Fresenius Kidney Care South Tacoma

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 45888 . Based on document review, observation, and interview, the facility failed to ensure that staff maintained patients in view during hemodialysis treatments to ensure patient safety. Failure to maintain patients in view of staff during hemodialysis treatments places patients at risk for harm from unobserved urgent and emergent needs including needle dislodgement, exsanguination, and hypotensive emergencies. Findings included: 1. Document review of the facility policy titled, “Patient Assessment and Monitoring,” dated 05/23, showed that clinical staff must maintain patients under visual observation during in-center hemodialysis treatments. 2. On 04/10/25 at 9:05 AM, Investigators #3 and #6 observed the facility’s in-center dialysis treatment floor. The observation showed no clinical staff visually monitoring Patient #322 who received dialysis in the facility’s permanent bed station, Station #29. The Patient Care Technician (PCT) (Staff #302) responsible for Patient #322 had their back turned to Patient #322 in Station #29 for approximately 5 minutes while taking another patient (Patient #323) off treatment at Station #1. No other clinical staff maintained visual observation of Station #29 while Staff #302 had their back turned. Clinical staff failed to respond when Patient #322’s machine in Station #29 alarmed due to high venous pressure, causing the blood pump to stop, for the 5 minutes Staff #302 provided care to Patient #323 in Station #1. 3. On 04/10/25 at 9:07 AM, Investigator #3 interviewed a PCT (Staff #303) regarding Station #29. Staff #303 stated that the PCT (Staff #302) responsible for Station #29 was also responsible for Stations #1, #2, and #3 which were located directly across from Station #29, preventing the PCT from observing patients in Station #29 while caring for patients in Stations #1, #2, or #3. 4. On 04/10/25 at 11:30 AM, Investigators #3 and #6 interviewed the facility Charge Nurse (Staff #304) regarding patient observation by clinical staff. Staff #304 stated that patients receiving dialysis in the facility’s permanent bed station, Station #29, were not always under visual observation by clinical staff due to the location of the station. Staff #304 stated that sometimes clinical staff checked on patients in Station #29 only every 30 minutes when blood pressure alarms alerted. Staff #304 stated that at times clinical staff relied on other patients with a view of Station #29 to alert them if patients in Station #29 had a medical concern or appeared unwell and that other patients were the “eyes and ears” for the clinical staff. .”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 45888 . Based on document review and interview, the facility failed to ensure staff demonstrated the necessary competencies and skills to serve the comprehensive needs of patients and to perform the specific duties of their positions in 3 of 3 personnel files reviewed (Staff #305, #306, and #307). Failure to ensure staff demonstrate the necessary competencies and skills to serve patient needs and to perform position duties places patients at risk for harm related to receiving care from untrained and/or unqualified personnel. Findings included: 1. Document review of the facility policy titled, “Dialysis Experience Counts,” dated 05/23, showed that all staff hired who have previous dialysis experience, including staff hired from other parent company locations, must have validation of their dialysis skills documented by a preceptor, and either pass the facility’s new employee dialysis skills exam or complete all/pertinent portions of the facility’s dialysis staff education program. - Document review of the facility’s experienced new staff training guide titled, “Progressive Renal Education Program Experienced Day In-Center Reference Guide,” dated 03/23, showed that staff hired with previous dialysis experience must receive an orientation to the facility, including facility-specific emergency procedures, on their first day of employment. - Document review of the facility document titled, “InCenter [sic] Training Requirements for External Agency Traveler,” dated 11/24, showed that all staff contracted to work at the facility through an external agency must have validation of their dialysis skills documented, a knowledge assessment identifying training needs and receive training as indicated, must receive orientation to the facility, and emergency preparedness training. 2. Document review of personnel files showed the following: - A patient care technician (PCT) (Staff #305), hired 09/15/24, had previous dialysis experience from another parent company location. Personnel file review showed no evidence that Staff #305 took the facility’s new employee dialysis skills exam or completed any portions of the facility’s dialysis staff education program. File review showed no evidence of dialysis skills validation until 03/26/25. Staff #305 completed an orientation to the facility, including facility-specific emergency procedures, on 10/30/24. - A PCT (Staff #306), hired 09/15/24, had previous dialysis experience from another parent company location. Personnel file review showed no evidence that Staff #306 took the facility’s new employee dialysis skills exam or completed any portions of the facility’s dialysis staff education program. File review showed no evidence of dialysis skills validation until 03/01/25. Staff #306 completed an orientation to the facility, including facility-specific emergency procedures, on 10/29/24. - A PCT (Staff #307), contracted at the facility through an external agency from 09/23/24 - 12/21/24, had no evidence of validation of their dialysis skills documented, knowledge assessment identifying training needs, training as necessary, orientation to the facility, or emergency preparedness training. 3. Document review of staff assignments and patient treatment flowsheets showed that on 10/01/24, the above PCTs (Staff #305, #306, and #307) provided independent direct patient care to 21 dialysis patients (Patients #311, #312, #313, #314, #315, #316, #317, #318, #319, #320, #321, #324, #325, #326, #327, #328, #329, #330, #331, #332, and #333) without a preceptor. 4. On 04/10/25 at 12:40 PM, Investigator #3 interviewed the covering Facility Administrator (FA) (Staff #301) regarding education for staff hired with previous dialysis experience. . Staff #301 confirmed that personnel file review showed no evidence of skills validation prior to PCTs providing independent patient care, no evidence of new employee dialysis skills exam and/or completion of the facility’s dialysis staff education program, and no evidence of facility orientation and emergency procedure review according to policy for the PCTs hired with previous dialysis experience. 5. On 04/10/25 at 1:16 PM, Investigator #3 interviewed the covering FA (Staff #301) regarding education for staff contracted through an external agency. Staff #301 acknowledged that personnel file review showed no evidence of dialysis skills validation, knowledge assessment, necessary training, facility orientation, or emergency preparedness training for the PCT contracted through an external agency. .”

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 45888 . Based on document review and interview, the facility failed to develop an emergency preparedness program including a communication plan based on the requirements of §42 CFR-Part 416.54. Failure to establish and maintain a comprehensive emergency preparedness program including a communication plan places patients, staff, and visitors at risk for delayed or compromised care, injury, or death and is evidence that this Condition for Coverage is NOT MET. (References: Tag E033 and Tag E034). .”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 45888 . 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 facility emergency preparedness, water and dialysate quality, and appropriate prioritization of Quality Assurance and Performance Improvement projects. 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: Tag E003, Tag E033, Tag E034, Tag V175, Tag V196, Tag V625, and Tag V639). .”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 45888 . 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 facility emergency preparedness, water and dialysate quality, and appropriate prioritization of Quality Assurance and Performance Improvement projects. Failure of the GB to assume full responsibility for the complete operation of the facility places patients at risk for receiving inadequate and unsafe care and is evidence this Condition for Coverage is NOT MET. (References: Tag E003, Tag E033, Tag E034, Tag V175, Tag V196, Tag V625, Tag V639, and Tag V710). .”

“Methods for Sharing Information CFR(s): §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility’s] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility’s] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI’s care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). This Standard is not met as evidenced by: 45888 . Based on document review and interview, the facility failed to develop a communication plan that included all required methods for sharing information including a means of providing information about the general condition and location of patients under the facility’s care in its emergency plan. Failure to establish a communication plan that includes all required elements including a means of providing information about the general condition and location of patients under the facility’s care puts patients at risk for unmet care needs, delay in treatment, and inability to provide coordinated health care services with external organizations under emergency conditions. Findings included: 1. Document review of the facility’s emergency plan titled, “Fresenius Kidney Care S. Tacoma Emergency Plan,” last reviewed 01/25/24, showed no evidence of a communication plan that included a process for providing information about the general condition and location of patients under the facility’s care. 2. On 03/13/24 at 4:00 PM, Surveyor #4 interviewed the facility Director of Operations (Staff #401) and the Area Team Lead (Staff #402) regarding the missing communication plan elements. Staff #401 and #402 confirmed the findings and acknowledged the facility failed to have a communication plan that included a means of providing information about the general condition and location of patients. 3. This is a repeat citation. DOH previously cited the facility for this finding during a 03/24/23 End Stage Renal Disease Facility Recertification Survey. .”

“Information on Occupancy/Needs CFR(s): §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.542(c)(7), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility’s] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice’s inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This Standard is not met as evidenced by: 45888 . Based on document review and interview, the facility failed to develop and implement a communication plan that includes a means of providing information about the facility’s occupancy, needs, and its ability to provide assistance to the authority having jurisdiction in an emergency or disaster. Failure to develop and maintain an emergency preparedness communication plan that includes a means of providing information about the facility’s occupancy, needs, and its ability to provide assistance to the authority having jurisdiction in an emergency or disaster risks patient harm related to the facility’s inability to access critical resources in an emergency. Findings included: 1. Document review of the facility’s emergency plan titled, “Fresenius Kidney Care S. Tacoma Emergency Plan,” last reviewed 01/25/24, showed no evidence of a process for providing information about the facility’s occupancy, needs, and its ability to provide assistance to the authority having jurisdiction in an emergency or disaster. 2. On 03/23/24 at 3:30 PM, Surveyor #4 interviewed the facility Director of Operations (Staff #401) and the Area Team Lead (Staff #402) regarding the missing communication plan elements. Staff #401 and #402 confirmed the findings and acknowledged the facility failed to have a communication plan that included a process for providing information about the facility’s occupancy, needs, and its ability to provide assistance to the authority having jurisdiction in an emergency or disaster. 3. This is a repeat citation. DOH previously cited the facility for this finding during a 03/24/23 End Stage Renal Disease Facility Recertification Survey. .”

“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: 45888 . Based on document review, observation, and interview, the facility failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents by failing to ensure patient care supplies were stored appropriately. Failure to provide a sanitary environment to minimize the transmission of infectious agents places patients at risk of exposure to infectious agents from contaminated patient care supplies. Findings included: 1. Document review of the facility policy titled, “General Cleanliness and Infection Control Guidelines,” dated 04/07/22, showed that food and drink shall not be kept where blood or other potentially infections materials are present. 2. On 03/12/24 at 2:04 PM, Surveyor #4 observed 2 opened boxes of Jimmy Protein Bars (a nutritional supplement provided to patients receiving dialysis treatment) stored in a cupboard under the sink in the medication room. The sides and bottoms of the cupboard had dried green and brown stains. The cupboard door had a label showing, “do not store anything under sink.” 3. On 03/12/24 at 2:15 PM, Surveyor #4 interviewed the facility Charge Nurse (Staff #403) regarding the nutritional supplements stored under the sink. Staff #403 confirmed the findings and acknowledged no food items or patient care items were to be stored under the sink. .”

“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: 45888 . Based on document review, observation, and interview, the facility failed to ensure all staff followed facility policies and procedures for glove use and hand hygiene. Failure to change gloves and perform hand hygiene places patients at risk for exposure to and transmission of infectious agents. Findings included: 1. Document review of the facility policy titled, “Post Treatment Fistula Needle Removal,” dated 07/06/21, showed that patients holding dialysis access sites are to remove gloves and perform hand hygiene after hemostasis is achieved. Staff are to instruct patient holding sites to perform hand hygiene. 2. On 03/12/24 at 10:40 AM, Surveyor #4 observed a Patient Care Technician (PCT) (Staff #421) discontinue dialysis treatment for Patient #457. The observation showed that Patient #457 held their access sites with a gloved hand after being disconnected from dialysis treatment to achieve hemostasis, exposing Patient #457 to blood and bodily fluids. - Staff #421 failed to ensure Patient #457 performed hand hygiene after hemostasis was achieved and when Patient #457 removed their glove. 3. On 03/12/24 at 4:00 PM, Surveyor #3 and Surveyor #4 interviewed the facility Director of Operations (Staff #301) and the Area Team Lead (Staff #302) regarding the hand hygiene practice observations. Staff #301 and #302 acknowledged the findings and confirmed that facility policy required staff to ensure patients perform hand hygiene when exposed to blood or bodily fluids. .”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 45888 . Based on document review, observation, and interview, the facility failed to ensure all staff adhered to industry standards of practice and facility policy when wearing facemasks. Failure to ensure all staff correctly wear facemasks places staff and patients at risk for contamination and exposure to infectious agents. Reference: Centers for Disease Control and Prevention (CDC). “Mask Use” (2023) - “Wear masks correctly covering nose and mouth ...disposable masks should be thrown away after they’re worn once.” Findings included: 1. Document review of the facility policies titled, “Personal Protective Equipment,” dated 11/06/23, and “Infection Control Practices of COVID-19 in Fresenius Kidney Care Dialysis Clinics,” dated 05/19/23, showed that all staff must correctly wear facemasks covering nose and mouth at all times in patient-facing areas. 2. On 03/12/24 at 9:10 AM, Surveyors #3 and #4 observed the facility Charge Nurse (Staff #303) in the facility’s patient waiting area with patients present. The observation showed that Staff #303 failed to cover their nose with their facemask. 3. On 03/12/24 at 2:20 PM, Surveyor #3 observed the facility Charge Nurse (Staff #303) on the facility dialysis treatment floor with patients present. The observation showed that Staff #303 failed to cover their nose with their facemask. 4. On 03/12/24 at 4:15 PM, Surveyors #3 and #4 interviewed the facility Director of Operations (Staff #301) and Area Team Lead (Staff #302) regarding the observed facemask use. Staff #301 and #302 acknowledged the observation and confirmed that facility policy required facemasks to be worn covering nose and mouth in patient-facing areas. .”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 45888 . Based on document review, observation, and interview, the facility failed to ensure staff followed policies for safe preparation, handling, and storage of medications by failing to label multidose vials and syringes containing medications according to industry standards of practice and facility policy. Failure to ensure staff follow policies for safe preparation, handling, and storage of medications places patients at risk of harm from exposure to infectious agents. Findings included: 1. Document review of the facility policy titled, “Medication Preparation and Administration,” dated 02/06/23, showed the following: - All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time, and initials of the person who prepared the medication. - Multidose vials must have the date and time the vial was opened on the medication label along with the initials of the staff member who opened the vial. The staff member must never walk away from an opened multidose vial without writing the date and time the vial was opened. 2. On 03/12/24 at 1:50 PM, Surveyor #4 toured the medication room and observed the following: - Three unlabeled syringes containing 4 milliliters (mL) of clear fluid unattended on the counter. - One unlabeled syringe containing 2mL of clear fluid unattended on the counter. - One opened vial of Heparin (a medication used to prevent clotting) without the date opened noted on the vial. 3. On 03/12/24 at 2:15 PM, Surveyor #4 interviewed the facility Charge Nurse (Staff #403) regarding the unattended, unlabeled syringes and multidose vial. Staff #403 confirmed the findings and acknowledged that staff failed to follow safe medication management policies. .”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 45888 . Based on document review and interview, the facility failed to accurately monitor common supply carts used to store clean supplies in patient treatment areas and ensure carts remained away from patient stations. Failure to accurately monitor common supply carts places patients at risk for cross-contamination and exposure to infectious agents. Findings included: 1. Document review of the undated facility document titled, “Clinic Audit Checklist Job Aid,” showed that the facility must conduct a monthly audit of patient care areas, including review of the use of common supply carts. 2. Document review of facility monthly patient care area audits from 03/07/23 to 03/11/24 showed the following: - On 04/07/23, the facility Charge Nurse (Staff #303) documented that a common cart was used to distribute supplies to patient stations. - On 06/02/23, the facility Charge Nurse (Staff #303) documented that a common cart was used to distribute supplies to patient stations. - On 07/06/23, the facility Charge Nurse (Staff #303) documented that a common cart was used to distribute supplies to patient stations. - On 08/08/23, the facility Charge Nurse (Staff #303) documented that a common cart was used to distribute supplies to patient stations. - On 09/12/23, the facility Charge Nurse (Staff #303) documented that a common cart was used to distribute supplies to patient stations. - On 10/06/23, the facility Charge Nurse (Staff #303) documented that a common cart was used to distribute supplies to patient stations. - On 11/30/23, the facility Charge Nurse (Staff #303) documented that a common cart was used to distribute supplies to patient stations. - On 12/06/23, the facility Charge Nurse (Staff #303) documented that a common cart was used to distribute supplies to patient stations. - On 02/05/24, the facility Charge Nurse (Staff #303) documented that a common cart was used to distribute supplies to patient stations. 3. On 03/13/24 at 3:53 PM, Surveyors #3 and #4 interviewed the facility Charge Nurse (Staff #303) regarding the common cart use documented in the monthly patient care area audits. Staff #303 stated that they did not understand how to complete the monthly patient care audit forms. Staff #303 stated that common carts were not used to distribute supplies to patient stations but that Staff #303 failed to accurately document responses regarding common cart use within the facility monthly patient care audit forms. .”

“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: 45888 . 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 fully conduct a baseline Tuberculosis (TB) screening in 1 of 5 personnel files reviewed (Staff #311). Failure to implement infection control policies consistent with CDC guidelines places patients and staff at risk for exposure to infectious diseases such as 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. Baseline individual TB risk assessment [should assess] residence of > 1 month in a country with a high TB rate, current or planned immunosuppression [and] close contact with someone who has had infectious TB disease since the last TB test.” Findings included: 1. Document review of the facility policy titled, “Employee Tuberculosis Testing,” dated 02/05/24, showed that all staff must complete a baseline TB test, symptom screening, and risk assessment upon hire. 2. Document review of employee personnel files failed to show a baseline TB risk assessment in 1 of 5 personnel files reviewed (Staff #311). 3. On 03/15/24 at 8:30 AM, Surveyor #3 interviewed the facility Area Team Lead (Staff #302) regarding the missing TB baseline risk assessment. Staff #302 confirmed that document review of employee personnel files failed to show a baseline TB risk assessment in 1 of 5 files reviewed. .”

“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: 45888 . 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 policy titled, “Termination of Treatment with a 2008 Series Hemodialysis Machine using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer,” dated 01/28/15, showed that a clean field, pad, or gauze must be placed under CVC limbs prior to disconnecting dialysis bloodlines from a CVC. 2. On 03/12/24 at 11:14 PM, Surveyor #3 observed a Registered Nurse (Staff #311) disconnect Patient #342’s CVC from dialysis bloodlines at the end of dialysis treatment. The observation showed that Staff #311 failed to place a clean field, pad, or gauze under Patient #342’s CVC limbs prior to disconnecting the dialysis bloodlines. 3. On 03/12/24 at 4:15 PM, Surveyors #3 and #4 interviewed the facility Director of Operations (Staff #301) and Area Team Lead (Staff #302) regarding the observed CVC care. Staff #301 and #302 acknowledged the observation and confirmed that facility policy required a clean field, pad, or gauze to be placed under CVC limbs prior to disconnecting dialysis bloodlines from a CVC. .”

“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: 45888 . Based on document review and interview, the facility failed to ensure staff performed testing for free chlorine, chloramine, or total chlorine prior to the beginning of each patient shift, or approximately every 4 hours. Failure to ensure chlorine testing occurs at the required frequency places patients at risk for harm from exposure to harmful contaminates during dialysis. Findings included: 1. Document review of the facility policy titled, “Carbon Filtration Monitoring for Incenter Central Water Systems Policy,” dated 11/07/22, showed that facility total chlorine checks must occur prior to initiating the first dialysis treatment of the day, and then subsequently at a minimum of every 4 hours. 2. Document review of facility total chlorine monitoring logs from 09/01/23 to 03/01/24 showed the following: - On 09/18/23, facility staff failed to document a total chlorine check between 10:46 AM and 3:40 PM. - On 09/30/23, facility staff failed to document a total chlorine check between 1:38 PM and 6:12 PM. - On 11/06/23, facility staff failed to document a total chlorine check between 2:16 PM and 8:11 PM. - On 11/24/23, facility staff failed to document a total chlorine check between 11:16 PM and 5:15 PM. - On 12/08/23, facility staff failed to document a total chlorine check between 2:23 PM and 7:19 PM. - On 12/12/23, facility staff failed to document a total chlorine check between 8:16 AM and 1:06 PM. - On 12/20/23, facility staff failed to document a total chlorine check between 4:57 AM and 11:09 AM. - On 12/29/23, facility staff failed to document a total chlorine check between 8:23 AM and 2:09 PM. - On 01/20/24, facility staff failed to document a total chlorine check between 11:03 PM and 5:07 PM. - On 02/08/24, facility staff failed to document a total chlorine check between 2:12 PM and 8:06 PM. - On 02/23/24, facility staff failed to document a total chlorine check between 5:12 AM and 1:24 PM. 3. On 03/15/24 at 10:45 AM, Surveyors #3 and #4 interviewed a facility Patient Care Technician (Staff #320) regarding the late total chlorine checks. Staff #320 stated that facility staff were aware of the required timing of total chlorine checks and confirmed that facility chlorine monitoring logs showed 11 total chlorine checks documented late between 09/01/23 and 03/01/24. 4. On 03/13/24 at 4:20 PM, Surveyor #3 interviewed the facility Director of Operations (Staff #301) and Area Team Lead (Staff #302) regarding the late total chlorine checks. Staff #301 and Staff #302 acknowledged the findings and confirmed that facility policy required staff to perform total chlorine checks a minimum of every 4 hours while patients received dialysis. 5. This is a repeat citation. DOH previously cited the facility for this finding in a 03/24/23 Medicare End Stage Renal Disease Facility Recertification Survey. .”

“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: 45888 . Based on document review and interview, the facility failed to maintain all equipment, including dialysis machines, in accordance with manufacturer recommendations. Failure to maintain all equipment in accordance with manufacturer recommendations places patients at risk for harm from equipment malfunction. Findings included: 1. Document review of the undated Fresenius Medical Care document titled, “2008T Hemodialysis System Preventative Maintenance Procedures,” the manufacturer’s preventative maintenance instructions for the facility’s hemodialysis machines, showed that each machine must receive preventative maintenance after 4000 hours of operation. 2. Document review of the facility’s hemodialysis machine preventative maintenance records showed that the facility failed to accurately record the hours between preventative maintenance occurrences. 3. Document review of the facility’s hemodialysis machine preventative maintenance records showed the following: - No preventative maintenance was performed for hemodialysis machine #7T0S-172929 between 31,562 hours of operation and 320,113 hours of operation. - No preventative maintenance was performed for hemodialysis machine #7T0S-172951 between 32,293 hours of operation and 322,078 hours of operation. 4. On 03/14/24 at 2:00 PM, Surveyor #3 interviewed the facility Biomedical Technician (Staff #306) regarding the dialysis machine preventative maintenance records. Staff #306 acknowledged that review of hemodialysis machine preventative maintenance records showed greater than 4000 hours of operation between preventative maintenance cycles for two dialysis machines. .”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 45888 . Based on document review and interview, the facility failed to ensure patients received all necessary services outlined in each patient’s plan of care by failing to ensure patients received dialysis treatments as prescribed in 2 of 11 patient medical records reviewed (Patients #343 and #350). Failure to ensure patients receive all necessary services outlined in plans of care places patients at risk for harm or death related to unmanaged medical conditions. Findings included: 1. Document review of the facility policy titled, “Patient Assessment and Monitoring,” dated 09/29/18, showed that each patient must receive dialysis treatments according to the patient’s dialysis prescription. 2. Document review of Patient #343’s medical record showed the following: - Patient #343’s dialysis prescription required 4 hour and 15 minute hemodialysis treatments 3 times weekly. - On 01/05/24, Patient #343 called the facility to state they would be arriving two hours late for dialysis treatment. A Registered Nurse (RN) (Staff #314) documented that they informed Patient #343 to not come to the facility to receive dialysis treatment due to the patient’s late arrival time. Staff #314 failed to set up a replacement dialysis treatment for Patient #343. 3. Document review of Patient #350’s medical record showed the following: - Patient #350’s dialysis prescription required 4 hour hemodialysis treatments 3 times weekly. - On 02/01/24, an RN (Staff #316) documented that Patient #350 arrived at the facility without a transfer device and was therefore unable to be transferred to a dialysis chair and could not receive dialysis as scheduled. Staff #316 failed to set up a replacement dialysis treatment for Patient #350. - The facility failed to establish an agreement, contract, or other communication with Patient #350’s skilled nursing facility residence to ensure Patient #350 subsequently arrived to the dialysis facility with an appropriate transfer device. 4. On 03/14/24 at 2:05 PM, Surveyors #3 and #4 interviewed the facility Director of Operations (Staff #301), Area Team Lead (Staff #302), Charge Nurse (Staff #303), Social Worker (Staff #307), and Registered Dietician (Staff #308) regarding the missed dialysis treatments. Staff #301, #302, #303, #307, and #308 confirmed that patient medical record document review failed to show that patients received the necessary services outlined in each patient’s dialysis prescription in 2 of 11 patient medical records reviewed. .”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 45888 . Based on document review and interview, the facility failed to evaluate and adhere to each patient’s dialysis prescription in 2 of 11 patient medical records reviewed (Patients #350 and #352). Failure to evaluate and adhere to each patient’s dialysis prescription places patients at risk for ineffective dialysis and at risk for undetected complications. Findings included: 1. Document review of the facility policies titled, “Patient Assessment and Monitoring,” dated 09/29/18, and “Nursing Supervision and Delegation,” dated 05/13/23, showed that that each patient must receive dialysis treatments according to the patient’s dialysis prescription, and that a nurse must review each patients’ dialysis treatment prescription to ensure the correct prescription is being followed each dialysis treatment. 2. Document review of patient medical records showed the following: - On 02/28/24, a Registered Nurse (RN) (Staff #318) verified dialysis prescription settings for Patient #352. Patient #352’s blood flow rate was 50 milliliters per minute (mL/min) less than their prescribed blood flow rate for 2 hours and 30 minutes of Patient #352’s treatment. - On 03/02/23, an RN (Staff #312) verified dialysis prescription settings for Patient #350. Patient #350’s blood flow rate was 150 mL/min less than their prescribed blood flow rate for the full 4 hour duration of Patient #350’s treatment. - On 03/05/24, a Licensed Practical Nurse (Staff #319) verified dialysis prescription settings for Patient #350. Patient #350’s blood flow rate was 100 mL/min less than their prescribed blood flow rate for the full 4 hour duration of Patient #350’s treatment. 3. On 03/14/24 at 2:05 PM, Surveyors #3 and #4 interviewed the facility Director of Operations (Staff #301), Area Team Lead (Staff #302), Charge Nurse (Staff #303), Social Worker (Staff #307), and Registered Dietician (Staff #308) regarding the incorrect blood flow rates. Staff #301, #302, #303, #307, and #308 confirmed that patient medical record review showed that nurses failed to ensure patient prescribed blood flow rates were followed in 2 of 11 patient medical records reviewed. .”

“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: 45888 . Based on document review and interview, the facility failed to appropriately assess and respond to issues related to patients’ laboratory profiles in 1 of 11 patient medical records reviewed (Patient #444). 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 policy titled, “Use of 1.0 mEq/L Potassium Dialysate in Chronic Outpatient Setting,” dated 07/06/21, showed that patients with a serum potassium (K+) result equal to or greater than 6.0 mEq/L must have an order from the physician to dialyze on 1.0 mEq/L K+ dialysate. The order must be renewed each week. 2. Medical record review of Patient #444’s medical record showed the following: - A dialysate order for 2.0 K+ dated 02/29/24 through 02/27/25. The medical record showed no evidence of a 1.0 K+ dialysate order. - On 03/12/24 at 5:33 PM, Patient #444 was started on dialysis treatment utilizing the correct 2.0 K+ dialysate. At 7:00 PM, a Licensed Practical Nurse (LPN) (Staff #419) documented receipt of a K+ value of 6.4 mEq/L and documented “faxed doctor and put on 1K.” - On 03/14/24, Patient #444 received dialysis treatment beginning at 5:26 PM and ending at 8:48 PM. At 11:00 PM, a Registered Nurse (RN) (Staff #418) documented “Pt has a potassium of 7.1 ran on 1K per MD order.” 3. On 03/15/24 at 10:15 AM, Surveyor #4 interviewed the covering RN Clinic Manager (Staff #404) regarding the missing dialysate order. Staff #404 confirmed that the patient received dialysis treatment utilizing 1.0 K+ without a physician’s order. .”

“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: 45888 . Based on document review and interview, the facility failed to ensure that an evaluation of suitability for a transplant referral, or basis for nonreferral was documented in the patient medical record in 1 of 11 medical records reviewed (Patient #445). Failure to evaluate suitability and document the reason for a nonreferral places patients at risk of not getting a renal transplant. Findings included: 1. Document review of the facility policy titled, “Transplant Responsibilities and Guidelines,” dated 03/02/20, showed the responsibilities of the social worker (MSW), nurse and the nephrologist regarding transplant education and referral. The policy showed that the nephrologist will oversee transplant suitability and referral to a transplant center. The nephrologist will document patient suitability for transplant in the electronic medical record. The MSW will educate the patient within the first 120 days. -Document review of the facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 04/24/19, showed that each patients’ plan of care (POC) must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, the patient or designee, a registered nurse, the patients attending physician or physician extender, MSW, and registered dietitian. The POC will be guided and developed based on the findings identified in the comprehensive IDT assessment and includes an evaluation of suitability for a transplant referral. 2. Document review of Patient #445’s medical record showed the following: - Patient #445 was admitted on 07/21/23. - On 08/09/23 at 8:46 PM an MSW (Staff #407) documented a progress note that stated “Patient is interested in kidney transplant and was referred to speak to their nephrologist about referral to transplant center.” - On 11/29/23 a Plan of Care Meeting was held by the IDT including the MSW, dietician, nurse, and physician extender. The IDT documentation shows no evidence the nephrologist or patient participated in the meeting. The transplant status portion of the POC document shows, “discuss with patient if they are interested in a transplant. Educate patient on transplant.” The transplant information from the supporting IDT assessment dated 11/24/23 and 08/02/24 shows, “Patient is interested in kidney transplant and was referred to speak to their nephrologist about referral to transplant center.” - On 01/08/24 at 8:17 PM, an MSW (Staff #407) documented a progress note that stated, “Patient is interested in kidney transplant and was referred to speak to their nephrologist about referral to transplant center.” - On 01/17/24, a nephrologist (Staff #435) conducted a face-to-face assessment. The documentation shows a template related to interest and eligibility of transplant in the note. The template shows the patient is interested in transplantation and not on the transplant list. “No” is filled in for the question of “Has patient’s physician identified one or more exclusions per the contraindication list provided by the transplant center?” The transplant comments show, “10/25/23 - Patient still interested in kidney transplant. Pt. has not followed up with discussions with the nephrologist. 07/24/23 - SW met with pt and his wife who reported that the pt. is interested in kidney transplant. SW educated pt. and spouse on kidney transplant. Pt. and spouse understood and in agreement.” The provider discussion date and provider transplant comment sections are blank. - On 02/14/24, the nephrologist (Staff #435) conducted a virtual visit. The documentation shows a template related to interest and eligibility of transplant in the note. The template shows the patient is interested in transplantation and not on the transplant list. “No” is filled in for the question of “Has patient’s physician identified one or more exclusions per the contraindication list provided by the transplant center?” The transplant comments show “01/24/24 - Patient still interested in kidney transplant. Pt. has not followed up with discussions with the nephologist. 10/25/23 - Patient still interested in kidney transplant. Pt. has not followed up with discussions with the nephologist. 07/24/23 - SW met with pt and his wife who reported that the pt. is interested in kidney transplant. SW educated pt. and spouse on kidney transplant. Pt. and spouse understood and in agreement.” The provider discussion date and provider transplant comment sections are blank. - The medical record showed no evidence of additional follow up to assess patient for transplant eligibility. 3. On 03/12/24 at 3:00 PM, Surveyor #4 interviewed the facility Director of Operations (Staff #401), Area Team Lead (Staff #402), and Charge Nurse (Staff #403) regarding the missing evaluation of transplant suitability. Staff #401, #402, and #403 confirmed the findings and acknowledged that the IDT failed to document an evaluation of transplant suitability and transplant referral coordination. .”

“PA-ASSESS HD ADEQ Q MO;PD ADEQ Q 4 MO CFR(s): 494.80(c) The adequacy of the patient’s dialysis prescription, as described in §494.90(a)(1), must be assessed on an ongoing basis as follows: (1) Hemodialysis patients. At least monthly by calculating delivered Kt/V or an equivalent measure. (2) Peritoneal dialysis patients. At least every 4 months by calculating delivered weekly Kt/V or an equivalent measure. This Standard is not met as evidenced by: 45888 . Based on document review and interview, the facility failed to ensure physicians assessed patient dialysis adequacy on an ongoing basis in 1 of 11 patient medical records reviewed (Patient #343). Failure to assess patient dialysis adequacy on an ongoing basis places patients at risk for inadequate dialysis and at risk for subsequent health complications, including death. Findings included: 1. Document review of the facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 04/24/19, showed that members of patients’ interdisciplinary team must assess dialysis adequacy at least monthly. 2. Document review of Patient #343’s medical record showed the following: - Interdisciplinary team members, including a Registered Nurse (Staff #317) and facility Registered Dietician (Staff #308), noted that Patient #343’s dialysis adequacy lab work showed the patient’s dose of dialysis remained consistently inadequate and lab levels were below required clearance levels between 10/16/23 to 03/01/24. - On 01/13/24, a Nurse Practitioner (Staff #339) documented that Patient #343 met their dialysis adequacy parameters, despite lab work from 11/27/23, 12/18/23, and 12/29/23 demonstrating that the patient failed to meet dialysis adequacy parameters. - On 02/14/24, a Physician (Staff #335) failed to address Patient #343’s dialysis adequacy despite lab work from 12/29/23, 01/15/24, and 01/24/24 demonstrating that the patient failed to meet dialysis adequacy parameters. 3. On 03/14/24 at 2:05 PM, Surveyor #3 interviewed the facility Director of Operations (Staff #301), Area Team Lead (Staff #302), Charge Nurse (Staff #303), Social Worker (Staff #307), and Registered Dietician (Staff #308) regarding assessment of patient dialysis adequacy. Staff #301, #302, #303, #307, and #308 confirmed that patient medical record review showed that patients’ interdisciplinary team members failed to address inadequate dialysis in 1 of 11 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: 45888 . 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 manage patient blood pressure (BP) and heart rate (HR) per facility protocol in 3 of 11 patient medical records reviewed (Patients #445, #449, and #451) (1), failing to assess patients at facility policy-specified intervals in 5 of 11 patient medical records reviewed (Patients #444, #445, #446, #448, and #452) (2), and failing to ensure nursing assessments occurred per facility policy in 3 of 11 patient medical records reviewed (Patients #445, #449, and #451) (3). Failure to provide the necessary care and services to manage patients’ dose of dialysis places patients at risk for ineffective treatments and at risk for undetected complications. Findings Included: Item #1 - BP and HR 1. Document review of the facility policy titled, “Patient Assessment and Monitoring,” dated 09/29/18, and “Hypertension,” dated 09/07/21, showed the following: - Patient systolic blood pressure (SBP) (a pressure measurement when the heart contracts) greater than 180 millimeters of mercury (mm/Hg) or less than 100 mm/Hg is an abnormal finding. - Patient diastolic blood pressure (DBP) (a pressure measurement of the heart at rest) greater than 100 mm/Hg is an abnormal finding. - Patient HR assessed below 60 beats per minute (BPM) or above 100 BPM is an abnormal finding. - Abnormal findings collected by a Patient Care Technician (PCT), or a Licensed Practical Nurse (LPN) must be reported to a Registered Nurse (RN), who must assess the affected patient. - Staff will recognize, report, and immediately address SBP greater than 180 mm/Hg and DBP greater than 100 mm/Hg. 2. Document review of patient medical records showed staff failed to manage patient BP and HR as required in the following: - On 03/01/24 Patient #445 received dialysis treatment. A PCT (Staff #437) failed to document RN notification of SBP greater than 180 mmHg in 1 of 9 BP measurements. - On 03/01/24 Patient #449 received dialysis treatment. PCT’s (Staff #426, #429 #438) failed to document RN notification of HR greater than 100 in 7 of 9 HR measurements. - On 03/06/24 Patient #449 received dialysis treatment. A PCT (Staff #426) failed to document RN notification of HR greater than 100 in 5 of 11 HR measurements. - On 03/11/24 Patient #445 received dialysis treatment. PCT’s (Staff #430 and #437) failed to document RN notification of SBP greater than 180 mmHg and DBP greater than 100 in 4 of 14 BP measurements. - On 03/11/24 Patient #449 received dialysis treatment. A PCT (Staff #431) failed to document RN notification of HR greater than 100 in 2 of 10 HR measurements. - On 03/12/24 Patient #451 received dialysis treatment. A PCT (Staff #421) failed to document RN notification of SBP less than 100 in 2 of 11 BP measurements. 3. On 03/12/24 at 3:00 PM, Surveyor #4 interviewed the Director of Operations (Staff #401), the Area Team Lead (Staff #402), and the RN in Charge (Staff #403) regarding the unmanaged patients’ BP and HR. Staff #401, #402, and #403 confirmed the findings and acknowledged patient medical record review failed to show RN notification of abnormal findings in 3 of 11 patient medical records reviewed. Item #2 -Patient Assessment Intervals 1. Document review of the facility policy titled, “Patient Assessment and Monitoring,” dated 09/29/18, showed that staff must obtain BP and HR every 30 minutes or as needed but not to exceed 45 minutes. 2. Document review of patient medical records showed staff failed to obtain BP and HR within the approved time limits in the following medical records reviewed: - On 03/01/24, Patient #445 received dialysis treatment. A PCT (Staff #437) documented a BP/HR at 4:40 PM. Repeat readings were not documented until 5:37 PM. - On 03/04/24, Patient #445 received dialysis treatment. A PCT (Staff #429) documented a BP/HR at 4:54 PM. Repeat readings were not documented until 5:49 PM. On the same treatment day, a PCT (Staff #430) documented a BP/HR at 8:07 PM. Repeat readings were not documented until 8:54 PM. - On 03/04/24, Patient #446 received dialysis treatment. A PCT (Staff #424) documented a BP/HR at 11:05 AM. Repeat readings were not documented until 12:33 PM. - On 03/06/24, Patient #448 received dialysis treatment. A PCT (Staff #430) documented a BP/HR at 4:35 PM. Repeat readings were not documented until 5:23 PM. - On 03/06/24, Patient #452 received dialysis treatment. A PCT (Staff #429) documented a BP/HR at 8:37 PM. Repeat readings were not documented until 9:37 PM. - On 03/08/24, Patient #446 received dialysis treatment. A PCT (Staff #426) documented a BP/HR at 10:30 AM. Repeat readings were not documented until 11:31 AM. - On 03/11/24, Patient #446 received dialysis treatment. A PCT (Staff #424) documented a BP/HR at 12:07 PM. Repeat readings were not documented until 1:30 PM. - On 03/12/24, Patient #444 received dialysis treatment. A PCT (Staff #431) documented a BP/HR at 7:08 PM. Repeat readings were not documented until 7:59 PM. 3. On 03/12/24 at 3:00 PM, Surveyor #4 interviewed the Director of Operations (Staff #401), the Area Team Lead (Staff #402), and the RN in Charge (Staff #403) regarding the missing BP and HR documentation. Staff #401, #402, and #403 confirmed the findings and acknowledged patient medical record review failed to show documentation of BP and HR within the facility required timeframes in 5 of 11 patient medical records reviewed. Item #3 - Nursing Assessment 1. Document review of the facility policies titled, “Patient Assessment and Monitoring,” dated 09/29/18 and “Hypertension,” dated 09/07/21, showed the following: - Patient SBP greater than 180 mmHg, DBP greater than 100 mmHg, and Patient HR above 100 BPM are abnormal findings. - Abnormal findings collected by a Patient Care Technician (PCT), or a Licensed Practical Nurse (LPN) must be reported to a Registered Nurse (RN), who must assess the affected patient. - Staff will recognize, report, and immediately address SBP greater than 180 mm/Hg and DBP greater than 100 mm/Hg. - The registered nurse will assess/re-asses any findings addressed pre or during treatment as needed. The registered nurse will document findings and interventions in the medical record. 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 Patient #449 received dialysis treatment. A PCT (Staff #426) documented notification to an RN (Staff #412) regarding Patient #449’s HR greater than 100. Staff #412 failed to document a subsequent assessment of Patient #449. - On 03/11/24 Patient #445 received dialysis treatment. PCTs (Staff #429 and #430) documented notification to an RN (Staff #412) regarding Patient #445’s SBP greater than 180 and DBP greater than 100 mmHg. Staff #412 failed to document a subsequent assessment of Patient #445. - On 03/12/24 Patient #451 received dialysis treatment. A PCT (Staff #421) documented notification to a LPN (Staff #419) regarding Patient #451’s SBP less than 100. Staff #419 failed to document a subsequent assessment of Patient #451. 3. On 03/12/24 at 3:00 PM, Surveyor #4 interviewed the Director of Operations (Staff #401), the Area Team Lead (Staff #402), and the RN in Charge (Staff #403) regarding the late and missing nursing assessments. Staff #401, Staff #402, and Staff #403 confirmed the findings and acknowledged nursing staff failed to document patient assessments or interventions in 3 of 11 patient medical records reviewed. .”

“POC-MANAGE MINERAL METABOLISM CFR(s): 494.90(a)(3) Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease. This Standard is not met as evidenced by: 45888 . Based on document review, observation, and interview, the facility failed to provide the necessary care to manage patient mineral metabolism and treat renal bone disease. Failure to provide the necessary care to manage patient mineral metabolism and treat renal bone disease places patients at risk for harm including detrimental bone disease and death. Findings included: 1. Document review of the facility policies titled, “Medication Preparation and Administration,” dated 02/06/23, and “Medication Preparation and Administration Procedure,” dated 09/05/23, showed that facility staff must complete administration of all prescribed medications during patients’ dialysis treatments. 2. On 03/12/24 at 11:14 AM, Surveyor #3 observed Patient #342 during their dialysis treatment. The observation showed a Registered Nurse (RN) (Staff #311) hand Patient #342 a medication cup containing a Cinacalcet pill (a medication to lower high calcium levels). Staff #311 failed to ensure Patient #342 took the Cinacalcet pill. Patient #342 placed the Cinacalcet pill in their purse and stated that they would take it at home. Patient #342 discharged from the facility after dialysis treatment with the Cinacalcet pill still in their purse. 3. On 03/12/24 at 12:00 PM, Surveyor #3 interviewed the RN (Staff #311) regarding the Cinacalcet pill. Staff #311 stated that facility practice included allowing patients to take oral medications, such as Cinacalcet, home with them without observing that patients took the prescribed medications. .”

“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: 45888 . 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 pre-dialysis. 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, “Access Assessment and Cannulation”, dated 07/05/22, showed that a patient’s access site is to be washed with soap and water prior to skin antisepsis. 2. On 03/12/24 at 11:03 AM, Surveyor #4 observed a Patient Care Technician (PCT) (Staff #321) initiate dialysis treatment for Patient #358. The observation showed that Patient #321’s access site was not washed with soap prior to skin antisepsis by the patient or staff as required. 3. On 03/12/24 at 4:00 PM, Surveyor #3 and Surveyor #4 interviewed the Director of Operations (Staff #301) and the Area Team Lead (Staff #302) regarding infection control policies and practices. Staff #301 and #302 acknowledged the findings and confirmed that staff are educated on and expected to adhere to the described infection control practices around vascular access. .”

“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: 45888 . Based on document review and interview, the facility failed to ensure all members of the interdisciplinary team (IDT) signed each patient’s plan of care according to regulation requirements and facility policy in 10 of 11 patient medical records reviewed (Patients #342, #343, #344, #345, #346, #347, #348, #349, #350, and #351). Failure to ensure all members of the IDT sign each patient’s plan of care places patients at risk for having incomplete or unapproved plans of care. Findings included: 1. Document review of the facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 04/24/19, showed that each patient plan of care must be signed by all members of the IDT within 30 days of completing an interdisciplinary plan of care meeting. 2. Document review of patient medical records showed the following: - On 04/26/23, the IDT held a plan of care meeting for Patient #347. The Physician (Staff #340) signed the patient’s plan of care on 07/20/23. - On 06/15/23, the IDT held a plan of care meeting for Patient #350. The Physician (Staff #309) signed the patient’s plan of care on 09/28/23. - On 09/27/23, the IDT held a plan of care meeting for Patient #343. The Physician (Staff #335) failed to sign the patient’s plan of care. - On 09/27/23, the IDT held a plan of care meeting for Patient #348. The Physician (Staff #335) failed to sign the patient’s plan of care. -On 10/17/23, the IDT held a plan of care meeting for Patient #342. The Physician (Staff #334) signed the patient’s plan of care on 01/01/24. - On 11/29/23, the IDT held a plan of care meeting for Patient #345. The Physician (Staff #335) failed to sign the patient’s plan of care. - On 11/29/23, the IDT held a plan of care meeting for Patient #351. The Physician (Staff #341) failed to sign the patient’s plan of care. - On 12/28/23, the IDT held a plan of care meeting for Patient #346. The Physician (Staff #335) failed to sign the patient’s plan of care. - On 02/13/24, the IDT held a plan of care meeting for Patient #349. The Physician (Staff #334) failed to sign the patient’s plan of care. - On 02/28/24, the IDT held a plan of care meeting for Patient #344. The Physician (Staff #340) failed to sign the patient’s plan of care. 3. On 03/15/24 at 1:45 PM, Surveyors #3 and #4 interviewed the facility Director of Operations (Staff #301) regarding the plan of care documentation. Staff #301 confirmed that patient medical record review failed to show appropriate physician plan of care signatures in 10 of 11 patient medical records reviewed. .”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 45888 . Based on document review and interview, the facility failed to set priorities for performance improvement based on identified prevalence and severity of problems, incorporating Centers for Medicare and Medicaid (CMS)-generated data reports, with priority applied to improvement activities affecting clinical outcomes and patient safety. Failure to set priorities for performance improvement based on identified prevalence and severity of problems, taking into account CMS generated data reports, with priority applied to activities affecting clinical outcomes and patient safety places patients at risk for severe harm, endangerment, and death. Findings included: 1. Document review of the most current annual CMS-generated dialysis facility data report for the facility showed that CMS identified hospitalizations related to septicemia, use of central venous catheters (CVCs) for greater than 90 days, and the number of patients on an age-adjusted transplant waitlist as areas of concern for the facility. 2. Document review of the facility’s Quality Assurance and Performance Improvement (QAPI) online dashboard failed to show that the facility prioritized or established performance improvement goals or projects related to the CMS-identified areas of concern of hospitalizations related to septicemia, use of CVCs for greater than 90 days, and the number of patients on an age-adjusted transplant waitlist. 3. Document review of the facility’s QAPI meeting minutes from 09/23 to 03/24 failed to show that the facility prioritized or established performance improvement goals or projects related to the CMS-identified areas of concern of hospitalizations related to septicemia, use of CVCs for greater than 90 days, and the number of patients on an age-adjusted transplant waitlist. 4. On 03/14/24 at 5:00 PM, Surveyors #3 and #4 interviewed the facility Director of Operations (Staff #301), Area Team Lead (Staff #302), Charge Nurse (Staff #303), Biomedical Technician (Staff #306), Social Worker (Staff #307), and Registered Dietician (Staff #308) regarding the facility’s performance improvement priorities. Staff #301, #302, #303, #306, #307, and #308 confirmed that the facility failed to prioritized or established performance improvement goals or projects related to the CMS-identified areas of concern within the most current annual CMS-generated dialysis facility data report. .”

“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: 45888 . 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 in 1 of 5 employee personnel files reviewed (Staff #311). 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, “Knowledge, Skills and Competency Evaluation for Clinical Staff,” dated 10/12/21, and the undated facility document titled, “Initial and Annual Water Skills Validation,” showed that all staff must have documented assessments of patient care skills and competency in dialysis water monitoring procedures upon completion of initial training, and then annually. 2. Document review of employee personnel files showed the following: - Staff #311 failed to have a record or documentation of patient care skills assessment since 02/23/23. - Staff #311, hired 08/21, failed to have a record or documentation assessing competency in dialysis water monitoring procedures. 3. On 03/15/24 at 8:30 AM, Surveyor #3 interviewed the facility Area Team Lead (Staff #302) regarding the missing assessments. Staff #302 confirmed that document review of employee personnel files failed to show competency in dialysis water monitoring procedures or a current patient care skills assessment in 1 of 5 files reviewed. .”