Davita Lake Tapps Dialysis

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 49119 . Based on document review and interviews, the facility failed to ensure that each patient’s plan of care was followed according to facility policy and clinical standards. Failure to follow facility policy and clinical standards related to patient plan of care places patients at risk of receiving inadequate or unsafe care, resulting in patient harm. The cumulative effect of these systemic problems results in the facility’s inability to provide care in a safe environment and is evidence that this Condition for Coverage is NOT MET. (Reference: Tags V541, V543, V554, V556, V557, V560) .”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to provide training in emergency preparedness policies and procedures for all new and existing staff in 5 of 5 personnel files reviewed (Staff #601, #602, #611, #612, and #613). Failure to provide emergency preparedness training and clinical emergency protocols for all new and existing staff places patients and staff at risk of harm during emergencies related to inadequately prepared staff. Findings included: 1. Document review of the facility document titled “Facility Emergency Management Plan,” last revised 10/24, showed that all staff must receive education about the facility’s emergency management plan upon hire and then annually. 2. Document review of personnel files showed no evidence of facility emergency management plan training for the following: - A Registered Nurse (RN) (Staff #601) hired 12/27/22. - A Registered Dietician (RD) (Staff #602) hired 02/19/24. - A Patient Care Technician (PCT) (Staff #611) hired 08/31/22. - A PCT (Staff #612) hired 10/28/24. - A Social Worker (SW)(Staff #613) hired 09/19/22. 3. On 01/24/25 at 5:40 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), Regional Operations Director (Staff #115), Medical Director (Staff #117), and Group Facility Administrator (Staff #118), regarding staff emergency preparation training. Staff #105, #115, #117, and #118 acknowledged that personnel file review showed no evidence of facility emergency management plan training on hire or annually in 5 of 5 files reviewed. .”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to complete documentation of emergency preparedness training for patients in 5 of 6 patient medical records reviewed (Patients #637, #642, #644, #653, and #671). Failure to provide emergency preparedness training to patients places them at risk for harm during emergencies related to inadequate knowledge of emergency procedures. Findings included: 1. Document review of the facility document titled “Facility Emergency Management Plan,” last revised 10/24, showed that all patients must receive annual emergency preparedness education. 2. Document review of patient medical records showed the following: - Patient #637, admitted to the facility on 09/09/23, showed no evidence of the required contact information or the date the training occurred. - Patient # 642, admitted to the facility on 09/21/23, showed no evidence of the required contact information or the date the training occurred. - Patient # 644, admitted to the facility on 01/27/21, showed no evidence of emergency training since 06/17/22. - Patient #653, admitted to the facility on 10/01/24, showed no evidence of the date the emergency preparedness education occurred. - Patient #671, admitted to the facility on 12/08/24, showed no evidence of emergency preparedness education. 3. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), Regional Operations Director (Staff #115), Medical Director (Staff #117), and Group Facility Administrator (Staff #118) regarding patient emergency preparedness training. Staff #105, #115, #117, and #118 confirmed the facility failed to complete documentation of emergency preparedness training for patients in 5 of 5 patient medical records reviewed. .”

“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: 49119 . Based on document review, observation, and interview, the facility failed to ensure that all staff followed facility policies and procedures for glove use and hand hygiene. Failure to change gloves and perform hand hygiene places patients at risk for exposure to and transmission of infectious agents. Findings included: 1. Document review of the facility policy titled “Infection Control for Dialysis Facilities,” last revised 04/23, showed that disposable gloves must be worn by staff during patient care and when touching equipment at the dialysis station. Hand hygiene must be performed following: - Before gloving and immediately after removal of gloves. - After interacting with the dialysis machine. - When exiting the patient’s treatment area. 2. On 01/21/25 at 09:45 AM, Surveyor #1 observed a Patient Care Technician (PCT) (Staff #111) initiate dialysis treatment for Patient #169 at Station #2. The observation showed Staff #111 typing on the Station #2 keyboard and repeatedly using a partially gloved index finger to enter data on the dialysis machine without performing hand hygiene or wearing gloves correctly. 3. On 01/21/25 at 4:15 PM, Surveyor #1 interviewed the Facility Administrator (Staff #105) and Clinical Services Manager (Staff #114) regarding the observed glove use and hand hygiene practices. Staff #105 and Staff #114 acknowledged the observations and confirmed that staff failed to follow infection control policies. .”

“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: 49119 . Based on document review, observation, and interview, the facility failed to ensure staff followed facility policies and procedures for mask use during patient care. Failure to follow facility policies and procedures for mask use while in the patient treatment area places patients and staff at risk of potential exposures. Findings included: 1. Document review of the facility policy titled “Infection Control for Dialysis Facilities,” last revised 04/23, showed that staff are to use personal protective equipment (PPE) appropriately during patient care. 2. Document review of the facility document titled “Annual Skills Checklist In-Center (PCT),” last revised 04/21, showed that staff are to demonstrate proper use of PPE barrier precautions, including putting on a mask. 3. On 01/21/25 at 11:20 AM, observations showed that a Patient Care Technician (PCT) (Staff # 611) wore a mask below their nose while caring for Patient #653 at dialysis station #6. 4. On 01/21/25 at 11:55 AM, observations showed that a PCT, Staff # 611, wore a mask below their nose while caring for Patient #642 at dialysis station #3. 5. On 01/21/25 at 3:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff 105), Regional Operations Director (Staff #115), Medical Director (Staff #117), and Group Facility Administrator (Staff #118) regarding staff not using PPE appropriately. Staff #105, #115, #117, and #118 confirmed that Staff #111 wore a mask below their nose while caring for patients. .”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 49119 . Based on document review, observation, and interview, the facility failed to follow standard infection control precautions for the handling and disposal of infectious waste. Failure to follow standard infection control precautions for the handling and disposal of infectious waste places staff and patients at risk of potential harm from exposure and transmission of infectious agents. Findings included: 1. Document review of the facility policies titled “Medical Waste Management Plan,” last revised 10/23, showed that staff must appropriately dispose of gauze sponges contaminated with blood. 2. On 01/21/25 between 2:45 PM and 3 PM, Surveyor #1 observed a Patient Care Technician (PCT) (Staff #111) remove 2 pressure dressings from Patient #161 arteriovenous fistula site and discarded the 2 blood-soaked gauzes into the wastepaper basket. 3. On 01/21/25 at 4:15 PM, Surveyor #1 interviewed the Facility Administrator (Staff #105) and Clinical Services Manager (Staff #114) regarding the appropriate receptacle for biohazard waste disposal. Staff #105 and Staff #114 stated that biohazard bins must be used when disposing of medical supplies contaminated with blood. .”

“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: 49119 . Based on document review and interview, the facility failed to document the vaccination of all susceptible staff members against the Hepatitis B Virus (HBV). Failure to vaccinate all susceptible staff members against HBV places patients and staff at risk of infection with HBV. Findings included: 1. Document review of the facility policy titled “Teammate Health Monitoring Program,” last revised 04/19, showed that teammates would be screened for HBV and offered an HBV vaccination. 2. Document review of personnel files showed no HBV vaccination screening documentation for the following. - A Registered Nurse (RN) (Staff #601) hired 12/27/22. - A Social Worker (SW) (Staff #613) hired 09/19/22 3. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff 105), Regional Operations Director (Staff #115), Medical Director (Staff #117), and Group Facility Administrator (Staff #118) regarding staff missing HBV vaccination screening. Staff #105, #115, #117, and #118 confirmed that 2 of 5 personnel files were missing documentation of HBV vaccination screening. .”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to implement infection control policies and activities by failing to ensure all personnel completed a baseline tuberculosis (TB) risk assessment consistent with Centers for Disease Control and Prevention (CDC) guidelines in 3 of 5 personnel files reviewed (Staff #602, #612, and #613) (1) and failing to implement infection control policies for vaccine storage (2). Failure to implement infection control policies and activities places patients and staff at risk for exposure to infections agents. Reference: Centers for Disease Control and Prevention. “Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers and Association and CDC,” (2019). “The 2005 CDC recommendations for baseline testing U.S. health care personnel have been updated and now include: TB Screening with an individual risk assessment and symptom evaluation at baseline, TB testing with an interferon-gamma release assay (IGRA) or a (2 step) TB skin test.” Findings included: Item #1 - TB Risk Assessment 1. Document review of the facility policy titled “Tuberculosis Monitoring and Follow-Up,” last revised 10/24, showed that all staff will complete a baseline TB test and a baseline and annual TB Risk Assessment and Symptom Evaluation Questionnaire. 2. Document review of personnel files showed no TB risk assessment documented for the following: - A Registered Dietician (RD) (Staff 602) hired 02/19/24. - A Patient Care Technician (PCT) Staff #612) hired 10/28/24. - A Social Worker (SW) (Staff #613) hired 09/19/22 3. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), Regional Operations Director (Staff #115), Medical Director (Staff #117), and Group Facility Administrator (Staff #118) regarding staff TB screening. Staff #105, #115, #117, and #118 confirmed that the personnel file review showed no evidence of a TB risk assessment in 3 of 5 files reviewed. Item #2 - Vaccine Storage 1. Document review of the facility policy titled “Medications Requiring Refrigeration,” last revised 10/22, showed that staff are to follow Centers for Disease Control (CDC) guidelines and store vaccines in their original packaging, within a designated storage tray, and 2-3 inches from the refrigerator walls. 2. On 01/21/25 at 11:15 AM, Surveyor #1 observed the facility’s medication storage area. The observation showed that vaccines stored in a medication-designated refrigerator were not placed in a designated storage tray. The vaccine packaging was wet with condensation from resting against the refrigerator’s interior. 3. On 01/21/25 at 3:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), Regional Operations Director (Staff #115), Medical Director (Staff #117), and Group Facility Administrator (Staff #118) regarding vaccine storage in the medication refrigerator. Staff #105, #115, #117, and #118 confirmed that refrigerated vaccines were not stored in compliance with guidelines. .”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 49119 . Based on document review, observation, and interview, the facility failed to ensure that staff members followed infection prevention technique standards, policies, and procedures during central venous catheter (CVC)-related care (1) and failed to monitor CVC exit site for manifestations suggesting infection in 1 of 6 patient medical records reviewed (Patient #371) (2). Failure to ensure that staff members follow infection prevention technique standards, policies, and procedures when working with a patient’s CVC risks infection of the access site, which can result in serious patient harm. Findings included: Item #1- CVC Related Care 1. Document review of the facility policy titled “Central Venous Catheter (CVC) Care,” last revised 10/22, showed that CVC care requires staff to use an aseptic technique while performing CVC-related procedures and the effective contact time of 15 seconds when cleaning CVC hubs. 2. On 01/21/25 at 11:55 AM, Surveyor #6 observed a Patient Care Technician (PCT) (Staff#611) during a CVC dressing change on Patient #642. The observations showed that Patient #642’s clothing contacted the clean site during cleanser drying time. Staff #611 placed a clean dressing over the contaminated CVC site. Staff #611 cleaned the CVC hub for 10 seconds. 3. On 01/21/25 at 3:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #605), Regional Operations Director (Staff #615), Medical Director (Staff #617), and Group Facility Administrator (Staff #618) regarding staff members not following infection prevention technique standards, policies, and procedures during CVC-related care. Staff #605, #615, #617, and #618 confirmed that staff are required to follow infection prevention technique standards, policies, and procedures during CVC-related care. Item #2 - CVC Exit Site Monitoring 1. Document review of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised 04/24, showed that when staff identify possible symptoms of vascular access infection, such as swelling, redness, warmth, or other change, a nurse must assess the access. 2. Document review of patient #308’s medical records showed no evidence of a nurse assessment when the following possible symptoms of infection were documented: - On 01/16/25, a PCT (Staff #308) documented that Patient #371’s CVC exit site was red and that the patient noted itching at the exit site. - On 01/18/25, a PCT (Staff #308) documented that Patient #371’s CVC exit site was red. - On 01/21/25, a PCT (Staff #308) documented that Patient #371’s CVC exit site was red and that the patient noted itching at the exit site. 3. On 01/24/25 at 2:34 PM, Surveyor #3 interviewed the Facility Administrator (Staff #305), Regional Operations Director (Staff #315), Medical Director (Staff #317), and Group Facility Administrator (Staff #318) regarding the CVC exit site assessment. Staff #305, #315, #317, and #318 acknowledged that a review of patient medical records showed that nurses did not assess vascular access related to symptoms of infection in the above medical record. .”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 49119 . Based on document review and interviews, the facility failed to ensure each patient received a comprehensive assessment of their current health status, medical condition, and co-morbidities for 3 of 6 patient medical records reviewed (Patient #137, #142, and #144). Failure to ensure that providers complete a comprehensive health screening and medical condition assessment places patients at risk for harm from undetected medical concerns and unanticipated health outcomes. Findings included: 1. Document review of the facility document titled “Medical Staff Bylaws,” last approved 05/21, showed that each provider must have a documented physical evaluation and examination on admission and every 30 days thereafter. The monthly comprehensive care note must include an assessment and evaluation of the patient’s current health needs, diagnosis, comorbidities, laboratory results, transplant status, dialysis prescription, dialysis access evaluation, and education. 2. Document review of the facility policies titled, “History and Physical (H&P) Policy,” last revised 10/21, and “Progress Notes Policy,” last revised 10/24, showed that all patients must have on file a comprehensive H&P within 30 days of admission by the provider, which includes the patient’s clinical presentation, current medications, hospitalizations, medical history, and health status. Every 30 days, the provider must provide the interdisciplinary team with clinical status updates by documenting in the progress notes any clinical events. 3. Document review of patient medical records showed the following: - On 10/02/24, a Provider (Staff #119) documented an initial assessment of Patient #142 without a complete physical exam, medical conditions, or comorbid conditions. On 11/15/24, 12/26/24, and 01/14/25 Staff #119 documented a monthly assessment without completing a physical exam. - On 01/18/25 a Provider (Staff #117) documented a monthly assessment of Patient #137 without addressing the patient’s post dialysis cardiac arrest that occurred on 01/07/25, the recent 3-day hospitalization, or newly prescribed hypertension medication. - A Provider (Staff #122) did not document an assessment for Patient #144 for the month of September 2024. 4. On 01/23/25 at 5:03 PM, Surveyor #1 interviewed a Provider (Staff #117). Staff #117 stated they were aware of Patient #137’s cardiac arrest, hospitalization, and new changes in blood pressure medication. Staff #117 failed to document recent health events in the patients’ comprehensive assessment. 5. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding the physician documentation. Staff #105, #117, and #118 confirmed that patient medical record review failed to show current health status and medical conditions and list comorbid conditions in the comprehensive assessments for 3 of 6 patient medical records reviewed. .”

“PA-TRANSPLANTATION REFERRAL CFR(s): 494.80(a)(10) The patient’s comprehensive assessment must include, but is not limited to, the following: (10) Evaluation of suitability for a transplantation referral, based on criteria developed by the prospective transplantation center and its surgeon(s). If the patient is not suitable for transplantation referral, the basis for nonreferral must be documented in the patient’s medical record. This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to ensure each patient’s comprehensive assessment included evaluation of suitability for transplantation referral, based on criteria developed by prospective transplantation centers, and documentation of the basis for non-referral of unsuitable patients in the patient’s medical record in 6 of 6 patient medical records reviewed (Patients #337, #342, #344, #353, #359, and #371). Failure to ensure each patient’s comprehensive assessment includes evaluation of suitability for transplantation referral based on transplantation center criteria, and to document the basis for non-referral of unsuitable patients in the patient’s medical record, places patients at risk of not receiving a renal transplant. Findings included: 1. Document review of the facility’s policies titled “Social Work Intervention and Documentation Requirements,” last revised 10/23, and “Transplant Referral and Tracking Process,” last revised 10/24, showed that patient comprehensive assessments, the first of which must occur within 30 days of admission to the facility, must address patient transplant suitability evaluation. The interdisciplinary team (IDT) must educate patients on all local transplant center’s referral criteria, and eligibility concerns must be documented in the patient’s medical record. 2. Document review of an untitled, undated document of patient transplant tracking provided by the facility showed that the document listed barriers to patient transplantation, including substance use, age, body mass index, and comorbidities, but showed no evidence the assessment was based on transplantation centers’ criteria. 3. Document review of current IDT comprehensive assessments showed no evidence of patient evaluation based on transplantation center criteria or eligibility concerns for the following: - Patient #337, admitted to the facility on 09/29/23. - Patient #342, admitted to the facility on 09/21/23. - Patient #344, admitted to the facility 01/27/21. - Patient #353, admitted to the facility 10/01/24. - Patient #369, admitted to the facility on 01/04/24. - Patient #371, admitted to the facility on 12/08/24. 4. On 01/24/25 at 2:34 PM, Surveyor #3 interviewed the Facility Administrator (Staff #305), Regional Operations Director (Staff #315), Medical Director (Staff #317), and Group Facility Administrator (Staff #318) regarding comprehensive assessment documentation of transplantation suitability. Staff #305, #315, #317, and #318 acknowledged that medical record review showed no evidence of evaluation of suitability for transplantation referral based on transplantation center criteria or eligibility concerns in 6 of 6 records reviewed. .”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to ensure unstable patients received a comprehensive reassessment at least monthly in 2 of 6 patient medical records reviewed (Patient #137 and #144). Failure to ensure unstable patients receive a comprehensive reassessment at least monthly places patients at risk for serious harm related to unidentified needs and inadequate care planning. Findings included: 1. Document review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care (POC),” last revised 10/24, showed that patients determined to be unstable must have a comprehensive reassessment monthly by the IDT until the patient is determined to be stable. 2.Document review of patient medical records showed the following: - On 08/23/24, Patient #137’s IDT documented in the POC that Patient #137 was unstable. Patient #137’s IDT failed to complete a subsequent comprehensive assessment until 10/16/24. - On 11/09/24, Patient #137’s IDT documented in the POC that Patient #137 was unstable. Patient #137’s IDT failed to complete a subsequent comprehensive assessment until 01/14/25. - On 08/27/24, Patient #144’s IDT documented in the POC that Patient #144 was unstable. Patient #144’s IDT failed to complete a subsequent comprehensive assessment until 10/01/24. 3. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding the missing comprehensive assessment. Staff #105, Staff #117, and Staff #118 confirmed that the patient medical record review failed to show timely completion of the monthly comprehensive assessments for 2 of 6 patient medical records reviewed. .”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to develop and implement an individualized plan of care (POC) that identifies the specific care needs and services to stabilize patients’ experiencing uncontrolled high blood pressure and frequent hospitalizations for 1 of 6 patient medical records reviewed (Patient #137). Failure to ensure that the facility implements an individualized POC that identifies the complex care needs of unstable patient, places patients at higher risk of harm from frequent hospitalizations, uncoordinated and unmet care needs. Finding included: 1. Document review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and POC,” last revised 10/24, showed that the IDT is responsible for developing comprehensive and individualized POCs that specify services, care needs, and changes in condition. 2. Document review of patient #137’s medical record showed the following: - On 11/12/24, Patient #137 was hospitalized for leg pain and uncontrolled high blood pressure after not applying a blood pressure patch for 2 weeks. The IDT completed the POC on 11/19/24, which contained no information addressing hospitalization, pain management, or noncompliance with medication regime. - On 01/07/25, Patient #137 received an incorrect dialysate bath, had an initial systolic blood pressure (SB/P) of 221/133, and ongoing high blood pressure during dialysis with no documented nursing assessment, which resulted in cardiac arrest in the facility. On 01/12/25, Patient #137 was hospitalized for hypertension emergency and sternum pain from chest compressions. The IDT completed the POC on 01/14/25, which contained no information addressing dialysate bath, blood pressure, cardiac arrest, recent hospitalization, or new blood pressure medication. 3. On 01/23/25 at 5:03 PM, Surveyor #1 interviewed Patient #137’s Provider (Staff #117). Staff #117 stated they were aware of Patient #137’s cardiac arrest and hospitalization but did not know what blood pressure medication was ordered. 4. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding the IDTs individualized POC. Staff #105, Staff #117, and Staff #118 confirmed that the POC was not customized to the changing and unique needs of the patient. .”

“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: 49119 . Based on document review and interviews, the facility failed to provide the necessary care and services to manage patients’ volume status by failing to notify, assess, and manage patient blood pressure (B/P) and heart rate (HR) per facility policy in 1 of 6 patients medical records reviewed, (Patient #137 (1), Failure to monitor and assess patients estimated dry weight (EDW) after dialysis treatment per facility policy in 1 of 6 patients medical records reviewed (Patient #172)(2), Failing to complete ambulatory patient blood pressure (B/P) assessment before discharge in 2 of 6 patient medical records reviewed (Patient #144 and #153)(3), and failed to adhere to patients’ prescribed dose of dialysis in 1of 6 patient medical records reviewed,(Patient #137)(4). Failure to provide the necessary care and services to manage patients’ orders, vitals, and volume status places patients at higher risk of harm from ineffective dialysis treatments and associated complications. Findings included: Item 1 - B/P and HR Management 1. Document review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised 04/24, and document review of the facility document titled, “Abnormal Findings Job Aid: ICHD/DSD,” last revised 04/24, showed that the facility defined pretreatment and intradialytic systolic B/P (SB/P) greater than 180 millimeters of mercury (mm/Hg) or less than 90 mm/hg, a diastolic B/P (DB/P) greater than 100mm/Hg or less than 50mm/Hg, and a HR greater than 100 beats per minute (B/PM) as abnormal findings. The Patient Care Technician (PCT) must notify the nurse of any abnormal B/P and HR findings. 2. Document review of patient medical records showed the following: - On 01/18/25, a PCT (Staff #103) failed to document a nursing notification of a SB/P greater than 180 mm/Hg and DB/P greater than 100 mm/Hg in 3 of 4 readings on Patient #137. - On 01/20/25, a PCT (Staff #110) failed to document a nursing notification of a DB/P greater than 100 mm/Hg in 4 of 5 readings on Patient #137. 3. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding abnormal vital signs reporting. Staff #105, Staff #117, and Staff #118 acknowledge that the patient medical record review showed missing documentation of nurse notification of abnormal vital signs for the above medical record dates. Item 2 - EDW Assessment 1. Document review of the facility document titled “Abnormal findings Job Aid: ICD/DSD,” last revised 04/24, showed that the PCT must notify the nurse when the patient’s weight or fluid status is above or below target weight. The nurse must complete a nursing assessment, including an assessment of EDW, before discharge. 2. Document review of patient medical records showed the following: - On 01/04/25, Patient #172 discharged 9.1 kilograms (kgs) over their EDW. The Registered Nurse (RN) (Staff #121) failed to assess the patient related to the EDW before discharge. - On 01/07/25, Patient #172 discharged 10.8kgs over their EDW. The RN (Staff #121) failed to assess the patient related to the EDW before discharge. - On 01/14/25, Patient #172 EDW discharged 14.4kgs over their EDW. The RN (Staff #121) failed to assess the patient related to the EDW before discharge. - On 01/18/25, Patient #172 EDW discharged 14.4kgs over their EDW. The RN (Staff #121) failed to assess the patient related to the EDW before discharge. 3. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding the patient being discharged over their EDW without assessments. Staff #105, Staff #117, and Staff #118 acknowledge that patient medical record review showed no evidence of nursing assessments when patients are being discharged over their EDW for the above medical record dates. Item #3 - Discharge Monitoring 1. Document review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised 04/24, showed that patients must have a standing B/P taken at the end of dialysis treatment if the patient is ambulatory. 2. Document review of patient medical records showed the following: -Facility staff documented that Patient #144 left all dialysis treatments ambulatory between 01/01/25 and 01/20/25. There was no evidence of a post-dialysis standing B/P after 8 of 10 Dialysis treatments. -Facility staff documented that Patient #153 left all dialysis treatments ambulatory between 01/01/25 and 01/20/25.There was no evidence of a post-dialysis standing B/P after 3 of 9 Dialysis treatments. 3. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding the monitoring for hypotension upon discharge. Staff #105, Staff #117, and Staff #118 acknowledge that the patient medical record review showed no evidence of standing B/P assessment prior to discharge for ambulatory patients for the above medical record dates. Item #4 - Dose of Dialysis Orders 1. Document review of the facility policies titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised 04/24, “Physician Orders for Patient Care,” last revised 10/24, and “Treatment Initiation Utilizing B Braun Dialog+ Dialysis Delivery Systems with All Single Use Dialyzer Tyes and Streamline Blood Lines,” last revised 10/24, showed that staff must adhere to each patient’s dialysis treatment orders, that patient prescriptions cannot be changed without a physician order, and that a licensed nurse must verify each patient’s dialysis prescription including dialysate composition is correct every dialysis treatment. 2. Document review of patient medical records showed that Patient #337’s ordered dialysate prescription was for potassium at 2.0 millimoles per liter (mmol/L) and calcium at 3.0 milligrams per deciliter (mg/dL). - On 01/07/25, a PCT (Staff #308) documented that due to a dialysate bath shortage, Patient #337 received dialysis with a 2.0 mmol/L potassium and 2.5 mg/dL calcium dialysate bath. - The RN (Staff #321) documented verification of Patient #337’s treatment prescription without addressing that Patient #337 received dialysis with an incorrect calcium dialysate setting and failed to document a physician order for the changed dialysate bath calcium prescription. 3. On 01/24/25 at 5:19 PM, Surveyor #1 interviewed the Medical Director (Staff #117) and the Group Facility Administrator (Staff #118) regarding dose of dialysis. Staff #117 and #118 acknowledged that patient medical record review showed that a changed dialysate bath was used for a patient without a physician order. .”

“POC-TRANSPLANT STATUS PLAN OR WHY NOT CFR(s): 494.90(a)(7)(ii) When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient’s plan of care must include documentation of the- (A) Plan for transplantation, if the patient accepts the transplantation referral; (B) Patient’s decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or (C) Reason(s) for the patient’s nonreferral as a transplantation candidate as documented in accordance with §494.80(a)(10). This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to ensure each patient’s plan of care addressed patient transplant referral candidate status and plan for pursuing transplantation for 7 of 7 patients interested in transplantation referral (Patients #331, #337, #338, #351, #365, #367, and #371). Failure to ensure each patient’s plan of care addresses patient transplant referral candidate status and plan for pursuing transplantation places patients at risk of not receiving a renal transplant. Findings included: 1. Document review of the facility policies titled “Social Work Intervention and Documentation Requirements,” last revised 10/23, and “Transplant Referral and Tracking Process,” last revised 10/24, showed that all patients who express interest in transplantation must be referred to a transplantation center and that a transplant referral plan must be included in each plan of care, the first of which must occur within 30 days of admission to the facility. 2. Document review of an untitled, undated document of patient transplant tracking provided by the facility showed that patients who had expressed interest in transplantation had not been referred to a transplantation center. Plan of care review for the same patients showed no evidence for a transplant referral plan for the following: - Patient #331, admitted to the facility on 06/27/24. - Patient #337, admitted to the facility on 09/29/23. - Patient #338, admitted to the facility on 12/28/23. - Patient #351, admitted to the facility on 06/29/23. - Patient #365, admitted to the facility on 03/22/22. - Patient #367, admitted to the facility on 02/24/21. - Patient #371, admitted to the facility on 12/08/24. 3. On 01/24/25 at 2:34 PM, Surveyor #3 interviewed the Facility Administrator (Staff #305), Regional Operations Director (Staff #315), Medical Director (Staff #317), and Group Facility Administrator (Staff #318) regarding transplant referral candidate interest and plan for pursuing transplantation. Staff #305, #315, #317, and #318 acknowledged that document review of facility patient transplant tracking and patient medical records showed no evidence of referring interested patients to transplantation centers or plan for pursuing transplantation for 7 of 7 patients interested in transplantation referral. .”

“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: 49119 . Based on document reviews and interviews, the facility failed to ensure all members of the interdisciplinary Team (IDT), including the patient/patient’s designees, participated in and signed the plan of care (POC) in 3 of 6 patient medical records reviewed (Patient #137, #142, and #169). Failure to include patients in the creation and implementation of the POC, and failure to ensure all members of the IDT sign each patient’s POC, places patients at risk for having incomplete, inadequate, or unapproved plans of care. Finding included: 1. Document review of the facility policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care (POC),” last revised 10/24, showed that patient POC must be completed and signed by all members of the IDT, including patients within 30 days of initiating a patient. If a patient does not participate in a POC meeting, the IDT must document the reason why the patient/representative did not participate in the POC. 2. Document review of patient medical records showed the following: - The facility’s IDT met to complete Patient #137’s POC on 07/09/24, 08/23/24, 10/16/24, and 11/19/24. The POC signature page contained no signature page for 4 of 4 POCs. - On 06/11/24, the facility’s IDT met to complete Patient #142’s POC, and the patient signature was collected after 30 days on 08/30/24. - On 01/11/24, and 08/27/24, the Facility IDT met to complete Patient #142’s POC. The provider signed both POCs after 30 days on 11/01/24. - On 02/08/24, the facility’s IDT met to complete Patient #169’s POC. The POC stated, “Patient not present at meeting.” The POC signature page contained no information indicating why the patient did not participate or did a review with the patient/representative. The provider signed the POC after 30 days on 11/06/24. 3. On 01/21/25 at 11:35 AM, Surveyor #1 interviewed Patient #169. Patient #169 stated that they do not participate in POC meetings. 4. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding the patient not being included in the POC process and missing or late signatures. Staff #105, Staff #117, and Staff #118 confirmed that the patients’ POC review failed to show patient inclusion or documents why the patient was not present at the POC and confirmed that signatures were not collected within 30 days for 3 of 6 patient medical records reviewed. .”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to initiate a plan of care (POC) within 30 days or within 13 outpatient hemodialysis sessions, in 1 of 6 patient medical records reviewed, (Patient #153). Failure to develop and implement an initial POC places patients at risk for poor health outcomes due to inadequate and inappropriate interventions. Findings included: 1. Document review of the facility policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 10/24, showed that the initial POC must be completed for all new patients within 30 days or within 13 dialysis treatments. 2. Document review of patient medical records showed the following: - Patient #153 was admitted to the facility on 10/01/24. - Patient #153 IDT failed to complete a POC for Patient #153. 3. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding the missing POCs. Staff #105, Staff #117, and Staff #118 confirmed that the IDT team had failed to initiate or complete a POC for a newly admitted patient. .”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to ensure a provider completed a periodic in-facility assessment and evaluation of their patients during hemodialysis for 2 of 6 patients medical records reviewed (Patient #153 and #169). Failure to ensure that each patient is periodically evaluated by their provider during hemodialysis prevents evaluation of the patient’s response to dialysis and places patients at higher risk of receiving inappropriate care and inadequate dialysis treatments. Findings included: 1. Document review of the facility policy titled, “Interdisciplinary team Patient Assessment and POC,” last revised 10/24, and facility document titled ‘Medical Staff Bylaws,” last approved 05/21, showed that each provider must complete an in-person face-to-face evaluation of their in-center hemodialysis patients while on dialysis every 30 days and document progress notes in the patients’ electronic health records (EHR). On rare occasions, the evaluation of patients can be completed in their clinics. 2. Document review of patient medical records showed the following: - A Provider (Staff #120) documented evaluating Patient #153 in the provider’s clinic on 10/1/24, 11/20/24, and 12/23/24. The documentation showed no evidence of an evaluation while the patient was on dialysis during that time frame. - A Provider (Staff #119) documented evaluating Patient #169 in the provider’s clinic on 11/25/24, and over the phone on 10/23/24 and 12/18/24. The documentation showed no evidence of an evaluation while the patient was on dialysis during that time frame. 3. On 01/21/25 at 11:35 AM, Surveyor #1 interviewed Patient #169. Patient #169 stated that their Provider (Staff #119) had never seen the patient at the dialysis facility. 4. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding the providers not doing in-facility visits. Staff #105, Staff #117, and Staff #118 confirmed that not all providers make in- facility evaluations. .”

“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: 49119 . Based on document review and interview, the facility failed to measure, analyze, and track medical injuries and medical errors by failing to analyze patient injuries (1) and failing to fully document medical errors and the implementation of follow-up actions to prevent medical error recurrence (2). Failure to fully measure, analyze, and track medical injuries and medical errors places patients at risk for harm related to unidentified and uncorrected medical risks. Findings included: Item #1 - Medical Injury Analysis 1. Document review of the facility policy titled “Risk Event Reporting Policy (Non-Teammate Related),” last revised 10/24, showed that serious safety events, including cardiac arrest, unexpected hospitalizations, or death, must be reported by the facility administrator to their operational supervisors and to the facility risk manager, and that the risk manager will direct the manager of clinical services to undertake an investigation within 14 days of the occurrence. 2. Document review of a facility risk event report regarding a cardiac arrest within the facility of Patient #337 on 01/07/25 showed no evidence that the Facility Administrator (Staff #105) notified operational supervisors, including the facility Regional Operations Director (Staff #115) and Group Facility Administrator (Staff #118), of the cardiac arrest. The report showed no evidence that the Risk Manager (Staff #120) directed the Manager of Clinical Services (Staff #114) to investigate the event, or that an investigation of the event was conducted. 3. On 01/23/25 at 4:30 PM, Surveyor #1 interviewed the Manager of Clinical Services (Staff #114) and Group Facility Administrator (Staff #118) regarding safety event reporting and investigation. Staff #114 and #118 stated that the facility did not conduct an investigation of the cardiac arrest event on 01/07/25 and that neither of them had been notified of the event. 4. On 01/23/25 at 5:42 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), Manager of Clinical Services (Staff #114), and Group Facility Administrator (Staff #118) regarding safety event reporting and investigation. Staff #105, #114, and #118 stated that the Facility Administrator must notify operational supervisors of serious safety events including cardiac arrest, and that an investigation of serious safety events should be conducted. Item #2 - Medical Error Documentation 1. Document review of the facility policy titled “Risk Event Reporting Policy (Non-Teammate Related),” last revised 10/24, and the undated facility event reporting template titled “Risk Event Management,” showed that events such as injury or potential injury to a patient must have a full report completed, including specification of the affected party and follow-up actions, and be reviewed during facility quality assessment and performance improvement (QAPI) meetings. 2. Document review of facility risk event reports showed that a risk event report, for an unspecified patient receiving dialysis on an incorrect dialysate bath, was documented as complete and closed on 12/21/24. The risk event report showed no evidence that it identified the affected patient or detailed follow-up actions to prevent recurrence. 3. Document review of the facility’s QAPI dashboard and meeting notes showed that the facility’s QAPI committee met on 01/24/25. The QAPI dashboard and meeting notes showed no evidence that the risk event report from 12/21/24 was reviewed or that documentation of affected patient or follow-up actions were noted as missing. 4. On 01/24/25 at 4:33 PM, Surveyors #3 and #6 interviewed the Facility Administrator (Staff #105) and Group Facility Administrator (Staff #118) regarding medical error documentation. Staff #105 and #118 confirmed that review of the facility’s risk event reports and QAPI documentation showed no evidence of patient identification or identification of follow-up actions to prevent recurrence related to the identified risk report. .”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to measure, analyze, and track patient grievances within its quality assessment and performance improvement (QAPI) program. Failure to measure, analyze, and track grievances within a QAPI program places patients at risk of unresolved clinical or safety issues and patient harm. Findings included: 1. Document review of the facility policies titled “Addressing Patient Grievances: DaVita Teammates,” last revised 03/13, and “Continuous Quality Improvement Program,” last revised 04/21, and the undated facility document detailing patient grievance steps titled “Patient Grievance Log,” showed that there must be documentation of discussion between the facility and affected patient related to each grievance filed by a patient, documentation of the final outcome of the grievance, and that all grievances must be measured, analyzed, and tracked within the facility’s QAPI program. 2. Document review of the facility’s patient grievance log showed two grievances filed on 04/18/24 by Patients #376 and #377. 3. Document review of the facility’s QAPI dashboard and meeting notes showed no evidence that the grievances filed on 04/18/24 were analyzed or tracked within QAPI, and no evidence of documented discussion between the facility and affected patients or final grievance outcome. 4. On 01/24/25 at 5:10 PM, Surveyors #3 and #6 interviewed the Facility Administrator (Staff #305) regarding QAPI grievance documentation. Staff #305 confirmed that review of QAPI documentation showed no evidence of facility-patient grievance communication, grievance resolution, or analysis or tracking of filed grievances within QAPI related to the identified grievances. .”

“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: 49119 . Based on document review and interview, the facility failed to measure, analyze, and track infection control quality indicators by failing to maintain oversight of immunization within its quality assessment and performance improvement (QAPI) program. Failure to measure, analyze, and track infection control quality indicators places patients and staff at risk for infection from preventable diseases. Findings included: 1. Document review of the facility policies titled “Continuous Quality Improvement Program,” last revised 01/21, and “Teammate Health Monitoring Program,” last revised 04/19, showed that the facility must monitor staff for infectious disease and immunization status, and must track vaccination rates for immunizations such as Hepatitis B and influenza within the facility’s QAPI program. 2. Document review of the facility’s QAPI documentation and online dashboard showed no evidence that the facility tracked staff immunization status within its QAPI program. 3. On 01/24/25 at 5:10 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), Regional Operations Director (Staff #115), Medical Director (Staff #117), and Group Facility Administrator (Staff #118) regarding immunization tracking. Staff #105, #115, #117, and #118 confirmed that the facility did not track staff immunization status within its QAPI program. .”

“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: 49119 . Based on document review and interview, the facility failed to take actions that resulted in performance improvements and ensure that improvements were sustained over time within its quality assessment and performance improvement (QAPI) program. Failure to take actions that result in performance improvements within a QAPI program places patients at risk for harm related to unaddressed improvement needs. Findings included: 1. Document review of facility policies titled “Continuous Quality Improvement Program,” last revised 04/21, and “Social Work Intervention and Documentation Requirements,” last revised 10/23, showed that the facility social worker must complete a quality of life assessment for all patients within 120 days of admission and then annually. Quality of life assessments must be measured, analyzed, and tracked within the facility’s QAPI program as a quality indicator, and any facility quality indicators identified as underperforming will have an action plan created that will result in performance improvement. 2. Document review of the facility’s QAPI dashboard and meeting notes showed the following: - On 10/06/22, the facility identified that the facility was underperforming by failing to ensure all patients received quality of life assessments within 120 days of admission and annually. - The facility’s performance improvement action plan, initiated on 10/06/22, showed no evidence of action steps or processes by which the facility would improve timeliness of quality of life assessments. - Between 10/06/22 and 01/24/25, the facility was unable to improve the timeliness of quality of life assessments, with quality of life assessments failing to be completed within 120 days and annually for all patients. The facility was unable to resolve the quality of life assessment performance improvement plan. 3. On 01/24/25 at 5:04 PM, Surveyors #3 and #6 interviewed the facility Regional Operations Director (Staff #315) regarding performance improvement actions. Staff #315 stated that the QAPI improvement plan opened for timeliness of quality of life assessments did not identify actions by which the timeliness would be improved, and that improvement had not been met and sustained since the improvement plan was opened 15 months prior. .”

“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: 49119 . Based on document review and interview, the facility failed to set priorities for performance improvement based on identified prevalence and severity of problems, incorporating Centers for Medicare and Medicaid (CMS) data and national thresholds, with priority applied to improvement activities affecting clinical outcomes and patient safety. Failure to set priorities for performance improvement based on identified prevalence and severity of problems, incorporating CMS data and national thresholds, with priority applied to activities affecting clinical outcomes and patient safety places patients at risk for poor health outcomes. Findings included: 1. Document review of the facility policies titled “Continuous Quality Improvement Program,” last revised 04/21, and “Transplant Referral and Tracking Process,” last revised 10/24, showed that the facility will track patient transplant education, referrals, work-up, and waitlist status in the facility’s quality assessment and performance improvement (QAPI) program, and that the facility will identify underperforming quality indicators through measurement, analysis, and tracking, and will review underperforming areas through a root cause analysis. 2. Document review of the facility’s transplant data showed that the facility’s transplant waitlist was 18% lower than the CMS-identified national threshold. 3. Document review of the facility’s QAPI dashboard and meeting notes showed the following: - The facility documented transplant education, referrals, work-up, and waitlist status for only 29 of the facility’s 64 patients on census within QAPI. - The facility did not identify the transplant waitlist below the CMS-identified national threshold or only 29 of 46 patients’ transplant information documented in QAPI as an underperforming area, or perform a root cause analysis of the issue. 4. On 01/24/25 at 4:47 PM, Surveyors #3 and #6 interviewed the Facility Administrator (Staff #305) and Regional Operations Director (Staff #315) regarding transplantation tracking within QAPI. Staff #305 and #315 acknowledged that the facility’s QAPI program showed that transplantation tracking was an underperforming facility quality indicator. .”

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to ensure a nurse manager was responsible for all nursing services within the facility. Failure to ensure a nurse manager is responsible for all nursing services within the facility places patients at risk for harm related to receiving care from unqualified or unsupervised nursing personnel. Findings included: 1. Document review of the undated facility document titled, “Job Description: Clinical Coordinator,” showed that a nurse manager within each facility must be responsible for directing all nursing care and ensuring all nursing staff compliance with policies and appropriate documentation of delivered patient care. 2. Document review of patient medical records between 01/07/25 and 01/24/25 showed that 7 of 8 missing or incorrect nursing documentation was performed by a float Registered Nurse (RN) (Staff #321), based out of a different facility but providing care at the surveyed facility. 3. On 01/24/25 at 12:18 PM, Surveyor #3 interviewed the facility Clinical Coordinator Nurse Manager (Staff #307) regarding nursing documentation and nursing oversight. Staff #307 stated that they do not maintain oversight of float RNs who provide care in the facility, do not educate float RNs on policy compliance or appropriate documentation of delivered care, and had not addressed the missing and incorrect documentation by a float RN noted by Surveyors with the associated float RN. 4. On 12/24/25 at 2:55 PM, Surveyor #3 interviewed the facility Regional Operations Director (Staff #315) regarding float RN oversight. Staff #315 stated that the clinical coordinator nurse manager is responsible for the oversight of all nursing staff, including float RNs, who provide care within their facility. .”

“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: 49119 . Based on document review and interview, the facility failed to maintain complete and accurate medical records by failing to maintain patient assessment provider notes for 3 of 6 patient records reviewed (Patients #144, #153, and #169) (1) and failing to document emergency procedures in patient records (Patient #637) (2). Failure to ensure that providers provide the facility with complete and accurate medical records places patients at risk for harm and delay in care delivery due to outdated assessments. Findings included: Item #1 - Provider Notes 1. Document review of the facility policies titled, “Interdisciplinary team Patient Assessment and POC,” last revised 10/24, “History and Physical (H&P) Policy,” last revised 10/21, “Progress Notes Policy,” last revised 10/24, and facility document titled ‘Medical Staff Bylaws,” last approved05/21, showed that that providers must document history and physical assessments and progress notes in the patients’ electronic health records (EHR). On the rare occasions that patient assessments are completed in the clinic or over telehealth, the provider must promptly provide the facility with a copy of the assessment. 2. Document review of patient medical records showed the following: - The facility had not received a copy of a Provider (Staff #121) monthly assessments and progress notes for Patient #144 completed on 10/04/24, 11/01/24,12/16/24, and 01/09/25. - The facility had not received a copy of a Provider (Staff #120) monthly assessments and progress notes for Patient #153 completed on 10/1/24, 11/20/24, and 12/23/24. - The facility had not received a copy of a Provider (Staff #119) monthly assessments and progress notes for Patient #169 completed on 11/25/24, 10/23/24, and 12/18/24. 3. On 01/22/25 at 11:05 AM, Surveyor #1 interviewed the Group Facility Administrator (Staff #118). Staff #118 stated that facility staff must request the providers’ clinics to fax the completed monthly assessments and progress notes to the facility. 4. On 01/22/25 at 11:56 AM, Surveyor #1 interviewed the Facility Administrator (Staff #105). Staff #105 stated that provider notes are not in the patient EHR and must be faxed over by the providers’ clinics. 5. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #105), the Medical Director (Staff #117), and the Group Facility Administrator (Staff #118) regarding the missing documentation in the patient’s medical records. Staff #105 and Staff #118 stated they had the assessments faxed over after the surveyors requested them. Staff #117 confirmed that the clinics have not been faxing the documents. Item #2 - Emergency Documentation 1. Document review of the facility policy titled “Cardiopulmonary Arrest,” last revised 10/22, showed that the Cardiopulmonary Arrest sheet must be completed for a cardiopulmonary arrest occurring in the facility and must be reviewed and signed by a Registered Nurse (RN). The sheet is to be added to the patient’s medical record. 2. Document review of patient medical records showed that on 01/07/25, Patient #137 experienced a cardiac arrest while in the facility. Patient #137’s medical records showed no evidence that a Cardiopulmonary Arrest sheet was added to the record. 3. On 01/23/25 at 4:05 PM, Surveyor #6 interviewed a Registered Nurse (RN) (Staff #107), who confirmed that the staff member responsible for completing the Cardiopulmonary Arrest sheet did not complete it, that an RN did not review or sign it, and that it was not entered into the patient’s medical record. .”

“GOV-GB RESP FOR STAFF ORIENTATION CFR(s): 494.180(b)(3) The governing body or designated person responsible must ensure that- (3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; This Standard is not met as evidenced by: 49119 . Based on document review and interview, the facility failed to ensure that all staff have documentation of an appropriate orientation to the facility and their work responsibilities in 2 of 5 personnel files reviewed (Staff #601 and #612). Failure to ensure that all staff have an appropriate orientation to the facility and their work responsibilities places patients at risk of receiving improper and inadequate care and services. Findings included: 1. Document review of facility policy titled “Training Programs For New Patient Care Provider Teammates,” last revised 04/22, showed that new teammates would complete modality-specific training requirements before delivering patient care. 2. Document review of personnel files showed no orientation documented for the following: - A Registered Nurse (RN) (Staff #601) hired 12/27/22. - A Patient Care Technician (PCT) (Staff #612) hired 10/28/24. 3. On 01/24/25 at 2:30 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #605), Regional Operations Director (Staff #615), Medical Director (Staff #617), and Group Facility Administrator (Staff #618) regarding 2 of 5 staff not having documentation of completing an orientation. Staff #605, #615, #617, and #618 confirmed that Staff #601 and Staff #612 did not have documentation of completing orientation. .”