Davita Lee Street Dialysis

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 27513 Based on a review of the Hepatitis B Summary report and interview with the Charge Nurse, the facility staff failed to promptly review the Hepatitis B serological test result, to ensure that three (3) of 11 sampled patients and 4 supplemental patients on the record that are Hepatitis B virus (HBV) susceptible were managed appropriately based on the status of their testing results. (Patient #1, #3, #5, #17, #19, #20, and #23) The findings include ... A review of the Hepatitis B Summary report on 04/07/2025 showed 7 patients with their Hepatitis lab result less than 10 and no documentation that the patients were managed appropriately based on their following testing results. 1.Patient #1 admitted 12/24/2024 HBV serological status less than 10. Hepatitis B Surface Antigen (HBsAg) lab results were <3 on 12/24/2024, and <3 on 05/10/2024. 2.Patient #3 admitted 02/26/2024. HBV serological status dated 02/27/2024. Hepatitis B Surface Antigen (HBsAg) lab results <3 on 02/27/2024. 3.Patient #5 was admitted 01/21/2025 with HBV serological status less than 10. Hepatitis B Surface Antigen (HBsAg) lab results were <3 on 08/15/2024 and 6 on 01/28/2025. 4.Patient #17 was admitted 01/06/2025 with HBV serological status less than 10. Hepatitis B Surface Antigen (HBsAg) lab results were 5 on 01/07/2024. 5.Patient #19 was admitted 09/14/2022 with HBV serological status less than 10. Hepatitis B Surface Antigen (HBsAg) lab results <3 on 12/09/2024, <3 on 12/20/24, and <3 on 1/27/2025. 6.Patient #20 was admitted 03/17/2025 with HBV serological status less than 10. Hepatitis B Surface Antigen (HBsAg) lab results were 7 on 03/20/2025. 7. Patient #23 was admitted 08/16/2024 with HBV serological status less than 10. Hepatitis B Surface Antigen (HBsAg) lab results were <3 on 08/20/2024 and 3 on12/05/2024. It should be noted that the patients HBV serological status reported were less than 10 with no documented evidence of the patients being vaccinated immediately as recommended by CDC. In accordance with the Centers for Disease Control (CDC) recommendation: “Hepatitis B vaccine has been recommended for ... hemodialysis patients. Routinely test all chronic hemodialysis patients for HBV and HCV infection, promptly review results, and ensure that patients are managed appropriately based on their testing results. The hemodialysis unit should ensure that the laboratory performing the testing for anti-HBs can define a 10 mIU/mL concentration to determine protective levels of antibody. Susceptible Patients should begin receipt of hepatitis B vaccine immediately upon admission. Hepatitis B vaccination is recommended for all susceptible chronic hemodialysis patients.” www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm The evidence showed that the facility staff failed to promptly review the hepatitis B lab results and ensure that Hepatitis B susceptible patients with [HBV serological status to be less than 10 found on the Hepatitis B Summary Report were managed appropriately based on their testing results according to CDC recommendations. A face -to- face interview conducted on 4/11/2025, at approximately 2:00PM with the Employee#3 [Charge Nurse]. She acknowledged the findings.”

“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: 27513 Based on a review of on three (3) of 11 sampled patients and 4 supplemental patients on the record and an interview with the Charge Nurse, it was determined that the facility staff failed to start administration of the Hepatitis B vaccine series for seven (7) Hepatitis B virus (HBV) susceptible patient in a timely manner. (Patient #1, #3,#5, #17, #19, #20, and #23). The findings include: 1.A review of the clinical records for Patient#1 revealed that the HBV vaccine series were not administered for Hepatitis B Surface Antigen (HBsAg) lab results less than ten (10) on following dates: <3 on 12/24/2024, and <3 on 05/10/2024. The record showed that Hep B vaccine [Engerix] series administration was not started. 2. A review of the clinical records for Patient#3 revealed that the HBV vaccine series were not administered for Hepatitis B Surface Antigen (HBsAg) lab results less than ten (10) on following date: <3 on 02/27/2024. The record showed that Hep B vaccine [Engerix] series administration was not started until 07/13/2024. 3. A review of the clinical records for Patient#5 revealed that the HBV vaccine series were not administered for Hepatitis B Surface Antigen (HBsAg) lab results less than ten (10) on following date: 08/15/2024 was <3 and on 01/28/2025 was 6. The record showed that Hep B vaccine [Engerix] series administration was not started until 02/06/2025. 4. A review of the clinical records for Patient#17 revealed that the HBV vaccine series were not administered for Hepatitis B Surface Antigen (HBsAg) lab results less than ten (10) on following date: 01/07/2024 was 5. The record showed that Hep B vaccine [Engerix] series administration was not started until 03/10/2025. 5. A review of the clinical records for Patient#19 revealed that the HBV vaccine series were not administered for Hepatitis B Surface Antigen (HBsAg) lab results less than ten (10) on following date: 12/09/2024 was <3, on 12/20/24 was <3, and on 1/27/2025 was<3. The record showed that Hep B vaccine [Engerix] series administration was not started until 03/10/2025. 6. A review of the clinical records for Patient#20 revealed that the HBV vaccine series were not administered for Hepatitis B Surface Antigen (HBsAg) lab results less than ten (10) on following date: 03/20/2025 was 7. The record showed that Hep B vaccine [Engerix] series administration was not started. 7. A review of the clinical records for Patient#23 revealed that the HBV vaccine series were not administered for Hepatitis B Surface Antigen (HBsAg) lab results less than ten (10) on following date: 08/20/2024 was <3 and on12/05/2024 was 3. The record showed that Hep B vaccine [Engerix] series administration was not started until 10/17/2024. According to the Centers for Disease Control (CDC): The recommended primary series of hepatitis B vaccine induces protective anti-HBs [antibodies for Hepatitis B] response (defined as greater than 10 milli-International Units per milliliter [>10 mIU]/mL) in 90%- 95% of adults with normal immune status... The Primary vaccination comprises three intramuscular doses of vaccine, with the second and third doses given 1 and 6 months, respectively, after the first. An alternative schedule of four doses given at 0, 1, 2, and 12 months to persons with normal immune status or at 0, 1, 2, and 6 months to hemodialysis patients has been approved for Engerix-B (The Morbidity and Mortality Weekly Report, Centers for Disease Control, p. 7) cdc.gov/mmwr/pdf/rr/rr5005.pdf There was no evidence that the facility staff started the primary Hepatitis B vaccination series in a timely manner for patients #1, #3, #5, #17, #19, #20 and #23 in accordance with CDC recommendations. A face-to-face interview conducted with the Employee #3 [Charge Nurse] on 04/11/2025, at approximately 2:00PM. She acknowledged the findings”

“DI-CONTIN MONITOR/LOGGED 2X/DAY CFR(s): 494.40(a) 5.2.8 Deionization: continuous monitor resistivity/logged 2 X day Refer to RD62:2001, 4.3.6 Deionization: Deionization systems, when used to prepare water for hemodialysis applications, shall be monitored continuously to produce water of one megohm/cm or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25°C. 6.2.8 Deionization Deionizers shall be monitored continuously using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms. Resistivity monitors shall have a minimum sensitivity of 1.0 megohm-cm. Patients shall not be dialyzed on deionized water with resistivity less than 1.0 megohm-cm measured at the output of the deionizer Resistivity monitor readings should be recorded on a log sheet twice each treatment day. This Standard is not met as evidenced by: 27689 Based on records review, and interview, facility staff failed to show documented evidence that resistivity monitor readings were recorded at least twice, each treatment day on two (2) occasions, between May 14, 2024, and June 8, 2024. Additionally, facility staff failed to document resistivity monitor readings for 12 days of dialysis between June 10, 2024, through June 22, 2024, the last day the DI system was used. The findings include: Per DaVita facility policy titled “Daily water treatment system monitoring”, Policy 1-17-02, Revision Date April 2025 stipulates..”Purpose: To verify the dialysis water system operates safely and reliably through daily observation and/or testing of specific component performance parameters......10. When DI is used in a facility, in the event the RO is inoperable or as a polish: “ The DI Monitoring Log will be implemented “ The resistivity monitor readings should be recorded on the DI Monitoring Log every four (4) hours of each treatment day. This should be in concurrent with documenting Total Chlorine checks..” On April 7, 2025, at approximately 2:00 p.m., a review of the facility’s DI Monitoring logs, dated May 14, 2024, through June 8, 2024, revealed no resistivity meter readings entries on May 5, 2024, and June 1, 2024. DI monitoring logs from June 9 through June 22, 2024, also were not available for review, indicating that the DI system was not monitored for 14 of 35 dialysis days. During a face-to-face interview with the Biomed Technician on April 7, 2025, at approximately 3:00 pm, he acknowledged the missing entries on May 5, and June 1, 2024, and confirmed that the newly installed RO system was not in operation until June 24, 2024. When asked for the DI monitoring logs dated June 9, 2024, through June 22, 2024, the last day the DI system was used, he said he would look for them, but did not locate them. Facility leadership also acknowledged there were no DI monitoring log sheets available for the period of June 9, 2024, through June 22, 2024. During the 14 treatment days when the DI system was not monitored, approximately 41 patients were dialyzed, and 269 dialysis treatments were completed. The Facility Administrator confirmed the findings during a face-to-face interview on April 11, 2025, at approximately 2:00 PM.”

“DI-CHEMICAL ANALYSIS-FREQUENCY CFR(s): 494.40(a) 6.2.8 Deionization: chemical analysis: frequency When deionization is employed as the primary method for removing inorganic contaminants (reverse osmosis is not employed), or when deionization is necessary to polish RO-treated water, chemical analyses to ensure that the requirements of AAMI 4.1.1 (Table 1) are met should be performed when the system is installed and at annual intervals thereafter. This Standard is not met as evidenced by: 27689 Based on records review, and interview, facility staff failed to perform a chemical analysis of the product water, when installing a new Deionization (DI) system as its primary water purification system, to ensure that it meets the allowable chemical contaminants concentration in water used for the treatment of dialysis patients. The findings include: On April 7, 2025, at approximately 2:00 p.m., a review of the facility’s water treatment records for the month of May 2024, revealed no chemical water analysis for the new DI system, that was installed and used beginning May 14, 2024. During a face-to-face interview on April 7, 2025, at approximately 3:00 pm, the Biomed Technician was asked if a chemical water analysis of the new DI system was completed when the system was installed, and he confirmed that it was not done. During the 35 dialysis treatment days the DI system was used, approximately 41 patients were dialyzed, and 662 dialysis treatments were completed. Part 494 Conditions for Coverage for End-Stage Renal Disease Facilities states: 6.2.8 Deionization: chemical analysis: frequency When deionization is employed as the primary method for removing inorganic contaminants (reverse osmosis is not employed), or when deionization is necessary to polish RO-treated water, chemical analyses to ensure that the requirements of AAMI 4.1.1 (Table 1) are met should be performed when the system is installed and at annual intervals thereafter. AAMI 4.1.1 (Table 1) is the maximum allowable chemical contaminant levels in water used for dialysis treatments. The Facility Administrator confirmed the findings during a face-to-face interview on April 11, 2025, at approximately 2:00 PM.”

“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: 27689 Based on observations made from April 4, 2025, to April 8, 2025, it was determined that facility staff failed to provide dialysis patients with a safe, functional, and comfortable treatment environment. The findings include: 1. The dialysis treatment floor was stained throughout with several dark spots. 2. There were holes in the walls located on the treatment floor and at the entrance of the water treatment system room. The Facility Administrator confirmed the findings during a face-to-face interview on April 11, 2025, at approximately 2:00 PM”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 27689 Based on records review and interview, it was determined that facility staff failed to comply with the 2012 edition of the Life Safety Code of the National Fire Protection Association (NFPA) 101, as evidenced by a lack of documented fire drills for the year 2024. The findings include: Fire drills documentation for both shifts, on Tuesdays, Thursdays, and Saturdays (TTS), during the second, third, and fourth quarter of the year 2024, were incomplete as fire drills were not conducted once per quarter per shift as required. The facility provides dialysis treatments for two (2) shifts on Mondays, Wednesdays, and Fridays (MWF), two (2) shifts on Tuesdays, Thursdays, and Saturdays (TTS). The 2012 Edition of NFPA 101section 21.7.1.6 states “...Drills shall be conducted quarterly on each shift to familiarize facility personnel (nurses, interns, maintenance engineers, and administrative staff) with the signals and emergency action required under varied conditions”. The Facility Administrator confirmed the findings during a face-to-face interview on April 11, 2025, at approximately 2:00 PM.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 27513 Based on observation, patients and staff interviews, it was determined that facility staff failed to display the State Agency’s (current address and telephone complaint numbers), the dialysis network 5 contact information in a area of their facility lobby where it will be visible to patients, patient significant others and visitors. Findings included... During a tour of the facility’s waiting area on 04/04/2025, at approximately 2:19 PM, the surveyor observed that there was no posting of the State Agency and/or Dialysis Network 5 contact information. An enquiry was made with Employee #2, the Administrator, regarding State Agency contact information. A tour of the waiting area was conducted that showed there was no information for the state agency, Patients Right, and the Network 5 contact information visibly posted in the patient waiting room area. The administrator found incomplete contact information in a front office that did not include the State Agency correct contact information or the Network 5 contact information, plus the patient rights information. It should be noted that the documents presented did not have the current new address for the state agency, the Patient Rights information, and the writing on the signage was not visible to patients or anyone in the waiting room area because they were kept in the office behind a window. This observation was made and acknowledged by Employee #2, [Facility Administrator] on 04/04/2025, at approximately 2:25 PM, when he observed with the surveyor that contact the current information for the agencies mentioned above signage was not posted in a visible area of the facility waiting room area. During interviews of patients this surveyor conducted a face-to-face interview with one (1) patient [Patient#9] on 04/7/2025 and he stated, “I want to know how to contact state agency if I had to report a problem with dialysis treatment. He further stated there used to have the contact information in the waiting area to make a complaint about the facility to the state agency, but it is not there anymore”. A face-to-face interview conducted with the Employee#3 [Charge Nurse] on 04/11/2025, at approximately 2:00PM. She acknowledged the findings.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 27513 Based on a review of the Vaccination/ Report record for 11 sampled patients and 26 supplemental patients and an interview with the Charge Nurse, showed that facility staff failed to offer and to have immunization histories for Pneumococcal vaccines be tracked to include the following 19 patient’s immunization history for Pneumococcal documentation of the patient’s status as recommended by CDC. (Patients #1, #5, #9, #14, #20, #21, #23, #27 #28, #29, #30, #31, #32, #33, #34, #35, #36, #37, #38.) Findings include ... The Center for Disease Control and Prevention (CDC) recommends that all dialysis patients: “ ... Be offered the Influenza and Pneumococcal vaccine and have immunization histories for these vaccines to be tracked. Both are universally recommended for this population and relate directly to infection control issues.” On 04/09/2026, a review of the Vaccination/Test Result Report record showed the following: 1.The Pneumonia Vaccination Report record showed that 12 patients [1, #5, #20, #23, #27, #30, #31, #32, #34, #35, #37, and #38] vaccination result had no history of being vaccinated. Their Pneumococcal vaccine information received read, “The patient has no current pneumococcal vaccinations documented”, this indicated “not Done” 2. The Pneumonia Vaccination Report record showed that seven (7) patients vaccination result had no history that the Patient’s expired vaccination was updated after 5 years for the following dates. 1.Patient #9 vaccination was given on 01/21/2019 and has expired in 2024. 2.Patient #14 vaccination was given on 09/07/2015 and has expired in 2020. 3.Patient #21 vaccination was given on 05/11/2017 and has expired in 2022. 4.Patient #28 vaccination was given on 10/04/2019 and has expired in 2024. 5.Patient #29 vaccination was given on 10/09/2018 and has expired in 2023 6.Patient #33 vaccination was given on 01/21/2019 and has expired in 2024 7.Patient #36 vaccination was given on 05/19/2019 and has expired in 2024 It should be noted that there was no documented evidence that the patients were offered the Pneumococcal vaccine immunization and that the Pneumococcal records were tracked to document immunization status in the clinical record of the patients mentioned above, and no in accordance with the CDC recommended guidelines. A face-to-face interview was conducted with Employee#3 [Charge Nurse] on 04/11/2025, at approximately 2:00 PM. She acknowledged the findings.”

“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: 27513 Based on five (5) of 11 patient sampled record reviews, and interviews with the Charge Nurse, the facility staff failed to ensure that five (5) patients prescribed dry weight were achieved post their dialysis treatment. (Patient #1, #2, #4, #6, and #9) The Findings Include ... Facility staff failed to ensure that five (5) sampled patient achieved their prescribed estimated dry weight. (Patient #1, #2, #4, #6, and #9). 1.A review of Patient #1’s treatment flow sheet records dated 03/13/2025, to 04/01/2025 with a prescribed dry weight of 63.0kg showed the following dry weights: 03/13/2025, Post dry weight 64.9kg 03/15/2025, Post dry weight 65.5kg It is to be noted that change in dry weight to 64.5kg 03/18/ 2025, Post dry weight 65.9kg 03/20/2025, Post dry weight 65.5kg 03/22/2025, Post dry weight 63.7kg 2.A review of Patient #2’s treatment flow sheet records dated 03/14/2025, to 04/02/2025 with a prescribed dry weight of 59kg showed the following dry weights: 03/14/2025, Post dry weight 59.9kg 03/17/2025, Post dry weight 61.4kg 03/19/ 2025, Post dry weight 61.5kg A review of Patient #4’s treatment flow sheet records dated 03/14/2025, to 04/02/2025 with a prescribed dry weight of 53kg showed the following dry weights: 03/24/2025, Post dry weight52.6 03/26/2025, Post dry weight 52.4kg 03/28/2025, Post dry weight 52.1kg 03/31/2025, Post dry weight 51.7kg A review of Patient #6’s treatment flow sheet records dated 03/12/2025, to 04/02/2025 with a prescribed dry weight of 49kg showed the following dry weights: 03/12/2025, Post dry weight 48.3kg 03/15/2025, Post dry weight 48.1kg 03/17/2025, Post dry weight 48.3kg 03/26/2025, Post dry weight 47.5kg 03/28/2025, Post dry weight 48.2kg A review of Patient #9’s treatment flow sheet records dated 03/12/2025, to 04/02/2025 with a prescribed dry weight of 90kg showed the following dry weights: 03/24/2025, Post dry weight 91.2kg 03/26/2025, Post dry weight 91.3kg The evidence showed that facility staff failed to achieve Patient #1, #2, #4, #6 and #9 prescribed estimated dry weight according to the post treatment flow sheets reviewed. A face-to-face interview was conducted on 04/11/2025, at approximately 2:00PM with Employee #3 [Charge Nurse]. She acknowledged the findings.”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 27513 Based on the review of one (1) sampled patients records and 10 supplemental patients and an interview with the Charge Nurse, facility staff failed to ensure that the patient ’ s albumin levels were achieved and sustained according to their established target goals. (Patients #1, #13, #17, #22, #23, #26 #29, #34, #39, #40 and #41). Findings include .... Failed to ensure that albumin levels for 11 Patients were achieved and sustained according to their established target goals as follow: 1.Review of the Dialysis Lab Report for Patient #1 showed that the Albumin level goals of greater than 4.0 were not met for the following dates: 01/09/2025 albumin level was 3.9, 02/11/2025 Albumin level was 3.6, and 03/06/2025 Albumin level was 3.5. 2. Review of the Dialysis Lab Report for Patient #13 showed that the Albumin level goals of greater than 4.0 were not met for the following dates: 01/25/2025 Albumin level was 3.9, 02/27/2025 Albumin level was 3.8, and 03/06/2025 Albumin level was 3.8, 3. Review of the Dialysis Lab Report for Patient #17 showed that the Albumin level goals of greater than 4.0 were not met for the following dates 01/07/2025 albumin level was 2.9, and 02/05/2025 Albumin level was 2.9, and 03/07/2025 Albumin level was 3.0. 4. Review of the Dialysis Lab Report for Patient #22 showed that the Albumin level goals of greater than 4.0 were not met for the following dates 01/08/2025 Albumin level was 3.5, 02/05/2025 was 3.5, and 03/05/2025 Albumin level was 3.5. 5. Review of the Dialysis Lab Report for Patient #23 showed that the Albumin level goals of greater than 4.0 were not met for the following dates 01/09/2025 Albumin level was 3.8, and 02/06/2025 Albumin level was 3.5, and 03/13/2025 albumin level was 3.8. 6. Review of the Dialysis Lab Report for Patient #26 showed that the Albumin level goals of greater than 4.0 were not met for the following dates 01/08/2025 Albumin level was 3.8, 02/05/2025 Albumin level was 3.7, and 03/05/2025 albumin level was 3.5. 7. Review of the Dialysis Lab Report for Patient #29 showed that the Albumin level goals of greater than 4.0 were not met for the following dates 01/09/2025 Albumin level was 3.7, 02/06/2025 Albumin level was 3.7, and 03/06/2025 albumin level was 3.9. 8. Review of the Dialysis Lab Report for Patient #34 showed that the Albumin level goals of greater than 4.0 were not met for the following dates 01/08/2025 Albumin level was 3.8, 02/06/2025 Albumin level was 3.8, and 03/06/2025 albumin level was 3.8 9.Review of the Dialysis Lab Report for Patient #39 showed that the Albumin level goals of greater than 4.0 were not met for the following dates 01/08/2025 Albumin level was 3.9, 02/05/2025 Albumin level was 3.8, and 03/05/2025 albumin level was 3.9 10.Review of the Dialysis Lab Report for Patient #40 showed that the Albumin level goals of greater than 4.0 were not met for the following dates 01/08/2025 Albumin level was 3.3, 02/05/2025 Albumin level was 3.7, and 03/05/2025 albumin level was 3.7 11. Review of the Dialysis Lab Report for Patient #41 showed that the Albumin level goals of greater than 4.0 were not met for the following dates 01/08/2025 Albumin level was 3.7, 02/05/2025 Albumin level was 3.5, and 03/05/2025 albumin level was 3.6 The evidence showed that facility staff failed to ensure the patient ’ s albumin levels were achieved and sustained according to the established target goals of patients (#1, #13, #17, #22, #23, #26, #29, #34, #39, #40 and #41) as mentioned above. A face-to-face interview was conducted on 04/11/2025, at approximately 02:00PM with the Employee#3 [Charge Nurse]. She acknowledged the findings.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 27513 Based on reviews of two (2) of 11 sampled patient and six (6) supplemental patients clinical records and interview with the Charge Nurse, facility staff failed to ensure that the 8 patients received adequate dosage of Erythropoietin Stimulating Agent medication (ESA) to maintain their anemia management needs. (Patient #1, # 3, #13, #14, #15, #16, #17, and #18,) The findings include ... A review of the Lab Results/Medication Administration Summary record showed that facility staff failed to ensure that the 11 patients Erythropoietin Stimulating Agent medication (ESA) maintained their anemia management needs by maintaining clinical target level (10 -12 g/dl). 1. A review of Patient #1’s clinical record showed the Hemoglobin [Hgb] lab values on 01/23/25 was 8.9, 02/20/25 was 7.6, and 03/20/25 was 8.6. 2. A review of Patient #3’s medical record showed the Hemoglobin lab values on 01/09/25 was 9.8, 02/06/2025 was 9.2, and 03/06/2025 was 9.6. 3. A review of Patient #13’s clinical record showed the Hemoglobin [Hgb] lab values on 01/30/25 was 8.2, 02/27/2025 was 9.1, and 03/20/2025 was 9.7. 3. A review of Patient #4’s clinical record showed the Hemoglobin [Hgb] lab values on 01/03/25 was 13.2, 02/12/2025 was 12.8, and 03/26/2025 was 12.9. 4. A review of Patient #14’s clinical record showed the Hemoglobin [Hgb] lab values on 01/09/2025 was 8.8, 02/06/2025 was 9.5, and 03/06/2025 was 9.2. 5. A review of Patient #15’s clinical record showed the Hemoglobin [Hgb] lab values on 01/16/2025 was 9.9, 02/06/2025 was 9.8, and 3/5/2025 was 7.8. 6. A review of Patient #16’s clinical record showed the Hemoglobin [Hgb] lab values on 02/27/2025 was 6.5, and 03/20/2025 was 7.9. 7. A review of Patient #17’s clinical record showed the Hemoglobin [Hgb] lab values on 01/19/2025 was 9.0, 02/16/2025 was 8.7, and 03/16/2025 was 9.8. 8. A review of Patient #18s clinical record showed the Hemoglobin [Hgb] lab values on 01/23/2025 was 12.5, 02/20/2025 was 13.4, and 03/20/2025, was 12.7. It should be noted that the Lab Results / Medication Administration Summary Record of Hb [hemoglobin] values were not found within the range of 10-12 g/dL for the patients mentioned above anemia management. The evidence of Hb values show that over 2/3 months facility staff failed to ensure that the administration of the Patients mentioned above Erythropoietin Stimulating Agent medication (ESA) maintained the anemia level management within the clinical range of 10-12g/dL. According to CMS National Coverage Analysis Erythropoietin Stimulating Agents (ESA) for Treatment of Anemia in Adults with Chronic Kidney Disease (CKD) Including Patients on Dialysis and Patients not on Dialysis: “... With the use of ESAs in the anemic CKD patient, Hb [hemoglobin] values are well maintained and blood transfusions, with their associated risks, are reduced. When patients with anemia of CKD are treated to HB levels greater than 12 g/dL, there appears to be a greater risk for adverse outcomes compared to patients treated to Hb targets less than 12 g/dL. The current labels for ESAs marketed in the United States provide guidance on the appropriate Hb range for patients with chronic renal failure and dosage and administration guidance to initiate and maintain the HB within the range of 10-12 g/dL for all these patients.” www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/0715PhillipsComment.pdf A face-to-face interview was conducted on 04/11/2025 at approximately 2:00PM with Employee #3 [Charge Nurse]. She acknowledged the findings.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 27513 Based on a review of one (1) of 11 sampled patient’s clinical record and an interview with the Charge Nurse, facility staff failed to ensure that the Plans of Care (POC) were completed and signed by the Dietitian. (Patients #6). The findings include: A review of Patient #6’s clinical record showed that the patient was admitted to the dialysis center on 01/19/2023. The annual POC dated 09/11/2023 on the clinical record showed that at the space allotted for the dietitian to sign and date was left blank indicating not done. A face-to-face interview was conducted on 04/11/2025, at approximately 2:00PM with Employee#3 [Charge Nurse]. She acknowledged the findings and stated, “I will the Dietitian to sign the POC.””

“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: 27513 Based on the review of nine (9) of 11 sampled patient Treatment Detail Records and interview with the Charge Nurse, facility staff failed to maintain a complete, and accurate record of the seven patients’ replacement fluid as it pertains to the dialysis treatment record. (Patient #1, #2, #3, #4, #5, #6, #7, #8, and #9) The findings include ... 1.A review of Patient #1’s Treatment Details Report sheets dated from March 13, 2025, to April 1, 2025, showed that the patient had 10 treatments completed. The treatment flow sheet of the dates mentioned showed that nine (9) of the 10 treatment flow sheet showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicating that the amount of normal saline fluid given during the priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was not documented as given, indicating “not done”. 2. A review of Patient #2’s Treatment Details Report flow sheets dated from March 13, 2024, to April 2, 2024, showed that the patient had 12 treatments completed. Ten of the 12 treatment flow sheets showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicating that the amount of normal saline fluid given during the priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was not documented as given, indicating “not done”. 3. A review of Patient #3 Treatment Details Report sheets dated from 03/13/2025, to 04/01/2025, showed that the patient had nine (9) treatments completed. Two (2) of seven (7) treatment flow sheet showed the space allotted for documentation of fluid given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was left “blank” indicating “not done”. 4. A review of Patient#4’s Treatment Details Report sheets dated from 03/12/2025, to 04/02/2025, showed that the patient had 10 completed. Two (2) of 10 treatment detailed flow sheet showed that the space allotted for documentation of fluids given during the priming and the rinse back process for the dialysis treatment was left blank, indicating “not done”. 5. A review of Patient#5’s Treatment Details Report sheets dated from 03/15/2025 to 04/01/2025, showed that the patient had 10 treatments completed. The10 of 10 treatment sheets showed the space allotted for documentation of fluid given during the priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was not documented as given but was left “blank” indicating “not done”. 6. A review of Patient#6’s Treatment Details Report sheets dated from 03/12/2025, to 04/02/2025, showed that 8 treatments were completed. Two of eight treatment sheets showed the space allotted for documentation of fluid given during the priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was not documented as given but was left “blank” indicating “not done”. 7. A review of Patient#7 Treatment Details Report sheets dated from 03/12/2025, to 04/02/2025, showed that 10 treatments were completed. Five of ten treatment sheet dated mentioned above showed the space allotted for documentation of fluid given during the priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was not documented as given but left blank indicating “not done”. 8. A review of Patient#8 Treatment Details Report sheets dated from 03/13/2025 to 04/01/2025, 2024, showed that 9 treatments were completed. The 9 treatment flow sheets showed the space allotted for documentation of fluid given during the priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was not documented as given but was left “blank” indicating “not done”. 9. A review of Patient#9 Treatment Details Report sheets dated from 03/12/2025, to 04/02/2025, showed that 10 treatments were completed. The 10 treatment flow sheets showed the space allotted for documentation of saline fluid given during the priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was not documented as given but was left “blank” indicating “not done”. It should be noted that the saline fluid needs to be documented in Realtime [has it happens] because it is for treatment, the administration date, the amount and time the saline were administered. The Treatment Details Report sheets mentioned above for Patients #1, #2, #3, #4, #5, #6, #7, #8. and #9, showed evidence that facility staff failed to maintain a complete, and accurate record of the patients’ replacement fluid as it pertains to the dialysis treatment record during the priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment. The area under “Saline” allotted to document the amount of saline fluid administer during treatment was left Blank indicating “not done”. A face-to-face interview was conducted on 04/11/202 at approximately 2:00 PM with Employee #3 [charge nurse]. She acknowledged the findings and stated “The patients are receiving 250ml of saline fluid during initiation of dialysis, and at termination of dialysis another 250ml of saline fluids, equaling 500ml of normal saline unless otherwise throughout treatment (cramping or blood pressure drop, patient unresponsive) where fluids are given. We are using a new computer program here at Davita we do not have to document the time the or the amount of fluids being administered during treatment when it is done again.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 27513 Based on interviews and record reviews with Charge Nurse, it was determined that the facility failed to ensure that an adequate number of qualified personnel are available whenever patients are undergoing dialysis so that the three (3) to one (1) patient to staff ratio is adhered to at all times. The findings include: In accordance, with the policy interpretation of patient/staff ratio in the dialysis Units or facilities in the District of Columbia “... the ratio of patients to staff will be “ a maximum of three (3) patients for every staff member “(or equivalent language), “ staff member “ shall mean a registered nurse, a licensed practical nurse or a patient care technician. A charge nurse, or other staff member who is in charge of a unit or in charge of the facility, shall not be counted in the patient/staff ratio. Staff responsible for direct patient care, i.e., staff counted in the patient/staff ratio, must be available at all times for direct patient duties “. A review of the Daily Shift Assignment sheets and the Facility Labor Management sheet [Punch in-out record] for the time 03/24/2025 - 04/09/2025 showed four (4) days when the Dialysis recorded inadequate staffing. 1.Monday, March 24, 2025, daily shift assignment scheduled, showed that there were one (1) RN, one (1) LPN, and four (4) Certified Clinical Hemodialysis Technicians (CCHT) with 16 patients on the second shift that was confirmed by the Facility Labor Management sheet [Punch in-out record] The daily assignment showed the Employee#9 [LPN] was assigned four (4) patients on the second shift. All the other 4 CCHTs were assigned to three (3) patients to one (1) staff each on the second shift. 2.Wednesday, March 26, 2025, showed that there were one (1) RN, one (1) LPN, and three (3) Certified Clinical Hemodialysis Technicians (CCHT) with 13 patients on the first shift and 14 patients on the second shift. The daily assignment showed the one Employee#10 [CCHT] was assigned four (4) patients on the first shift, and another one (1) CCHT Employee#11 [CCHT] was assigned four patients on the second shift. All other CCHTs /LPN were assigned to three (3) patients to one (1) staff each on both the first and second shifts. 3.Friday, March 28, 2025, showed that there were one (1) RN, one (1) LPN and four (4) Certified Clinical Hemodialysis Technicians (CCHT) with 16 patients on the second shift. The daily assignment showed the one Employee#12 [CCHT] was assigned four (4) patients on the second shift. All other CCHTs /LPN were assigned to three (3) patients to one (1) staff each on the second shift. 4. Saturday, April 05, 2025, showed that there were one (1) RN, one (1) LPN and Three (3) Certified Clinical Hemodialysis Technicians (CCHT) with 17 patients on the first shift. The daily assignment showed the one Employee#13 [CCHT] assigned to four (4) patients and nondocumented Employee#14 was assigned four (4) patients each on the first shift. All other CCHTs/LPN were assigned to three (3) patients to one (1) staff each on the second shift. It should be noted that Nondocumented Employee #14 had no staff assigned to four Patients. Also documented information that read, “[staff name] will be in 2nd shift”. A face-to-face interview was conducted on 04/11/2025, at approximately 2:00 PM with Employee#3 [Charge Nurse]. After reviewing the schedule mentioned above, they acknowledged the findings, and stated, “staff called out and sometimes call will be in late”.”