Home Dialysis Centers of Rancho Cucamonga

“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: 47360 Based on interview and record review, the facility failed to follow regulatory requirements and their policy and procedure (P&P) for “Hepatitis B [a liver infection caused by a virus, Hepatitis B Virus [HBV], that can cause inflammation and damage to the liver] Vaccine [administering a less potent version of the virus to help the body learn how to defend itself from disease without the dangers of a full-blown infection] and Surveillance for Patients” and “Hepatitis B Vaccine Administration” for nine of 34 sampled patients (Patient 22, 2, 10, 3, 32, 30, 33, 34, and 35) when Hepatitis B vaccination was not provided for patients who Hepatitis B surface Antibodies (HBsAb - a protective shield against HBV, HBsAB greater than 12 mIU/mL [unit of measurement] in your blood means you are immune or protected to HBV) did not indicate immunity. This failure resulted in susceptible dialysis (a treatment that cleans your blood when your kidneys have failed, removing waste and extra fluid) patients (Patients 22, 2, 10, 3, 32, 30, 33, 34 and 35) not receiving a required HBV vaccination series (schedule of three to four vaccinations to achieve immunity) to prevent infection and had the potential to cause chronic liver damage. Findings: 1. During a review of Patient 22’s “Patient Face sheet” (demographic and medical information), the “Patient Face sheet” indicated, Patient 22 was admitted to the facility on January 31, 2025, as a new end-stage renal disease (ESRD - kidneys have stopped working permanently and can no longer keep you alive on their own) and Patient 22’s first day of chronic dialysis was on February 7, 2025. During a review of Patient 22’s hepatitis labs, dated February 7, 2025, the labs indicated Patient 22’s HBsAB was less than 5 mIU/mL, and Patient 22 was susceptible to contracting (getting an infection if exposed to the virus) Hepatitis B. During a concurrent interview and record review on August 19, 2025, at 9:20 AM, with Registered Nurse 1 (RN 1), Patient 22’s “Vaccine Report”, dated August 18, 2025 was reviewed. The “Vaccine Report” indicated, there was no documented evidence of a Hepatitis B vaccination series being provided to Patient 22. RN 1 stated, the dialysis facility does not offer vaccinations to patients that have managed healthcare, which was Patient 22’s insurance. RN 1 stated the vaccine was not offered to Patient 22 but instructed him to get the vaccination series from his managed health care company. RN 1 stated, Patient 22 has not reported he has had the vaccination series to this date. 2. During a review of Patient 2’s “Patient Face sheet”, the “Patient Face sheet” indicated, Patient 2 was admitted to the facility on December 27, 2022, as a new ESRD patient for chronic dialysis. During a review of Patient 2’s hepatitis labs, dated December 2, 2024, the labs indicated Patient 2’ HBsAb was less than 5 mIU/mL, and Patient 2 was susceptible to contracting Hepatitis B. During a concurrent interview and record review on August 20, 2025, at 10:55 AM, with RN 2, Patient 2’s “Vaccination Report,” August 18, 2025, was reviewed. The vaccination report indicated, Patient 2 received one series of hepatitis B vaccination including four shots between August 2022, and February 2023, but there was no documented evidence of a second series being provided to Patient 2. RN 2 stated, when a patient does not respond (develops antibodies higher than 12 mIU/mL) to the first vaccination series, a second vaccination series must be started. RN 2 stated, Patient 2 has not been offered a second hepatitis B vaccination series. RN 2 stated the vaccination was not given because he was told to refer the patients to their primary doctor for vaccination. 3. During a review of Patient 10’s “History and Physical” (H&P- document including patient history and medical evaluation), dated September 18, 2024, the “H&P” indicated Patient 10 was admitted to the facility in September 2024, for peritoneal dialysis (uses the lining of the stomach and to remove toxins and extra fluid from the blood). During a review of Patient 10’s hepatitis labs, dated December 7, 2024, the labs indicated Patient 10’s HBsAb was 7 mIU/mL, and Patient 10 was susceptible to contracting Hepatitis B. During a concurrent interview and record review on August 20, 2025, at 11:00 AM, with RN 2, Patient 10’s “Vaccination Report”, dated August 18, 2025, was reviewed. The “Vaccination Report” indicated, Patient 10 received the hepatitis B vaccination series in 2024. RN 2 stated, Patient 10 received vaccinations from her primary provider, as instructed by the dialysis facility, but was still susceptible and required a second series. RN 2 stated Patient 10 was not offered a second series by the facility; she was instructed to follow-up with her managed health care. 4. During a review of Patient 3’s “Patient Face sheet”, the “Patient Face sheet” indicated, Patient 3 was admitted to the facility on April 6, 2022, as a new ESRD patient for chronic dialysis. During a review of Patient 3’s hepatitis labs, dated December 1, 2024, the labs indicated Patient 3’s HbsAb was less than 5, and Patient 3 was susceptible to contracting hepatitis B. During a concurrent interview and record review on August 20, 2025, at 11:10 AM, with RN 2, Patient 3’s “Vaccination Report”, dated August 18, 2025, was reviewed. The “Vaccination Report” indicated, Patient 3 received the first hepatitis B vaccination series in 2023. RN 2 stated, Patient 3 received the first of four vaccinations to start the second series but was uncertain why the second series was not completed. 5. During a review of Patient 32’s “Patient Face sheet”, the “Patient Face sheet” indicated, Patient 32 was admitted to the facility on October 27, 2023, as a new ESRD patient for chronic dialysis. During a review of Patient 32’s hepatitis labs, dated December 3, 2024, the labs indicated Patient 32’s HBsAB was 8 mIU/mL and Patient 32 was susceptible to contracting hepatitis B. During a concurrent interview and record on August 20, 2025, at 11:20 AM, with RN 2, Patient 32’s “Vaccination Report,” dated August 18 2025, was reviewed. The “Vaccination Report” indicated, Patient 32 did not receive the complete first series of the hepatitis B vaccinations. RN 2, stated, Patient 32 reported he has received one hepatitis B vaccine from his primary care and he had instructed Patient 32 to follow-up to get the remainder of the series. RN 2 stated, Patient 32 has managed health care and facility staff were instructed to refer those patients, with managed health care, to their primary physician for hepatitis B vaccination. 6. During a review of Patient 30’s “Patient Face sheet”, the “Patient Face sheet” indicated Patient 30 was admitted to the facility on July 25, 2025, as a new ESRD patient for chronic dialysis. During a review of Patient 30’s hepatitis labs, dated July 25, 2025, the labs indicated, Patient 30’s HBsAb was less than 5 mIU/mL, and Patient 30 was susceptible to hepatitis B. During a concurrent interview and record review on August 19, 2025, at 1:20 PM, with RN 1, Patient 30’s “Vaccine Report,” dated August 18, 2025, was reviewed. The “Vaccine Report” indicated, there was no documented evidence of a hepatitis B vaccination series being provided to Patient 30. RN 1 stated, Patient 30’s hepatitis B vaccination series was not offered by the facility and Patient 30 was instructed to follow-up with his primary provider to receive the vaccination. During a concurrent interview and record review on August 19, 2025, at 2:25 PM, with RN 1, the facility’s P&P titled, “Hepatitis B Vaccine and Surveillance for Patients,” dated September 2017, was reviewed. The “P&P” indicated, “PURPOSE”: To prevent the spread of hepatitis infections in the dialysis setting ...1. Hepatitis B vaccination is recommended for all susceptible chronic dialysis patients ... 8. If HBsAB <12mIU/mL, consider the patient susceptible, revaccinate with an additional series, and retest for HBsAB one (1) to two (2) months after the last dose of second series ...9. If HBsAb is >12mIU/mL, consider the patient immune, and retest annually ...Administer a booster dose of vaccine if HBsAb declines to < 12mIU/mL on annual testing ...” RN 1 stated, she was instructed by management not to offer the hepatitis B vaccination series to patients with managed health care because the facility will not be reimbursed. RN 1 stated, she was not aware it was the dialysis facilities responsibility to ensure all susceptible patients were provided vaccination. During a review of the facility’s P&P titled, “Hepatitis B Vaccine Administration,” dated April 2022, the P&P indicated, “PURPOSE: To ensure safe, proper and effective administration of the Hepatitis B vaccine. All patients of [Name of Facility] will be offered the Hepatitis B vaccine ...The [Brand name of Hepatitis B vaccine] is administered in as a series of four intramuscular injections: Dose 1: On elected date, Dose 2: 1 month after the 1st dose, Dose 3: 2 months after the 1st dose, Dose 4: 6 months after the 1st dose ...Hepatitis B (HBsAB) will be drawn for detection of antibody response 1 month following the last vaccine administration ...” 47206 7. A review of Patient 33’s “Patient Face sheet,” indicated, Patient 33 was admitted to the facility on March 26, 2025, with a diagnosis of ESRD. HBsAB testing was collected on March 28, 2025, which indicated a result of less than 7 mIU/mL and Patient 33 was susceptible to hepatitis B. 8. A review of Patient 34’s “Patient Face sheet,” indicated, Patient 34 was admitted to the facility on September 18, 2024, with a diagnosis of ESRD. HBsAB testing was collected on December 9, 2024, which indicated a result of less than 5 mIU/mL and Patient 34 was susceptible to hepatitis B. 9. A review of Patient 35’s “Patient Face sheet,” indicated, Patient 35 was admitted to the facility on October 12, 2024, with a diagnosis of ESRD HBsAB testing was collected on October 12, 2024, indicated a result of less than 5 mIU/mL and Patient 35 was susceptible to hepatitis B. During a concurrent interview and record review on August 18, 2025, at 3:00 PM, with charge nurse (CN), Patient 33’s, Patient 34’s and Patient 35’s HBsAB testing results, were reviewed. The CN was unable to provide any documented evidence to show patients received Hepatitis B vaccination and assumed the vaccine was not given as of the last laboratory results. During a concurrent interview and record review on August 18, 2025, at 3:21 PM, with CN, the facility’s P&P titled, “Hepatitis B Vaccine and Surveillance for Patients,” dated September 2017, was reviewed. The P&P indicated. “ ...1. Hepatitis B vaccination is recommended for all susceptible chronic dialysis patients...7. Test all vaccinated patients for HBsAb one (1) to two (2) months after the last dose of the series (adequate response is defined as > [greater than] 12 mIU/mL). 8. If HBsAb is < [less than] 12 Miu/mL, consider the patient susceptible, revaccinate [give vaccine again] with an additional series, and retest for HBsAb one (1) to two (2) months after the last dose of the second series ...” The CN stated the policy was not followed. The CN stated, patients with HBsAB less than 12 mIU/ml are expected to have already received or been started on the hepatitis B vaccine.”

“IC-HBV-TEST PTS/STAFF POST LAST DOSE CFR(s): 494.30(a)(1)(i) Hepatitis B Screening: Patients and Staff Test all vaccines [patients and staff] for anti-HBs 1-2 months after last primary vaccine dose. -- If anti-HBs is <10 mIU/mL, consider patient or staff member susceptible, revaccinate with an additional three doses, and retest for anti-HBs. -- If anti-HBs are =10 mIU/mL, consider immune, and retest patients annually. -- Give booster dose of vaccine to patients if anti-HBs declines to <10 mIU/mL and continue to retest patients annually. This Standard is not met as evidenced by: 47360 Based on interview and record review, the facility failed to follow their policy and procedure (P&P) for “Hepatitis B [a liver infection caused by a virus, Hepatitis B Virus [HBV], that can cause inflammation and damage to the liver] Vaccine [administering a less potent version of the virus to help the body learn how to defend itself from disease without the dangers of a full-blown infection] and Surveillance for Patients” and “Hepatitis B Vaccine Administration” for five of 34 sampled patients (Patients 23, 4, 25, 26, 28) when 1. For one patients (Patient 23), Hepatitis B vaccine, Hepatitis B surface Antibodies (HBsAb - a protective shield against HBV, the result greater than 12 Million International Units/milliliter (mIU/mL-unit of measurement) in blood means you are immune or protected to HBV), and a HBV vaccination booster ( a single vaccination to boost immunity when HbsAb drops below 12mIU/mL) were not completed as stated on their P&P. 2. For one patient (Patient 25), HBsAb was not completed as stated on their P&P after Hepatitis B vaccine series were completed. 3. For three patients (Patient 4, 26 and 28), Hepatitis B vaccine and HBsAb were not completed as stated on their P&P. These failures resulted in the facility not knowing Patient’s 23, 4, 25, 26, 28 HBV immunity status, delaying further vaccine intervention and the potential for preventable infection which can cause chronic liver damage. Findings: 1. During a review of Patient 23’s “Patient Face sheet”, the “Patient Face sheet” indicated, Patient 23 was admitted to the facility on August 15, 2022, with a diagnoses of new end-stage renal disease (ESRD - kidneys have stopped working permanently and can no longer keep you alive on their own) and chronic dialysis (a treatment that cleans your blood when your kidneys have failed, removing waste and extra fluid) was started. During a concurrent interview and record review on August 19, 2025, at 1:40 PM, with Registered Nurse 1 (RN 1), Patient 23’s “Vaccination Record,” dated August 18, 2025, was reviewed. The “Vaccination Record” indicated, Patient 23 received the HBV vaccine on April 4, 2025. There was no documentation for further vaccinations administered as part of a series. Patient 23’s “Hepatitis labs,” dated August 18, 2025, were reviewed. The “Hepatitis labs” did not include a HBsAb result one to two months after the HBV vaccine was administered. RN 1 stated, the Hepatitis B labs are generated by the lab itself, not by the nursing staff. RN 1 further stated, the HBsAb is only scheduled to occur twice a month and does not coincide with each patients’ vaccination schedule. 2. During a review of Patient 25’s “Patient Face sheet”, the “Patient Face sheet” indicated Patient 25 was admitted to the facility on January 1, 2022, with a diagnosis of ESRD requiring chronic dialysis. During a concurrent interview and record review on August 19, 2025, at 1:50 PM, with RN 1, Patient 25’s “Vaccination Record,” dated August 18, 2025, was reviewed. The “Vaccination Record” indicated, Patient 25 received a series of the HBV vaccine that was completed on April 1, 2025. Patient 25’s “Hepatitis labs,” dated August 18, 2025, were reviewed. The “Hepatitis labs” did not include a HBsAb result one to two months after the completion of the second HBV vaccine series. RN 1 stated, the HBsAb was not ordered or drawn after the completion of the second HBV series. 3a. During a review of Patient 4’s “History and Physical” (H&P - includes patient history and current diagnosis and medical plan), the “H&P” indicated Patient 4 was diagnosed with ESRD and started on chronic dialysis in May 2016. During a concurrent interview and record review on August 20, 2025, at 11:30 AM, with RN 2, Patient 4’s “Vaccination Record,” dated August 18, 2025, was reviewed. The “Vaccination Record” indicated, Patient 4 received the HBV vaccine on January 14, 2025. There was no documentation for further vaccinations administered as part of a series. Patient 4’s “Hepatitis labs,” dated August 18, 2025, were reviewed. The “Hepatitis labs” did not include a HBsAb result one to two months after the HBV vaccine was administered. RN 2 stated the Hepatitis B labs are generated by the lab and resulted on a preset schedule. RN 2 stated, the facility did not have an updated HBsAb after Patient 4 received the HBV vaccine booster in January 2025. 3b. During a review of Patient 26’s “Patient Face sheet”, the “Patient Face sheet” indicated Patient 26 was admitted to the facility on January 3, 2022, with a diagnosis of ESRD requiring chronic dialysis. During a concurrent interview and record review on August 19, 2025, at 2:00 PM, with RN 1, Patient 26’s “Vaccination Record,” dated August 18, 2025, was reviewed. The “Vaccination Record” indicated, Patient 26 received the HBV vaccine on December 20, 2024. There was no documentation for further vaccinations administered as part of a series. Patient 26’s “Hepatitis labs,” dated August 18, 2025, were reviewed. The “Hepatitis labs” did not include a HBsAb result one to two months after the HBV vaccine was administered. RN 1 stated, Patient 26 received a HBV booster vaccine in December 2024, and the HBsAb was not drawn one to two months after Patient 26 received the HBV vaccine. 3c. During a review of Patient 28’s “Patient Face sheet”, the “Patient Face sheet” indicated Patient 28 was admitted to the facility on January 3, 2022, with a diagnosis of ESRD requiring chronic dialysis. During a concurrent interview and record review on August 19, 2025, at 2:10 PM, with RN 1, Patient 28’s “Vaccination Record,” dated August 18, 2025, was reviewed. The “Vaccination Record” indicated, Patient 28 received the HBV vaccine on January 7, 2025. There was no documentation for further vaccinations administered as part of a series. Patient 28’s “Hepatitis labs,” dated August 18, 2025, were reviewed. The “Hepatitis labs” did not include a HBsAb result one to two months after the HBV vaccine was administered. RN 1 stated, Patient 28 received a HBV booster vaccination and a HBsAb was not completed to see if Patient 28 had developed immunity. During a concurrent interview and record review on August 19, 2025, at 2:30 PM, with RN 1, the facility P&P titled, “Hepatitis B Vaccine and Surveillance for Patients,” dated September 2017, was reviewed. The “P&P” indicated, “PURPOSE”: To prevent the spread of hepatitis infections in the dialysis setting ...1. Hepatitis B vaccination is recommended for all susceptible chronic dialysis patients ...If HBsAb is < [less than] 12 mIU/mL, consider the patient susceptible, revaccinate (give vaccine again) with an additional series, and retest for HBsAb one (1) to two (2) months after the last dose of second series ...9. If HBsAb is > [greater than] 12mIU/mL, consider the patient immune, and retest annually ...Administer a booster dose of vaccine if HBsAb declines to < 12mIU/mL on annual testing ...” RN 1 stated, she was not aware the HBsAb was to be drawn one to two months after the last vaccination does to assess for immunity. RN 1 stated, the facility had the lab set up biannual (two times per year) HBsAb testing that does not indicate when a patient is due to check for immunity in response to the vaccine schedule. RN 1 stated, HBsAb were not monitored per P&P for patients who received HBV vaccinations. During a review of the facility P&P titled, “Hepatitis B Vaccine Administration,” dated April 2022, the P&P indicated, “PURPOSE: To ensure safe, proper and effective administration of the Hepatitis B vaccine. All patients of [Name of Facility] will be offered the Hepatitis B vaccine ...The [Brand name of Hepatitis B vaccine] is administered in as a series of four intramuscular injections: Dose 1: On elected date, Dose 2: 1 month after the 1st dose, Dose 3: 2 months after the 1st dose, Dose 4: 6 months after the 1st dose ...Hepatitis B (HBsAB) will be drawn for detection of antibody response 1 month following the last vaccine administration ...””

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 47360 Based on interview and record review, the facility failed to ensure the Quality Assurance Performance Improvement (QAPI) Plan included infection control monitoring and quality performance interventions when: 1. For four of 10 sampled patients (Patient 21, 25, 26 and 31) and two unsampled patients, Peritonitis (a serious infection of the lining of the abdomen that can happen to people on peritoneal dialysis [PD - a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body]) infections were not analyzed to identify the source of infection and there was no documented action plan to reduce future incidents of peritonitis infections. This failure resulted in the facility’s inability to identify peritonitis trends and implement interventions to prevent avoidable peritonitis infections which jeopardize patients’ safety and potentially increased patients’ hospitalization rates. 2. For nine of 34 sampled patients (Patients 22, 2, 10, 3, 32, 30, 33, 34 and 35), Hepatitis B (a liver infection caused by the hepatitis B virus) vaccinations (contain weakened or inactive part of a particular organism that triggers an immune response within the body and prevents infection) and for five of 34 sampled patients (Patient 23, 4, 25, 26, 28), Hepatitis B antibody (part of the immune system which recognizes an organism and removes it from the body, preventing infection) were not tracked or analyzed and there was no action plan to promote patient immunizations and tracking for antibody response. This failure resulted in the facility’s inability to identify vulnerable patients, a risk of developing a hepatitis B infection and the potential for transmission of a chronic infection that could lead to life threatening complications. Findings: 1. During a review of the facility’s document titled, “Infection Tracking Report,” dated August 18, 2025, the document indicated, four of 10 sampled patients (Patient 21, 25, 26 and 31) for PD had diagnoses of peritonitis between February 18, 2025, and August 18, 2025. The document indicated that Patient 21 had two episodes of peritonitis in the past six months and Patient 25, 26, 31 and two unsampled patients had one episode of peritonitis each in the past six months. During an interview on August 19, 2025, at 10:45 AM, with Registered Nurse 2 (RN 2), RN 2 stated, peritonitis is an infection of the peritoneum (lining of the inside of the abdomen) that, many times, can be prevented with good infection control techniques. RN 2 stated the importance of preventing peritonitis is to prevent scarring of the peritoneum. RN 2 further stated, scarring to the peritoneum can cause decreased efficiency of dialysis and membrane failure, which would result in a patient requiring hospitalization and transitioning to hemodialysis (a medical treatment where the blood passes through a machine to remove toxins and extra fluid). During a review of the facility’s document titled, “QAPI- Home Program Meeting covering the month of March 2025,” dated April 30, 2025, the document indicated, “ ...Peritonitis: There were 2 patients with peritonitis for the month ...See infection track report ...”. The “Infection Tracking Record” dated August 18, 2025, indicated Patient 21 and 25 were diagnosed with peritonitis in the month of March 2025. There was no other documentation regarding peritonitis in the meeting document. During a review of the facility’s document titled, “QAPI- Home Program Meeting covering the month of April 2025,” dated May 28, 2025, the document indicated, “ ...Peritonitis: There were 2 patients with peritonitis for the month. See infection track report ...”. The “Infection Tracking Record” dated August 18, 2025, indicated Patient 26 and 31 were diagnosed with peritonitis in the month of April 2025. There was no other documentation regarding peritonitis in the meeting document. During a review of the facility’s document titled, “QAPI- Home Program Meeting covering the month of May 2025,” dated June 25, 2025, the document indicated, “ ...Peritonitis: There was 1 peritonitis for month ...See infection track report ...”. The “Infection Tracking Record” dated August 18, 2025, indicated two patients (not sampled) were diagnosed with peritonitis in the month of May 2025. There was no other documentation regarding peritonitis in the meeting document. During a concurrent interview and record review on August 20, 2025, at 2:05 PM, with RN 1, the facility document’s titled, “QAPI - Home Program Meeting covering the month of June 2025,” dated July 30, 2025, was reviewed. The document indicated, “ ...Peritonitis: There were 2 peritonitis for the month. See infection tracking record ...”. The “Infection Tracking Record” dated August 18, 2025, indicated Patient 31 and 21 were diagnosed with peritonitis in the month of June 2025. RN 1 stated this document is just the minutes and does not include specific information reviewed in the QAPI meeting. RN 1 stated, the QAPI meeting utilizes the “Dialysis Manager: QAPI Tool” in the facility electronic health record system. During a concurrent interview and record review on August 20, 2025, at 2:10 PM, with RN 1, the “Dialysis Manager: QAPI Tool,” dated July 2025, was reviewed. The “Dialysis Manager: QAPI Tool” had an infection control metric, but peritonitis was not included in the metric. RN 1 stated, the QAPI reviews the culture reports, and the peritonitis events are discussed, but there is no documented evidence of these discussions. RN 1 stated that the QAPI does not analyze cause of peritonitis or implement interventions to attempt to decrease the prevalence of peritonitis infections among the PD patients in the clinic. RN 1 further stated, she does not know the facility’s current peritonitis rate and the facility does not have a tool to calculate the facility’s peritonitis rate. During a review of the facility’s policy and procedure (P&P) titled, “Quality Assessment Performance Improvement Program (QAPIP),” dated April 2021, the P&P indicated, “ ...Members of the Quality Assessment Performance Improvement Committee” (QAPIC) will be responsible for the implementation of comprehensive data collection; as well as monitoring and improvement activities to include, but not limited to, measurement, evaluation, and analysis of the data related to the following items and the development of improvement plans for the following measures when indicated ...l. Infection Control ...The QAPIC will meet to review the collected data, verifying measures where goals are met, and identifying areas below the expected thresholds where improvement plans may be indicated ...The QAPIC will be responsible for the oversight and implementation of identified improvement plans and periodic review of efficacy of improvement plans ...”. 2. During concurrent interview and record review on August 20, 2025, at 2:16 PM, with RN 1, the facility’s documents titled, “Vaccination Report,” dated August 18, 2025, and “Hepatitis Report,” dated August 18, 2025, were reviewed. The documents indicated, nine of 34 sampled patients (Patients 22, 2, 10, 3, 32, 30, 33, 34 and 35), susceptible to Hepatitis B did not receive hepatitis immunizations. The documents further indicated that five of 34 sampled patients (Patient 23, 4, 25, 26, 28) were not tested for Hepatitis B immunity after receiving a full series of Hepatitis B immunizations or a booster immunization. RN 1 stated, each RN is responsible for managing their own patient regarding Hepatitis B surveillance and tracking. RN 1 stated, the QAPI will review who was vaccinated for that month but does not monitor who has antibodies or needs to be screened for antibodies after receiving the vaccination. During a concurrent interview and record review of on August 20, 2025, at 2:22 PM, with RN 1 the “Dialysis Manager: QAPI Tool,” dated July 2025, was reviewed. The “Dialysis Manager: QAPI Tool” indicated there was a vaccination tab that included hepatitis B vaccination tracking and hepatitis B antibody tracking, but there was no documented evidence of analysis or improvement plan. RN 1 stated, this tool was not currently being used because it does not include accurate data from the vaccinations administered to patients, because there are different ways to input vaccinations into the chart. RN 1 stated, the tool does not include patients that have antibodies because the tool does not communicate with the lab. RN 1 stated, each RN is responsible for tracking each patient individually and there are no performance improvement activities implemented by the QAPI to focus on hepatitis B vaccinations and Hepatitis B antibodies. During a review of the facility’s policy and procedure (P&P) titled, “Quality Assessment Performance Improvement Program (QAPIP),” dated April 2021, the P&P indicated, “ ...Members of the Quality Assessment Performance Improvement Committee” (QAPIC) will be responsible for the implementation of comprehensive data collection; as well as monitoring and improvement activities to include, but not limited to, measurement, evaluation, and analysis of the data related to the following items and the development of improvement plans for the following measures when indicated ...m. vaccinations ...”.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 47360 Based on interview and record review, the facility failed to implement continuous performance improvements to ensure sustained improvement when the Quality Assurance Performance Improvement (QAPI) plan for dialysis (a treatment that cleans your blood when your kidneys have failed, removing waste and extra fluid) adequacy (Kt/V - equation that measures the amount of toxins removed from a patient blood stream during dialysis to determine if a patient is receiving enough dialysis) was not updated and new interventions were implemented by QAPI to achieve and sustain dialysis adequacy since July 26, 2023. This failure resulted in the facility’s inability to identify quality improvement activities through a data-driven process and implement interventions to provide effective dialysis treatments which could potentially prevent hospitalization and cause complications with poor fluid management. Findings: During a review of a facility’s document titled, “QAPI - Home Program Meeting covering the month of June 2025,” dated July 30, 2025, the document indicated, the program dialysis adequacy goal of more than 95 percent (%) of facility patients meeting adequacy goal, was not met. The document further indicated that only 50% of home hemodialysis (HHD - dialysis services provided in a home setting, usually completed by the patient and/or a caregiver) patients were meeting adequacy and 78% of peritoneal dialysis (PD - uses the lining of the abdomen and sterile prescription fluids to remove waste and fluid from the patients body, when the kidneys no longer work effectively) patients were meeting the adequacy goal. The document further indicated, “ ...See lab report for patients that did not meet the Kt/V goals ...”. There was no other documentation regarding adequacy. During an interview on August 20, 2025, at 10:55 PM, with Registered Nurse 2 (RN 2), RN 2 stated, adequacy measures how well the patient is being dialyzed. RN 2 stated, there are different factors that affect the results: patients do not collect lab samples correctly, the lab loses samples, and sometimes patients’ kidney function will completely stop, and patients require adjustments to the prescription to get them to meet the dialysis adequacy goals. During a concurrent interview and record review on August 20, 2025, at 2:30 PM, with RN 1, the facility’s document title, “Dialysis Manager: QAPI Tool,” date of document, was reviewed. The “Dialysis Manager: QAPI Tool” indicated, dialysis adequacy metric included a performance action plan that was started on July 26, 2023. In the “status, Outcomes, and Evaluation Comments” section was a note “Continue action plan”. RN 1 stated, the QAPI action plan for adequacy had not been re-evaluated or updated since July 2023, because patient’s not meeting adequacy is a constant issue. RN 1 stated, each nurse manages their assigned patients on their own. RN 1 stated, patients that are not meeting adequacy are discussed during the QAPI, but there have been no new interventions, performance improvement plans, evaluations driven by the QAPI since July 2023. RN 1 stated, inadequate dialysis can lead to poor patient outcomes and hospitalization. During a review of the facility’s policy and procedure (P&P) titled, “Quality Assessment Performance Improvement Program (QAPIP),” dated April 2021, the P&P indicated, “ ...The essential functions of the QAPIP are to conduct appropriate review of data and information; prioritizing areas for improvement; determining root causes influencing outcomes and incidents; and developing, implementing, evaluating, and modifying action plans that result in improvements of care ... Members of the Quality Assessment Performance Improvement Committee” (QAPIC) will be responsible for the implementation of comprehensive data collection; as well as monitoring and improvement activities to include, but not limited to, measurement, evaluation, and analysis of the data related to the following items and the development of improvement plans for the following measures when indicated ...d. HD [hemodialysis] Adequacy e. PD [Peritoneal Dialysis] Adequacy ...”.”

“MR-TRANSFER REQ RECORDS IN 1 WORKING DAY CFR(s): 494.170(d) When a dialysis patient is transferred, the dialysis facility releasing the patient must send all requested medical record information to the receiving facility within 1 working day of the transfer. This Standard is not met as evidenced by: 46696 Based on interview and record review, the facility failed to provide patient medical records to a receiving dialysis facility for one of 34 patients (Patient 9) when Patient 9 was discharged home from a contracted skilled nursing facility (SNF). This failure resulted in inadequate continuation of care and the potential for inaccurate treatment planning, treatment errors and complications relating to infection. Findings: During a review of Patient 9’s “History and Physical” (H&P - includes patient history and current diagnosis and medical plan), dated May 21, 2025, the H&P indicated, Patient 9 was admitted to [Name of SNF] on May 9, 2025, with diagnoses including End Stage Renal Disease (ESRD-kidneys have stopped working permanently and can no longer keep you alive on their own) and chronic dialysis (requires a routine treatment that cleans your blood when your kidneys have failed, removing waste and extra fluid) was provided by this facility. During a review of the facility’s document titled, “Patient List” for [Name of SNF], dated August 18, 2025, Patient 9 was listed as an active (currently admitted to the facility and reeving dialysis treatments) patient. During a review of Patient 9’s “HHD [Home Hemodialysis] Treatment Flowsheet,” dated August 1, 2025, the “HHD Treatment Flowsheet” indicated, Patient 9 was receiving dialysis treatments at [Name of SNF] four hours a day, three days per week, and her last treatment was on August 1, 2025. During a concurrent interview and record review on August 19, 2025, at 2:45 PM, with Registered Nurse 2 (RN2), Patient 9’s “Electronic Health Record” (EHR), was reviewed. The “EHR” indicated, there was no documented evidence of discharge or transfer of Patient 9 to a receiving dialysis facility upon patient discharge home. RN 2 stated there was no documentation in the Patient 9’s record regarding discharge or transfer from Patient 9’s doctor or from case management. During a concurrent interview and record review on August 19, 2025, at 2:45 PM, with the Facility Manager (FM), Patient 9’s “Nursing - Progress Notes Report,” dated August 6, 2025, was reviewed. The “Nursing - Progress Notes Report” indicated, “ ...Late Entry 8/3/2025 [August 3, 2025] Patient was discharged home on Sunday, August 3, 2025 ...” The FM stated she was not aware of Patient 9’s discharge home. The FM stated, she did not receive any communication from the SNF or the facility’s dialysis nurse at [Name of SNF] notifying her that Patient 9 was to be discharged on August 3, 2025. The FM stated, usually the SNF’s social workers will take care of discharges and transfers. The SNF social worker should notify me of details regarding transfer including which dialysis center will be receiving the patient and what information needs to be provided. The FM further stated, communication regarding transfers and discharges from the SNF has been an issue identified for several months. During a review of the facility’s policy and procedure (P&P) titled, “Patient Transfer Policy,” dated December 2024, the P&P indicated, “Policy: Patients may be transferred when medically necessary, at patient requires tor when program reequipment are not met. All transfers ensure safety and continuous care ...2. Responsibilities: Home Program nurse: assess need, notify nephrologist, coordinate transfer, and provide records. Nephrologist: approve transfer and communicate with receiving provider ...3. Documentation reason for transfer in medical record. Send current treatment orders, medication list, and labs to new program/facility ...Continuity of Care: Arrange transfer so there is no gap in dialysis treatment ...””

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 47360 Based on interview and record review, the facility failed to conduct a full scale emergency drills (a community wide drill to address an emergency such as an earthquake, fire, or flood) or a mock (pretend) disaster drills to test their emergency preparedness plan and facility’s response to a disaster on an annual basis. This failure had the potential for staff and patients to respond in an ineffective manner during a disaster, which could cause injury and delay in medical treatment to anyone in the facility in the event of an emergency. Findings: During a concurrent interview and record review on May 22, 2024, at 1:31 PM, with Registered Nurse 2 (RN 2), the facility’s “Emergency Preparedness” binder was reviewed. The binder contained a signature page titled, “Comprehensive Emergency Drill for Staff” and was signed by staff dated December 29, 2021. RN 2 stated, the facility did not have any type of fire drill or evacuation drill in over two years and the last signature page, dated December 29, 2021, was the last drill she believed was done. RN 2 further stated, she was not aware who was assigned to the “Emergency Preparedness” binder and who was responsible for training, assigning specific roles during an emergency or scheduling the annual disaster drills. During a concurrent interview and record review on May 22, 2024, at 3:15 PM, with the Administrator (Admin), the facility’s “Emergency Preparedness” binder was reviewed. The binder contained a signature page titled, “Comprehensive Emergency Drill for Staff” and was signed by staff dated December 29, 2021. The Admin stated, he did not have a signature page to prove a disaster drill was performed at the facility since December 29, 2001, and was uncertain if that was the last date an emergency drill was performed. During a review of the facility’s undated, policy and procedure (P&P) titled, “Emergency Preparedness”, the P&P indicated, “ ...3. This facility maintains written policies and procedures that specifically define the handling of emergencies, which may threaten the health, and safety of patients. Such emergencies include fire or natural disasters and during functional failures in equipment. Specific emergency preparedness procedures are maintained for different kinds of emergencies. 4. These emergencies policies and procedures are reviewed and tested at least annually and revised as necessary under the direction of the administrator. 5. All personnel are knowledgeable and trained in their respective roles in emergency situations ...7 ....The emergency preparedness plan provides for orientation and regular training and periodic drills for all procedures so that each person promptly and correctly carries out a specific role in case of an emergency ...”.”

“QA-GENERAL/RECORDS/TREND ANALYSIS CFR(s): 494.50(b)(1) 14 Quality assurance: general/records/trend analysis The criteria chosen as the internal standards of a facility shall be documented in its policy and/or procedure manual. Process review should be part of the activity of the individual carrying out the process, and oversight of that review by another qualified member of the staff or a group of staff members should affirm, modify, or repeat these observations to confirm or improve the process. Clinical outcomes serve as the most important indicator of quality of all dialysis treatment practices including reuse. Final oversight is the responsibility of the medical director. See Table 2 for a summary of the audit schedule. 14.1 Records A record of review, comments, trend analysis, and conclusions arising from QA practices serve as a foundation for future review and as documentation to external evaluation. This Standard is not met as evidenced by: 47360 Based on observation, interview, and record review, the facility failed to implement and maintain their policies and procedures when: 1. The Peritoneal Dialysis (PD - a treatment for kidney failure that uses the lining of your abdomen to filter your blood inside your body) transfer set (used to connect the PD catheter to the PD treatment fluid) for one of three sampled patients (Patient 1) was not changed every six months. This failure had the potential for the peritoneal dialysis transfer set to have caused decreased integrity related to daily use and increased risk of peritonitis (an infection in the lining of the abdomen). 2. The crash cart (a cart stocked with emergency equipment, supplies, and drugs for use by medical personnel in life -saving efforts) was not locked and secured for a universe of 38 patients . This failure had the potential for unsecured medications to be accessed by anyone (staff, patient or visitors) without the facility’s knowledge and jeopardize the lives of residents at risk when the crash cart is needed in times of emergency. 3. Medications were stored in one unlocked cabinet and two unlocked refrigerators in patient training room 4. This failure made the medications accessible to unauthorized personnel for tampering or diversion of medications. Findings: 1.During a review of Patient 1’s, “History and Physical” (H&P- a formal document, produced by the physician related to the patients medical history and physical exam) dated November 16, 2023, indicated Patient 1 was admitted on October 27, 2023 with diagnoses including End Stage Renal Disease (Kidney failure) and hypertension (high blood pressure). During a concurrent interview and record review on May 22, 2024, at 9:35 AM, with RN 1 , Patient 1’s “Nurse Visit” dated May 6, 2024, was reviewed. The “Nurse Visit” indicated, “ ...Transfer set placement date: 10/04/2023 ...Reminder Replacement Date 4/4/24 ...”. The comments portion did not mention the PD transfer set was changed between October 4, 2023, and May 22, 2024. RN 1 stated, there was no nursing note stating the transfer set was changed between the dates listed, nor was it was changed since being due for change on April 4, 2024. RN 1 further stated, it was the facility’s policy to change pt PD transfer set every six months per manufacturer recommendations and the electronic charting system tracks when the PD transfer set needs to be changed every 6 months. During a concurrent interview and record review on May 22, 2024, at 2:45 PM, with the Director of Nursing (DON), the facility’s policy and procedure (P&P) titled, “Transfer Set Change: Peritoneal Dialysis Catheter” dated February 14, 2022, was reviewed. The P&P indicated, “ ...1. The transfer set will be routinely changed every 6 months, or more often if the transfer set is faulty or needed to prevent infection ...3. Transfer set changes will be done according to manufacturer’s guidelines and an approved [name of company] procedure that includes the use of sterile technique ...”. The DON stated, the facility policy was not followed when the transfer set is to be changed every six months at the patient nurse visit. 47206 2. During an observation on May 20, 2024, at 10:00 AM, in the hallway between rooms 4 and 5, it was noted that the crash cart was found open. The crash cart contained heparin (a medication to prevent blood clots from forming), intravenous (IV- a tube used to administer fluids and medication into the blood stream) fluid, and syringes (a medical tool used to inject or withdrawal fluids from the body). During a concurrent observation and interview on May 20, 2024 at 10:10 AM, with Registered Nurse (RN 1), in the hallway between rooms 4 and 5, RN 1 acknowledged that the crash cart was not locked and stated that the crash cart must be kept locked at all times due to the presence of medications. During an interview on May 22, 2024, at 1:50 PM, with Registered Nurse (RN 2), in the hallway between rooms 4 and 5, RN 2 stated the crash cart must be locked at all times in accordance with the facility policy. During a concurrent interview and record review on May 22, 2024, at 2:00 PM, with the Director of Nursing (DON), the facility’s P&P titled, “Home Dialysis Centers Crash Cart Policies,” revised on November 28, 2017, was reviewed. The P&P indicated, “ .... A crash cart or med drawer that is kept locked will be checked daily as above ...”. The DON stated the current policy governing the crash cart is consistent with the one documented in the crash cart log on May 20, 2024, at 10:00 AM, which stipulates the daily locking and inspection of the crash cart. During an interview on May 22, 2024, at 3 PM, with the Administrator (Admin) , the Admin stated the facility intends to replace the current crash cart with a lockable cart. 49231 3. During a concurrent observation and interview on May 20, 2024 at 10:13 AM, with Registered Nurse 1 (RN1) in room 4, Refrigerator 1 was unlocked and contained influenza vaccine (to protect against the flu) and Purified Protein Derivative (PPD - used in a skin test for tuberculosis [infection of the lungs]). A further observation indicated, Refrigerator 2 was unlocked and contained a medication name Mircera (medicine for anemia [deficiency of blood]). An unlocked cabinet contained the following medications: Cefazolin (medicine to treat infections), Vancomycin (medicine to treat infections), Ceftazidime (medicine to treat infections), Venofer (medicine to treat low iron levels). RN 1 verified and confirmed that storage with medications needs to be locked based on the facility’s policy. During a concurrent interview and record review on May 20, 2024, at 2:25 PM, with Director of Nursing (DON) and Chief Executive Officer (CEO), the facility’s policy and procedure (P&P) titled, “General Medications Policy”, undated, was reviewed. The P&P indicated, ... Medication Storage a. Medications available in the patient training room are kept in a locked cabinet drawer except for heparin (medicine to prevent blood clots from forming), normal saline (solution mixture of salt and water), and xylocaine (medicine that numbs part of the body). The DON verified and confirmed that the facility should have followed the policies accordingly . The DON stated, the medications are to be locked, but staff are unable to find the keys to lock the refrigerators and the cabinet. The DON also stated, the room is used for patient visits and training and medications could be tampered with.”