Davita La Plata Dialysis

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 47759 Based on the overall findings of the survey, the facility’s governing body failed to ensure that staff members adhered to the established written prescriptions for all patients as well as conducted individualize patient assessments for all patients. These failures placed the affected patients at potential risk of harm, denied the affected patients the right to a minimum standard of medical care, and resulted in a determination that the facility was out of compliance with the Condition for Coverage (CfC: 494.80) for Patient Assessment. Findings Included: 1. The facility’s governing body failed to ensure that the dialysis treatment provided to patients B and K was in accordance with the written prescription. Cross Reference: Patient Assessment- Appropriateness of dialysis prescription (V0503) 2. The facility’s governing body failed to ensure that patients’ hematologic status were evaluated for their individual anemia management needs. Cross Reference: Patient Assessment-Assess Anemia (V0507) 3. The facility’s governing body failed to ensure that patients who recently had a significant change in psychosocial needs receive re-evaluation of psychosocial needs by a social worker. Cross Reference: Patient Assessment-MSW Psychosocial Needs (V0510) 4. The facility’s governing body failed to ensure that patients who were recently hospitalized for falls were re-evaluated to prevent and/or reduce future hospitalizations. Cross reference: Patient Assessment-Evaluation of Current Physical Activity level/physical rehab (V0515)”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 47759 Based on the overall findings of this survey, the facility’s governing body failed to ensure that 1) all staff members are knowledgeable on how to document adverse events and felt safe from retaliation when documenting adverse event occurrences; and 2) the facility’s Interdisciplinary team discussed problems that have been identified in the facility, taking into account the prevalence, severity, and prioritizing improvement activities. These failures denied the patients their rights for quality and effective care, placed patients at risk of harm, and resulted in a determination that the facility was out of compliance with the Condition for Coverage (CfC: 494.110) for Quality Assessment and Performance Improvement. Findings Included: 1. The facility’s governing body failed to ensure that staff members were knowledgeable on how to document adverse event occurrences and felt safe from retaliation when documenting adverse event occurrences. Cross Reference: QAPI-Indicator-Medical Injuries/errors (V0634). 2. The facility’s governing body failed to ensure that the facility staff discussed problems that have been identified in the facility, taking into account the prevalence, severity, and prioritizing improvement activities. Cross Reference-QAPI-Prioritizing improvement activities (V0639).”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the standards of care related to hand hygiene requirements were complied with by the clinical staff. This failure placed patients at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Findings included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01), page 1 number 1 determined that the policy stated, “All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves ...d. after patient and dialysis delivery system contact ...f. between patients even if the contact is casual.” Page 2 number 7 stated, “Disposable gloves will be changed when:... ii. When going from a “dirty” area or task to a “clean” area or task.” On 05/12/2025, during observations of the clinical treatment area, the surveyor observed the following: 1. At 10:01 a.m., the surveyor observed Staff #1 fail to perform hand hygiene after glove change. 2. At 11:12 a.m., the surveyor observed Staff #1 fail to perform glove change while transitioning from the patient machine to direct patient care. 3. At 11:45 a.m., the surveyor observed Staff #1 use the same gloves from Station #2 to address Station #3 machine alarm. 4. At 11:51 a.m., the surveyor observed Staff #2 fail to perform hand hygiene after glove change.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that: 1) personal protective equipment (PPE) was properly worn in the treatment area, and 2) protective footwear was properly worn in the treatment area. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to staff members, as well as patients. Findings Included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01) determined that page 2 number 6 stated, “Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physician (NPP) and visitors when in the treatment area.” According to Occupation Safety and Health Administration (OSHA), employers must ensure employees wear protective footwear when exposed to hazards like falling or rolling objects, or punctures. On 05/12/2025 at 10:04 a.m., during observations of the treatment floor, the surveyor observed the following: 1. Staff #1 with a gown that was not completely buttoned. 2. Staff #4 wearing shoes with holes.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews and review of facility’s policies and procedures, the facility’s governing body failed to ensure that the disinfection log provided to staff members was accurate and met the requirement set forth by the facility. This failure placed patients at potential risk of harm due to possible exposure to blood-borne pathogens and infectious diseases. Findings included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Fresenius Dialysis Delivery System Cleaning and Disinfection Policy” (Policy 1-15-01) determined that page 2 number 7 stated, “at a minimum the facility specific log must include the following elements: Serial number ...Teammate initials ...Signature/initials legend...” On 05/12/2025 between 01:00 p.m. - 03:00 p.m., the surveyor completed interviews with the Bio-Medical Personnel and a review of the “Dialysis Delivery System Disinfect Log” from 04/02/2025-05/09/2025. According to the Bio-Med Personnel, the Dialysis Delivery System Disinfect Log: 1) Did not provide information which machines were disinfected; 2) Solely accounted for 19 out of 21 machines in use at the facility; 3) Provided the wrong machine serial number on the legend.”

“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: 47759 Based on observations, staff interview, and review of the facility’s policies and procedures, the facility’s governing body failed to ensure susceptible patients with X<10 Hepatitis B Antibody (HBsAb) complete antigen testing monthly. This failure placed patients and staff at risk of contracting infectious diseases. Findings Included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” (Policy 1-05-02) determined that page 3 stated that susceptible patients with X<10 Hepatitis B Antibody (HBsAb) must have Hepatitis B Antigen (HBsAg) testing done monthly. On 05/14/2025 at 10:00 a.m., during record review of the facility’s Hepatitis B Audit Report, the surveyor observed that 13 out of the 14 (93%) susceptible patients with a HBsAB <10 did not have April 2025 HBsAg results. According to the Manager of Clinical Services, the company had a system disruption that led to issues obtaining laboratory test results within the company. As a result, the facility staff members were advised to use an alternative resource for laboratory testing; however, the facility was not able to present the surveyor the results for the 13 patients.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47759 Based on observations and review of policies and procedures, the facility’s governing body failed to ensure that staff utilized aseptic technique when accessing central venous catheters. This failure places the affected patients at an increased risk of infection(s). Findings Included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps procedure” (Procedure 1-04-02 B) determined that page 2 states, “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason.” Page 5 number 16 states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly...minimize the time it is open.” Page 4 number 8 states, “clean exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol swab for a minimum of 30 seconds...Then wait 60 seconds for air dry time.” Between 05/09/2025 and 05/12/2025, during observations of the clinical treatment floor, the surveyor observed the following: 1. On 05/09/2025 at 10:30 a.m., during CVC termination of the patient connected to machine #11- Station #5, the surveyor observed Staff #3 disconnect the blood line from the patient’s CVC and flush the patient’s CVC prior to disinfecting the patient’s CVC. 2. On 05/09/2025 at 11:31 a.m., during CVC initiation of the patient connected to machine #18 station #4, the surveyor observed Staff #2 disinfect the patient’s exit site with an alcohol pad for 12 seconds. 3. On 05/12/2025 at 09:54 a.m., during CVC initiation of the patient connected to machine #8 station #8, the surveyor observed Staff #2 disinfect the patient’s exit site for 13 seconds as well as disinfect the CVC hub for 5 seconds each. 4. On 05/12/2025 at 10:20 a.m., during CVC termination of the patient connected to machine #3 station #5, the surveyor observed Staff #2 not perform CVC hub disinfection. 5. On 05/12/2025 at 11:52 a.m., during CVC initiation of the patient connected to machine #5-station #3, the surveyor observed Staff #2 disinfect the patient’s exit site for 9 seconds and the CVC hub for 3 seconds each.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and review of facility’s policies and procedures, the facility’s governing body failed to ensure the Granuflo Batch Production Record mixing log documentation was complete. This failure placed patients at risk of potential harm. Findings Included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Granuflo Concentrate Dissolution Unit (132 Gallon) Mixing Procedure” (Procedure 1-20-04 A) determined that page 3 number 7 stated, “Operator and Licensed Nurse must compare Catalog Number on Granuflo boxes to verify they are the same and then document on the Granuflo Batch Production Record where indicated.” Page 7 number 21 stated, “Using the chart provided, review the acceptable limits for the specific gravity based on formulation and temperature of the concentrate. Document the hydrometer and temperature reading on the Granuflo Batch Production Record where indicated. Be certain that the Licensed Nurse has observed both of the tests, documentation of test results and the specific gravity acceptable limits.” On 05/12/2025 between 01:00 p.m. -03:00 p.m., review of the “Granuflo (132) Batch Production Record” from 02/10/2025-04/25/2025 revealed the following: 1. For 04/25/2025, the surveyor observed that the licensed nurse signature line on page 1 number 8, which attests to the verification of the catalog numbers were the same, was left blank. 2. For 03/07/2025, the surveyor observed that the licensed nurse signature lines on page 1 numbers 14 and 15, which attests to the verification of the hydrometer and temperature reading on the Granuflo Batch Production Record, were left blank. Interviews with the Bio-Med personnel revealed that the nurse should have signed the records as an attestation that the procedure witnessed was performed correctly.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 47759 Based on interviews, observations, and record reviews, the facility’s governing body failed to ensure that 1) the dialysis facility maintained a safe environment where patients were treated with respect by staff members and patients, and 2) machine alarms were tended to in a prompt manner as to ensure comfort in the dialysis facility. This failure denied the patients their right to a minimum standard of medical care. Findings Included: According to the National Kidney Foundation’s Dialysis Patients’ Bill of Rights and Responsibilities, page 4 number 3 stated that as an individual, “You have the right to ...Be treated with dignity, respect, and consideration.” According to the Occupational Safety and Health Administration (OSHA), dialysis sessions can last several hours, and a quiet atmosphere helps patients rest, relax, or even sleep during treatment, which can reduce stress and anxiety. A quiet environment is crucial in dialysis because excessive noise can negatively impact patient and staff well-being, potentially affecting treatment outcomes and overall safety. Noise can interfere with patient concentration, exacerbate existing conditions, and contribute to stress and burnout among staff, ultimately leading to increased risks of medical errors and reduced quality of care. 1) On 05/12/2025 at 10:26 a.m., the surveyor observed a patient sitting at Station #2 with another patient who was receiving treatment at Station #19. During the observation, the surveyor observed the patient from Station #19 search the patient sitting at Station #2’s bag. This incident occurred in the presence of Staff #1 who was with the patient at Station #2. Unsure of the two patients’ relationship, the surveyor interviewed the patient at Station #2 to ask if the occurrence was a friendly interaction. The patient at Station #2 stated no, and that the occurrence had made him/her feel “uncomfortable” and was not an isolated incident. According to the patient, the patient who sits at Station #19 goes through his/her bag and takes candies. This information was immediately brought to the Facility Administrator’s attention, who stated that Staff #1 should have intervened. 2) On 05/12/2025 at 10:44 a.m., after some of the patients had been taken off their machines, the surveyor observed that the machines continued to alarm for 10 consecutive minutes without staff members addressing them. This incident was witnessed by the Facility Administrator who immediately instructed the staff members to address the alarms. According to an anonymous patient, staff members are not prompt at addressing machine alarms because they know there are no patients connected: however, the sound can be disturbing to those who simply want to rest.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47759 Based on observations, staff interview, and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the dialysis treatment provided to patients B and K was in accordance with the written prescription. This failure placed the affected patients at potential risk of harm and denied patients their rights to a minimum standard of medical care. Findings Included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” (Policy 1-03-08) determined that page 2 number 3 stated, “The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: ...d. Ultrafiltration Rate (UFR) and Maximum UFR.” Page 4 number 10 stated, “If the dialysis prescription is not being met ...the reason will be documented and the licensed nurse informed.” Number 12 stated, “The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status.” Number 13 stated, “All findings, interventions and patient response will be documented in the patient’s medical record.” Under “Abnormal Findings,” the policy stated, “Unless other abnormal parameters are established by the facility governing body and documented in the governing body meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient ’ s medical record.” Those abnormal findings include “If unable to obtain patient weight, the nurse is to contact physician for orders ....Removal goal not to exceed maximum ordered by physician.” 1. On 05/12/2025 at 01:00 p.m., during observations of the treatment floor, the surveyor observed that Patient B was unwell and had started to vomit. Review of the treatment flowsheet of Patient B dated 05/12/2025 revealed the following: a. The maximum UFR ordered by the physician was 13.0 mL/kg/hr, which calculates to a maximum hourly UFR of approximately 630 mL per hour. The following documentation was signed by Staff #8 at 12:33 p.m., “I verify that the patient ’ s prescription matches what is currently being delivered during the dialysis treatment.” b. The UFR was set at the following rates at the following times: i. From 11:57 a.m.-12:31 p.m., UFR was recorded as “1,000” ii. At 01:00 p.m., UFR was recorded as “1,150.” c. In response to the patient being unwell, the UFR rate was decreased. The second nurse then reverified the prescription and set UFR rate to the prescribed rate. d. Manager of Clinical Services along with the Facility Administrator did an immediate in-service on the staff members involved in care of Patient B. 2. From 05/09/2025 through 05/16/2025, interviews with 2 out of 7 staff members revealed concerns about timely verification of physician orders. 3. Further investigation revealed multiple instances of noncompliance with Patient K ’ s UFR orders. a. Review of 19 treatment flowsheets of Patient K from 04/2025 through 05/14/2025 revealed that the UFR was not followed in 4 out of 19 instances (21%) despite the Registered Nurse verification of the UFR. i. For example: On 05/09/2025, the maximum Ultrafiltration rate ordered by the provider was 14mL/kg/hr. Actual UFR revealed a UFR of 16mL/kg/hr with hourly UFR documented as 1140 mL/hr from 06:36 a.m. - 09:31 a.m. 4. On 05/16/2025, an interview with the Medical Director revealed that staff members were instructed to follow provider orders and not exceed the maximum UFR. According to the Medical Director, noncompliance with the maximum UFR can lead to signs and symptoms such as hypotension, cramping, cardiac arrhythmias, coronary ischemia, and angina.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 47759 Based on staff interview and record review, the facility’s governing body failed to ensure that patients’ hematologic status were evaluated for their individual anemia management needs. This failure placed patients at potential risk for rehospitalization. Findings Included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 12-16-01) determined that page 1 number 2 stated, “The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs.” 1. On 05/13/2025 between 11:00 a.m.-12:00 p.m., review of Patient C’s medical record revealed the following: a. Hemoglobin Lab trend from 02/23/2025-05/04/2025 revealed the following: i. 02/24/2025-9.5 L ii. 03/10/2025-7.2 L iii. 03/21/2025-8.6 L iv. 03/24/2025-8.3 L v. 03/26/2025-7.8 L vi. 04/02/2025-7.5 L vii. 05/07/2025-9.6 L viii. 05/09/2025-8.7 L b. Patient Note revealed that Patient C was hospitalized on 3/17/2025 and received a blood transfusion due to symptomatic anemia. c. Hospital log revealed that Patient C was hospitalized again on 04/25/2025 due to Gastrointestinal bleeding. d. Patient Notes from 03/21 through 05/12/2025 revealed no documentation of discussions regarding patient’s past hospitalization and/or discussions of other causes of hypo-response. 2. On 05/13/2025 between 11:00 a.m.-12:00 p.m., review of Patient I’s medical record revealed the following: a. Hemoglobin Lab trend from 03/03/2025-03/31/2025 revealed the following: i. 03/03/2025- 12.6 L ii. 03/14/2025- 9.3 L iii. 03/23/2025- 7.7 L iv. 03/24/2025- 7.7 L v. 03/26/2025- 7.7 L vi. 03/31/2025- 7.8 L b. Hospitalizations and Treatment Behaviors log for March 2025 revealed that the patient was hospitalized from 03/07/2025-03/13/2025, discharged, and readmitted again on 03/17/2025-03/22/2025. c. Patient Notes from 02/17/2025-03/19/2025 revealed no documentation of discussions regarding patient ’ s past hospitalization and/or discussions of other causes of hypo-response. d. According to the notes written by Staff #8 on 03/19/2025, “Hemoglobin is in range for patient.” On 05/13/2025 between 11:00 a.m.-12:00 p.m., Interviews with Staff #8 stated that the patient hemoglobin trend and action plan is handled by the “Anemia Manager.” On 05/16/2025, Interviews with the Medical Director revealed that the responsibility for assessing the factors related to anemia does not lie solely with the Anemia Manager; rather, it is a shared responsibility among the entire Interdisciplinary team.”

“PA-MSW-PSYCHOSOCIAL NEEDS CFR(s): 494.80(a)(7) The patient’s comprehensive assessment must include, but is not limited to, the following: (7) Evaluation of psychosocial needs by a social worker. This Standard is not met as evidenced by: 47759 Based on record review and staff interview, the facility’s governing body failed to ensure that patients who recently had a significant change in psychosocial needs receive re-evaluation of psychosocial needs by a social worker. This failure placed the affected patients at risk of potential harm by failing to utilize the information gathered to identify potential problems resulting in delays in helpful interventions. Findings Included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 12-16-01) determined that page 2 number 7 stated, “A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: at least monthly for unstable patients including, but not limited to, patients with the following: ...significant change in psychosocial needs.” On 05/13/2025 between 09:00 a.m.- 10:00 a.m., review of the hospitalization records revealed hospitalizations with the reason “psych” written on the hospitalization log. Review of the hospital discharge summary identified “chief complaint: overdose/bradycardia.” Review of the patient’s PHQ-9 (Patient Health Questionnaire-9 questionnaire) revealed the last completion date as 05/01/2024 as well as KDQOL (Kidney Disease Quality of Life questionnaire) as 02/14/2025. Interviews with the Manager of Clinical Services revealed that there should have been a re-assessment conducted after the first knowledge of patient suspected attempt of suicide.”

“PA-EVAL CURRENT PHYS ACT LVL/VOC/PHYS REHAB CFR(s): 494.80(a)(12), (13) The patient’s comprehensive assessment must include, but is not limited to, the following: (12) Evaluation of current patient physical activity level. (13) Evaluation for referral to vocational and physical rehabilitation services. This Standard is not met as evidenced by: 47759 Based on interviews and record review, the facility’s governing body failed to ensure that patients who were recently hospitalized for falls were re-evaluated to prevent and/or reduce future hospitalizations. This failure placed the affected patient at risk for falls in the future. Findings Included: On 05/13/2025 between 09:00 a.m.- 10:00 a.m., review of the hospitalization records revealed falls of Patient F on 01/30/2025 and 04/05/2025. According to the fall risk and mobility assessment of Patient F, the patient was last assessed and educated on risk factors and prevention on 06/19/2024. No fall risk and mobility reassessment or referral to vocational and physical rehabilitation services has been made since then. Interviews with the Manager of Clinical Services revealed that there should have been a re-assessment conducted after the first knowledge of patient fall to serve as an intervention to prevent falls in the future.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the clinical staff members complied with the facility’s access assessment and cannulation protocol. This failure placed patients at potential risk for infection. Findings Included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Arteriovenous Fistula (AVF) or Arteriovenous Graft (AVG) Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (Policy 1-04-01E) determined that Page 2 provided a list of effective contact time with the minimum contact time as 30 seconds for Providone Iodine and 60 seconds for both ExSept Plus and Isopropyl Alcohol 70%. Page 3 number 13 stated, “Do not palpate insertion site once area has been prepped.” On 05/12/2025, during observation of AVF/AVG treatment initiation, the surveyor observed the following: 1. At 11:05 a.m., Staff #5 disinfected the patient’s access at Station #8 Machine #8 and then palpated the patient’s access site prior to cannulation 2. At 11:13 a.m., Staff #1 disinfected the patient’s access at Station #1 Machine #1 for 10 seconds total.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that 1) staff members were knowledgeable on how to document adverse event occurrences; and 2) staff members felt safe from retaliation when documenting adverse event occurrences. These failures placed patients at potential risk of harm, possibly delaying interventions aimed at improvement. Findings Included: On 05/16/2025 at 12:45 p.m., review of the facility’s policy titled “Risk Event Reporting Policy” (Policy 13-01-02) determined that page 1 number 2 and 3 stated, “All risk events will be promptly reported to the Facility Administrator/Manager or designee. The teammate involved in the risk event or who witnessed the risk event firsthand will complete a Risk Event Management (REM) Report. The teammate will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened .... Risk Event Management (REM) Reports are to be completed by DaVita teammates only.” Facility Policy titled “Continuous Quality Improvement Program” (Policy 01-14-06) determined that page 2 number 7 stated, “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: Patient Safety including: -Review of sentinel events, review of trends of adverse patient occurrences.” On 05/16/2025 at 10:00 a.m., the surveyor received information regarding an incident that occurred on 03/10/2025. According to the anonymous staff member, medication was not given to Patient L due to missed administration. Record review of the treatment flowsheet dated 03/10/2025 confirmed the anonymous staff member’s concern. According to the flowsheet, Venofer and Micera were not given by Staff #8 due to “missed administration.” Although the medication was given the following treatment day, according to the Manager of Clinical Services, the incident should have been documented on the Risk Event Management (REM) report either by the anonymous staff member or Staff #8. On the same day, the surveyor received additional information regarding incidents of non-compliance related to provider order and untimely prescription verification by nurses. As an example, the anonymous staff member provided Patient K (See Vtag 503 for more information). According to the Manager of Clinical Services, the example provided was another example of an incident that should have been documented on the REM. From 05/09/2025 to 05/16/2025, interviews with 2 out of 4 staff members revealed that staff members do not know how to document Adverse Event occurrences and relayed to the surveyor that they would appreciate further education. Interviews with the anonymous staff member revealed that the reason for the lack of documentation was fear of retaliation and lack of knowledge. On 05/16/2025, interviews with the Medical Director and the Facility Administrator indicated that the facility’s practice for adverse event reporting is for patient care technicians to relay adverse event concerns to the Charge Nurse. Review of the facility policy, however, revealed that all staff members are responsible for reporting concerning events. According to the Facility Administrator, a reiteration of “If you see something, say something” will be emphasized to all staff members.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 47759 Based on staff interviews and record reviews, the facility’s governing body failed to ensure that the interdisciplinary team discussed problems that have been identified in the facility, taking into account the prevalence, severity, and prioritizing improvement activities. This failure compromised the opportunity to improve the quality of care being provided at the facility and denied patients’ their rights to a minimum standard of medical care. Findings Included: On 05/16/2025, at 02:00 p.m., record review of the facility’s health record (FHR) also known as Quality Assurance and Performance Improvement (QAPI) from January through March revealed the following: 1. Hospitalization a. FHR data for January revealed no documentation of discussions identifying potential problems that may be causing high hospitalization rate nor identifying opportunities to decrease hospitalization rate. b. FHR data for February revealed the following: i. From March 2024 through October 2024, and again in December 2025 and January 2025 hospitalization rate remained x>1. ii. Under root cause outcomes of concerns, it stated “No outcomes of concern.” iii. Under active interventions, it stated “There are no active interventions.” c. FHR data for March revealed documentation that stated, “RN monitors hospital admits. Speak with MD to see how to keep patients out of hospital.” i. On 05/13/2025, review of 3 random patients (Patients C, H, and I) that were hospitalized in March showed no documentation of reassessments performed after hospitalization. d. On 05/13/2025, in an interview, the Manager of Clinical Services stated that a reassessment should be conducted every time a patient is hospitalized to determine if there are ways in which hospitalization can be prevented in the future. 2. Adverse Event a. Review of the Adverse Event log revealed 5 adverse event occurrences in March 2025 that were documented. FHR data for March 2025 revealed no documentation of discussions of adverse event occurrences.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and review of the facility’s policies and procedures, the medical director failed to ensure that the staff members adhered to the facility’s policies and procedures. This failure posed a potential risk of safety to the patients, and denied patients their rights to a minimum standard of medical care. Findings Included: On 05/27/2025, review of the facility’s “Medical Director Agreement” under “Physician Duties” determined that page 28 number 7 letter g stated that the Medical director shall: “assure that patient care policies and procedures are followed by each person who treats patients.” The Medical Director’s signature on the “Medical Director Agreement” and interviews conducted on 05/16/2025 at 01:00 p.m. both confirmed awareness of the duties outlined in the agreement. 1. On 05/12/2025, observations of Staff #1 and #2 revealed instances of non compliance with the hand hygiene requirement of the facility. This finding failed to meet the facility’s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01). 2. On 05/16/2025, observations of Staff #1 and #4 revealed instances of non compliance with the PPE requirement of the facility. This finding failed to meet the facility’s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01). 3. On 05/12/2025, review of the facility’s dialysis delivery system disinfect log revealed failure to ensure that the disinfection log provided to staff members were accurate and met the requirement set forth by the facility. This finding failed to meet the facility’s policy titled “Fresenius Dialysis Delivery System Cleaning and Disinfection Policy” (Policy 1-15-01). 4. On 05/14/2025, record review of the facility’s Hepatitis B audit report revealed failure to ensure susceptible patients with X<10 Hepatitis B Antibody (HBsAb) complete antigen testing monthly. This finding failed to meet the facility’s policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” (Policy 1-05-02). 5. Between 05/09/2025 and 05/12/2025, observations of the treatment floor revealed failure to ensure that staff utilized aseptic technique when accessing central venous catheters. This finding failed to meet the facility’s policy titled “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps procedure” (Procedure 1-04-02 B). 6. On 05/12/2025, review of the “Granuflo (132) Batch Production Record” from 02/10/2025-04/25/2025 revealed failure to ensure that the Granuflo Batch Production Record mixing log documentation was complete. This finding failed to meet the facility’s policy titled “Granuflo Concentrate Dissolution Unit (132 Gallon) Mixing Procedure” (Procedure 1-20-04 A). 7. During the survey process, observations, record review, and staff interviews revealed failure to ensure that the dialysis treatment provided to patients B and K was in accordance with the written prescription. This finding failed to meet the facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment.” (Policy 1-03-08). 8. During the survey process, observations, record review, and staff interviews revealed failure to ensure that patients’ hematologic status were evaluated for their individual anemia management needs. This finding failed to meet the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 12-16-01). 9. On 05/13/2025, review of medical records of Patient H revealed failure to ensure that patients who recently had a significant change in psychosocial needs receive reevaluation of psychosocial needs by a social worker. This finding failed to meet the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (Policy 12-16-01). 10. On 05/12/2025, observations of the treatment floor revealed failure to ensure that clinical staff members complied with the facility’s access assessment and cannulation protocol. This finding failed to meet the facility’s policy titled “Arteriovenous Fistula (AVF) or Arteriovenous Graft (AVG) Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (Policy 1-04-01E). 11. On 05/16/2025, observations and staff interviews revealed failure to ensure that 1) staff members were knowledgeable on how to document adverse event occurrences, and 2) staff members felt safe from retaliation when documenting adverse event occurrences. These findings failed to meet the facility’s policy titled “Risk Event Reporting Policy” (Policy 13-01-02).”