Davita Tacoma Dialysis Center

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 49209 . Based on observation and interview, the facility failed to maintain a sanitary environment by failing to ensure the surfaces of the dialysis chairs were intact, wipeable, and sanitary. Failure to maintain cleanable surfaces in high-risk areas risks transmission of blood-borne pathogens and puts patients and staff at risk for infections. Findings include: 1. Document review of the facility’s policy titled, “Infection Control For the Dialysis Center,” dated 04/23, showed that non-disposable items must be cleaned and disinfected after each patient using a bleach solution, ensuring the surface is visibly wet and allowed to air dry. 2. On 09/15/25 at 10:45 AM, Investigator #1 toured the facility. The observation showed the chairs had the following : - Chair no. 3 had cracked vinyl on the back cushion, and seams were showing. - Chair no. 20 had cracked vinyl on the back cushion, a tear on the right armrest, and seams were showing. 3. On 09/15/25 at 12:30 PM, Surveyor #1 interviewed the Manager of Clinical Services (Staff #122) about the unsanitary chairs. Staff #122 confirmed that the upholstery on the chairs was compromised and was porous. .”

“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: 49209 . Based on document review, observation, and interview, the facility failed to follow standard infection control precautions for the disposal of potentially infectious waste. Failure to follow standard infection control precautions for the disposal of potential infectious waste places staff and patients at risk of 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 dialysis staff must dispose of medical waste daily. 2. On 09/15/25 at 1:50 PM, Inspector #1 inspected the isolation room. The observation showed that there was trash and medical waste left inside the room. 3. On 09/15/25 between 1:55 PM and 3:10 PM, Surveyor #1 interviewed the Facility Administrator (Staff #121) and Clinical Services Manager (Staff #122) about the isolation room and waste disposal. Staff #121stated that the isolation room was last used on 09/13/25. Staff #122 confirmed the observation, stating that all trash and medical waste should be removed from the isolation room daily. .”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 49209 . Based on document review, observation, and interview, the facility failed to maintain a safe, functional, and comfortable environment for patients and staff. Failure to maintain a safe, functional, and comfortable environment for patients and staff places patients and staff at risk for harm and unsafe care. Findings included: 1. Document review of facility policy titled, “Teammate Slip, Trip and Fall Prevention Program,” dated 10/23, showed that wet floors increase the risk of trip, slips, and falls within the facility, and staff need to be continuously aware of their surroundings to ensure safety. - Document review of facility policy titled, “Physical Environment,” dated 04/18, showed that staff must maintain a safe, functional, and comfortable treatment environment for patients, staff, and visitors. 2. On 09/15/25 at 10:05 AM, Investigator #1 observed a Patient Care Technician (Staff #127) providing care to a patient in Station 18. The observation showed the following: - Water pooling under the dialysis machine at Station 18, with water spreading into Stations 19 and 17. - Electrical cords from the computers at Stations 19 and 18 were lying in the pooling water. 3. On 09/15/25 at 10:06 AM, Investigator #1 interviewed Staff #127 about the water on the floor. Staff #127 confirmed that dialysis machine #1 at Station 18 was leaking, and the leakage occurs when the dialysis machine recalibrates. 4. On 09/15/25 at 10 AM, Investigator #1 interviewed Bio Medical Staff (Staff #123) about dialysis machine no.1. Staff #123 stated there was no service ticket for machine no.1, and human error was the most common cause of water leakage during recalibration. .”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 49209 . Based on observation and interviews, the facility failed to effectively maintain the building’s plumbing system, resulting in the loss of the floor’s integrity around the drains, promoting microbial growth, and preventing effective cleaning (1) and by failing to ensure its building systems were free from defects, and/or hazards. Failure to maintain the building in a safe operating condition places patients, staff, and visitors at risk for injury and infections from damaged and/or contaminated surfaces. Findings included: Item 1: Drains and flooring 1. Document review of facility policy titled, “Water and/or Potential Mold Intrusion, Remediation and Reconstruction Program,” dated 04/23, showed that water damage, leaks or an alleged presence of water reported by staff must be investigated to determine the scope and extent of the damage. - Review of facility document titled, “BioMed Safety Snapshot - Electric Audit/Questions “ dated 05/25, showed that Biomed staff must monitor and observe for the following: i. Water damage. ii. The presence of mold in patient areas. iii. Brocken floor surfaces. - Review of facility document titled, “BioMed Safety Snapshot - Report,” dated 06/18/25, showed no evidence that the drains were inspected for foul odor or damage flooring from standing water. 2. On 09/15/25 between 09:30 AM and 11:30 AM, Investigator #1 inspected the clinical area. The observation showed that the drains between Stations 2 and 3, Stations 9 and 10, Stations 19 and 20 had standing water, lifting of flooring around the drain, and a foul odor. 3. On 09/15/25 at 11:03 AM, Investigator #1 interviewed a Patient Care Technician (PCT) (Staff #125) who stated that the facility had several drains with foul odors and noted that water was pooling around the drains. 4. On 09/15/25 at 12:45 PM, Investigator #1 interviewed the Facility Administrator (Staff #121) and Clinical Services Manager (Staff #122) about the drains and the flooring. Staff 121 confirmed the above-noted findings.. Item 2: Dialysis delivery system in the chase access panel 1. Document review of facility policy titled, “Physical Environment,” dated 04/18, showed that the facility will maintain the water treatment and dialysis delivery systems according to the manufacturer’s recommendations. - Review of facility document titled, “BioMed Safety Snapshot - Electric Audit/Questions ,” dated 05/25, showed that Biomed staff must check each chase access panel and validate no debris, build-up, or leaks within the chases. - Review of facility document titled, “BioMed Safety Snapshot - Report,” dated 06/18/25, showed no evidence that the chase access panels were inspected, or the presence of acid concentrate buildup or debris. 2. On 09/15/25 at 10:36 AM, Investigator #1 inspected the clinical area with the Biomed staff (Staff #123). The inspection showed acid build-up and black debris in the following stations access panels: - Station 9 - Station 10 - Station 15 - Station 18 - Station 19 - Station 20 3. On 09/15/25 at 10:45 AM, Investigator #1 interviewed Staff #123 about the acid build-up and black debris in the chase access panels. Staff #123 confirmed the findings. 4. On 09/15/25 at 12:45 PM, Investigator #1 interviewed the Facility Administrator (Staff #121) and Clinical Services Manager (Staff #122) about the acid buildup and black debris inside the 6 access panels. Staff #122 confirmed the finding, stating that this should be cleaned routinely. .”

“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: 49209 . Based on document review and interview, the facility failed to document emergency preparedness training for patients in 2of 13 patient medical records reviewed (Patients #132, and #140). Failure to provide emergency preparedness training to patients places patients 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, including emergency contact information. 2. Document review of patient medical records showed the following: - Patient #132, admitted to the facility on 07/18/23, showed no evidence of the date emergency education and training occurred. - Patient #140, admitted to the facility on 05/25/22, showed no evidence of the required emergency contact information or the date emergency education and training occurred. 3. On 02/05/25 at 4:25 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #101), Clinical Services Manager (Staff #102), Charge Nurse (Staff #103) regarding emergency education documentation requirements. Staff #101, #102, and #103 confirmed that patient medical record review showed that annual emergency preparedness training and education were incomplete for 2 of 13 records reviewed. . .”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 49209 . Based on document review, observation, and interview, the facility failed to maintain all equipment in accordance with manufacturer’s recommendations by failing to discard medications by the manufacturer’s expiration date. Failure to maintain equipment in accordance with manufacturer’s recommendations, including expiration dates, places patients at risk of harm and injury from the use of expired products. Findings included: 1. Document review of the facility policy titled, “Medication Policy,” last revised 10/23, showed multidose refrigerated medications should be discarded per manufacturer’s recommendation or discarded 28 days after opening, and that expired medications are not to be used. 2. On 02/05/25 at 11:10 AM, Surveyor #1 observed the facility’s Home Hemodialysis Clinic medication refrigeration storage. The observation showed Tuberculin Purified Protein Derivative (Tubersol) was opened on 12/31/24, with a discard date of 01/30/25. 3. At the time of the observation, the Home Hemodialysis Clinic Registered Nurse (RN) Preceptor (Staff #129) verified that the identified medication was expired and discarded the medication. .”

“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: 49209 . Based on document review and interview, the facility failed to provide the necessary care and services to manage patients’ dose of dialysis by failing to document the rationale for changing the blood flow rate (BFR) during treatment for 2 of 13 patients (Patient #135 and #138) (1), failing to monitor and report to the licensed nurse abnormal vital sign in 3 of 13 patients (Patient #130, #135, and #139) (2), and failing to assess patients not meeting target weight post-treatment before discharge in 2 of 13 medical records reviewed (Patients #133 and #136) (3). Failure to provide the necessary care and services to manage a patient’s dialysis dose, monitor and report abnormal vital signs, and reassess patients with abnormal vital signs place patients at a higher risk of harm from ineffective dialysis treatments and associated complications. Findings included: Item #1: Blood Flow Rate Management 1. Document review of the facility policy titled “Incenter Hemodialysis Policies and Procedures,” last revised 04/24, showed that if the dialysis prescription is not being met, including BFR, the reason will be documented. 2. Document review of patient medical records showed the following: a. On 01/15/25 at 12:31 PM, a Patient Care Technician (PCT) (Staff #119) decreased the BFR for Patient #135 from the prescribed 450 milliliters per minute (mL/min) to 430 mL/min without documenting a rationale. - On 01/15/25 at 12:46 PM, a Registered Nurse (RN) (Staff #113) decreased the BFR for Patient #135 from 430 mL/min to 410 mL/min for the remaining 1 hour and 43 minutes of their treatment without documenting a rationale. b. On 01/20/25 at 1:09 PM, an RN (Staff #113) decreased the BFR for Patient #135 from the prescribed 450 mL/min to 420 mL/min without documenting a rationale. -On 01/20/25 at 1:46 PM, a PCT (Staff #115) decreased the BFR for Patient #135 from 420 mL/min to 350 mL/min for the remaining 45 minutes of their treatment without documenting a rationale. c. On 01/31/25 at 12:02 PM, a PCT (Staff #145) decreased the BFR for Patient #138 from the prescribed 350 mL/min to 300 mL/min without documenting a rationale. Patient #138 ran at 300mL/min for the remaining 57 minutes of their treatment without documenting a rationale. 3. On 02/05/25 at 4:25 PM< Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff#101), Clinical Services Manager (Staff #102), and Charge Nurse (Staff# 103) regarding a change to the BFR during treatment. Staff #101, #102, #103, and #103 confirmed that changes to the BFR during treatment were made without a documented rationale in 2 of 13 patient medical records reviewed. Item #2: Reporting Abnormal Vital Signs 1. Document review of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised 04/24, showed that the facility defined pretreatment and intradialytic systolic blood pressure (SB/P) greater than 180 millimeters of mercury (mm/Hg), a diastolic blood pressure (DB/P) greater than 100mm/Hg, and a heart rate (HR) greater than 100 beats per minute (B/PM) or less than 60 B/PM as abnormal findings. The Patient Care Technician (PCT) must notify the nurse of abnormal blood pressure (BP) and HR findings. 2. Document review of patient medical records showed no evidence of reporting sustained and/or excessively abnormal BP and HR findings to a licensed nurse in the following: - On 01/03/25, 2 PCTs (Staff #121 and #145) failed to document nurse notification of a HR reading less than 60 B/PM for Patient #131 in 6 of 9 HR measurements. - On 01/13/25, a PCT (Staff #119) failed to document nurse notification of a DB/P reading greater than 100 mm/Hg on Patient #135 in 2 of 7 BP measurements (135 mm/Hg and 117 mm/Hg). - On 01/15/25, a PCT (Staff #119) failed to document nurse notification of SB/P readings greater than 180 mm/hg on Patient #135 in 6 of 8 BP measurements. - On 01/17/25, 2 PCT (Staff #119) failed to document nurse notification of S/BP greater than 180 mm/Hg readings and DB/P greater than 100 mm/Hg readings on Patient #135 for 6 of 11 BP measurements. - On 01/23/25, 2 PCTs (Staff #120 and #126) failed to document nurse notification of HR readings less than 60 B/PM on Patient #139 in 7 of 9 HR measurements. - On 01/28/25, a Patient Care Technician (PCT) (Staff #124) failed to document nurse notification of DB/P greater than 100 mm/hg for Patient #130 in 4 of 9 BP measurements. 3. On 02/05/25 at 4:25 pm, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff#101), Clinical Services Manager (Staff #102), and Charge Nurse (Staff# 103), ) regarding the PCT notifying the nurse of any abnormal BP and HR findings. Staff #101, #102, and #103 confirmed that PCTs failed to notify a licensed nurse of abnormal findings in 3 of 13 patient medical records reviewed. Item#3: Report and Reassess Target Weight 1. Document review of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised 04/24, showed that during post-treatment data collection and assessment, any abnormal findings are reported to the nurse, and a re-assessment is to be completed before discharge. Abnormal findings to be reported and assessed include a patient weight of 1 kilogram (kg) or more, above or below their target weight (TW). 2. Document review of patient medical records showed the following: - On 01/23/25 at 9:51 AM, Patient #136 was discharged after dialysis 4.1 kg above TW without the Patient Care Technician (PCT) (Staff #124) documenting nurse notification. The documentation showed no evidence of TW reassessment by the nurse. - On 01/24/25 at 9:45 AM, Patient #136 was discharged after dialysis 2.6 kg above TW without the PCT (Staff #101) documenting nurse notification. The documentation showed no evidence of TW reassessment by the nurse. - On 01/25/25 at 5:02 PM, Patient #133 was discharged 2.3 kg below TW without the PCT (Staff #114) documenting nurse notification. The documentation showed no evidence of TW reassessment by the nurse. - On 01/30/25 at 9:56 AM, Patient #136 was discharged 1.1 kg above TW without the PCT (Staff #114) documenting nurse notification. The documentation showed no evidence of TW reassessment by the nurse. 3. On 02/05/25 at 4:25 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #101), Clinical Services Manager (Staff 102), and Charge Nurse (Staff# 103) regarding patient TW assessment. Staff #101, #102, and #103 confirmed that patients were discharged with abnormal TW findings and no reassessment by a nurse. .”

“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: 49209 . Based on document review and interview, the facility failed to ensure all patients were seen by a provider at least monthly 1 of 2 home dialysis patients’ medical records reviewed (Patient #140). Failure to ensure that all patients are seen by their provider at least monthly 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 document titled “Medical Staff Bylaws,” effective 08/01/21, showed that home dialysis patients must be evaluated once a month by a provider, including a once-per-quarter in-facility evaluation. 2. Document review of Patient #140’s medical records from 08/01/24 to 02/05/25 showed the following: - A Nephrologist (Staff #129) conducted a virtual visit on 08/22/24. - A Nephrologist (Staff #129) conducted a virtual visit on 11/19/24. - The medical record contained no evidence of monthly provider evaluations and no evidence of quarterly in-facility evaluations. 3. On 02/05/25 at 4:25 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #101), Clinical Services Manager (Staff #102), and Charge Nurse (Staff # 103) regarding providers completing monthly evaluations and quarterly an in-facility evaluation of their home dialysis patients. Staff #101, #102, and #103 confirmed that a nephrologist did not evaluate the patient monthly or in-facility once per quarter. .”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 49209 . Based on document review and interviews, the facility failed to measure, analyze, and track quality indicators or other aspects of performance that influence patient outcomes, including mortality (1) failing to identify, analyze, and track data related to equipment failure (2), and failing to track and trend adverse risk events within the quality assessment and performance improvement (QAPI) program (3). Failure to adopt a method to measure, analyze, and track quality indicators for mortality, machine failures and adverse risk events impedes the facilities’ ability to achieve significant improvement and places patients at risk from preventable harm and injury. Findings included: Item #1: Mortality 1. Document review of the facility policy titled, “Continuous Quality Improvement Program,” last revised 04/21, showed that the facility will continuously measure, analyze, and track quality indicators, including mortality. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 2. Document review of the facility’s Facility Health Meetings (FHM)/Quality Assurance and Performance Improvement (QAPI) online dashboard data from February 2024 and January 2025 showed no evidence that the facility identified or analyzed the cause of death in 2 of 2 patient deaths (Patients #142 and #143). 3. On 02/06/25 at 11:55 AM, Surveyor #1 interviewed the Charge Nurse (Staff # 103), who stated they did not collect mortality information on patients who expired in their home. 4. On 02/06/25 at 2:10 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #101), Clinical Services Manager (Staff #102), Charge Nurse (Staff #103) regarding quality indicator measurement, analyzation, and tracking. Staff #101, #102, and #103 confirmed that the facility failed to measure, analyze, and identify patient cause of death for 2 of 2 patient deaths. 5. This is a repeat citation. DOH previously cited the facility for this finding during a 03/28/24 End Stage Renal Disease Facility Recertification Survey. Item #2: Tracking and Monitoring of Dialysis Machine Failure 1. Document review of the facility policy titled, “Risk Event Reporting Policy (Non-Teammate Related),” last revised 10/24, showed that any unexpected event related to routine operations, including equipment failure, must be promptly reported to the facility administrator and an adverse event report submitted. - Document review of the facility policy titled, “Continuous Quality Improvement Program,” last revised 04/21, showed that the facility will continuously measure, analyze, and track quality indicators related to patient safety events. 2. Document review of patient medical records showed the following: -On 01/03/25, at 12:13 PM the Patient Care Technician (Staff #121) documented that dialysis machine #1 failed multiple times during Patient #131 initial set-up. Staff #121 had Patient #131 set-up on a different dialysis machine which caused a 29 minute treatment delay. 3. Document review of the facility’s Risk Event Management (REM) adverse event reports showed no evidence of an adverse event report submitted for dialysis machine failures related to the dialysis machine #1 failure on 01/03/25. 4. On 02/06/25 at 12:30 PM, Surveyors #1, #3, and #6 interviewed the Biomedical Staff (Staff #105) regarding machine failures. Staff #105 stated that an adverse event report must be submitted when there is a dialysis machine failure. Staff #105 confirmed that no work orders or REMs were submitted for dialysis machine #1. 5. On 02/06/25 at 2:10 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #101), Clinical Services Manager (Staff #102), Charge Nurse (Staff #103) regarding adverse event reporting. Staff #102 and Staff #105 confirmed that the facility failed to identify, track, or analyze the dialysis machine failure adverse event. Item #3: Adverse Risk Events reported in quality assessment and performance improvement (QAPI) program. 1. Document review of the facility policy titled, “Continuous Quality Improvement Program,” last revised 04/21, showed that the facility will measure, analyze, and track quality indicators, emergency ambulance transfers, and patient safety risk events. The facility will track performance outcomes verifying improvements are sustained. 2. Document review of facility risk event reports showed the following: - On 08/30/24, Patient #144 experienced a sudden and prolonged period of tachycardia during treatment, requiring transfer by ambulance to a local hospital for treatment. 3. Document review of the facility’s Facility Health Meeting (FHM)/Quality Assessment and Performance Improvement (QAPI) online dashboard showed no evidence that the adverse risk event on 08/30/24 was tracked, trended, or analyzed within the facility’s QAPI program. 4. On 02/06/25 at 2:10 PM, Surveyors #1, #3, and #6 interviewed the Facility Administrator (Staff #101), Clinical Services Manager (Staff #102), Charge Nurse (Staff #103), Registered Dietician (Staff #104), and Biomedical Staff (Staff #105) regarding risk event reporting in QAPI. Staff #101, Staff #102, and Staff #3 confirmed that the facility failed to continuously track, trend, and analyze all adverse risk events in QAPI. .”

“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: 49209 . Based on document review and interview, the facility failed to maintain accurate patient medical records in 2 of 2 medical records containing patient-specific vital sign parameter orders (Patients #131 and #132). Failure to maintain accurate patient medical records places patients at risk for ineffective dialysis and cardiovascular complications. Findings included: 1. Document review of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised 04/24, showed that any abnormal findings, or findings outside of any patient-specific physician order, discovered during pre-treatment data collection will be documented and reported to the licensed nurse. The nurse will use their clinical judgment to determine if any interventions are needed and notify the provider before initiating treatment. 2. Document review of patient medical records showed the following: a. Patient #631 had the following patient-specific treatment parameter order: - Do not initiate treatment and notify a nurse for pre-assessment for a heart rate (HR) above 45 beats per minute (BPM), notify the provider for an intradialytic HR below 45 BPM, and notify the nurse for post-assessment if the HR is above 45 BPM. - 6 of 6 treatment detail reports (01/03/25-02/03/25) reviewed showed no actions taken by staff to follow the patient-specific treatment orders or to clarify these orders with the ordering physician before initiating treatment. b. Patient #632 had the following patient-specific treatment parameter order: - Do not initiate treatment and notify a nurse for a pre-assessment for a HR above 50 BPM and notify a nurse for a post-assessment if the HR is above 50 BPM. - 6 of 6 treatment detail reports (01/22/25-02/03/25) reviewed showed no actions taken by staff to follow the patient-specific treatment orders or to clarify these orders with the ordering physician before initiating treatment. 3. On 02/05/25 at 2:00 PM, Surveyor #6 interviewed the Clinical Services Manager (Staff# 602) regarding staff not following patient-specific physician orders. Staff #602 reported that a recent upgrade to the facility’s electronic medical records system caused the verbiage of orders to be incorrect for 2 of 2 of the medical records reviewed. Staff #602 confirmed that staff did not follow the patient-specific orders or clarify the orders with the ordering physician before initiating treatment for Patients #631 and #632. .”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 45034 . Based on interview and document review, the facility failed to ensure the plan of care for each patient 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 for receiving inadequate or unsafe care, with the resultant risk of 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: Tag V552, V556, V557, V558, V560) .”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 45034 . Based on document review and interview, the facility medical director failed to ensure the delivery of quality patient care and clinical outcomes by failing to ensure compliance with patient assessment, patient plan of care, and the Quality Assurance and Performance Improvement program. Failure to ensure the delivery of quality patient care and clinical outcomes places patients at risk for receiving inadequate and unsafe care and is evidence this Condition for Coverage is NOT MET. (References: V142, V196, V500, V502, V510, V520, V540, V552, V556, V557, V558, V560, V625, V628, V633, V637, and V638). .”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 45034 . Based on document review and interview, the facility’s Governing Body (GB) failed to assume full responsibility for the complete operation of the facility by failing to ensure compliance with patient assessment, patient plan of care, and the Quality Assurance and Performance Improvement program. Failure of the GB to assume full responsibility for the complete operation of the facility places patients at risk of receiving inadequate and unsafe care and is evidence this Condition for Coverage is NOT MET. (References: V142, V196, V500, V502, V510, V520, V540, V552, V556, V557, V558, V560, V625, V628, V633, V637, V638, and V710). .”

“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: 45034 . Based on document review, observation, and interview, the facility failed to ensure all staff followed facility policies and procedures for changing gloves 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 policies titled, “Infection Control for Dialysis Facilities,” last revised 04/23, showed that all staff must perform hand hygiene: -prior to gloving and immediately after removal of gloves, -after contamination with blood or other infectious material, -after patient and dialysis delivery system contact, -between patients even if the contact is casual, -before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse. -Patients and caregivers will be encouraged to perform hand hygiene after treatment before leaving the treatment area. 2. On 03/26/24 at 10:35 AM, Surveyor #4 observed a Patient Care Technician (PCT) (Staff #421) discontinue dialysis treatment for Patient #340. The observation showed that Patient #439 held their access sites with their gloved hand after being disconnected from dialysis treatment to achieve hemostasis (when active bleeding stops). Patient #439 then left the treatment area to weigh themselves, returned to the treatment chair to remove their glove without performing hand hygiene. -Staff #421 failed to encourage Patient #439 to perform hand hygiene after hemostasis was obtained and before Patient #439 exited the dialysis treatment area to use common equipment. 3. On 03/26/24 at 11:30 AM, Surveyor #4 observed patient care on the treatment floor. The observations showed: - A PCT (Staff #421) typing on the dialysis machine at station #2 then moved to the computer next to station #3 and began typing without performing hand hygiene. - Staff #421 typing on the computer between station #1 and Station #2, donned a glove on one hand then moved to touch the screen on the dialysis machine at station #3 without performing hand hygiene before or after glove use. - Staff #421 donned a glove, removed an item from the garbage for Patient #440, removed the glove, obtained clean supplies from the supply area, then began typing on the computer without performing hand hygiene. 4. On 03/26/24 at 11:35 AM, Surveyor #4 observed a PCT (Staff #421) initiate dialysis treatment for Patient #441. The observations showed Staff #421 palpating Patient #441’s access site, typing on the machine, touching the patient’s arm, and returning to typing on the machine without performing hand hygiene. 5. On 03/26/24 at 4:00 PM, Surveyor #4 interviewed the incoming Facility Administrator (Staff #402), the Manager of Clinical Services (Staff #404), and the Nurse Clinical Coordinator (Staff #405) regarding the hand hygiene observations. Staff #402, #404, and #405 acknowledged the findings and confirmed that facility policy required staff to perform hand hygiene after contact with patients, blood, or infectious material and before touching clean areas, and to encourage patients to perform hand hygiene before leaving the treatment area. 6. On 03/27/24 at 9:45 AM, Surveyor #4 observed a PCT (Staff #418) provide education and oversight to a home hemodialysis caregiver initiating treatment on Patient #443. The caregiver used their gloved hand to remove the lid on the biohazard container and throw contaminated items into the container. The caregiver proceeded to return to the patient and placed a clean dressing under their dialysis access arm. Staff #418 failed to advise the caregiver to change gloves and perform hand hygiene after glove contamination. 7. On 03/27/24 at 10:00 AM, Surveyor #4 interviewed the Regional Operations Director (Staff #409) and the Home Hemodialysis Nurse (Staff #413) regarding the observation, Staff #409 and #413 acknowledged the findings and confirmed that the staff educating patients and caregivers are to assure hand hygiene and occurs according to policy. .”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to reeducate existing staff members regarding infection control practices for hemodialysis units and bloodborne pathogens annually per regulation and facility policy. Failure to reeducate existing staff members regarding infection control practices and bloodborne pathogens places patients, staff, and visitors at risk for exposure to infectious diseases. Reference: Occupational Safety and Health Administration (OSHA). “Bloodborne Pathogens and Needlestick Prevention” (2024) - “Employers must offer this training [bloodborne pathogen and needlestick prevention] on initial assignment, at least annually thereafter, and when new or modified tasks or procedures affect a worker’s risk of occupational exposure.” Findings included: 1. Document review of the facility policy titled, “Training and Education of Teammates on the Exposure Control Plan,” last revised 10/23, showed that all personnel must receive bloodborne pathogen education within 10 days of hire and then annually thereafter. 2. Document review of facility personnel infection control and bloodborne pathogen education logs showed the following: - A Registered Nurse (RN) (Staff #314) completed infection control and bloodborne pathogen education on 02/16/23, greater than one year prior to the day of personnel file review. - A Patient Care Technician (PCT) (Staff #326) completed infection control and bloodborne pathogen education on 02/20/23, greater than one year prior to the day of personnel file review. 3. On 03/27/24 at 3:30 PM, Surveyor #3 interviewed the incoming Facility Administrator (Staff #302), covering Director of Clinical Services (Staff #303), and Regional Operations Director (Staff #309) regarding the annual infection control and bloodborne pathogen education. Staff #302, #303, and #309 confirmed that facility personnel education logs showed that an RN and a PCT failed to receive infection control and bloodborne pathogen education annually. .”

“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: 45034 . Based on document review and interview, the facility failed to implement infection control policies and activities consistent with Centers for Disease Control and Prevention (CDC) guidelines by failing to conduct staff Tuberculosis (TB) screening as required in 2 of 6 personnel files reviewed (Staff #306 and #321). Failure to develop and implement infection control policies consistent with CDC guidelines for TB screening places patients, staff, and visitors at risk for exposure to TB. Reference: Centers for Disease Control and Prevention (CDC). “TB Screening and Testing of Health Care Personnel” (2022) - “All U.S. health care personnel should be screened for TB upon hire...TB screening is a process that includes a TB blood test or TB skin test, TB symptom evaluation and a baseline individual TB risk assessment.” Findings included: 1. Document review of the facility policy titled, “Tuberculosis Monitoring and Follow-Up,” last revised 04/20, showed that all personnel must complete a TB test, TB symptom evaluation, and TB risk assessment upon hire. 2. Document review of employee personnel files showed the following: - The facility Registered Dietician (Staff #306) completed a TB symptom screening and risk assessment on 03/26/24, greater than one year after their hire date on 02/16/23. - A Patient Care Technician (Staff #321) failed to complete a TB risk assessment since their hire date on 04/11/22. 3. On 03/28/24 at 4:25 PM, Surveyor #3 interviewed the incoming Facility Administrator (Staff #302) regarding the missing TB documentation. Staff #302 confirmed that employee personnel file review failed to show TB screening as required by the CDC for 2 of 6 personnel files reviewed. 4. This is a repeat citation. DOH previously cited the facility for this finding during a 04/06/23 End Stage Renal Disease Facility Recertification Survey. .”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 45034 . Based on document review, observation, and interview, the facility failed to ensure staff demonstrated compliance with aseptic technique and facility policy when dispensing intravenous medications. Failure to adhere to aseptic technique and facility policy when dispensing intravenous medications places patients at risk for harm from receiving contaminated medications. Findings included: 1. Document review of the facility policy titled, “Medication Policy,” last revised 10/23, showed that all staff administering medications must utilize aseptic technique. 2. On 03/26/24 at 11:20 AM, Surveyor #4 observed a Patient Care Technician (PCT) (Staff #421) initiate dialysis treatment for Patient #450. The observations showed Staff #421 handling potentially contaminated items such as the dialysis machine, the patient, and dialysis lines prior to attaching a syringe containing heparin (a medication used to prevent blood clotting) to the patient’s dialysis machine. 3. On 03/26/24 at 11:35 AM, Surveyor #4 observed a PCT (Staff #421) initiate dialysis treatment for Patient #441. The observations showed Staff #421 handling potentially contaminated items such as the dialysis machine, the patient, and dialysis lines prior to attaching a syringe containing heparin to the patient’s dialysis machine. 4. On 03/26/24 at 4:00 PM, Surveyor #4 interviewed the incoming Facility Administrator (Staff #402), the Manager of Clinical Services (Staff #404), and the Nurse Clinical Coordinator (Staff #405) regarding the hand hygiene observations. Staff #402, #404, and #405 acknowledged the finding and confirmed that facility policy requires aseptic technique to be used with all medication administration. .”

“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: 45034 . Based on document review, observation, and interview, the facility failed to ensure staff members followed infection prevention technique policies and standards during Central Venous Catheter (CVC) related procedures by failing to use aseptic technique during catheter care. Failure to follow policies and standards when working with a patient’s CVC risks infection of the access site, with the resultant risk of serious patient harm. Findings included: 1. Document review of the facility’s policy titled “Central Venous Catheter (CVC) with Cleargaurd HD Antimicrobial End Caps Procedure,” last revised 10/23, showed that aseptic technique must be used throughout the procedure. Staff shall perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines. Upon completion of dialysis, staff are to discard the barrier that was used during treatment and place a new clean barrier under the catheter. 2. On 03/26/24 at 11:20 AM, Surveyor #4 observed a Patient Care Technician (PCT) (Staff #421) initiate dialysis treatment utilizing a CVC on Patient #450. During the observation, Staff #421 scrubbed the arterial catheter connection for 8 seconds and the venous catheter connection for 7 seconds which is less than the required 15 seconds. The venous catheter connection showed visible blood residue after the scrub. 3. On 03/12/24 at 12:01 PM, Surveyor #4 observed a PCT (Staff #421) disconnect Patient #440’s CVC from dialysis bloodlines at the end of dialysis treatment. The observation showed that Staff #421 failed to place a new clean field under Patient #440’s CVC prior to disconnecting the dialysis bloodlines. 4. On 03/26/24 at 4:00 PM, Surveyor #4 interviewed the incoming Facility Administrator (Staff #402), the Manager of Clinical Services (Staff #404), and the Nurse Clinical Coordinator (Staff #405) regarding the CVC care observations. Staff #402, #404, and #405 acknowledged the findings and confirmed that staff are educated on and expected to adhere to the described infection control practices around CVC care. .”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to ensure personnel performing colorimetric testing (solution concentration testing that differentiates results through colors,) including chlorine testing, could discern colors by completing colorblindness testing in 1 of 6 personnel files reviewed (Staff #311). Failure to ensure personnel performing colorimetric testing, including chlorine testing, can discern colors places patients at risk for harm from exposure to water contaminates during dialysis due to undiscerned colorimetric results. Findings included: 1. Document review of the facility policy titled, “Color Vision Evaluation,” last revised 10/17, showed that all staff who use test kits relying on color differentiation for test results, such as chlorine testing, must have a colorblindness test performed upon hire. 2. Document review of personnel files for staff who were qualified to perform chlorine testing failed to show complete colorblindness test documentation, confirming whether staff passed or failed a colorblindness test upon hire, in 1 of 6 personnel files reviewed (Staff #311). 3. On 03/26/24 at 3:54 PM, Surveyor #3 interviewed the incoming Facility Administrator (Staff #302), Manager of Clinical Services (Staff #304), Nurse Clinical Coordinator (Staff #305) and Biomedical Services Educator (Staff #310) regarding the incomplete colorblindness test documentation. Staff #301, #304, #305, and #310 confirmed that per policy all staff who were qualified to perform chlorine testing must have colorblindness testing documented upon hire, and that personnel file review failed to show complete colorblindness testing in 1 of 6 personnel files reviewed. 4. This is a repeat citation. DOH previously cited the facility for this finding during a 04/06/23 End Stage Renal Disease Facility Recertification Survey. .”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to ensure that all personnel who operate the facility’s water and dialysate system were audited at least annually as required for compliance with all procedures. Failure to ensure all personnel who operate the water and dialysate system are audited at least annually for procedural compliance places patients at risk for harm during dialysis due to system monitoring by unqualified personnel. Findings included: 1. Document review of the facility policy titled, “Teammate Qualifications, Licensure and Adequate Teammate Staffing,” last revised 10/17, showed that all personnel who perform monitoring and testing of the facility water treatment system must periodically demonstrate the ability to perform skills in compliance with facility procedures. 2. Document review of facility personnel water, dialysate, and equipment training logs showed that a Patient Care Technician (PCT) (Staff #324) last received a water and dialysate system audit on 02/15/23, greater than one year prior to the day of personnel file review. 3. On 03/27/24 at 3:30 PM, Surveyor #3 interviewed the incoming Facility Administrator (Staff #302), covering Director of Clinical Services (Staff #303), and Regional Operations Director (Staff #309) regarding the water and dialysate system audits. Staff #302, #303, and #309 confirmed that facility personnel education logs showed that a PCT failed to receive a water and dialysate system audit annually. .”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 45034 . Based on document review, observation, and interview, the facility failed to maintain a safe treatment environment for patients and staff by failing to secure oxygen tanks in the patient treatment area. Failure to maintain a safe treatment environment by failing to secure oxygen tanks places patients and staff at risk for injury from unsecured objects and places the facility at increased risk for fire from unsecured flammable agents. Reference: National Fire Protection Association (NFPA). “Medical Gas Cylinder Storage” (2018) - “[Gas] cylinders must be attached to a cylinder stand or to medical equipment designed to receive and hold cylinders.” Findings Included: 1. Document review of the electronic facility document titled “Monthly OSHA Audit,” showed that the facility is to monitor that oxygen tanks are secured in a cart, stand, or chained. 2. On 03/26/24 at 11:25 PM, Surveyor #4 toured the facility treatment area and observed seven unsecured oxygen tanks in the oxygen tank storage area located on the treatment floor. 4. On 03/26/24 at 11:45 PM, Surveyor #4 interviewed the outgoing Facility Administrator (Staff #401) regarding the unsecured oxygen tanks. Staff #401 observed the finding and confirmed that per facility policy all supplies, including oxygen tanks, must be stored in a safe manner. .”

“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: 45034 . Based on document review and interview, the facility failed to ensure each patient received a comprehensive assessment of current health status, medical condition, and comorbid conditions by a physician in 2 of 12 patient medical records reviewed (Patients #351 and #355). Failure to ensure each patient receives a comprehensive current health and medical condition assessment by a physician places patients at risk for harm from undetected medical concerns and unanticipated health outcomes. Findings included: 1. Document review of the facility policies titled, “Progress Note Policy,” last revised 10/23, and “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that each patient must receive, at minimum, a monthly physician assessment, evaluating current health status, medical condition, comorbid conditions, laboratory results, transplant status, dialysis prescription, and dialysis access. 2. Document review of patient medical records showed the following: - On 01/02/24, a Physician (Staff #334) documented an assessment of Patient #351, stating, “seen and assessed,” without documentation of health status, medical condition, comorbid conditions, laboratory results, transplant status, dialysis prescription, or dialysis access. - On 01/02/24, a Physician (Staff #334) documented an assessment of Patient #355, stating, “seen and assessed,” without documentation of health status, medical condition, comorbid conditions, laboratory results, transplant status, dialysis prescription, or dialysis access. - On 01/30/24, a Physician (Staff #334) documented an assessment of Patient #355, stating, “seen and assessed,” without documentation of health status, medical condition, comorbid conditions, laboratory results, transplant status, dialysis prescription, or dialysis access. - On 02/06/24, a Physician (Staff #334) documented an assessment of Patient #351, stating, “seen and assessed,” without documentation of health status, medical condition, comorbid conditions, laboratory results, transplant status, dialysis prescription, or dialysis access. - On 02/06/24, a Physician (Staff #334) documented an assessment of Patient #355, stating, “seen and assessed,” without documentation of health status, medical condition, comorbid conditions, laboratory results, transplant status, dialysis prescription, or dialysis access. - On 03/05/24, a Physician (Staff #334) documented an assessment of Patient #355, stating, “seen and assessed,” without documentation of health status, medical condition, comorbid conditions, laboratory results, transplant status, dialysis prescription, or dialysis access. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the physician documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show a comprehensive physician assessment of current health status, medical condition, and comorbid conditions in 2 of 12 patient medical records reviewed. 4. This is a repeat citation. DOH previously cited the facility for this finding during a 04/06/23 End Stage Renal Disease Facility Recertification Survey. .”

“PA-ASSESS LAB PROFILE CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: (3) Laboratory profile, This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to appropriately assess and respond to issues related to patients’ laboratory profiles in 2 of 12 patient medical records reviewed (Patients #350 and #352). Failure to assess and respond appropriately to issues with a patient’s laboratory profile places patients at risk of harm from not having medical conditions adequately treated. Findings included: 1. Document review of the facility policies titled, “Progress Note Policy,” last revised 10/23, and “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that each patient must receive, at minimum, a monthly physician assessment, evaluating patient laboratory results. 2. Document review of patient medical records showed the following: - On 01/20/24, a Physician (Staff #312) failed to note, address, or evaluate Patient #350’s Albumin (protein level used to measure patient nutrition status) lab value of 3.3 grams per deciliter (g/dL), below the 4.0 g/dL federally established minimum threshold for End Stage Renal Disease dialysis patients. - On 02/01/24, a Physician (Staff #335) failed to note, address, or evaluate Patient #352’s Albumin lab value of 2.6 g/dL, below the 4.0 g/dL federally established threshold. - On 02/06/24, a Physician (Staff #312) failed to note, address, or evaluate Patient #350’s Albumin lab value of 3.3 g/dL, below the 4.0 g/dL federally established threshold. - On 02/15/24, a Physician (Staff #335) failed to note, address, or evaluate Patient #352’s Albumin lab value of 2.3 g/dL, below the 4.0 g/dL federally established threshold. - On 02/15/24, a Physician (Staff #335) failed to note, address, or evaluate Patient #352’s Hemoglobin (Hgb) (an oxygen-transporting protein) lab value of 9.5 g/dL, below the 10 g/dL federally established threshold for End Stage Renal Disease dialysis patients. - On 03/12/24, a Physician (Staff #335) failed to note, address, or evaluate Patient #352’s Albumin lab value of 2.7 g/dL, below the 4.0 g/dL federally established threshold. - On 03/12/24, a Physician (Staff #335) failed to note, address, or evaluate Patient #352’s Hgb lab value of 9.2 g/dL, below the 10 g/dL federally established threshold. - On 03/19/24, a Physician (Staff #312) failed to note, address, or evaluate Patient #350’s Albumin lab value of 3.6 g/dL, below the 4.0 g/dL federally established threshold - On 03/19/24, a Physician (Staff #335) failed to note, address, or evaluate Patient #352’s Albumin lab value of 2.7 g/dL, below the 4.0 g/dL federally established threshold. - On 03/19/24, a Physician (Staff #335) failed to note, address, or evaluate Patient #352’s Hgb lab value of 9.2 g/dL, below the 10 g/dL federally established threshold. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the physician documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show assessment and evaluation of patient laboratory profiles by a physician in 2 of 12 patient medical records reviewed. .”

“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: 45034 . Based on document review and interview, the facility failed to ensure each patient received an evaluation of psychosocial needs by a social worker at facility-determined intervals in 7 of 12 patient medical records reviewed (Patient #344, #348, #349, #350, #352, #353, and #354). Failure to ensure each patient receives a psychosocial evaluation by a social worker places patients at risk for unidentified psychological, social, emotional, and physical needs. Findings included: 1. Document review of the facility policies titled, “Social Work Intervention and Documentation Requirements,” last revised 10/23, “Progress Note Policy,” last revised 10/23, and “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that each patient must have a progress note documented by a social worker at minimum once every 3 months, evaluating psychosocial status, modality options, transplant status, and rehabilitation status. 2. Document review of patient medical records between 01/01/24 and 03/26/24 showed no evidence of a social work progress note, documentation, patient evaluation, or needs assessment in 7 of 12 patient medical records reviewed (Patient #344, #348, #349, #350, #352, #353, and #354). 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the social worker documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show social work evaluation of patients’ psychosocial needs within the past 3 months in 7 of 12 patient medical records reviewed. .”

“PA-EVAL FOR SELF CARE/MODALITY/SETTING CFR(s): 494.80(a)(9) The patient’s comprehensive assessment must include, but is not limited to, the following: (9) Evaluation of the patient’s abilities, interests, preferences, and goals, including the desired level of participation in the dialysis care process; the preferred modality (hemodialysis or peritoneal dialysis), and setting, (for example, home dialysis), and the patient’s expectations for care outcomes. This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to present all modality options to patients and evaluate patients’ preferred dialysis modality in 1 of 12 patient medical records reviewed (Patient #350). Failure to present all modality options and evaluate patients’ preferred dialysis modality places patients at risk for non-participation in dialysis care and dissatisfaction with dialysis modality. Findings included: 1. Document review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that each patient must be educated regarding all dialysis modalities, including hemodialysis, peritoneal dialysis, in-center treatments, and treatments at home, and provided the resources to receive dialysis through the patient’s preferred modality. 2. Document review of patient medical records showed the following: - On 12/27/23, Patient #350’s interdisciplinary team documented in a comprehensive Plan of Care that the interdisciplinary team must provide modality option education to Patient #350 within 1 month. - No member of the interdisciplinary team documented modality option education for Patient #350 between 12/27/23 and 03/26/24. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding modality education. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show patient modality education or evaluation in 1 of 12 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: 45034 . Based on document review and interview, the facility failed to document consistent evaluation of patient transplantation referral suitability across the interdisciplinary team in 1 of 12 patient medical records reviewed (Patient #350). Failure to document consistent evaluation of patient transplantation referral suitability places patients at risk for not receiving a renal transplant. Findings included: 1. Document review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that each patient’s interest in transplantation and transplant referral status must be assessed by each patient’s interdisciplinary team. 2. Document review of patient medical records showed the following: - On 12/27/23, Patient #350’s interdisciplinary team documented in a comprehensive Plan of Care that Patient #350 was interested in a transplant referral and eligible to be referred to a transplant center. - On 01/20/24, a Physician (Staff #312) documented that Patient #350 was not a candidate for a renal transplant without clarification of the change in status differing from Patient #350’s plan of care assessment. - On 02/06/24, a Physician (Staff #312) documented that Patient #350 was not a candidate for a renal transplant without clarification of the change in status differing from Patient #350’s plan of care assessment. - On 03/19/24, a Physician (Staff #312) documented that Patient #350 was not a candidate for a renal transplant without clarification of the change in status differing from Patient #350’s plan of care assessment. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the transplant status documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show consistent evaluation of patient transplantation referral suitability across the interdisciplinary team in 1 of 12 patient medical 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: 45034 . Based on document review and interview, the facility failed to ensure patients determined to be unstable received a comprehensive reassessment at least monthly in 1 of 12 patient medical records reviewed (Patient #351). Failure to ensure that patients determined to be unstable 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,” last revised 07/23, showed that patients determined to be unstable must have a comprehensive reassessment and plan of care meeting monthly by the interdisciplinary team until the patient is determined to be stable. 2. Document review of patient medical records showed the following: - On 11/20/23, Patient #351’s interdisciplinary team documented in a comprehensive plan of care that they assessed Patient #351 to be unstable. - Patient #351’s interdisciplinary team failed to document a subsequent comprehensive reassessment or plan of care for Patient #351 until 03/14/24. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the unstable patient documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show monthly interdisciplinary comprehensive reassessment of unstable patients in 1 of 12 patient medical records reviewed. .”

“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: 45034 . Based on document review and interview, the facility failed to provide the necessary care and services to manage patients’ volume status by failing to manage patient blood pressure (BP) and heart rate (HR) per facility protocol in 6 of 12 patient medical records reviewed (Patient #448, #449, #450, #451, #452, and #454) (1), and failing to ensure nursing assessments occurred per facility policy in 7 of 11 patient medical records reviewed (Patient #446, #448, #449, #451, #453, #454 and #455) (2). Failure to provide the necessary care and services to manage patients’ volume status places patients at risk for ineffective treatments and at risk for undetected complications. Findings Included: Item #1 - BP and HR Management 1. Document review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised 10/23, showed the following to be abnormal findings are to be reported to the licensed nurse immediately: -Blood pressure pre-dialysis: Systolic (SBP) greater than 180mmg/Hg or less than 90 mm/Hg. Diastolic (DBP) greater than or equal to 100 mm/Hg. -Intradialytic blood pressure (BP): Difference of 20mm/Hg increase or decrease from the patient’s last intradialytic treatment BP reading. -Blood pressure post treatment: SBP greater than 140 mm/Hg or less than 90 mm/Hg. DBP greater than 90 mm/Hg or less than 50 mm/Hg. -Patient heart rate (HR) less than 60 beats per minute (BPM) or above 100 BPM. 2. Document review of patient medical records showed staff failed to manage patient BP and HR as required in the following: -On 03/06/24 PCTs (Staff #422, #425, and #432) failed to document nurse notification of a HR greater than 100 on Patient #448 in 5 of 13 HR measurements. -On 03/13/24 a PCT (Staff #422) failed to document nurse notification of a HR greater than 100 and a change of more than 20mm/Hg on Patient #448 in 5 of 7 measurements. -On 03/14/24 a PCT (Staff #421) failed to document nurse notification of a change of more than 20mm/Hg on Patient #451 in 1 of 6 BP measurements. -On 03/19/24 a PCT (Staff #430) failed to document nurse notification of a change of more than 20mm/Hg on Patient #450 in 5 of 10 BP measurements. -On 03/21/24 a PCT (Staff #421) failed to document nurse notification of a DBP greater than 100 mm/Hg on Patient #450 in 2 of 10 BP measurements. -On 03/21/24 a PCT (Staff #432) failed to document nurse notification of a change of more than 20mm/Hg on Patient #452 in 1 of 10 BP measurements. -On 03/25/24 a PCT (Staff #422) failed to document nurse notification of SBP greater than 180 mmHg and DBP greater than 100 on Patient #454 in 7 of 8 BP measurements. -On 03/26/24 a PCT (Staff #421) failed to document nurse notification of a change of more than 20mm/Hg on Patient #449 in 3 of 10 BP measurements. 3. On 03/28/24 at 3:15 PM, Surveyor #4 interviewed the incoming Facility Administrator (Staff #402) and the Nurse Clinical Coordinator (Staff #405) regarding the unmanaged patients’ BP and HR. Staff #402 and #405 confirmed the findings and acknowledged patient medical record review failed to show nurse notification of abnormal findings in 6 of 12 patient medical records reviewed. Item #2 - Nursing Assessment 1. Document review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised 10/23, showed the following: -Any abnormal findings discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse. The nurse will assess the patient prior to the initiation of dialysis. -Any abnormal findings during treatment will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgement to determine if any clinical interventions are necessary. -All findings, interventions, and response will be documented in the patients’ medical record. -Any abnormal findings identified post treatment will be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 2. Document review of patient medical records showed the RN staff failed to assess patients as required in the following medical records reviewed: -On 03/06/24 at 8:03 PM, a PCT (Staff #422) documented treatment termination on Patient #448 with abnormal findings post treatment. The RN, (Staff #457) failed to document a nursing assessment prior to discharge. -On 03/08/24 at 6:03 AM, a PCT (Staff #426) documented initiation of dialysis on Patient #454 with an abnormal BP reading of 179/113. The RN, (Staff #414) failed to document a nursing assessment prior to initiation of dialysis. -On 03/14/24 at 1:43 PM and 2:16 PM, a PCT (Staff #420) notified a nurse (Staff #457) of Patient #455’s abnormal changes in BP. Staff #457 failed to document a subsequent assessment of Patient #455. -On 03/15/24 at 6:07 AM, a PCT (Staff #423) documented initiation of dialysis on Patient #454 with an abnormal BP reading of 174/119. The RN, (Staff #414) failed to document a nursing assessment prior to initiation of dialysis. -On 03/16/24 at 9:07 AM, a PCT (Staff#428) documented treatment termination on Patient #453 with abnormal findings post treatment. The RN, (Staff #414) failed to document a nursing assessment prior to discharge. -On 03/16/24 at 10:51 AM, a PCT (Staff #428) documented initiation of dialysis on Patient #455 with an abnormal BP reading of 160/103. The RN, (Staff #416) failed to document a nursing assessment prior to initiation of dialysis. -On 03/18/24 at 6:13 AM, a PCT (Staff #423) documented initiation of dialysis on Patient #454 with an abnormal BP reading of 167/101. The RN, (Staff #405) failed to document a nursing assessment prior to initiation of dialysis. -On 03/19/24 at 11:02 AM, a PCT (Staff #420) documented initiation of dialysis on Patient #455 with a BP reading of 187/104. The RN, (Staff #415) failed to document a nursing assessment prior to initiation of dialysis. -On 03/19/24 at 2:31 PM, a PCT (Staff #422) notified a nurse (Staff #415) of Patient #455’s abnormal changes in BP. Staff #415 failed to document a subsequent assessment of Patient #455. -On 03/19/24 at 5:04 PM, a PCT (Staff #422) documented treatment termination on Patient #451 with abnormal findings post treatment. The RN, (Staff #416) failed to document a nursing assessment prior to discharge. -On 03/20/24 at 6:03 AM, a PCT (Staff #426) documented initiation of dialysis on Patient #454 with an abnormal BP reading of 156/101. The RN, (Staff #414) failed to document a nursing assessment prior to initiation of dialysis. -On 03/23/24 at 2:01 PM, a PCT (Staff #428) notified a nurse (Staff #416) of Patient #455’s abnormal changes in BP. Staff #416 failed to document a subsequent assessment of Patient #455. -On 03/25/24 at 6:01 AM, a PCT (Staff #422) documented initiation of dialysis on Patient #454 with an abnormal BP reading of 186/110. The RN, (Staff #405) failed to document a nursing assessment prior to initiation of dialysis. -On 03/25/24 at 9:19 AM, a PCT (Staff #422) documented treatment termination on Patient #454 with abnormal findings post treatment. The RN, (Staff #405) failed to document a nursing assessment prior to discharge. -On 03/26/24 at 9:33 AM and 9:47 AM, PCTs (Staff #421 and #423) notified a nurse (Staff #405) of Patient #446’s abnormal changes in BP. Staff #405 failed to document a subsequent assessment of Patient #446. -On 03/26/24 at 10:00 AM, a PCT (Staff #421) documented treatment termination on Patient #446 with abnormal findings post treatment. The RN, (Staff #405) failed to document a nursing assessment prior to discharge. -On 03/26/24 at 11:30 AM, a PCT (Staff #423) documented initiation of dialysis on Patient #455 with a BP reading of 174/102. The RN, (Staff #414) failed to document a nursing assessment prior to initiation of dialysis. -On 03/26/24 at 12:46 PM and 12:15 PM, a PCT (Staff #419) notified a nurse (Staff #405 and #414) of Patient #449’s abnormal changes in BP and symptoms. Staff #405 and #414 failed to document a subsequent assessment of Patient #449. -On 03/26/24 at 12:59 PM, a PCT (Staff #426) documented initiation of dialysis on Patient #451 with an abnormal BP reading of 168/104. The RN, (Staff #414) failed to document a nursing assessment prior to initiation of dialysis. 3. On 03/28/24 at 3:15 PM, Surveyor #4 interviewed the incoming Facility Administrator (Staff #402) and the Nurse Clinical Coordinator (Staff #405) regarding the late and missing nursing assessments. Staff #402 and #403 confirmed the findings and acknowledged nursing staff failed to document patient assessments or interventions in 7 of 12 patient medical records reviewed. .”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to document care and services related to patient nutritional status based on professionally accepted clinical nutrition indicators in 2 of 12 patient medical records reviewed (Patients #344 and #350). Failure to document care and services related to patient nutritional status places patients at risk for harm and possible death related to malnutrition and laboratory instability. Findings included: 1. Document review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that each patient’s interdisciplinary team must specify the services necessary to address comprehensive patient needs, including nutritional care. 2. Document review of Patient #344’s medical records showed the following: - On 10/18/23, Patient #344’s interdisciplinary team failed to specify necessary nutritional services for Patient #344 within a comprehensive plan of care. - On 01/31/24, the facility Registered Dietician (RD) (Staff #306) documented that no goals related to Patient #344’s nutritional status had been established. - On 02/29/24, the facility RD (Staff #306) documented that no goals related to Patient #344’s nutritional status had been established. 3. Document review of Patient #350’s medical records showed the following: - On 12/27/23, Patient #350’s interdisciplinary team established nutritional goals for Patient #350 within a comprehensive plan of care. - On 01/31/24, the facility RD (Staff #306) documented that no goals related to Patient #350’s nutritional status had been established. 4. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the nutritional status documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show care, services, or goals established related to patient nutritional status in 2 of 12 patient medical records reviewed. .”

“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: 45034 . Based on document review, observations, and interview, the dialysis facility failed to ensure staff members properly evaluated and cared for a patient’s vascular access. Failure to effectively care for a patient’s vascular access risks harm to patients from potential infection and malfunctioning of the access leading to missed dialysis treatments. Findings included: 1. Document review of the facility policy titled, “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose,” last revised 10/22, showed that cannulation sites are not to be touched after skin disinfection. - Document review of the facility policy titled, “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles,” last revised 04/23, showed that once hemostasis is achieved post dialysis, staff are to discard gauze or band-aid used to hold site and apply a new band-aid or sterile dressing over cannulation site. 2. On 03/26/24 at 10:35 AM, Surveyor #4 observed a Patient Care Technician (PCT) (Staff #421) discontinue dialysis treatment for Patient #439. The observation showed that after hemostasis was achieved, blood was visibly noticeable on the gauze. Staff #421 failed to reinforce or change the soiled gauze on the needle sites prior to discharge. 3. On 03/26/24 at 4:00 PM, Surveyor #4 interviewed the incoming Facility Administrator (Staff #402), the Manager of Clinical Services (Staff #404), and the Nurse Clinical Coordinator (Staff #405) regarding the vascular access site observations. Staff #402, #404, and #405 acknowledged the findings and confirmed that facility policy required staff to change the dressing prior to discharge. 4. On 03/27/24 at 9:40 AM, Surveyor #4 observed a PCT (Staff #418) provide education and oversight to a home hemodialysis caregiver initiating dialysis on Patient #443. During the observation, the caregiver performed skin antisepsis then touched the clean access site prior to inserting needles. Staff #418 failed to ensure the caregiver performed skin antisepsis after contaminating the access site. 5. On 03/27/24 at 10:00 AM, Surveyor #4 interviewed the Regional Operations Director (Staff #409) and the Home Hemodialysis Nurse (Staff #413) regarding the observation, Staff #409 and #413 acknowledged the findings and confirmed that the staff educating patients and caregivers are to assure vascular access care occurs according to policy. .”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to monitor each patient’s psychosocial status through measurements using standardized mental and physical assessment tools at regular intervals in 4 of 12 patient medical records reviewed (Patients #346, #350, #353, and #355). Failure to monitor each patient’s psychosocial status places patients at risk for unmet psychological or social needs. Findings included: 1. Document review of the facility policy titled, “Social Work Intervention and Documentation Requirements,” last revised 10/23, showed that facility social work staff must conduct a quality of life assessment and a depression screening to assess patient psychosocial status for each patient within 90 days of admission, and at least annually thereafter. 2. Document review of patient medical records showed the following: - Social work staff failed to conduct a quality of life assessment and depression screening for Patient #346 since 09/27/22. - Patient #350 admitted to the facility on 11/24/23. Document review of Patient #350’s medical record showed no evidence of a quality of life assessment or depression screening conducted by social work staff. - Social work staff failed to conduct a quality of life assessment for Patient #353 since 09/09/21. - Social work staff failed to conduct a depression screening for Patient #353 since 09/10/22. - Social work staff failed to conduct a depression screening for Patient #355 since 02/03/23. - Social work staff failed to conduct a quality of life assessment for Patient #355 since 02/28/23. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the missing psychosocial assessments. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show quality of life assessments or depression screening within 90 days of patient admission and then annually in 4 of 12 patient medical records reviewed. 4. This is a repeat citation. DOH previously cited the facility for this finding during a 04/06/23 End Stage Renal Disease Facility Recertification Survey. .”

“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: 45034 . Based on document review and interview, the facility failed to include patients in the creation and implementation of patient plans of care in 7 of 12 patient medical records reviewed (Patients #346, #347, #350, #351, #352, #354, and #355) (1), and failed to ensure all members of the interdisciplinary team signed each patient’s plan of care according to regulation requirements and facility policy in 7 of 12 patient medical records reviewed (Patients #344, #346, #347, #348, #350, #351, and #353) (2). Failure to include patients in the creation and implementation of plans of care, and failure to ensure all members of the interdisciplinary team sign each patient’s plan of care, places patients at risk for having incomplete, inadequate, or unapproved plans of care. Findings included: Item #1 - Patient Inclusion in Plans of Care 1. Document review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that patients must be included as members of the interdisciplinary team when creating patient plans of care. 2. Document review of patient medical records showed the following: - Patient #346’s plan of care initiated on 11/29/23 included the statement, “Not reviewed with patient. Patient not present at meeting.” - Patient #347’s plan of care initiated on 01/04/24 included the statement, “Not reviewed with patient. Patient not present at meeting.” - Patient #350’s plan of care initiated on 12/27/23 included the statement, “Not reviewed with patient. Patient not present at meeting.” - Patient #351’s plan of care initiated on 03/06/23 included the statement, “Not reviewed with patient. Patient not present at meeting.” - Patient #352’s plan of care initiated on 08/23/23 included the statement, “Not reviewed with patient. Patient not present at meeting.” - Patient #354’s plan of care initiated on 08/21/23 included the statement, “Not reviewed with patient. Patient not present at meeting.” - Patient #355’s plan of care initiated on 01/29/24 included the statement, “Not reviewed with patient. Patient not present at meeting.” 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the plan of care documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show patient inclusion in the creation and implementation of patient plans of care in 7 of 12 patient medical records reviewed. Item #2 - Plan of Care Signatures 1. Document review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that patient plans of care must be signed by all members of the interdisciplinary team, including the patient, within 30 days of initiating a patient plan of care. 2. Document review of patient medical records showed the following: - Patient #344’s plan of care initiated on 10/18/23 contained no interdisciplinary team member signatures. - Patient #346’s plan of care initiated on 11/29/23 contained no interdisciplinary team member signatures. - Patient #347’s plan of care initiated on 01/04/24 contained no interdisciplinary team member signatures. - Patient #348’s plan of care initiated on 12/27/23 contained no registered dietician, social worker, or patient signatures. - Patient #350’s plan of care initiated on 12/27/23 contained no social worker signature. - Patient #351’s plan of care initiated on 11/20/23 contained no social worker, physician, or patient signatures. - Patient #353’s plan of care initiated on 11/01/23 contained no interdisciplinary team member signatures. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the plan of care documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show interdisciplinary team member plan of care signatures in 7 of 12 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: 45034 . Based on document review and interview, the facility failed to initiate a plan of care within 30 days, or within 13 outpatient hemodialysis sessions, in 1 of 12 patient medical records reviewed (Patient #348). Failure to develop and implement an initial plan of care 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 07/23, showed that the interdisciplinary team must complete an initial plan of care for all new patients within 30 calendar days, or within 13 outpatient hemodialysis sessions. 2. Document review of patient medical records showed the following: - Patient #348 was admitted to the facility on 11/07/23. - Patient #348’s interdisciplinary team failed to initiate a plan of care until 12/27/23. - Patient #348’s interdisciplinary team failed to complete a plan of care for Patient #348. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the plan of care documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review showed that the interdisciplinary team failed to initiate a plan of care within 30 days or 13 dialysis treatments in 1 of 12 patient medical records reviewed. .”

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to implement updates to patient plans of care within 15 days of the completion of comprehensive patient assessments in 6 of 12 patient medical records reviewed (Patients #344, #346, #350, #351, #353, and #355) (1), and failed to use data from comprehensive patient assessments to create plans of care in 6 of 12 patient medical records reviewed (Patients #344, #346, #350, #351, #353, and #355) (2). Failure to implement updates to patient plans of care within 15 days of the completion of a comprehensive patient assessment, or to use data from comprehensive patient assessments to create plans of care, places patients at risk for poor health outcomes due to inadequate and inappropriate interventions. Findings included: Item #1 - 15-Day Implementation Timeframe 1. Document review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that the interdisciplinary team must complete an updated plan of care for each patient within 15 days of completing a comprehensive patient monthly or annual reassessment. 2. Document review of patient medical records showed the following: - Patient #344’s interdisciplinary team documented a comprehensive annual patient assessment on 10/18/23. The interdisciplinary team failed to complete a subsequent updated plan of care. - Patient #346’s interdisciplinary team documented a comprehensive annual patient assessment on 11/29/23. The interdisciplinary team failed to complete an updated plan of care until 03/08/24. - Patient #350’s interdisciplinary team documented a comprehensive annual patient assessment on 12/27/23. The interdisciplinary team failed to complete an updated plan of care until 02/03/24. - Patient #351’s interdisciplinary team documented a comprehensive monthly patient assessment on 03/06/23. The interdisciplinary team failed to complete an updated plan of care until 04/19/23. - Patient #351’s interdisciplinary team documented a comprehensive annual patient assessment on 11/20/23. The interdisciplinary team failed to complete a subsequent updated plan of care. - Patient #353’s interdisciplinary team documented a comprehensive annual patient assessment on 11/01/23. The interdisciplinary team failed to complete a subsequent updated plan of care. - Patient #355’s interdisciplinary team documented a comprehensive annual patient assessment on 01/29/24. The interdisciplinary team failed to complete an updated plan of care until 03/08/24. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the plan of care documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review showed that the interdisciplinary team failed to implement updates to patient plans of care within 15 days of the completion of comprehensive patient assessments in 6 of 12 patient medical records reviewed. Item #2 - Patient Assessment Data 1. Document review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” last revised 07/23, showed that the interdisciplinary team must utilize data from a comprehensive patient monthly or annual reassessment to complete an updated plan of care for each patient. 2. Document review of patient medical records showed the following: - Patient #344’s interdisciplinary team documented a comprehensive annual patient assessment on 10/18/23. The interdisciplinary team’s incomplete patient plan of care for Patient #344 drew on patient data collected after 10/18/23. - Patient #346’s interdisciplinary team documented a comprehensive annual patient assessment on 11/29/23. The interdisciplinary team’s completed patient plan of care for Patient #346 drew on patient data collected after 11/29/23. - Patient #350’s interdisciplinary team documented a comprehensive annual patient assessment on 12/27/23. The interdisciplinary team’s completed patient plan of care for Patient #350 drew on patient data collected after 12/27/23. - Patient #351’s interdisciplinary team documented a comprehensive monthly patient assessment on 03/06/23. The interdisciplinary team’s completed patient plan of care for Patient #351 drew on patient data collected after 03/06/23. - Patient #351’s interdisciplinary team documented a comprehensive annual patient assessment on 11/20/23. The interdisciplinary team’s incomplete patient plan of care for Patient #351 drew on patient data collected after 11/20/23. - Patient #353’s interdisciplinary team documented a comprehensive annual patient assessment on 11/01/23. The interdisciplinary team’s incomplete patient plan of care for Patient #353 drew on patient data collected after 11/01/23. - Patient #355’s interdisciplinary team documented a comprehensive annual patient assessment on 01/29/24. The interdisciplinary team’s completed patient plan of care for Patient #355 drew on patient data collected after 01/29/24. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the plan of care documentation. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review showed that the interdisciplinary team failed to use data from comprehensive patient assessments to create plans of care in 6 of 12 patient medical records reviewed. .”

“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: 45034 . Based on document review and interview, the facility failed to ensure a physician, nurse practitioner, or physician’s assistant assessed and evaluated each patient at least monthly in 3 of 12 patient medical records reviewed (Patients #344, #346, and #349). Failure to ensure each patient is evaluated at least monthly by a physician, nurse practitioner, or physician’s assistant places patients at risk for inadequate care and inadequate dialysis treatment. Findings included: 1. Document review of the facility policy titled, “Progress Note Policy,” last revised 10/23, showed that physicians or physician extenders must document progress notes providing current assessment of patient status at least monthly. 2. Document review of patient medical records showed the following: - A Physician (Staff #336) failed to document a patient progress note between 09/22/23 and 03/26/24 for Patient #344. - A Physician (Staff #337) and a Nurse Practitioner (Staff #338) failed to document a patient progress note between 08/17/23 and 02/13/24, and between 02/13/24 and 03/26/24, for Patient #346. - A Physician (Staff #356) failed to document a patient progress note between 11/28/23 and 03/26/24 for Patient #349. 3. On 03/28/24 at 2:02 PM, Surveyors #3 and #4 interviewed the incoming Facility Administrator (Staff #302), Nurse Clinical Coordinator (Staff #305), Registered Dietician (Staff #306), Social Worker (Staff #307), and Regional Home Modality Manager (Staff #308) regarding the physician progress notes. Staff #302, #305, #306, #307, and #308 confirmed that patient medical record review failed to show monthly physician or physician extender progress notes in 3 of 12 patient medical records reviewed. .”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to measure, analyze, and track quality indicators or other aspects of performance that influence patient outcomes related to mortality, hospitalization/readmission, and the End Stage Renal Disease (ESRD) Network identified projects. Failure to systematically measure, analyze, and track quality indicators related to mortality, hospitalization/readmission, and the End Stage Renal Disease (ESRD) Network identified projects impairs the development of effective action plans to improve patient outcomes. Findings included: 1. Document review of the facility policy titled, “Continuous Quality Improvement Program,” last revised 04/21 showed that the facility will measure, analyze, and track quality indicators or other aspects of performance. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 2. Document review of the facility’s Facility Health Meetings (FHM)/Quality Assurance and Performance Improvement (QAPI) online dashboard, associated meeting minutes dated September 2023 thru February 2024, and the most current annual CMS-generated dialysis facility report showed the following: -The facility’s standardized mortality ratio is higher than expected. The facility recorded only the number of deaths, the gross mortality rate, and number of deaths by associated diagnosis. The facility failed to document any analysis to identify root cause or implement improvement measures to improve the mortality rate. - The facility’s hospitalization and readmission rates are higher than expected. The facility recorded the number of hospitalizations, the number of hospitalizations by select diagnosis, and the number of readmissions. The facility failed to document any established performance goals, any analysis to identify root cause, or implement improvement measures to improve hospitalizations and readmissions. -The CMS-ESRD Network identified quality improvement projects are to increase home modality and increase percentage of patients receiving mental health treatment for depression. The facility failed to document the collection of data metrics, analysis, or action items for the two identified CMS-ESRD Network quality improvement projects. 3. On 03/28/24 at 3:20 PM, Surveyor #4 interviewed the outgoing Facility Administrator (Staff #401), the incoming Facility Administrator (Staff #402), Nurse Clinical Coordinator (Staff #405), Registered Dietician (Staff #406), Social Worker (Staff #407), and Regional Home Modality Manager (Staff #408) regarding the underperforming metrics related to mortality, hospitalization/readmission, and the End Stage Renal Disease (ESRD) Network identified projects. Staff #401, #402, #405, #406, #407, and #408 confirmed that the facility failed to measure, analyze, and develop action plans for the identified underperforming metrics. .”

“QAPI-INDICATOR-VASCULAR ACCESS CFR(s): 494.110(a)(2)(v) The program must include, but not be limited to, the following: (v) Vascular access. This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to document assessments of collected information and develop action plans to improve the patient central-venous catheter (CVC) rate that remained below identified goals. Failure to assess for root cause and apply corrective action to identified issues that were not meeting established goals places patients at risk of harm related to inappropriate use of catheters. Findings: 1. Document review of the facility policy titled, “Continuous Quality Improvement Program,” last revised 04/21 showed that the facility will measure, analyze, and track quality indicators including vascular access. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 2. Document review of the facility’s Facility Health Meetings (FHM)/Quality Assurance and Performance Improvement (QAPI) online dashboard, associated meeting minutes dated September 2023 thru February 2024, and the most current annual CMS-generated dialysis facility report showed the following: -The percentage of patients with a CVC greater than 90 days was above the national threshold of 10.7% for the past 12 months with no significant improvements. Facility rates ranged from 32.1% to 42%. -Interventions included “monitor weekly in interdisciplinary team meeting: Goal will be met at less than 10.7%. Access Manager will attend weekly core team meetings to update progress/barrier associated with CVC removal process and to review monthly during FHM.” -The meeting minutes and electronic dashboard showed patient data was only collected. The minutes and dashboard showed no evidence of a root cause analysis or action plan identified for performance improvement. 3. On 03/28/24 at 3:20 PM, Surveyor #4 interviewed the outgoing Facility Administrator (Staff #401), the incoming Facility Administrator (Staff #402), Nurse Clinical Coordinator (Staff #405), Registered Dietician (Staff #406), Social Worker (Staff #407), and Regional Home Modality Manager (Staff #408) regarding the percentage of patients with a CVC greater than 90 days. Staff #401, #402, #405, #406, #407, and #408 confirmed that the facility failed to analyze for cause and develop action plans aimed at improving rates. .”

“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: 45034 . Based on document review and interview, the facility failed to analyze all identified infections and develop action plans to minimize infection transmission or reduce future incidents. Failure to analyze infections and develop action plans places patients at risk for harm related to unidentified infection risks within the facility. Findings included: 1. Document review of the facility policy titled, “Continuous Quality Improvement Program,” last revised 04/21 showed that the facility will measure, analyze, and track quality indicators including infections. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 2. Document review of the facility’s Facility Health Meetings (FHM)/Quality Assurance and Performance Improvement (QAPI) online dashboard, associated meeting minutes dated September 2023 thru February 2024, and the most current annual CMS-generated dialysis facility report showed the following: -The facility’s blood stream infection rate was shown to be trending up for the previous two months. The facility rate for January 2024 was 0.76% which is not meeting the goal of 0.5%. -The documentation under “Process Deep Dive” in the meeting minutes showed “there were recorded bloodstream infections that caused the increase of blood stream infections”. -The meeting minutes and electronic dashboard showed the number and type of blood stream infections were collected. The minutes and dashboard showed no evidence of identification of trends, a root cause analysis, or action plans identified for performance improvement. 3. On 03/28/24 at 3:20 PM, Surveyor #4 interviewed the outgoing Facility Administrator (Staff #401), the incoming Facility Administrator (Staff #402), Nurse Clinical Coordinator (Staff #405), Registered Dietician (Staff #406), Social Worker (Staff #407), and Regional Home Modality Manager (Staff #408) regarding the facility’s infection rates. Staff #401, #402, #405, #406, #407, and #408 confirmed that the facility failed to analyze for cause and develop action plans aimed at improving rates. .”

“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: 45034 . Based on document review and interview, the facility failed to take action to improve performance related to the transplant waitlist and patient depression screenings and monitor performance to ensure that any improvements are sustained over time for. Failure to develop action plans to improve facility performance related to the transplant waitlist and patient depression screenings and to develop a process to ensure improvements are sustained over time places patients at risk for harm related to unidentified or unaddressed improvement needs. Findings included: 1. Document review of the facility policy titled, “Continuous Quality Improvement Program,” last revised 04/21 showed that the facility will measure, analyze, and track quality indicators. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 2. Document review of the facility’s Facility Health Meetings (FHM)/Quality Assurance and Performance Improvement (QAPI) online dashboard, associated meeting minutes dated September 2023 thru February 2024, and the most current annual CMS-generated dialysis facility report showed the following: -The percentage of eligible patients waitlisted for transplant was below the national threshold of 20.1% for the past 12 months with a downward trend noted for the previous six months. Facility rates ranged from 11.1% to 4.7%. -The meeting minutes and electronic dashboard showed a start date of 03/25/22 for the improvement plan related to the percentage of eligible patients waitlisted for transplant. A discussion of staffing shortages contributing to rates was documented without an effective action plan for staffing coverage, identification of other root causes, or any adjustments in the plan when staffing remained inefficient while rates continued to drop. -The facility goal for overdue annual depression screenings was set at 0%. The facility has been above that rate since June 2023 with a worsening trend. The last reported date of January 2024 showed a rate of 39% overdue annual depression screenings. -The meeting minutes showed a social worker was hired on 10/09/23 and awaiting licensure. An additional social worked began providing coverage in December 2023. The minutes showed no evidence of an effective action plan for staffing coverage or any adjustments in the plan when staffing remained inefficient while rates continued to rise. 3. On 03/28/24 at 3:20 PM, Surveyor #4 interviewed the outgoing Facility Administrator (Staff #401), the incoming Facility Administrator (Staff #402), Nurse Clinical Coordinator (Staff #405), Registered Dietician (Staff #406), Social Worker (Staff #407), and Regional Home Modality Manager (Staff #408) regarding transplant waitlist and depression screenings. Staff #401, #402, #405, #406, #407, and #408 confirmed that the facility failed to develop action plans aimed at improving rates or respond when action plans showed no improvements. .”

“GOV-STAFF HAVE ACCESS TO CONTINUING ED CFR(s): 494.180(b)(4) The governing body or designated person responsible must ensure that- (4) All employees have an opportunity for continuing education and related development activities This Standard is not met as evidenced by: 45034 . Based on document review and interview, the facility failed to ensure that all staff received continuing education and related developmental activities in accordance with standards of practice and facility policy. Failure to ensure all staff receive continuing education and related developmental activities places patients at risk for harm from receiving inadequate or substandard care. Findings included: 1. Document review of the facility policy titled, “Teammate Qualifications, Licensure and Adequate Teammate Staffing,” last revised 10/17, showed that all personnel who perform clinical activities must periodically demonstrate the ability to perform skills in compliance with facility procedures. 2. Document review of facility personnel competencies and skills training logs showed that a Patient Care Technician (PCT) (Staff #324) last received a clinical skills audit on 02/23/23, greater than one year prior to the day of personnel file review. 3. On 03/27/24 at 3:30 PM, Surveyor #3 interviewed the incoming Facility Administrator (Staff #302), covering Director of Clinical Services (Staff #303), and Regional Operations Director (Staff #309) regarding the clinical skill audits. Staff #302, #303, and #309 confirmed that facility personnel education logs showed that a PCT failed to receive a clinical skill audit annually. .”