set to 400 due to machines sharing RO. . . “ During a concurrent observation and interview on 11/6/23 at 2:46 p.m. with Biomedical Technician (BMT) in the dialysis treatment area, the following dialysis machines were connected to one portable RO machine: 1. Station 1 and Station 2 dialysis machine connected to one portable RO machine. 2. Station 3 and Station 4 dialysis machine connected to one portable RO machine. 3. Station 5 and Station 6 dialysis machine connected to one portable RO machine. 4. Station 7 and Station 8 dialysis machine connected to one portable RO machine. BMT stated, the dialysis machines in Station 1 and Station 2 were unable to run if the DFR was more than 400 ml/minute. BMT stated, “We have an emergency order of a portable RO machine requested in September 2023, but the expected shipping is on 11/12/23.” During an interview on 11/8/23, at 9:20 a.m. with Senior Biomedical Engineer (SBME), SBME stated, the standard of practice for the portable RO was to connect one RO to one dialysis machine. SBME stated, one portable RO connected to two dialysis machines was not the standard of practice. SBME stated, there were three ROs that went down and had bad membranes (a semi-permeable membrane that allows the passage of water molecules) around six to eight weeks ago. The shipping date for the new membranes for the ROs would be on 11/12/23. SBME stated, there were three ROs already fixed before and all three ROs were shipped to the other sister facility in another state. SBME was unable to state when the ROs were down. SBME stated, “Sometimes last week one portable RO [connected to Station 1 dialysis machine and Station 2 dialysis machine] was not capable of running at the designated physician’s order for the DFR [if more than 400ml/minute]. The dialysis machine needs anywhere from 500 to 800 ml (milliliter, a unit of measure) of water per minute delivered by the flow rate. The RO between Stations 1 and 2 could not meet the specifications and capability of the dialysis machine water usage. If the DFR cannot be achieved it can affect the toxin removal from the patient. The amount of ml/minute for the DFR can influence the removal of the toxins.” During an interview on 11/8/23 at 10:40 a.m. with Patient Care Technician Orientee (PCTO) 1, PCTO 1 stated the dialysis machines in Station 1 and Station 2 were connected to one portable RO machine. PCTO 1 stated the dialysis machines can run up to 500 ml/minute to 600 ml/minute if there was only one patient in either Station 1 or Station 2. PCTO 1 stated when there are two patients dialyzing at the same time, the dialysis machines can only run the DFR at 400 ml/minute. PCTO 1 stated, “That’s all we can run if there are two patients. If we run the dialysis machines to 500 ml/minute to 600 ml/minute the dialysis machines will continuously alarm.” During an interview on 11/8/23 at 2:25 p.m. with RN 1, RN 1 stated one portable RO connected to two dialysis machines started around two to three months ago. RN 1 stated when the first portable RO got bad, the facility started connecting the two dialysis machines to one portable RO. RN 1 stated SBME was notified and ordered the membranes for the portable ROs that were not working. RN 1 was unable to find documentation the physician or the Medical Director was notified the portable ROs were connected to two dialysis machines in Station 1, Station 2, Station 3, Station 4, Station 5, Station 6, Station 7, and Station 8. During a review of the facility’s “Portable RO Manual (PROM)” [undated], the PROM indicated, “The MROs is a stand-alone water treatment system for use in hemodialysis applications. It is designed to pretreat and purify water. . . It is a portable water treatment unit that has the capacity to supply one dialysis machine. . . “”

“VERIFY PT ID-2 PEOPLE CFR(s): 494.50(b)(1) 12.2 Verification of patient identification: 2 people Except in the case of home dialysis, two persons should check that the first and last names on the dialyzer and any other appropriate identifying information correspond to the identifying information on the patient’s permanent record. If possible, one of the persons checking identification should be the patient. Completion of this step shall be recorded, along with the signature or other unique means of identifying the person verifying patient identification. NOTE-This step may be done later in the procedure but shall precede initiation of dialysis. This Standard is not met as evidenced by: 32234 Based on interview and record review, the dialysis facility failed to ensure two dialysis staff members performed verification of patient/dialyzer (an artificial kidney - used to remove the excess wastes and fluid from the blood) identification prior to initiation of dialysis treatment for six of 11 in-center HD sampled patients (Patient 1, Patient 2, Patient 3, Patient 5, Patient 6, and Patient 10). This failure had the potential for staff to use an incorrect dialyzer or another patient’s dialyzer placing patients at risk for adverse health outcomes. Findings: 1. During a concurrent interview and record review on 11/13/23 at 11:45 a.m. with Facility Administrator (FA), Patient 1’s “Hemodialysis Flowsheet (HDF),” dated 10/18/23 to 11/6/23 was reviewed. The HDF indicated “Maintenance (default setting of the HD machine)” as the “Additional Verifier” for the dialyzer used by Patient 1 on the following dates: 10//23/23 - “Dialyzer: Elisio - 25 [a type of dialyzer used to remove excess wastes, toxins, and fluid from the blood] . . .Dialyzer Checklist. . .Additional Verifier: Maintenance. . . [at 2:08 p.m.].” Treatment initiated at 2:59 p.m. 10/25/23 - “Dialyzer: Elisio - 25. . .Dialyzer Checklist. . .Additional Verifier: Maintenance. . . [at 12:02 p.m.].” Treatment initiated at 2 p.m. 10/30/23 - “Dialyzer: Elisio - 25. . .Dialyzer Checklist. . .Additional Verifier: Maintenance [at 2:25 p.m.].” Treatment initiated at 2:35 p.m. 11/1/23 - “Dialyzer: Elisio - 25. . .Dialyzer Checklist. . .Additional Verifier: Maintenance [at 1:11 p.m.].” Time of Treatment initiation was not documented. 11/3/23 - “Dialyzer: Elisio - 25. . . Dialyzer Checklist. . .Additional Verifier: Maintenance [at 1:51 p.m.].” Time of Treatment initiation was not documented. FA stated, “Maintenance was used as default to verify the dialyzer. It should be an in-center HD staff or another in-center HD staff [to verify the dialyzer] prior to the initiation of the dialysis treatment.” 2. During a concurrent interview and record review on 11/13/23 at 4 p.m. with FA, Patient 2’s HDF dated 10/16/23 to 11/6/23 were reviewed. The HDF indicated “Maintenance” as the “Additional Verifier” for the dialyzer used by Patient 2 on the following dates: 10/20/23 - “Dialyzer: Elisio - 25. . . Dialyzer Checklist. . .Additional Verifier: Maintenance [at 9:59 a.m.].” Treatment started at 10:55 a.m. 10/23/23 - “Dialyzer: Elisio - 25. . .Dialyzer Checklist. . .Additional Verifier: Maintenance [at 10:05 a.m.].” Treatment started at 10:36 a.m. 11/3/23 - Dialyzer: Elisio - 25. . . Dialyzer Checklist. . .Additional Verifier: Maintenance [at 1:59 p.m.].” Treatment started 10:58 a.m. FA stated the dialyzer should be verified by a second in-center HD staff prior to the initiation of the dialysis treatment. 3. During a concurrent interview and record review on 11/13/23 at 5:15 p.m. with FA, Patient 3’s HDF dated 10/18/23 to 11/6/23 were reviewed. The HDF indicated “Maintenance” as the “Additional Verifier” for the dialyzer used by Patient 3 on the following dates: 10/23/23 - “Dialyzer: Revaclear 400 [a type of dialyzer designed to remove excess wastes and fluid from the blood] . . . Dialyzer Checklist. . .Additional Verifier: Maintenance [at 4:52 p.m.].” Treatment initiated at 5:57 p.m. 11/1/23 - “Dialyzer: Revaclear 400. . .Dialyzer Checklist. . .Additional Verifier: Maintenance [at 5:36 p.m.].” Treatment initiated at 5:40 p.m. 11/3/23 - “Dialyzer: Revaclear 400. . .Dialyzer Checklist. . .Additional Verifier: Maintenance [at 4:41 p.m.].” Treatment initiated at 5:47 p.m. 11/6/23 - “Dialyzer: Revaclear 400. . .Dialyzer Checklist. . .Additional Verifier: Maintenance [at 5:27 p.m.].” Treatment started at 5:43 p.m. FA stated the dialyzer should be verified by a second in-center HD staff prior to the initiation of dialysis. 4. During a concurrent interview and record review on 11/14/23 at 11:20 a.m. with FA, Patient 5’s HDF dated 10/18/23 to 11/6/23 were reviewed. The HDF indicated “Maintenance” as the “Additional Verifier” for the dialyzer used by Patient 5 on the following dates: 10/20/23 - “Dialyzer: Revaclear 400. . .Dialyzer Checklist. . .Additional Verifier: Maintenance [at 2:43 p.m.].” Treatment initiated at 2:47 p.m. 10/30/23 - “Dialyzer: Revaclear 400. . .Dialyzer Checklist. . .Additional Verifier: Maintenance [at 2:58 p.m.]” Treatment initiated at 3:13 p.m. FA stated, “Maintenance was used as a default on 10/20/23 and 10/30/23” as the “Additional Verifier.” FA stated, “Maintenance” should not be used as the second person verifier for the patients’ dialyzer. The in-center HD staff should be the second person verifier. 35649 5. During a concurrent interview and record review on 11/9/23 at 10:54 a.m. with Chief Nursing Officer (CNO), Patient 10’s HDF. The HDF dated 10/18/23, 10/20/23, 10/23/23, 10/25/23, 10/27/23, 11/1/23, 11/3/23, and 11/6/23 were reviewed. HDF indicated, Patient 10 used the Revaclear 400 dialyzer and two team members did not verify Patient 10’s dialyzer. HDF indicated, Dialyzer Checklist. . .Additional Verifier “Maintenance”. HDF indicated “Maintenance” as the “Additional Verifier” was used to verify Patient 10’s dialyzer on the following dates and times: 10/20/23 at 1:20 p.m. 10/30 23 at 2:10 p.m. 11/1/23 at 1:43 p.m. 11/3/23 at 1:42 p.m. HDF indicated, Patient 10’s dialysis treatment were initiated on the following dates and times with unverified dialyzers: 10/20/23- Patient Care Technician (PCT) 3 initiated treatment at 1:38 p.m. 10/30 23- PCT 1 initiated dialysis treatment at 1:54 p.m. 11/1/23 - Patient Care Technician Orientee (PCTO) 3 initiated dialysis treatment at 2:47 p.m. 11/3/23- PCTO 3 initiated dialysis treatment at 2:43 p.m. CNO stated she has not seen “Maintenance” as additional verifier documented in the past. CNO stated, “Two staff members should verify the dialyzer used.” 6. During a concurrent interview and record review on 11/9/23 at 2 p.m. with CNO, Patient 6’s HDF dated 10/16/23, 10/18/23, 10/20/23, 10/23/23, 10/27/23, 10/30/23, 11/1/23, 11/3/23, and 11/6/23 were reviewed. The HDFs indicated Patient 6 used Elisio-25 dialyzer and two team members did not verify Patient 6’s dialyzer. HDF indicated, “Dialyzer Checklist. . .Additional Verifier: “Maintenance.” HDF indicated “Maintenance” as the “Additional Verifier” used to verify Patient 6’s dialyzer on the following dates and times: 10/18/23 at 9:29 a.m. 10/23/23 at 9:36 a.m. 10/30/23 at 9:26 a.m. 11/1/23 at 9:19 a.m. 11/3/23 at 9:12 a.m. 11/6/23 at 9:38 a.m. HDF indicated, Patient 6’s dialysis treatment were initiated on the following dates and times with unverified dialyzers: 10/18/23- Registered Nurse (RN) 1 initiated dialysis treatment at 9:54 a.m. 10/23/23- PCTO 1 initiated dialysis treatment at 9:45 a.m. 10/30/23 - RN 2 initiated dialysis treatment at 9:52 a.m. 11/1/23 - no documentation when treatment was initiated. 11/3/23 - RN 1 initiated dialysis treatment at 10 a.m. 11/6/23 - RN 2 initiated dialysis treatment at 10:03 a.m. CNO stated, “Two staff members should verify the dialyzer used.” The facility policy and procedure on verification of patient/dialyzer identification was requested and none was provided.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 32234 Based on observation, interview, and record review, the dialysis facility failed to ensure two of two in-center HD sampled patients’ (Patient 17 and Patient 18) access sites (site used to insert needles during dialysis treatment) and bloodline connections were visible during the entire HD treatment. This failure had the potential for bloodlines to disconnect without staff being aware, which could lead to the patient experience massive bleeding, and eventually death. Findings: 1. During a concurrent observation and interview on 11/6/23 at 9 a.m. with Patient Care Technician (PCT) 1, in the in-Center HD treatment area, Patient 17’s access site (AV [arteriovenous] fistula - a connection between an artery and a vein) on his right forearm was covered with his jacket. PCT 1 stated Patient 17’s dialysis access site should always be visible to prevent accidental needle dislodgement or undetected line disconnection. 2. During a concurrent observation and interview on 11/6/23 at 12:05 p.m. with PCT 2 in the In-Center HD treatment area, Patient 18’s access site (AV fistula) on his left upper arm was covered with his blanket. PCT 2 confirmed the findings and stated the access site should be always visible. During a review of the facility’s document for patient’s signature titled, “Your Safety is our Top Priority,” dated 5/09, the document indicated, “It is important that the dialysis staff be able to view your access and your face at all times. . . The staff needs to view your access for: Bleeding from the Needle Site. . . Needle Dislodgement. . .Infiltrations or Swelling. . . Each patient, including his/her face, vascular access site, and bloodline connections, must be able to be seen by staff member throughout the dialysis treatment. Allowing patients to cover access site and line connections provides an opportunity for accidental needle dislodgement to go undetected.””

“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: 35649 Based on interview and record review, the dialysis facility failed to ensure the Interdisciplinary Team (IDT-a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) conducted IDT meetings, developed comprehensive assessment to formulate a plan of care, and provided evidence IDT discussed the plan of care (POC) for nine of 11 in-center HD sampled patients (Patient 1, Patient 3, Patient 4) Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, and Patient 11) and one of eight HHD patients (Patient 21). This failure had the potential for patients to not receive the appropriate treatment plan, which could negatively impact patient care. Findings: 1. During a concurrent interview and record review on 11/13/23 at 4;46 p.m. with CNO, Patient 8’s POC, dated 2023, was reviewed. CNO was unable to find documentation SW, RD, Nursing, and physician developed POC for Patient 8. CNO stated, “This patient was a new admit and should have a 30-day POC written.” CNO stated the facility has an IDT comprised of the Social Worker (SW), Registered Dietitian (RD), a Registered Nurse (RN), and a physician. SW and RD conduct patient interviews through zoom meetings, or facetime using the phone. 2. During a concurrent interview and record review on 11/13/23 at 4:55 p.m. with CNO, Patient 9’s POC, dated 2022 and 2023, were reviewed. The POC indicated the following: SW: 3/10/23 RD: 3/26/23 Nursing: 8/12/23 Physician: 11/10/23 Patient 9 did not have signature in any of the POC written. CNO was unable to find documentation IDT discussed POC with Patient 9. 3. During a concurrent interview and record review on 11/13/23 at 5:10 p.m. with CNO, Patient 10’s POC, dated 2022 and 2023, were reviewed. The POC indicated the following: SW: 9/29/23 RD: 8/23/23 Nursing: not done Physician: 9/15/23 Patient: no signature on written care plan CNO verified the physician encounter was cut and pasted with those written for Patient 11. CNO stated the Physician progress notes did not indicate evaluation of [Patient 10]’s dry weight, which was not achieved during dialysis treatment. During a review of Patient 10’s physician encounter notes, dated 11/10/23, the physician encounter notes indicated (blood pressure), DW (dry weight), symptomatology with HD, home BP if available. BP meds (medications) reviewed with pt (patient) and meds(sic), HD settings, DW adjusted as necessary.” CNO stated the physician did not write how the care plan will be implemented. 4. During a concurrent interview and record review on 11/13/23 at 5:15 p.m. with CNO, Patient 7’s POC, dated 2022 and 2023, were reviewed. The POC indicated the following: SW: 8/4/23 RD: 2/21/23 Nursing: 4/23/23 Physician: No physician encounter/progress notes/care plan. Patient: no signature on written care plans CNO stated, the physician does not write a POC. 5. During a concurrent interview and record review on 11/14/23 at 10:17 a.m. with CNO, Patient 6’s POC, dated 2022 and 2023, were reviewed. The POC indicated the following: SW: 2/18/22 RD: 2/18/22 Nursing: 2/19/22 Patient: no signature on written care plans Physician: no encounter/progress notes/care plan. CNO stated, the POCs were overdue and POC for stable patients are due annually. 6. During a concurrent interview and record review on 11/14/23 at 10:22 a.m. with CNO, Patient 11’s POC, dated 2022 and 2023, were reviewed. The POC indicated the following: SW: 8/24/23 RD: 8/24/22 Nursing: 8/12/22 Physician: 11/10/23 Patient: no signature on written care plan CNO stated Nursing and RD should have written an updated care plan, done annually. CNO stated, “The physician did not evaluate this patient deeply. He did not address [Patient 11]’s dry weight and the need to adjust it.” CNO verified the physician encounter notes were cut and pasted as those of Patient 10 and stated the physician encounter was not individualized, and the physician did not write a thorough evaluation of the patient, and how the care plan will be implemented. CNO stated, “We need a policy for IDT to hold meetings. CNO stated the plan of care does not reflect if someone was having issues. Each of the discipline collect data but there is no meeting to discuss their findings and make recommendations.” 32234 7. During a concurrent interview and record review on 11/13/23 at 9:55 a.m. with CNO, Patient 21’s Nursing Assessments, POC, and IDT documentations were reviewed. The “POC and IDT Nursing Component” was last done on 9/21/22. CNO stated, “The Nursing Care Plan was not done this year for 2023.” CNO stated, “We have problems with the Care Plans for HHD patients.” CNO stated an IDT meeting with the RN, Social Worker and the physician was needed with Patient 21. During a concurrent interview and record review on 11/13/23 at 10 a.m. with CNO, Patient 21’s physician care plan was reviewed. CNO stated Physician 6’s last progress notes were completed on 5/28/22. CNO stated every time the patient’s blood pressure or Ultrafiltration Rate (UFR-fluid removal) are high, there is an automatic email sent to the physician, but Physician 6 “was not responding.” During a concurrent interview and record review on 11/15/23 at 2:50 p.m. with Facility Administrator (FA), Patient 21’s assessment from the Dietitian was reviewed. FA was unable to find the initial assessment and the 90-day assessment from the Registered Dietitian (RD). FA stated Patient 21 was admitted on 4/5/22. FA stated the RD’s initial assessment, and 90-day assessment were missing since the time of admission on 4/5/22. During a concurrent interview and record review on 11/5/23 at 2:50 p.m. with FA, Patient 21’s assessment from the Social Worker (SW) was reviewed. The SW initial assessment was not done 30 days from admission on 4/5/22 and the SW annual assessment was missing. FA stated SW initial assessment should have been completed 30 days from admission. 8. During a concurrent interview and record review on 11/15/23 at 1:55 p.m. with FA, Patient 3’s assessments and IDT were reviewed. Patient 3’s date of admission was on 7/12/23. FA was unable to find the 90-day Nursing, SW, and RD IDT assessments were done. FA stated, the 90-day assessments by Nursing, Dietary and Social Worker should have been completed. During an interview on 11/15/23 at 11:19 a.m. with RD 1, RD 1 stated, “We do an initial assessment, a 90-day assessment, and an annual assessment for stable patients. We do another initial assessment if there is a change in patients’ modality (mode of dialysis, such as HHD or PD). IDT assessment, that is our care plan.” RD stated, “We do not have an IDT in this facility.” 9. During a concurrent interview and record review on 11/15/23, at 1:55 p.m. with FA, Patient 1’s assessments were reviewed. Patient 1’s date of admission was on 3/13/23. FA stated the initial Nursing assessment for Patient 1 was missing. She was unable to find the initial Nursing assessment and IDT were completed for Patient 1. FA was unable to find the 90-day Nursing, SW, and RD assessments. FA stated the 90-day nursing, SW and RD’s 90-day assessments should have been completed. 10. During a concurrent interview and record review on 11/15/23 at 2:50 p.m. with FA, Patient 4’s assessments were reviewed. Patient 4 was admitted on 1/16/23. The initial Nursing assessment was done on 5/11/23. FA stated the Nursing assessment was late. FA stated the nursing initial assessment should have been done 30 days from admission. FA stated, Patient 4’s 90-day Nursing and RD assessments were not completed. During a review of the facility’s policy and procedure (P&P) titled, “Performance of IDT and Plans of Care,” dated 1/18/16, the P&P indicated, “2. Each patient will receive an evaluation by each member of the IDT. . .a. An initial assessment by each member of the IDT at the earlier of 30 days from the date of admission or the performance of 13 hemodialysis sessions at the facility. . . Documentation: a. The Nurse, Social Worker, and Dietitian shall each complete the initial assessment or the follow-up re-assessment (whichever is appropriate) using the on-line Initial IDT Assessment and Plan of Care Forms that are specific to the IDT Member’s discipline. b. A copy of each form shall be reviewed and signed by the patient’s nephrologist or Medical Director. c. A copy of each form shall be presented to the patient, either on paper, or on electronic tablet. The patient will sign the assessment form. . .””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the dialysis facility failed to follow prescribed dialysis prescription, document, and notify the physician when prescribed dialysis prescription were adjusted without rationale for change, and when the target goals were not achieved for 10 of 11 in-center HD sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 9, Patient 10, Patient 11), and one of eight HHD patients (Patient 21). This failure had the potential for dialysis patients to not achieve adequate dialysis and meet their target goal. Findings: 1. During an interview on 11/8/23 at 9:07 a.m. with Senior Biomedical Engineer (SBME), SBME stated, “It is not a standard of practice to connect one Reverse Osmosis (RO - primary method for purifying water for dialysis treatments) to two dialysis machines. It only happens in an emergency. I was not aware there were issues with the Dialysate Flow Rate (DFR - used to increase dialysis efficiency to remove impurities or toxins in the blood) until last Friday, that with double hook up the RO could not sufficiently run two hemodialysis machines in Stations 1 and 2. The dialysis machine needs anywhere between 500 -800 ml (milliliter, a unit of measure) of water per minute delivered by the flow rate. The RO between Stations 1 and 2 could not meet the specifications and capability of the dialysis machine water usage. If DFR cannot be achieved that could affect the toxin removal from the patient.” During a review of Patient 6’s “Hemodialysis Flowsheet (HDF),” dated 10/16/23, 10/18/23, 10/20/23, 10/25/23, 10/27/23, 10/30/23, 11/1/23, 11/3/23 and 11/6/23, the HDF indicated, Patient 6’s dialysis order included a “Blood Flow Rate (BFR -the rate at which blood passes through the dialyzer, [artificial kidney] that removes waste products and excess fluid from the bloodstream.) of 400 and a Dialysate Flow Rate (DFR) of 800.” During a concurrent interview and record review, on 11/9/23 at 2:10 p.m. with Chief Nursing Officer (CNO), Patient 6’s HDF, dated 10/16/23, 10/18/23, 10/20/23, and 10/23/23 were reviewed. The HDFs indicated, Patient 6’s BFR 400/DFR 400. The HDF dated 10/27/23 indicated BFR 400/DFR 500. The HDF dated 10/30/23, 11/1/23, 11/3/23, and 11/6/23 indicated the BFR 400/ DFR 400. CNO stated the prescribed DFR order was not followed because the RO could not run the machine at 800 and meet the patient’s demand. CNO was unable find registered nurse documentation of intradialytic (during dialysis) assessment and stated nurses should evaluate patients during treatment. 2. During a review of Patient 10’s “HDF,” dated 10/18/23, 10/20/23, 10/23/23, 10/25/23, 10/27/23, 10/30/23, 11/1/23, 11/3/23, and 11/6/23, the HDFs indicated, Patient 10’s dialysis order included “BFR 400/DFR 500.” During a concurrent interview and record review on 11/9/23 at 11:10 a.m. with CNO, Patient 10’s HDF, dated 10/18/23, was reviewed. The HDF indicated Patient 10’s BFR was 350/DFR was 500. The arterial pressure (pressure generated by the pump when blood flows into the arterial segment of the dialysis circuit [arterial line]) was recorded at negative (-)144 at 2 p.m., -138 at 2:30 p.m., -137 at 3 p.m., -140 at 4 p.m., -143 at 4:30 p.m., and -142 at 5 p.m. CNO stated, Patient Care Technicians (PCT 7 and PCT 2) and Registered Nurse (RN) 1 did not address the continuous negative arterial pressures. PCT 7, PCT 2, and RN 1 all documented “no problems.” CNO stated, “The documentation was inaccurate. There should be a documentation why [Patient 10] could not achieve the blood flow. CNO stated, Patient 10’s dry weight was not achieved. . .Patient 10’s dry weight was 66 kg (kilogram, a unit of measure) and he left at 67.5 kg.” CNO was unable to find RN documentation of intradialytic assessment and stated nurses should evaluate patients during treatment. During a concurrent interview and record review on 11/9/23 at 12 p.m. with CNO, Patient 10’s HDF, dated 10/27/23, was reviewed. The HDF indicated, Nursing calculated fluid removal at 1500 ml. and the amount of fluid removed during this dialysis treatment was 1455 ml. Patient 10’s dry weight was 66 kg (kilogram, a unit of measure) and Patient10’s weight after three and one-half hours of dialysis treatment was 67.4 kg. CNO stated, “The UFR (ultrafiltration rate-mechanical removal of fluid during dialysis) was not set high enough to achieve the dry weight. [Patient 10]’s blood pressure was stable. [Patient 10] left at 1.4 kg above his dry weight. UFR was set too low.” CNO was unable to find RN documentation of intradialytic assessment and stated nurses should evaluate patients during treatment. During a concurrent interview and record review on 11/9/23 at 12:10 p.m. with CNO, Patient 10’s HDF, dated 11/3/23, was reviewed. The HDF indicated, Patient 10’s dry weight was 66 kg. Patient 10’s weight after post dialysis treatment was 69.3 kg. CNO stated, “[Patient 10] did not achieve goal, he weighed 3.3 kg above target weight. This necessitated a call to the doctor. The staff did not run [Patient 10]’s dialysis aggressively. The calculated machine removal was 2000 ml., but only removed 1635 ml.” CNO was unable to find documentation of RN intradialytic assessment and stated nurses should evaluate patients during treatment. During an interview on 11/9/23 at 12:20 p.m. with RN 1, RN 1 stated, “If patient goes up above dry weight, we need to let the doctor know. Patient may experience shortness of breath the next day. I did not close him (review and completed chart) right away. I did not see it. I make rounds and conduct assessment in conjunction with medication pass throughout the course of treatment.” During a concurrent interview and record review on 11/9/23 at 12:30 p.m. with CNO, Patient 10’s HDF, dated 11/6/23, was reviewed. The HDF indicated, Patient 10 left with 2.7 kg above dry weight. CNO was unable to find documentation of RN assessment during the treatment and there was no physician notification. CNO stated the physician should have been called and the nurse should evaluate patients during treatment. 3. During a review of Patient 7’s “HDF” dated 10/18/23, 1/20/23, 10/23/23, 10/25/23, 10/27/23, 11/1/23, 11/3/23, and 11/6/23, HDFs indicated, Patient 7’s dialysis order included “ BFR 400/DFR 600.” During a concurrent interview and record review on 11/13/23 at 11 a.m. with CNO, Patient 7’s HDF, dated 10/18/23, was reviewed. The HDF indicated, BFR 300/ DFR 500. The HDF, dated 10/20/23, indicated BFR 250/DFR 500. The HDFs, dated 10/23/23 and 10/25/23, indicated BFR 350/DFR 500. The HDF, dated 10/27/23, indicated BFR 300/DFR 500. The HDF, dated 11/1/23, indicated BFR 300/DFR 400. The HDFs, dated 11/3/23 and 11/6/23, indicated BFR 350/DFR 600. CNO stated the prescribed dialysis order was not followed and there was no documentation of justification for the adjustments made. CNO was unable to find RN documentation of intradialytic assessment and stated nurses should evaluate patients during treatment. 4. During a review of Patient 9’s “HDFs,” dated 10/16/23, 10/20/23, 10/23/23, 10/27/23, 10/30/23, and 11/6/23 the HDFs indicated, Patient 9’s dialysis order included “BFR 350/DFR 500.” During a concurrent interview and record review on 11/13/23 at 11:15 a.m. with CNO, Patient 9’s HDF, dated 10/23/23, was reviewed. The HDF indicated Patient 9’s BFR/DFR were 350/600 from 11 a.m. to 12:30 p.m. and BFR 300/DFR 600 from 1 p.m. to 1:25 p.m. CNO was unable to find documentation for the adjustments made and stated the prescribed doctor’s order was not followed. CNO was unable to find RN documentation of intradialytic assessment and stated nurses should evaluate patients during treatment. 5. During a review of Patient 11’s “HDFs,” dated 10/18/23, 10/20/23, 10/23/23, 10/25/23, 10/27/23, 10/30/23, 11/1/23, 11/3/23, and 11/6/23, the HDF indicated, Patient 11’s dialysis order included “BFR 350 and DFR 600.” During a concurrent interview and record review on 11/13/23 at 12:30 p.m. with CNO, Patient 11’s HDF, dated 10/18/23, 10/20/23, 10/27/23 were reviewed. The HDFs indicated BFR 350/DFR 500. The HDF dated 10/25/23 indicated BFR 350/DFR 400. The HDF dated 11/1/23 and 11/3/23 indicated BFR 350/DFR 500. CNO stated, there’s no reason to adjust the DFR. CNO stated the prescribed doctor’s order was not followed. CNO verified there was no RN documentation of intradialytic assessment and stated nurses should evaluate patient during treatment. 32234 6. During a concurrent interview and record review on 11/13/23 at 2 p.m. with Facility Administrator (FA), Patient 1’s HDF dated 10/18/23, 10/20/23, 10/23/23, 10/25/23, 10/27/23, 10/30/23, 11/1 23, 11/3/23, and 11/6/23 were reviewed. The HDFs indicated, Patient 1’s dialysis order included BFR 350/DFR 500 and duration of HD treatment for 225 minutes (3 hours 75 minutes) and the target weight of 96.5 kg (kilogram, a unit of measure). FA stated, if the BFR/DFR and duration of treatment prescription were not followed, there should be documentation. The following dates indicated the prescribed BFR/DFR, the duration of treatment was not followed, and the target weight not met for Patient 1: 10/18/23: DFR - 400 at 2:33 p.m. (start of HD treatment) to 6 p.m. (end of HD treatment). Duration of HD treatment - 214 minutes (3 hours 56 minutes) (HD treatment was short of 19 minutes). Target weight (wt.) - 96.5 kg. Post - dialysis wt. - 100 kg. Patient 1 left with more [>] 3.5 kg from the target wt. 10/20/23: Duration of HD treatment - Total of 262 minutes (4 hours 36 minutes) (started at 2:30 p.m. to 6:20 p.m.). The HD treatment exceeded for 42 minutes. Post - dialysis wt. - 100.5 kg. Patient left with 4 kg above the target weight. 10/23/23: DFR - 400 at 2:59 p.m. (start of HD treatment) to 6:39 p.m. (end of HD treatment). Patient 1’s dry weight was changed to 100 kg. on 10/22/23. Post - dialysis wt. - 103.3 kg. Patient 1 left with 3.3 kg above target weight. 10/25/23: DFR - 400 at 2 p.m. (start of HD treatment) to 5:30 p.m. (end of HD treatment). Duration of HD treatment - 210 minutes (3 hours 30 minutes) HD treatment time was short of 15 minutes). Post - dialysis wt. - 103.8 kg. Patient left with 3.8 kg above the target weight. 10/27/23: DFR - 400 at 2:33 p.m. (start of HD treatment) to 6 p.m. (end of HD treatment). Post - dialysis wt. - 104.4 kg. Patient left with 4.4 kg above the target weight. 10/30/23: BFR 400/DFR 400 at 2:35 p.m. (start of HD treatment) to 6 p.m. (end of HD treatment). RN documentation indicated, “Blood pump at 400 due to 2 machines sharing 1 RO.” Duration of HD treatment - 205 minutes (HD treatment was short of 20 minutes). Post - dialysis wt. - 102.8 kg Patient 1 left with 2.8 kg above the target weight. 11/1/23: BFR 400/DFR 400 at 2:30 p.m. (start of HD treatment) to 5:56 p.m. (end of HD treatment). Patient Care Technician Orientee (PCTO) 1 documentation indicated, “Dialysis flow set to 400 due to 2 machines sharing an RO.” Duration of HD treatment - 206 minutes (HD treatment was short of 19 minutes). Post - dialysis wt. - 104.2 kg Patient 1 left with 4.2 kg above the target weight. 11/3/23: DFR 400 at 2:30 p.m. (start of treatment) to 5:30 p.m. (end of treatment). Duration of HD treatment - 180 minutes (3 hours) (HD treatment was short of 45 minutes). Post - dialysis wt. - 102.4 kg Patient 1 left with 2.4 kg above the target wt. 11/6/23: DFR 400 at 2:30 p.m. (start of treatment) to 6:52 p.m. (end of treatment). Duration of HD dialysis - 252 minutes (4 hours 20 minutes) (The HD treatment exceeded for 27 minutes). Post - dialysis wt. - 102.4 kg Patient 1 left with 2.4 kg above the target wt. FA verified the above findings and stated the prescribed BFR/DFR and duration of treatment for Patient 1 were not followed consistently and the target wt. were not met. FA was unable to find documentation the physician was notified when the BFR/DFR were not followed consistently. During an interview on 11/13/23, at 4:35 p.m. with FA, FA stated, if the weight is consistently under or over the target weight and there is a trend, the physician had to be notified. FA was unable to find documentation of RN intradialytic assessments. 7. During a concurrent interview and record review on 11/13/24 at 4 p.m. with FA, Patient 2’s HDF dated 10/16/23, 10/18/23, 10/20/23, 10/25/23, 10/30/23, 11//1/23, 11/5/23, and 11/6/23 were reviewed. The HDFs indicated, Patient 2’s dialysis order included the duration of HD treatment for 180 minutes (3 hours). The following dates indicated the duration of treatment were not met for Patient 2: 10/16/23 10:22 a.m. (start of HD treatment) 12:44 p.m. (end of HD treatment) Duration of HD treatment - 142 minutes (HD treatment was short 38 minutes). 10/18/23 11 a.m. (start of HD treatment) 12:48 a.m. (end of HD treatment) Duration of HD treatment - 108 minutes (HD treatment was short 72 minutes) 10/20/23 10:55 a.m. (start of HD treatment) 12:41 p.m. (end of HD treatment). Duration of HD treatment - 106 minutes (Shortened HD treatment for 74 minutes) 10/23/23 10:36 a.m. (start of HD treatment) 12:41 p.m. (end of HD treatment) Duration of HD treatment - 125 minutes (Shortened HD treatment for 55 minutes) 10/25/23 10:43 a.m. (start of HD treatment) 12:30 p.m. (end of HD treatment) Duration of HD treatment - 107 minutes (Shortened HD treatment for 47 minutes) 10/30/23 11:18 a.m. (start of HD treatment) 12:30 p.m. (end of HD treatment) Duration of treatment - 72 minutes (Shortened HD treatment for 108 minutes) 11/1/23 11:12 a.m. (start of HD treatment) 12:02 p.m. (end of HD treatment) Duration of treatment - 50 minutes (Shortened HD treatment for 130 minutes) 11/3/23 10:58 a.m. (start of HD treatment) 12:48 p.m. (end of HD treatment) Duration of treatment - 110 minutes (Shortened HD treatment for 70 minutes) 11/6/23 10:42 a.m. (start of HD treatment) 12:53 p.m. (end of HD treatment) Duration of treatment - 131 minutes (Shortened HD treatment for 49 minutes) FA stated if a patient shortened his/her treatment, the patient must sign a form “Against Medical Advice (AMA)”. FA was unable to find the AMA form was signed by Patient 2 dated 10/16/23, 10/18/23, 10/20/23, and 10/23/23, and 10/30/23. FA stated, the staff should have documented why Patient 2 refused to sign the AMA form when he requested to shorten his HD treatments. FA stated, the physician should have been notified when Patient 2 shortened his HD treatments. During an interview on 11/15/23 at 11:45 a.m. with Social Worker (SW), SW stated, Patient 2 was considered “unstable” for three months (8/23, 9/23, 10/23). SW stated, “[Patient 2] leaves early because he has to catch the bus at a certain time. It’s been like that. We offered other shifts and he refused. He comes to treatment but shortens his dialysis treatment.” 8. During a concurrent interview and record review on 11/13/23, at 4:50 p.m. with Facility Administrator (FA), Patient 3’s HDF dated 10/18/23, 10/20/23, 10/23/23, 10/25/23, 10/27/23, 10/30/23, 11/1 23, 11/3/23, and 11/6/23 were reviewed. The HDFs indicated, Patient 3’s dialysis order included BFR 400/DFR 500. The following dates indicated the prescribed BFR/DFR were not followed: 10/18/23: DFR 400 RN 2 “Nursing Notes (NN),” indicated, “Dialysate flow rate at 400 due to 2 machines sharing 1 RO.” 10/20/23: DFR 400 Patient Care Technician Orientee (PCTO) 3 documentation’s indicated, “Dialysate flow set to 400 due to two machines sharing one RO.” FA stated, the physician needed to be notified when the DFR was set at 400 instead of 500 due to two machines sharing one RO. 9. During a concurrent interview and record review on 11/14/23 at 9:20 a.m. with FA, Patient 4’s HDF dated 10/18/23, 10/20/23, 10/23/23, 10/25/23, 10/27/23, 10/30/23, 11/1/23, 11/3/23, and 11/6/23 were reviewed. The HDFs indicated, Patient 4’s dialysis order included BFR 400/DFR 600, duration of HD treatment for 180 minutes (3 hours), and target wt. of 81 kg. The following dates indicated the Patient 1’s prescribed BFR/DFR, duration of treatment, and target weight were not met: 10/18/23: BFR ranging from 275 to 350 from the start of HD treatment at 7:04 p.m. to end of HD treatment at 10:25 p.m. post-dialysis wt. - 84.4 kg. Patient left with 3.4 kg above the target wt. 10/20/23: BFR 300 from the start of HD treatment at 8:15 p.m. to end of HD treatment at 10:58 p.m. post-dialysis wt. - 82 kg. Patient left with 1 kg above the target weight. 10/23/23: DFR ranging from 300 to 500 from the start of HD treatment at 7 p.m. to 10 p.m. 10/25/23: BFR ranging from 300 to 350 and DFR 400 from the start of HD treatment at 7:30 p.m. to end of HD treatment at 10:17 p.m. 10/27/23: DFR 500 from the start of HD treatment at 7:03 p.m. to end of HD treatment at 10:28 p.m. 10/30/23: BFR ranging from 250 to 300 from the start of HD treatment at 7:13 p.m. to end of HD treatment at 10 p.m. DFR - 500 from the start of HD treatment at 7:13 p.m. to 9:30 p.m. and DFR was decreased to 400 at 10 p.m. for the end of HD treatment. 11/1/23: BFR ranging from 250 to 300 from the start of HD treatment at 7:07 p.m. to end of HD treatment at 10:02 p.m. 11/3/23: BFR - 300 and DFR - 400 from 8 p.m. to end of HD treatment at 10:34 p.m. 11/6/23: BFR ranging from 200 to 350 and DFR - 500 from the start of HD treatment at 7:09 p.m. to 10:56 p.m. Duration of HD treatment - 236 minutes (HD treatment exceeded 47 minutes). FA was unable to find documentation BFR/DFR prescriptions were not being followed and stated the staff should document the rationale for adjusting for the BFR and DFR. During an interview on 11/14/23, at 10:45 a.m. with FA, FA stated staff should document what cause Patient 4 to go over the prescribed duration of HD treatment. FA stated, “RN must document the reason why it [HD treatment] run longer.” 10. During a concurrent interview and record review on 11/14/23 at 11:20 a.m. with FA, Patient 5’s HDF dated 10/18/23, 10/10/23, 10/23/23, 10/25/23, 10/27/23, 10/30/23, 11/1/23, 11/3/23, and 11/6/23 were reviewed. The HDFs indicated, Patient 5’s dialysis order included duration of HD treatment for 195 minutes (3 hours 15 minutes). Patient 5’s duration of HD treatment prescription was not followed on the following dates: 11/1/23: Start of HD treatment at 2:59 p.m. End of HD treatment at 6:46 p.m. Duration of HD treatment - 227 minutes (HD treatment exceeded 32 minutes). 11/3/23: Start of HD treatment at 3:03 p.m. End of HD treatment at 5:40 p.m. Duration of HD treatment - 157 minutes (HD treatment was cut short 38 minutes). 11/6/23: Start of HD treatment at 2:40 p.m. End of HD treatment at 6:40 p.m. Duration of HD treatment - minutes (HD treatment exceeded 45 minutes). FA stated the AMA form should have been signed by Patient 5 when his HD treatment was cut short for 45 minutes. FA was unable to find documentation Patient 5 signed the AMA form on 11/3/23 when his HD treatment was cut short for 45 minutes. FA stated the physician should have been notified when Patient 6’s HD treatment time was shortened or exceeded. 12. During a concurrent interview and record review on 11/13/23 at 8:30 a.m. with CNO, Patient 21’s HHDF, dated 10/9/23 to 11/4/23, were reviewed. The HHDFs indicated, Patient 21’s dialysis order included the target weight of 68 kg. The following dates indicated Patient 21 did not meet the target wt. of 68 kg post - dialysis treatment: 10/11/23: post-dialysis weight - 62.7 kg (wt. was below 5.3 kg from the target wt.). 10/13/23: post-dialysis weight - 63.2 kg (wt. was below 4.8 kg from the target wt.). 10/16/23: post-dialysis weight - 63 kg (wt. was below 5 kg from the target wt.). 10/18/23: post-dialysis weight - 63 kg (wt. was below 5 kg from the target wt.). 10/21/23: post-dialysis weight - 64.3 kg (wt. was below 3.7 kg from the target wt.). 10/24/23: post-dialysis weight - 64.9 kg (wt. was below 3.1 kg from the target wt.). 10/25/23: post-dialysis weight - 64.9 kg (wt. was below 3.1 kg from the target wt.). 10/28/23: post-dialysis weight - 64.6 kg (wt. was below 3.4 kg from the target wt.). CNO stated Patient 21’s post-dialysis weights were below his target weights and needed to be adjusted. CNO stated RN 1 should discuss and review Patient 21’s weights with the physician. CNO was unable to find documentation IDT addressed Patient 21’s weights. During a review of the facility’s policy and procedure (P&P) titled, “Pre-Assessment and Data Collection, dated 9/17/15, the P&P indicated, “ Report any changes deviating from patient’s normal status to the Nurse Manager. . .o. Document all assessment and data collection findings in the facility’s electronic medical record.””

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to: 1. Ensure Registered Nurse (RN) 2 assess and reassess three of 11 in-center HD sampled patients (Patient 1, Patient 3, and Patient 6) with labile blood pressure (when a person’s blood pressure repeatedly or suddenly changes from normal to abnormally high levels) and one of eight HHD sampled patients (Patient 21)’s elevated blood pressures and intervened appropriately pre (before), intra (during), and post (after) dialysis treatment. This failure resulted in patients dialyzing with elevated blood pressure and not meeting their target weights post dialysis. 2. Ensure registered nurses performed intradialytic (during dialysis) assessments and notified physicians for three of 11 in-center HD sampled patients (Patient 4, Patient 7, and Patient 11) and one of eight HHD sampled patients (Patient 21) when ultrafiltration rate (UFR-mechanical removal of fluid from the patient) were greater than 13 ml/kg/hour (limit of UFR monitored by the Centers for Medicare and Medicaid Services [CMS] to decrease the risk of heart failure symptoms and mortality). This failure had the potential to place patients at risk for harm during and post-dialysis treatment. 3. Ensure registered nurses performed reassessment of dry weights for two of 11 in-center HD sampled patients (Patient 1 and Patient 9) and one of eight HHD patients (Patient 21) to manage fluid and unmet targeted dry weights. This failure resulted in Patient 1, Patient 9, and Patient 21’s unmet care needs to achieve targeted dry weight. Findings: 1a. During a concurrent interview and record review on 11/9/23 at 2:10 p.m. with Chief Nursing Officer (CNO), Patient 6’s Hemodialysis Flowsheet (HDF), dated 10/16/23, was reviewed. The HDF indicated, “At 9:47 a.m., BP was 201/100, at 10:30 a.m. BP was 207/102, and at 11 a.m. BP was 210/110. Patient Care Technician (PCT) 1 documented he notified the supervising nurse at 11 a.m. when the BP was 210/110. CNO was unable to provide documentation supervising nurse assessed the patient and acted upon the report of elevated blood pressure. CNO stated, there was no evidence RN 2 assessed the patient and notified the physician. During a concurrent interview and record review on 11/9/23 at 2:20 p.m. with CNO, Patient 6’s HDF, dated 10/30/23, was reviewed. The HDF indicated, “Patient 6’s pre-dialysis BP was 214/106 at 9:47 a.m. Patient 6’s BP was 224/112 at 10 a.m. Patient Care Technician Orientee (PCTO) 3 notified the supervising nurse. CNO was unable to find documentation RN 2 assessed the patient when elevated blood pressure was reported and called the physician when pre-dialysis blood pressure was greater than 200 mm Hg (millimeters mercury, a unit of measure). CNO stated there was no documentation RN 2 assessed the patient and notified the physician. During a review of the facility’s policy and procedure (P&P) titled, “Hypertension,” dated 8/1/12, the P&P indicated, “4. If a patient’s pre-dialysis systolic blood pressure (measures the pressure in your arteries when your heart beats) is greater than 200 mm Hg, notify the physician unless this is normal for the patient. . .Hypertensive patients will have their BP monitored every 15 minutes until diastolic BP (measures the pressure in your arteries when one’s heart rests between beats) falls below 110 mmHg.” 1b. During a concurrent interview and record review, on 11/13/23 at 4 p.m. with Facility Administrator (FA), Patient 2’s HDFs dated 10/16/23 to 11/6/23 were reviewed. The HDF indicated Patient 2’s BP were elevated on the following dates and times during the in-center hemodialysis treatment days: 10/16/23 - At 10:16 a.m. BP - 206/95. 10/23/23 - At 12:40 p.m. BP sitting post dialysis treatment - 211/99. FA was unable to find PRN (as needed) BP medication for elevated blood pressure was administered to Patient 2. FA did not find documentation the physician was notified regarding Patient 2’s elevated blood pressures on 10/16/23 and 10/23/23. FA stated the PRN BP medication for elevated blood pressure should have been administered and Patient 2’s physician should have been notified. 1c. During a concurrent interview and record review, on 11/13/23 at 4:50 p.m. with FA, Patient 3’s HDFs, dated 10/18/23 to 11/6/23 were reviewed. The HDF indicated Patient 3’s BP (blood pressure) were elevated on the following dates and times during the in-center hemodialysis treatment days: 10/20/23 - At 5:40 p.m. BP - 204/122. 10/25/23 - At 5:32 p.m. BP - 223/135. At 5:45 p.m. BP - 223/135. At 6 p.m. BP - 212/126. 10/27/23 - At 6:36 p.m. BP - 210/123. 10/30/23 - At 7 p.m. BP - 202/118. FA was unable to find PRN BP medication for elevated blood pressure was administered to Patient 3. FA was unable to find documentation Patient 3’s physician was notified regarding elevated blood pressures on 10/20/23, 10/25/23, 10/27/23, and 10/30/23. FA stated Patient 3’s blood pressures were elevated during dialysis treatment. Patient 3’s PRN BP medication should have been administered. 1d. During a concurrent interview and record review on 11/14/23 at 2:30 p.m. with RN 1, Patient 21’s HHD “Treatment Flow Sheet (TFS),” dated 10/9/23 to 11/4/23 were reviewed. The TFS indicated, Patient 21’s BP were elevated on the following dates and times during the HHD dialysis treatment days: 10/9/23 - At 5:53 p.m. BP - 205/93. At 7:26 p.m. BP - 210/88. At 7:57 p.m. BP - 219/94. At 8:29 p.m. BP -218/91. 10/11/23 - At 3:57 p.m. BP - 201/98. At 6:57 p.m. BP - 201/89. At 7:34 p.m. BP - 208/83. At 8:05 p.m. BP - 222/91. At 8:17 p.m. BP - 214/90. At 8:24 p.m. BP 207/89. 10/13/23 - At 10:42 p.m. BP - 201/83. At 11:12 p.m. BP - 200/81. 10/16/23 - At 10:14 a.m. BP - 207/114. At 1:37 p.m. BP - 207/88. 10/18/23 - At 6:45 p.m. BP - 207/91. At 7:47 p.m. BP - 215/87. At 8:03 p.m. BP - 212/86 p.m. At 8:13 p.m. BP - 203/84. 10/21/23 - At 1:05 p.m. BP - 200/88. At 2:08 p.m. BP - 201/87. 10/24/23 - At 10:41 a.m. BP - 202/94. 10/25/23 - At 7:38 p.m. BP - 207/89. At 7:54 p.m. BP - 209/95. At 8:03 p.m. BP 210/93. 10/28/23 - At 5:06 p.m. BP - 200/93. At 6:07 p.m. BP 203/90. At 6:38 p.m. BP - 200/80. At 7:40 p.m. BP - 218/90. At 8:12 p.m. BP - 229/94. At 8:15 p.m. BP - 232/92. At 8:18 p.m. BP - 219/100. - At 8:28 p.m. BP - 223/95. 10/31/23 - At 7:12 p.m. BP - 202/83. At 8:14 p.m. BP - 228/115. At 8:45 p.m. BP - 213/88. At 9 p.m. BP - 212/91. At 9:08 p.m. BP - 206/77. 11/3/23 - At 7:03 p.m. BP - 210/99. At 7:34 p.m. BP - 214/91. At 8:36 p.m. BP - 208/92. At 9:07 p.m. BP - 205/93. At 9:20 p.m. BP 212/103. At 9:29 p.m. BP - 207/86. 11/4/23 - At 6:35 p.m. BP 212/95. At 7:06 p.m. BP - 209/96. At 7:37 p.m. BP 206/93. At 8:08 p.m. BP - 204/90. At 9:10 p.m. BP - 214/87. At 9:19 p.m. BP - 212/89. RN 1 stated Patient 21’s blood pressures were very high. RN 1 stated if the patient’s BP was too high, the physician was to be notified. RN 1 stated, “Something must be done about it [Patient 21’s elevated BP]. Something can happen.” RN 1 stated, [PCT 4] should have notified the RN. RN 1 stated, “I did not notify the doctor.” 2a. During a concurrent interview and record review on 11/13/23 at 2:54 p.m. with CNO, Patient 7’s HDF, dated 11/1/23, 11/3/23, and 11/6/23 were reviewed. The HDFs indicated, Patient 7’s UFRs were greater than 13 ml/kg/hour. Patient 7’s UFR on 11/1/23 was 17.54 ml/kg/hour, on 11/3/23 UFR was 17.54 ml/kg/hour, and on 11/6/23 UFR was 16.49 ml/kg/hour.” CNO verified the findings and stated, “The doctor should have been notified. He may increase the duration of dialysis to get to 13 ml/kg/hour. Physicians have access to the electronic medical records also. The physician can review [Patient 7]’s medical records. There were no MD (medical doctor) progress notes for [Patient 7].” CNO was unable to find documentation the nurses conducted an intradialytic assessment of Patient 7 and stated nurses should assess patients during treatment. During a concurrent interview and record review on 11/13/23 at 3:59 p.m. with CNO, Patient 11’s HDF, dated 10/23/23, was reviewed. The HDF indicated, “Patient 11’s UFR was greater than 13 ml/kg/hour. Patient 11’s UFR was 16.33 ml/kg/hour.” CNO stated, “[Patient 11]’s lungs were clear, and she had no edema. Her UFR was started at 1050 ml, but decreased to 970.” CNO was unable to find documentation of the rationale (logical reason for the course of action) for the adjustments made. CNO stated nurses should assess patients during treatment. During an interview on 11/13/23 at 4 p.m. with RN 1, RN 1 stated, “I decreased the UFR. There was no documentation made for the adjustments made.” 32234 2b. During a concurrent interview and record review on 11/14/23 at 10:45 a.m. with FA, Patient 4’s HDFs dated 10/18/23 to 11/6/23 were reviewed. The HDFs indicated Patient 4’s UFR were greater than 13 ml/kg/hour. On 10/23/23, Patient 4’s UFR was 13.295 ml/kg/hour and on 11/6/23 Patient 4’s UFR was 13.32 ml/kg/hour. FA stated when a patient has a UFR of more than 13 ml/kg/hour the physician needed to be notified if it’s ok for the UFR to exceed 13 ml/kg/hour or to decrease the UF goal or drop this goal. FA was unable to find documentation the physician was notified of Patient 4’s UFR more than 13 ml/kg/hour on 10/23/23 and 11/6/23. FA was unable to find the RN conducted an intradialytic assessment during treatment for Patient 4 on 10/23/23 and 11/6/23. 2c. During a concurrent interview and record review on 11/13/23 at 8:30 a.m. with CNO, Patient 21’s HHDFs dated 10/9/23 to 11/4/23 were reviewed. The HDFs indicated, Patient 21’s UFR were greater than 13 ml/kg/hour on the following dates: 10/24/23 -14.7 ml/kg/hour 10/28/23 - 13.77 ml/kg/hour 10/31/23 - 14.7 ml/kg/hour 11/3/23 - 17.15 ml/kg/hour CNO verified Patient 21’s UFR were greater than 13 ml/kg/hour. CNO stated Patient 21 had high venous pressure (obstruction of the veins proximal to the access site) and her access needed to be done. CNO was unable to find RN documentation the physician was notified. 3a. During a concurrent interview and record review on 11/13/23 at 4:10 p.m. with CNO, Patient 9’s HDFs, dated 10/16/23, 10/20/23, 10/23/23, 10/27/23, 10/30/23, and 11/6/23, were reviewed. The HDFs indicated, “Patient 9’s dry weight was 58.” During a concurrent interview and record review on 11/13/23 at 4:15 p.m.,with CNO, HDF dated 10/16/23 indicated, “Patient 9’s post-dialysis weight after four hours of dialysis treatment was 61.2 kg. The calculated fluid removal was 2800 ml and the fluid removed was 1942 ml.” CNO stated,” [Patient 9]’s dry weight was not achieved. [Patient 9] left with 3.2 kg above dry weight. RN should have assessed the patient and notified the physician.” During a concurrent interview and record review on 11/13/23 at 4:25 p.m. with CNO, HDF dated 10/20/23 indicated, “Patient 9’s post-dialysis weight after four hours of dialysis treatment was 61.6 kg. The calculated fluid removal was 1800 ml and the fluid removed was 1784 ml.” CNO stated, “[Patient 9]’s dry weight was not achieved. [Patient 9] left with 3.6 kg above dry weight. RN should have assessed the patient and notified the physician.” During a concurrent interview and record review on 11/13/23 at 4:30 p.m. with CNO, HDF dated 10/23/23 indicated, “Patient 9’s post-dialysis weight after four hours of dialysis treatment was 58.6 kg. The calculated fluid removal was 1500 ml and the fluid removed was 1495 ml.” CNO stated, “Patient 9’s dry weight still needs to be reviewed. Patient 9 left with 0.6 kg above her dry weight.” During a concurrent interview and record review on 11/13/23 at 4:40 p.m. with CNO, HDF dated 10/27/23 indicated, “Patient 9’s post-dialysis weight after four hours of dialysis treatment was 62 kg. The calculated fluid removal was 2000 ml and the fluid removed was 1792 ml.” CNO stated, “[Patient 9]’s dry weight was not achieved. [Patient 9] left with 4 kg above her dry weight. RN should have assessed the patient and notified the physician.” During a concurrent interview and record review on 11/13/23 at 4:50 p.m. with CNO, HDF dated 10/30/23 indicated, “Patient 9’s post dialysis weight after four hours of dialysis treatment was 63.3 kg. The calculated fluid removal was not documented, and the fluid removed was 1274.” CNO stated, “[Patient 9]’s dry weight was not achieved. [Patient 9] left with 5.3 kg above dry weight. RN should have assessed the patient and notified the physician.” During a concurrent interview and record review on 11/13/23, at 5 p.m., with CNO, HDF dated 11/6/23 indicated, “Patient 9’s post dialysis weight after four hours of treatment was 63.8 kg. The calculated fluid removal was 2500 ml and the fluid removed was 1780 ml.” CNO stated, [Patient 9]’s dry weight was not achieved. [Patient 9] left with 5.8 kg above dry weight. RN should have assessed the patient and notified the physician.” 3b. During a concurrent interview and record review on 11/13/23, at 8:30 a.m. with CNO, Patient 21’s HHDF dated 10/18/23 to 11/6/23 were reviewed. The HDF indicated Patient 21 did not met her target weight of 68 kg on the following dates: 10/11/23 - 62.7 kg 10/13/23 - 63.2 kg 10/16/23 - 63 kg 10/18/23 - 63 kg 10/21/23 - 64.3 kg 10/24/23 - 67.9 kg 10/25/23 - 64.9 kg 10/28/23 - 64.6 kg 10/31/23 - 67.8 kg. CNO stated Patient 21’s dry weight needed to be adjusted. RN should review the dry weight with the physician. CNO stated, “[RN 1] had to go through with the doctor and review [Patient 21’s] weights.” During a concurrent interview and record on 11/14/23 at 2:30 p.m. with RN 1, RN 1 stated, Patient 21’s target weight was not met. RN 1 stated dry weight should have been changed. 3c. During a concurrent interview and record review on 11/13/23, at 4:35 p.m. with FA, Patient 1’s HDF dated 10/18/23 to 11/6/23 were reviewed. The HDF indicated Patient 1 did not meet his target weight of 100 kg on the following dates: 10/23/23 - 103.3 kg 10/25/23 - 103.8 kg 10/27/23 - 104.4 kg 10/30/23 - 102.8 kg 11/1/23 - 104.2 kg 11/3/23 - 102.4 kg 11/6/23 - 102.4 kg. FA stated, “If target weight is not met, we need to continue to monitor weight trends. The doctor has to be notified when patients weights were over or under the target weight consistently, or when there is a trend.” During a review of the facility’s P&P titled, “Pre-Assessment and Data Collection,” dated 9/17/15, the P&P indicated, “Report any changes deviating from patient’s normal status to the nurse manager. . .o. Document all assessment and data collection findings in the facility’s electronic medical records system.” During a review of the facility’s policy and procedure (P&P) titled, “Hypertension,” dated 8/1/12, the P&P indicated, “Hypertension occurs in about 80% of patients with chronic renal failure. Hypertension may lead to heart attack or stroke and may result in death. . .3. If a patient’s pre-diastolic blood pressure is greater than 120 mm [millimeter- a unit of measurement/Hg [mercury], the nephrologist [a kidney disease specialist] will be notified unless this is normal for the patient. 4. If the pre-dialysis systolic blood pressure is greater than 200 mm/Hg, notify the physician unless this is normal for the patient. 5. The Charge Nurse will report hypertension that does not respond to prescribed antihypertensives to the nephrologist. . .8. Every effort will be made to identify and correct the cause of the patient’s hypertension.””

“PA-ASSESS RENAL BONE DISEASE CFR(s): 494.80(a)(5) The patient’s comprehensive assessment must include, but is not limited to, the following: (5) Evaluation of factors associated with renal bone disease. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to: 1. Ensure Registered Nurses (RN 1 and RN 2) addressed dietary recommendation based on Registered Dietitian (RD)’s renal bone assessment for three of three in-center HD sampled patients (Patient 7, Patient 16, and Patient 23). This failure resulted in Patient 7, Patient 16, and Patient 23 not benefiting from the medications to reduce calcium level and increase phosphate binders (help prevent extra phosphorus from being absorbed from food into the bloodstream). 2. Ensure physician’s order was carried out for one of one in-center HD sampled patient (Patient 7). This failure resulted in Patient 7 not receiving appropriate medication and dosage to improve high levels of phosphorus (a mineral found in bones. Along with calcium, phosphorus helps build strong, healthy bones, and keeps other parts of one’s body healthy). 3. Ensure RN 1 wrote the verbal order received for Cincalcet 120 mg three times a week for one of one in-center HD sampled patient (Patient 7). This failure had the potential for adverse consequences. Findings: 1. During a concurrent interview and record review on 11/13/23 at 2:41 p.m. with Chief Nursing Officer (CNO), Patient 7’s laboratory results on calcium and phosphorus, dated 8/9/23, 9/8/23, and 10/4/23, were reviewed. The laboratory report indicated the following: 8/9/23 Calcium: 9.5 mg/dl (milligrams per deciliter) Phosphorus: 8.4 mg/dl 9/8/23 Calcium: 9.8 mg/dl Phosphorus: 10 mg/dl 10/4/23 Calcium: 10.4 mg/dl Phosphorus 8.4 mg/dl Normal calcium level: 8.4 to 10.2 mg/dL Normal phosphorus level: 3.0 to 5.5 mg/dl CNO stated [Patient 7]’s phosphorus levels were high, and his calcium level was high on 10/4/23. During a review of the Registered Dietitian (RD)’s “Dietitian Visits,” dated 10/30 23, the dietitian visits notes indicated, “Reached out to [Patient 7] to review labs. Ca/Phos high: recommended decrease Calcitriol (medication to prevent low calcium). Parathyroid hormone (controls the level of calcium in the blood): WNL [within normal]. Enforced binder compliance and low phosphorus diet. . . “ CNO verified the recommendation for Calcitriol did not have the dosage, route, and frequency of the medication and stated they should have the appropriate dosage, route, and frequency on record. CNO stated RD writes the complete dosage, route, and frequency when she emails the recommendation to the nurses. RD’s recommendation on the email indicated, “Decrease Calcitriol to 0.25 mcg one cap every treatment.” During a review of Patient 7’s medication list, dated 10/30/23, the medication list indicated, “6/21/23 Calcitriol 0.25 mcg (micrograms, a unit of measure) three caps orally every treatment (three times a week).” During a review of Patient 7’s Hemodialysis Flowsheets (HDF), dated 11/1/23-11/6/23, HDF indicated, Patient has been receiving Calcitriol 0.25 mcg three capsules orally every treatment. CNO stated RD’s recommendation to decrease Calcitriol to 0.25 mcg one tablet every treatment was not acted upon. During an interview on 11/13/23 at 3:10 p.m. with RN 1, RN 1 stated he has not seen the request to decrease Calcitriol in his email. RN 1 stated whenever there is a dietary recommendation, the RD sends the nurses an email; however, RN 1 stated, he does not usually review his emails as frequently and promptly as he should. During an interview on 11/13/23 at 3:45 p.m. with RN 2, RN 2 stated she had not reviewed her emails and had not seen RD’s recommendation. During an interview on 11/15/23 at 9:30 a.m. with RD, RD stated, “I did not put the exact dose, frequency, and route in the note. I know the nurses do not read my notes. That has been my practice, but I write the dosage, route, and frequency of the medications in the email I send to the nurses. I was aware the recommendations were not acted upon. I questioned the Assistant Director of Nursing, and she told me she did not think it was done.” During a concurrent interview and record review on 11/13/23 at 2:55 p.m. with CNO, a copy of RD’s recommendation written on 10/25/23 for Patient 7, Patient 16, and Patient 23, emailed to CNO, dated 11/13/23, was reviewed. RD made a recommendation for Patient 16 to increase Parsabiv (medication used to reduce parathyroid levels for patients with chronic kidney disease in dialysis) to 10 mg (milligram, a unit of measure) per treatment. CNO was unable to find documentation registered nurses acted upon on the recommendation. During a concurrent interview and record review on 11/13/23 at 3 p.m. with CNO, Patient 16’s lab reports dated 8/9/23, 9/6/23, and 10/4/23 were reviewed. The lab reports indicated, “Patient 16’s parathyroid hormone levels (PTHIN) on 8/9/23 was 1267, on 9/6/23 was 1474, and on 10/4/23 was 1854.” Patient 16’s Hemodialysis Flowsheet (HDF), dated 11/13/23, was reviewed. The HDF indicated, “Patient 16 received Parsabiv 7.5 mg intravenous (IV) administer after rinse back at end of dialysis.” CNO stated RD’s recommendation to increase Parsabiv to 10 mg every treatment was not acted upon, and the physician has not been notified. During a concurrent interview and record review on 11/13/23 at 3:05 p.m., with CNO, a copy of RD’s recommendation written on 10/25/23 for Patient 7, Patient 16, and Patient 23 emailed to CNO, dated 11/13/23, was reviewed. RD made recommendation for Patient 23 to increase Zemplar (an active form of vitamin D used to prevent and treat increased in parathyroid hormone levels) to 9 mcg (micrograms, a unit of measure) per treatment. CNO was unable to find documentation registered nurses acted upon on the recommendation. During a concurrent interview and record review on 11/13/23 at 3:10 p.m. with CNO, Patient 23’s lab reports, dated 8/9/23, 9/6/23, and 10/4/23, were reviewed. The following were Patient 23’s lab reports: 8/9/23: Calcium: 8.3 Phosphorus: 7.8 PTHIN: 5923 9/6/23: Calcium: 8.4 Phosphorus: 8.7 PTHIN: 4703 10/4/23: Calcium: 7.9 Phosphorus: 9 PTHIN: 5499 Patient 23’s HDF, dated 11/13/23, was reviewed. The HDF indicated, “Patient 23 received Zemplar 6 mcg IV. CNO stated RD’s recommendation to increase Zemplar to 9 mcg IV every treatment was not acted upon, and physician has not been notified of RD’s recommendation. 2. During a concurrent interview and record review on 11/13/23, at 3:15 p.m., with CNO, Patient 7’s “Physician Progress Notes (PPN), dated 10/27/23, was reviewed. The PPN indicated, “Discontinue Calcitriol. Continue Zemplar. Binder adjusted: Two tabs of Phoslo (medication to control the level of phosphate in the blood for dialysis patients due to severe kidney disease) + (plus) 1-2 tabs of Renvela (a phosphate binder that helps prevent hypocalcemia [low levels of calcium in the body] caused by elevated phosphorus) with meals TID (three times a day).” During a concurrent interview and record review on 11/13/23 at 3:30 p.m. with CNO, Patient 7’s Hemodialysis Flowsheets (HDF), dated 10/18/23-11/6/23, were reviewed. The HDFs indicated, Patient 7’s Calcitriol medication was not discontinued. Patient 7 continued to receive Calcitriol 0.25 mcg three tablets every treatment. CNO stated the Calcitriol order was not carried out, including the order for the binder adjustment of two tabs of Phoslo plus one to two tabs of Renvela (phosphate binder) with meals TID. CNO stated the nurses should have carried out the orders. During an interview on 11/13/23, at 3:45 p.m. with RN 1, RN 1 acknowledged he had not carried out the orders and stated he would call the physician. During a concurrent interview and record review on 11/15/23 at 11:30 a.m., with CNO, Patient 7’s HDF, dated 11/13/23, was reviewed, The HDF indicated, Patient 7’s Calcitriol has not been discontinued. CNO stated, [Patient 7] is still receiving the medication; the nurses had not acted upon the physician’s order to discontinue the medication. 3. During a concurrent interview and record review on 11/13/23 at 11:35 a.m. with CNO, Patient 7’s HDF, dated 10/18/23, 10/20/23, 10/23/23, 10/25/23, 10/27/23, 11/1/23, 11/3/23, and 11/6/23 were reviewed. The HDFs indicated, “Patient 7 received Cincalcet (medication used to reduce calcium level) 30 mg one tablet orally and Cincalcet 90 mg one tablet orally for a total of 120 mg every treatment.” The physician’s order, dated 10/16/23, indicated, “Cincalcet 30 mg one tablet three times a week.” The physician order, dated 10/16/23, indicated, Cincalcet 90 mg one tablet three times a week.” CNO was unable to find documentation of a physician’s order to give [Patient 7] Cincalcet 120 mg three times a week. During an interview on 11/13/23, at 2:54 p.m. with Registered Nurse (RN) 1, RN 1 stated, “Doctor spoke with me. He asked to give Cincalcet 120 mg to be given to [Patient 7]. RN 1 stated, “I did not take it as a verbal order, and I did not write it.” The policy and procedure for Physician’s Order was requested, and not provided.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the dialysis facility failed to ensure one Patient Care Technician (PCT) 2 evaluated one of one in-center HD sampled patient (Patient 19)’s Arteriovenous (AV) Fistula (a connection that’s made between an artery and a vein for dialysis access) prior to insertion of dialysis needles before dialysis treatment. This failure had the potential to place patients at risk when staff is not aware if patients’ dialysis access is patent or working. Findings: During an observation on 11/6/23 at 3:20 p.m. with PCT 2, in the dialysis treatment area, Dialysis Station 5, PCT 2 inserted the dialysis catheters in Patient 19’s AV fistula without evaluating Patient 19’s access site. During an interview 11/6/23 at 3:45 p.m., with PCT 2, PCT 2 stated patients’ AV fistula are assessed by checking for the presence of bruit (a whooshing sound) and feeling for the presence of thrill (buzz-like vibration caused by blood flowing through the fistula). PCT 2 stated he did not have a stethoscope and he did not listen for the presence of bruit but felt for thrill before inserting the dialysis catheters. During a review of the facility’s policy and procedure (P&P) titled, “Cannulation with Fistula Needle,” dated 11/2/12, the P&P indicated, “5. Confirm access site patency: a. Feel access for thrill b. Assess bruit.””

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 32234 Based on interview and record review, the facility failed to ensure three of five in-center HD sampled patients (Patient 1, Patient 3, and Patient 4) and one HHD (Patient 21) the three-month follow-up assessment were completed. This failure had potential for unmet patient needs. Findings: 1. During a concurrent interview and record review on 11/13/23 at 9:55 a.m. with Chief Nursing Officer (CNO), Patient 21’s comprehensive nursing Assessments and IDT (Interdisciplinary Team (IDT) - group of professional and direct care staff that have primary responsibility for the development of a Service Plan for an individual receiving services) documentation were reviewed. The “POC (Plan of Care) and IDT Nursing Component” was last done on 9/21/22. CNO was unable to find a follow-up nursing assessment was completed since 9/21/22. CNO stated, “The Nursing Care Plan was not done this year for 2023.” CNO stated, “We have problems with the Assessments/Care Plans for HHD patients.” During a concurrent interview and record review on 11/15/23 at 2:50 p.m. with Facility Administrator (FA), Patient 21’s assessment from the Dietitian was reviewed. FA was unable to find the initial assessment and the 90-day assessment from the Registered Dietitian (RD). FA stated Patient 21 was admitted on 4/5/22. FA stated the RD’s initial assessment, and 90-day assessment were missing since the time of admission on 4/5/22. During a concurrent interview and record review on 11/5/23 at 2:50 p.m. with FA, Patient 21’s assessment from the Social Worker (SW) was reviewed. The SW initial assessment was not done 30 days from admission on 4/5/22 and the SW follow-up assessment was missing. FA stated SW initial assessment and a follow-up assessment should have been completed. 2. During a concurrent interview and record review on 11/15/23 at 1:55 p.m. with FA, Patient 3’s assessments and IDT were reviewed. Patient 3’s date of admission was on 7/12/23. FA was unable to find the 90-day Nursing, SW, and RD assessments were done. FA stated, the 90-day assessments by Nursing, Dietary and Social Worker should have been completed. 3. During a concurrent interview and record review on 11/15/23, at 1:55 p.m. with FA, Patient 1’s assessments were reviewed. Patient 1’s date of admission was on 3/13/23. FA stated the initial Nursing assessment for Patient 1 was missing. She was unable to find the initial Nursing assessment and a follow-up 90-day assessment were completed for Patient 1. FA was unable to find the 90-day SW and RD assessments. FA stated the 90-day nursing, SW, and RD’s 90-day assessments should have been completed. 4. During a concurrent interview and record review on 11/15/23 at 2:50 p.m. with FA, Patient 4’s assessments were reviewed. Patient 4 was admitted on 1/16/23. The initial Nursing assessment was done on 5/11/23. FA stated the Nursing assessment was late. FA stated the nursing initial assessment should have been done 30 days from admission and a follow-up 90-day assessment should have been completed. FA stated, Patient 4’s 90-day Nursing and RD assessments were not completed. During a review of the facility’s policy and procedure (P&P) titled, “Performance of IDT and Plans of Care,” dated 1/18/16, the P&P indicated, “2. Each patient will receive an evaluation by each member of the IDT. . .a. An initial assessment by each member of the IDT at the earlier of 30 days from the date of admission or the performance of 13 hemodialysis sessions at the facility. b. A follow-up assessment within 90 days of admission to the Facility (but not less than 60 days of admission) and then annually.””

“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: 35649 Based on interview and record review, the dialysis facility failed to ensure the Interdisciplinary Team (IDT-a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) conducted IDT meetings, developed comprehensive assessment to formulate a plan of care, and provided evidence IDT discussed the plan of care (POC) for six of 11 in-center hemodialysis sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, and Patient 11). This failure had the potential for patients to not receive the appropriate treatment plan, which could negatively impact patient care. Findings: During an interview on 11/13/23 at 4:46 p.m. with Chief Nursing Officer (CNO), CNO stated the facility has an IDT comprised of the Social Worker (SW), Registered Dietitian (RD), a Registered Nurse (RN), and a physician. SW and RD conduct patient interviews through zoom meetings, or facetime using the phone. CNO stated the physician does not write a plan of care. During a concurrent interview and record review on 11/13/23 at 4:55 p.m. with CNO, Patient 7’s Care Plan, dated 2022 and 2023, were reviewed. The Care Plan indicated the following: SW: 8/4/23 RD: 2/21/23 Nursing: 4/23/23 CNO was unable to provide documentation of Physician 4’s encounter or progress notes. CNO did not find documentation of Patient 7’s signature in any of the care plans. CNO stated there was none. During a concurrent interview and record review on 11/13/23 at 5:10 p.m. with CNO, Patient 8’s Care Plan, dated 2023, was reviewed. CNO was unable to find documentation SW, RD, Nursing, and physician developed care plans for Patient 8. CNO stated, “This patient was a new admit and should have a 30-day care plan written.” During a concurrent interview and record review on 11/13/23 at 5:20 p.m. with CNO, Patient 9’s Care Plan, dated 2022 and 2023, were reviewed. The Care Plan indicated the following: SW: 3/10/23 RD: 3/26/23 Nursing: 8/12/23 Physician: 11/10/23 CNO was unable to find documentation Patient 9 signed any of the care plans and stated there was none. During a concurrent interview and record review on 11/13/23 at 5:30 p.m. with CNO, Patient 10’s Care Plan, dated 2022 and 2023, were reviewed. The Care Plan indicated the following: SW: 9/29/23 RD: 8/23/23 Nursing: not done Physician: 9/15/23 CNO verified the physician encounter was cut and pasted with those written for Patient 11. CNO stated the Physician progress notes did not indicate evaluation of [Patient 10]’s dry weight, which was not achieved during dialysis treatment. During a review of Patient 10’s physician encounter notes, dated 11/10/23, the physician encounter notes indicated (blood pressure), DW (dry weight), symptomatology with HD (hemodialysis), home BP if available. BP meds (medications) reviewed with pt (patient) and meds, HD settings, DW adjusted as necessary.” CNO stated the physician did not write how the care plan will be implemented. CNO was unable to find Patient 9’s signature on the care plan. During a concurrent interview and record review on 11/14/23 at 10:17 a.m. with CNO, Patient 6’s Care Plan, dated 2022 and 2023, were reviewed. The Care Plan indicated the following: SW: 2/18/22 RD: 2/18/22 Nursing: 2/19/22 Physician: no encounter/progress notes/care plan. CNO stated, the care plans were overdue. The care plan for stable patients is due annually. CNO was unable to find documentation of Physician 2’s progress notes or care plan. During a concurrent interview and record review on 11/14/23 at 10:22 a.m. with CNO, Patient 11’s Care Plan, dated 2022 and 2023, were reviewed. The Care Plan indicated the following: SW: 8/24/23 RD: 8/24/22 Nursing: 8/12/22 Physician: 11/10/23 Patient: no signature on written care plan CNO stated Nursing and RD should have written an updated care plan. The care plans are done annually. CNO stated, “The physician did not evaluate this patient deeply. He did not address [Patient 11]’s dry weight and the need to adjust it.” CNO verified Physician 2’s encounter notes were cut and pasted as those of Patient 10 and stated [Physician 2]’s encounter note was not individualized, and the physician did not write a thorough evaluation of the patient, and how the care plan will be implemented. CNO stated, “We need a policy for IDT to hold meetings. CNO stated the plan of care (POC) does not reflect if someone was having issues. Each of the discipline collect data but there is no meeting to discuss their findings and make recommendations.” During an interview on 11/15/23 at 11:05 a.m. with SW, SW stated the Kidney Disease Quality of Life (KDQOL-tool used to measure quality of life of dialysis patients) Survey conducted in July 2023 were misplaced and the KDQOL had not been completed. SW stated, “KDQOL surveys are done once a year on all dialysis patients.” During a review of the facility’s policy and procedure (P&P) titled, “Performance of IDT and Plans of Care,” dated 1/18/16, the P&P indicated, “2. Each patient will receive an evaluation by each member of the IDT. . .a. An initial assessment by each member of the IDT at the earlier of 30 days from the date of admission or the performance of 13 hemodialysis sessions at the facility. . . Documentation: a. The Nurse, Social Worker, and Dietitian shall each complete the initial assessment or the follow-up re-assessment (whichever is appropriate) using the on-line Initial IDT Assessment and Plan of Care Forms that are specific to the IDT Member’s discipline. b. A copy of each form shall be reviewed and signed by the patient’s nephrologist or Medical Director. c. A copy of each form shall be presented to the patient, either on paper, or on electronic tablet. The patient will sign the assessment form. . .The KDQOL will be performed with 3rd party on-line service.””

“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: 32234 Based on interview and record review, the dialysis facility failed to ensure one of eight HHD patients (Patient 21) and two of 11 sampled in-center HD Patients (Patient 1 and Patient 4) post-dialysis target weights were reviewed and evaluated with physician. This failure had the potential for poor patient health outcome. Findings: 1. During a concurrent interview and record review on 11/13/23, at 8:30 a.m. with CNO, Patient 21’s HHDF dated 10/9/23 to 11/4/23 were reviewed. The HHDFs indicated, Patient 21’s dialysis order included the target weight of 68 kg. The following dates indicated Patient 21 did not meet the target wt. of 68 kg. post - dialysis treatment: 10/11/23: post-dialysis weight - 62.7 kg (wt. was below 5.3 kg from the target wt.). 10/13/23: post-dialysis weight - 63.2 kg (wt. was below 4.8 kg from the target wt.). 10/16/23: post-dialysis weight - 63 kg (wt. was below 5 kg from the target wt.). 10/18/23: post-dialysis weight - 63 kg (wt. was below 5 kg from the target wt.). 10/21/23: post-dialysis weight - 64.3 kg (wt. was below 3.7 kg from the target wt.). 10/24/23: post-dialysis weight - 64.9 kg (wt. was below 3.1 kg from the target wt.). 10/25/23: post-dialysis weight - 64.9 kg (wt. was below 3.1 kg from the target wt.). 10/28/23: post-dialysis weight - 64.6 kg (wt. was below 3.4 kg from the target wt.). CNO stated, RN 1 needed to adjust the target weight for Patient 21 and would review the post - dialysis weights with the physician. CNO stated, RN 1 must go through with the physician regarding Patient 21’s post-dialysis weights which were below the target weight. 2. During a concurrent interview and record review on 11/13/23, at 2 p.m. with Facility Administrator (FA), Patient 1’s HDF dated 10/18/23 to 11/6/23 were reviewed. The HDFs indicated, Patient 1’s dialysis order included a target weight (wt.) of 96.5 kg. The following dates indicated the target wt. was not met for Patient 1: 10/18/23: post-dialysis wt. - 100 kg. (Greater than [>] 3.5 kg from the target wt. of 96.5 kg). 10/20/23: post-dialysis wt. - 100.5 kg. (> 4 kg from the target wt. of 96.5 kg). 10/23/23: Target weight prescription was changed to 100 kg. Post - dialysis wt. - 103.3 kg. (>3.3 kg from the target wt. of 100 kg.). 10/25/23: post-dialysis wt. - 103.8 kg (>3.8 kg from the target wt. of 100 kg). 10/27/23: post-dialysis wt. - 104.4 kg (>4.4 kg from the target wt. of 100 kg.). 10/30/23: post-dialysis wt. - 102.8 kg (>2.8 kg from the target wt. of 100 kg.). 11/1/23: post-dialysis wt. - 104.2 kg (>4.2 kg from the target wt. of 100 kg). 11/3/23: post-dialysis wt. - 102.4 kg (>2.4 kg from the target wt.). 11/6/23: post-dialysis wt. - 102.4 kg (>2.4 kg from the target wt.). FA verified the above findings and stated the target weights were not achieved. During an interview on 11/13/23, at 4:35 p.m. with FA, FA stated if the weight is consistently under or over the target weight and there is a trend, physician must be notified. 3. During a concurrent interview and record review on 11/14/23, at 10:45 a.m. with FA, Patient 4’s HDF dated 10/18/23 to 11/6/23 were reviewed. The HDFs indicated, Patient 4’s dialysis order included the target wt. of 81 kg. The following dates indicated the target weights were not met for Patient 4: 10/18/23: post-dialysis wt. - 84.4 kg (>3.4 kg from the target wt. of 81 kg). 10/20/23: post-dialysis wt. - 82 (>1 kg from the target wt. of 81 kg). FA was unable to find documentation indicating Patient 4 did not meet the target weight on 10/18/23 and 10/20/23.”

“POC-TRANSPLANT STATUS PLAN OR WHY NOT CFR(s): 494.90(a)(7)(ii) When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient’s plan of care must include documentation of the- (A) Plan for transplantation, if the patient accepts the transplantation referral; (B) Patient’s decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or (C) Reason(s) for the patient’s nonreferral as a transplantation candidate as documented in accordance with §494.80(a)(10). This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to ensure Social Worker (SW) followed up on the transplant referral and update the plan of care for six of six in-center hemodialysis sampled patients (Patient 4, Patient 6, Patient 7, Patient 22, Patient 23, Patient 29). This failure had the potential for unmet care needs. Findings: During a concurrent interview and record review on 11/15/23 at 11:10 a.m. with Chief Nursing Officer (CNO), Patient 4’s SW POC, dated 5/30/23, was reviewed. The POC indicated, “Dialysis and Transplant Status: Referred to Transplant Center 1. SW’s Notes, dated 10/27/23, was reviewed. SW’s Notes indicated, “[Patient 4] stated he has an anticipated appointment with Transplant Center 1 on 11/2/23 and 11/8/23 as he is starting to work the process.” CNO was unable to find documentation SW followed up with [Patient 4] or Transplant Center 1 regarding Patient 4’s transplant status and stated SW should have made the follow-up and charted. During a concurrent interview and record review on 11/15/23 at 11:15 a.m. with CNO, Patient 6’s SW Plan of Care (POC), dated 2/18/22, was reviewed. The POC indicated, “Dialysis and Transplant Status: Referred to Transplant Center 2 on 11/10/21.” CNO was unable to find SW’s notes regarding follow-up of Patient 6’s transplant status. CNO stated, SW has not updated [Patient 6]’s POC. During a concurrent interview and record review on 11/15/23 at 11:20 a.m. with CNO, Patient 7’s SW’s Notes, dated 3/3/21, was reviewed. SW’s notes indicated, “[Patient 7] stated he would like to resume with transplant referral to Transplant Center 1. SW will make referral to transplant center and will continue to follow-up and provide resources as needed.” CNO was unable to find SW’s notes regarding follow up of Patient 7’s transplant status and stated [SW] should have followed up Patient 7’s transplant status and charted. During a concurrent interview and record review on 11/15/23 at 11:25 a.m. with CNO, Patient 22’s SW’s Notes, dated 8/11/23, was reviewed. SW’s Notes indicated, “SW called Transplant Center 1 to obtain an update on patient’s status.” Patient 22’s POC, dated 9/29/23, was reviewed. The POC indicated, “Dialysis and Transplant Status: Patient has been referred to kidney transplant center.” CNO was unable to find documentation SW followed up with Patient 22’s transplant status and stated [SW] should have followed-up with Patient 22’s transplant status. During a concurrent interview and record review on 11/15/23 at 11:30 a.m. with CNO, Patient 23’s SW Notes, dated 6/13/23 and 10/27/23, were reviewed. SW’s Notes indicated, “SW provided [Patient 23] Transplant Center 1 contact information. SW will continue to follow up and provide resources as needed.” CNO was unable to provide SW’s documentation regarding follow-up of Patient 23’s transplant status. CNO stated [SW] should have made the follow-up with the patient and the transplant center regarding Patient 23’s transplant status. During a concurrent interview and record review on 11/15/23 at 11:40 a.m. with CNO, Patient 29’s SW Notes, dated 9/20/23, was reviewed. SW’s Notes indicated, “[Patient 29 would like to be referred to Transplant Center 1.” CNO was unable to find documentation of SW’s follow-up of [Patient 29]’s referral and transplant status. CNO stated [SW] should have made the follow-up and charted on Patient 29’s transplant status.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to perform a 30-day patient assessment for one of one patient (Patient 10). This failure had the potential for patients’ unmet care needs. Findings: During a concurrent interview and record review on 11/13/23 at 4:46 p.m., with Chief Nursing Officer (CNO), Patient 8’s Facesheet indicated Patient 8 was admitted on 9/27/23. Patient 8’s Patient Assessment and Plan of Care, dated 10/2023, was reviewed. CNO was unable to provide evidence the Interdisciplinary Team (IDT-a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) comprised of physician, registered dietitian, social worker, and registered nurse completed an initial patient assessment and plan of care for [Patient 8] 30-days from admission. CNO stated, “Patient assessment should have been done in 30 days. Nothing was initiated.” During a review of the facility’s policy and procedure (P&P) titled, “Performance of IDT and Plan of Care,” dated 1/18/16, the P&P indicated, 2. Each patient will receive an evaluation by each member of the IDT in accordance with the following schedule: a. An initial assessment by each member of the IDT at the earlier of 30 days from the date of admission or the performance of 13 hemodialysis session at the facility.””

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to ensure five of five nephrologists (kidney doctors- Physician 1, Physician 2, Physician 3, Physician 4, Patient 5) documented monthly physician progress notes for three of three in-center hemodialysis sampled patients (Patient 6, Patient 7, and Patient 8) and one of one Peritoneal Dialysis (PD-a treatment for kidney failure that uses the lining of one’s abdomen or belly to filter blood) patient (Patient 20). This failure had the potential for Patient 6, Patient 7, Patient 8, and Patient 20 to have missed evaluation for medical care, which could be detrimental to their treatment plan and care. Findings: During a concurrent interview on 11/14/23, at 12:12 p.m., with Chief Nursing Officer (CNO), Patient 20’s Physician Progress Notes (PPN), dated 9/1/23, was reviewed. CNO was unable to find monthly Physician 4’s progress notes except those written on 8/18/21 by Registered Nurse (RN) 1 for the physician. CNO was unable to find documentation of Physician 4’s progress notes for [Patient 20] who does PD at home. CNO stated, “ Patient 20 comes to the dialysis center for blood draw and review of his monthly laboratory reports. There should be physician progress notes written for that evaluation, but I don’t see it.” During a concurrent interview on 11/14/23 at 4:46 p.m., with Chief Nursing Officer (CNO), Patient 6’s Physician Progress Notes (PPN), dated 9/29/23, 10/2023 and 11/13/2023, were reviewed. CNO was unable to find evidence of Physician 2’s progress notes documented monthly. CNO stated physicians are supposed to visit monthly and write progress notes or plan of care for the patient monthly. CNO stated, “I don’t see it.” During a concurrent interview on 11/14/23 at 5 p.m., with CNO, Patient 7’s PPN, dated 9/2023, 10/2023, 11/13/23, were reviewed. CNO was unable to provide evidence of Physician 4’s progress notes documented monthly. CNO stated, “I don’t see it.” During a concurrent interview on 11/14/23 at 5:05 p.m., with CNO, Patient 8’s PPN, dated 10/2023 and 11/13/23 were reviewed. CNO was unable to provide evidence of Physician 1’s progress notes documented monthly. CNO stated, “I don’t see it.” During a review of the facility’s Medical Staff By-Laws (MSBL), dated 12/18/12, the MSBL indicated, Delinquent Medical Records: A medical record shall be considered delinquent if . . .ii. progress notes are not recorded contemporaneously. . .” Facility policy and procedure titled, “Medical Staff Rules and Regulations” were requested, but none was provided.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to maintain an effective Quality Assurance and Performance Improvement (QAPI - a data driven and proactive approach to quality improvement, ensuring services are meeting quality standards) Program as evidenced by: 1. Three staff members, Registered Nurse (RN) 2, Patient Care Technician Orientee (PCTO) 3, Patient Care Technician (PCT) 2 were not aware and knowledgeable about the dialysis facility’s QAPI Program. This failure had the potential for the staff to not be aware of opportunities for improvement, address gaps in processes, develop action plans, and monitor effectiveness of interventions to achieve and improve quality of care. 2. The Interdisciplinary Team (IDT-a group of professionals from different discipline who work together, share knowledge and skills in assessing, planning, or evaluating patient care) did not act upon areas of concerns discussed in the quarterly QAPI meetings regarding anemia (a condition of not having enough healthy red blood cells to carry oxygen to the body’s tissues) management, high phosphorus (a chemical element that helps filter out waste in the kidneys), etc. This failure had the potential for past and current non-compliance opportunities to not be addressed, which could lead to negative outcomes for the dialysis patients. Findings: 1. During an interview on 11/8/23 at 12:20 p.m. with RN 2, RN 2 did not know what QAPI stands for and what QAPI meant. RN 2 stated, “What is that? I just know they have quarterly meetings. I am not involved and not aware of any process improvement projects. I don’t know if the patients are meeting their KT/V (a measurement of the efficacy of a hemodialysis session. It identifies the effective removal of a specific solute [clearance K] resulting from a given treatment [characterized by time t] in each patient [with a specific volume of distribution V for the solute considered] or their dialysis adequacy.” During an interview on 11/13/23, at 9:15 a.m., with Patient Care Technician Orientee (PTCO) 3, PCTO 3 was not aware of QAPI and stated, “I don’t know. I am not aware of any QAPI projects being done.” During a review of the facility’s policy and procedure (P&P) titled, “Quality Assessment and Performance Improvement Program,” dated 1/28/13, the P&P indicated, “ Purpose: To develop, implement, maintain, and evaluate an effective data-driven quality assessment and performance improvement program that reflects the complexity of the dialysis facilities patient population and its processes of care with participation by the professional members of the interdisciplinary team. . .” 2. During a concurrent interview and record review on 11/14/23, at 11 a.m., with Chief Nursing Officer (CNO), the third quarter Anemia (a problem of not having enough healthy red blood cells or to carry oxygen to the body’s tissues) Management Report-In Center, dated 7/2023, 8/2023, and 9/2023, were reviewed. The data indicated “For hemoglobin (protein in one’s red blood cells that carries oxygen to the body’s organs and tissues and transports carbon dioxide [natural gas produced by the air we exhale] back to the lungs) less than 10, 39% on 7/2023, 38% on 8/2023, and 47% on 9/2023.” The comments indicated, “Physician 5 questioned the timeliness of the dose changes after labs. Plan follow up with the nurses to make sure the dose changes were being made following both monthly labs and mid-month labs.” CNO was unable to find evidence of IDT’s analysis of the data, actions taken to follow up with the nurses and address the issue, implement process improvement measures to meet the goal of greater than 10 but less than 12 hemoglobin level, and evaluate the actions taken. CNO stated there was no follow up done. During a concurrent interview and record review on 11/14/23, at 11:05 a.m. with CNO, the third quarter Dietary Report In-Center, dated 7/2023, 8/2023, and 9/2023, were reviewed. The data indicated, “Phosphorus greater than 5.5, 57 % on 7/2023, 55% on 8/2023, and 47% on 9/2023. The comment indicated: Goal not met. CNO was unable to find evidence of IDT actions taken to implement an ongoing process improvement to decrease and meet the goal of 3.0 to 5.5 phosphorus level. During a review of the facility’s P&P titled, “Quality Assessment and Performance Improvement Program (QAPI), dated 1/28/13, the P&P indicated, “2. Each facility will designate a QAPI Committee that will identify the goals specific to that unit, develop tools to reach a resolution of the identified problem and implement an ongoing improvement and evaluation system that involves all staff members”

“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: 35649 Based on interview and record review, the dialysis facility failed to: 1. Conduct, analyze, act, evaluate, track and trend infection control surveillance (ongoing, systematic collection, analysis, and interpretation of data) activities. 2. Provide evidence of visual audits of each direct care staff to validate competency (knowledge and skills to perform the job) for infection control prevention. These failures had the potential for infection control issues to not be addressed, monitored, and acted upon, which could result in the spread and transmission of infectious diseases, directly or indirectly to patients, staff, and visitors. Findings: During a concurrent interview and record review on 11/7/23, at 2:46 p.m. with Facility Administrator, Facility Administrator stated handwashing, glove change, and AV Fistula/graft cannulation (insertion of dialysis needles) are some of the surveillance activities conducted in the facility for infection control. Facility Administrator was unable to provide evidence of audits conducted for handwashing, glove change, and AV fistula/graft monitoring and was unable to articulate the indicators used for the audits. Facility Administrator was unable to provide evidence of surveillance plan addressing quality improvement on infection control and prevention and stated “there is nothing.” During a concurrent interview and record review on 11/14/23, at 2: p.m. with Chief Nursing Officer (CNO), CNO was unable to provide evidence of infection control audits for each direct care staff to validate their infection control competencies during routine care of dialysis patients. CNO stated they don’t have it. During a review of the facility’s policy and procedure (P&P) titled, “Quality Assessment and Performance Improvement Program (QAPI- systematic, comprehensive, and data-driven approach to maintaining and improving safety and quality),” dated 1/28/23, the P&P indicated, “The scope of the QAPI Program at minimum includes Infection Control: a. Analyze and document the incidence of infections to identify trends and establish baselines on infection incidents. b. Develop recommendations and actions to minimize infection transmission and promote immunizations. c. Take actions to reduce future incidence. 5. Surveillance reviewed but not limited to. . .Infections.” During a review of the facility’s P&P titled, “Vascular Access Monitoring,” dated 11/9/12, the P&P indicated, “3. A member of the clinical staff must review the vascular access monitoring/surveillance documentation on a monthly basis to identify adverse trends and take action if indicated. . .””

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 35649 Based on interview and record review, the dialysis facility failed to maintain a complete and accurate medical record for five of 11 hemodialysis (HD- a procedure where a dialysis machine and a special filter called an artificial kidney, or a dialyzer, are used to clean blood) sampled patients (Patient 1, Patient 3, Patient 4, Patient 6, and Patient 8) with central venous catheters (CVC- type of access used for hemodialysis placed under the skin and into a large central vein). This failure had the potential for patient information to be incorrect and health care workers/providers to be misinformed, which could negatively impact patient care. This failure had the potential for patient information to be incorrect and health care workers/providers to be misinformed, which could negatively impact patient care. Findings: 1a. During a concurrent interview and record review on 11/13/23 at 10:40 a.m. with CNO, Patient 8’s Hemodialysis Flowchart (HDF) dated 10/18/23, 10/20/23, 10/25/23, 10/27/23, 11/1/23, 11/3/23, and 11/6/23 were reviewed. The HDFs indicated, on 10/18/23 at 3:11 p.m., 10/25/23 at 11:41 a.m., and 10/27/23 at 1:37 p.m., Patient Care Technician (PCT) 3 documented “using aseptic technique, ports aspirated and flushed. Tx (treatment) initiated without problems.” On 10/20/23 at 3:30 p.m., PCT 4 documented “cannulated two sites without difficulty. Treatment started without problems.” On 11/1/23 at 9:35 a.m., PCT 2 documented “using aseptic technique, ports aspirated and flushed. Tx initiated without problems.” On 11/3/23 at 1:10 p.m., Patient Care Technician Orientee (PCTO) 3 documented “cleaned two sites with aseptic technique. Cannulated two sites without difficulty. Treatment started without problems.” On 11/6/23 at 1:28 p.m., PCTO 3 documented “using aseptic technique, ports aspirated and flushed. Tx initiated without problems.” CNO stated the initial treatments were documented in error. If the PCTs document, they should indicate registered nurses initiated the treatment. PCTs do not cannulate and initiate treatment for patients with central venous catheters. During a concurrent interview and record review on 11/13/23 at 3:15 p.m. with CNO, Patient 6’s HDF, dated 10/16/23 and 10/23/23, were reviewed. The HDFs indicated on 10/26/23 at 9:47 a.m. PCT 1 documented, “using aseptic technique, ports aspirated and flushed. Tx initiated without problems.” On 10/23/23 at 9:45 a.m. PCTO 1 documented “using aseptic technique, ports aspirated and flushed. Tx initiated without problems.” CNO stated the charting was documented in error. CNO stated CVCs are never accessed by a technician. During a review of the facility’s policy and procedure (P&P) titled, “Documentation of Medical Records,” dated 11/9/12, the P&P indicated, “Provide medical records that are accurate and legible.” 32234 2. During a concurrent interview and record review on 11/13/23, at 12:25 p.m. with FA, Patient 1’s HDFs dated 10/18/23 to 11/6/23 were reviewed. The HDFs indicated “Access Used: Catheter only [CVC].” The following dates indicated the RN documentation were missing during the initiation and termination of the HD treatments: 10/18/23 - Missing documentation by the RN when HD treatment was initiated. 10/20/23 - Missing documentation by the RN when HD treatment was initiated. 10/25/23 - Missing documentation by the RN when HD treatment was initiated. HD treatment documentation indicated PCTO 3 initiated the HD treatment at 2 p.m. 10/27/23 - Missing documentation by the RN when HD treatment was completed and terminated. 10/27/23 - Missing documentation by the RN when HD treatment was terminated. 11/1/23 - Missing documentation by the RN when HD treatment was initiated and terminated. 11/3/23 - Missing documentation by the RN when HD treatment was initiated and terminated. Facility Administrator verified the findings and stated PCT never connect and terminate HD treatment using the CVC access line. During a review of the facility’s policy and procedure (P&P) titled, “Documentation of Medical Records,” dated 11/9/12, the P&P indicated, “Provide medical records that are accurate and legible.””