Renal Care Center - Wellington

“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: 29151 Based on policy review, clinical record review and interview, it was determined, the interdisciplinary team failed to ensure the patient plan of care was shared and signed by the patient acknowledging the problems, goals and interventions put in place. The failure affected Patient #1. The findings included: Facility policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 07/03/23 documents “The patient’s level of participation is determined by the patient. The patient must sign the plan of care meant to acknowledge the information in the plan. if the patient chooses not to sign their plan of care, the reason for the refusal must be documented in the patient’s medical record.” Clinical record review conducted on 06/17/25 revealed Patient #1 was admitted to the facility for dialysis treatment on 07/19/24. The record documents the interdisciplinary team completed an initial comprehensive plan of care on 08/31/24. There is no evidence of subsequent care plans due in December 2024. The record failed to provide evidence that Patient #1 participated and signed acknowledgement of the plan of care or refused to sign the care plan. The interview with Clinic Manager conducted on 06/17/25 at 12:13 PM revealed the facility failed to complete the 90-day plan of care due to the patient’s multiple no shows and hospitalizations. An unstable assessment was completed in March 2025, but because the patient is discharged, she is unable to retrieve or provide evidence the patient participated in the plan of care. The Clinic Manager confirmed there is no evidence of the patient’s participation in her unstable plan of care.”

“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: 29151 Based on observation, policy review and staff interview, the staff failed to utilize designated clean sink for hand hygiene during patient care to minimize the risk of cross contamination. The failure affected 2 of 3 observations for hand hygiene conducted on 06/10/25. According to the CDC, handwashing is the most important measure to prevent contaminant transmission. The findings included: Observation of care conducted on 06/10/25 starting at 9:23 AM revealed the clinical staff utilizing the sink designated and labeled as dirty for dialysate testing, rinsing dirty buckets and disposing of used solutions. Observation of care conducted on 06/10/25 at 10:23 AM revealed Staff J, a Registered Nurse, exiting the isolation room and removing the dirty gown and gloves. The staff was observed using the soap dispenser at the designated clean sink and then walked to the designated dirty sink to wash her hands. Staff J proceeded to the medication area and prepared medications. Observation of care conducted on 06/10/25 at 10:47 AM revealed Staff J exiting the isolation room, removed the gown and gloves and proceeded to the designated dirty sink to wash her hands and then proceeded to care for the patient at station #3. Interview with Staff J conducted on 06/10/25 at approximately 10:50 AM revealed the designated clean sink across from the isolation room is not working and confirmed she used the designated dirty sink because she has to attend to patients timely. Subsequent observation of the designated clean sink located across the isolation room verifies the sink is out of order, there is no running water. The treatment floor has two additional designated clean sinks that are operational and easily accessible to the staff for immediate use. Facility policy titled “Hand Hygiene” dated 11/06/23 documents “Hand washing sinks should be dedicated for hand washing only and should remain clean.””

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 22517 Based on observation and interview, the facility failed to have an adequate number of sinks in the Home Hemodialysis Training Room. The necessary sinks are a handwashing sink and a dirty sink to drain solutions from the NxStage dialysis machine. The findings included: An observation in the Home Hemodialysis Training Room was conducted on 06/11/25 beginning at 9:10 AM. There was one sink in the room that was labeled both as clean on one side and dirty on the other side. (photo evidence available). An interview was conducted at this time with the Clinical Manager of Home Therapies, who confirmed that there was only one sink in the room and she further acknowledged that this is not acceptable and has informed the Area Technical Operations Manager. She also stated that the facility has a “new/old” patient requiring retraining and has not connected the drainage tubing for the NxStage dialysis machine. An interview was conducted on 06/11/25 at approximately 2:00 PM with the Home Hemodialysis Training Nurse, who stated he was aware that there was one sink in the training room and has reported this to management that this is not optimum. He stated when he train patients, he encourages them to train at his other clinic. If they are unable to train at the other unit, he would use the one sink in the room as the dirty sink to drain and get the patient to go down the hall to another sink to wash their hands.”

“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: 29151 Based on observation, policy review and staff interview, the facility staff failed to adhere to current aseptic techniques policies and procedures for intravenous medications, as evidenced by the staff failure to appropriately label medication syringes. The findings included: An observation conducted on the treatment floor conducted on 06/10/25 beginning at 9:23 AM at the medication area, revealed six syringes stored in the drawer, filled with a clear substance and labeled as Heparin. Closer observation failed to provide evidence of the time the medication was prepared. Interview with Staff B conducted on 06/10/25 at 11:30 AM revealed she is the person that prepared the Heparin syringes for the next shift and verified she did not document the time the medication was drawn. Facility policy titled “Medication Administration and Preparation” dated 02/06/23 documents “All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of the patient, date, time and initials of the person who prepared the medication.””

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 22517 Based on observation and interview, the facility failed to ensure that access to the water purification and storage system was secure at all times. The findings included: An observation was conducted on 06/10/25 beginning at approximately 9:15 AM revealed the door on the treatment floor which leads to the water purification and storage system was propped open with a door stop and was not secure and restricted. (photo evidence available) An interview was conducted on 06/10/25 at 12:27 PM with the Area Technical Operations Manager, who confirmed that the door is to remain closed at all times.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 22517 Based on observation, administrative record review and staff interview, the facility failed to ensure the softener brine tank is monitored and maintained daily to ensure the saturated solution exists in the brine tank such that salt pellets fill at least half the tank and water is not visible above the salt pellets. The findings included: An observation of the water room was conducted on 06/10/25 beginning at approximately 9:20 AM revealed that the brine tank had approximately 10-12 inches of water that was visible above the salt pellets in the tank, and salt pellets was less than half full. Also observed in the tank was noted areas of brown colored substance floating in the water. (photo evidence available) Another observation and interview was conducted on 06/10/25 at approximately 12:30 PM with the Patient Care Technician, Staff G. Staff G confirmed that the water was visible above the salt pellets. She stated Bio Medical Staff has to assist with lifting the salt pellets bags because it is too heavy and he is not here today. Review of the daily Water Pre-TX Opening logs, revealed that the staff documented “YES” the “Salt Level greater than half full and above the water line? If salt is less than half full, or below the water level, add salt to the appropriate level and answer YES. Further review of the June log revealed that the staff have documented consistently the salt level is greater than half full and above the water line for the past 10 days. Also the staff documented “NA” that salt has been added for the past 10 days.”

“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: 22517 Based on administrative record review and staff interview, the facility failed to consistently follow the established policy and procedure to ensure that the results of monitoring of free chlorine, chloramine, or total chlorine is performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift or approximately every 4 hours for 3 of 3 months reviewed. The findings include: The facility’s policy regarding Carbon Filtration Monitoring for In-center Central Water Systems published 02/03/2025 documented, “Total Chlorine test will be performed prior to initial treatment and every four hours. If unable to perform total chlorine testing within 4 hours of the previous test, treatments must be discontinued. Staff must follow the patient assessment and monitoring” The facility’s policy regarding Daily Water System Total Chlorine Monitoring, Policy # 12-14-03 documented, “Total Chlorine testing is done on a daily basis prior to the first patient treatment and every four (4) hours until all activities that require use of dialysis quality water are completed. Review of the facility’s Post Worker Carbon Tank-TCL-1 revealed that the staff did not perform the chlorine test every 4 hours as follows: June On 06/03/25, the staff documented a chlorine test at 3:45 AM, the next test was not documented until 8:47 AM (5 hours and 2 minutes). May On 05/09/25, the staff documented a chlorine test at 5:19 AM and did not record another test until 10:48 AM (5 hours and 29 minutes) On 05/24/25, the staff documented a chlorine test at 11:36 AM and did not document another test until 3:41 PM (4 hours and 5 minutes) On 05/28/25, the staff documented a chlorine test at 12:00 PM and did not document another test until 4:11 PM (4 hours and 11 minutes). On 05/30/25, the staff documented a chlorine test at 4:15 AM and did not document another test until 8:26 AM (4 hours and 11 minutes). April On 04/03/25, the staff documented a chlorine test at 3:54 AM and did not document another test until 8:44 AM (4 hours and 50 minutes). On 04/30/25, the staff documented a chlorine test at 11:39 AM and did not document another test until 4:25 PM (4 hours and 46 minutes). An interview was conducted with the Area Technical Operations Manager (ATOM) on 06/11/25 in the afternoon. The surveyor reviewed with the ATOM regarding the multiple times the staff went beyond 4 hours for the chlorine test. He stated, he believes it was identified and the staff was in-serviced. The surveyor requested the information. However, as of this writing, no information was provided to the surveyor.”

“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: 51535 Based on observation and staff interview, the facility failed to ensure supplies were maintained and operated in accordance with the manufacturer’s recommendations, as evidenced by the staff failure to ensure supplies are not readily available for use beyond the manufacturer’s documented expiration date. The facility staff also failed to follow the established policy for the appropriate testing procedure of the pHoenix and myron meters. The findings included: 1) An observation of the treatment floor conducted on 06/10/25 at 09:40 AM revealed the following: Glucose control solution 4 boxes (2.5 ml bottles x 2 per box) expired 06/2024. An interview conducted with Staff B at 09:40 AM, who acknowledged the expired supplies and stated that supplies will be discarded. An observation of the storage supply room conducted on 06/10/25 at 11:10 AM revealed the following: Standard Buffer Solution 4.00 PH (16 ounces x 2 bottles) expired 05/29/2025, BD vacutainer red top (45) expired 04/30/2025, TB Safety Syringe with Fixed Needle 22 g/1 milliliter (15) expired 04/08/2025, and Sterile- Non-Woven Sponges 50 per box (3 Boxes) expired 01/2025. An interview with the Registered Nurse, Staff B, was conducted at the time of the observation, who confirmed the supplies were expired, removed supplies, and stated that the supplies will be discarded. 29151 2a) Observation of the treatment floor conducted on 06/10/25 starting at 9:23 AM while accompanied by the Registered Nurse revealed the following: Thirty three Nipro dual fistula needles, 15 gauge, expired on 11/30/24. One bottle of alcohol expired on 02/2021. The items were easily available to staff for immediate use. Interview conducted with the Registered Nurse on 06/10/25 at approximately 9:30 AM confirmed the items were expired. 2b) Observation of the crash cart conducted on 06/10/25 at 11:28 AM revealed the following: One full bottle of Nitroglycerin tablets 0.4 mg expired on 01/2025. Twelve yellow male luer adapters expired on 03/16/25. Four safe day intravenous administration sets expired on 12/08/24. Four boxes of sodium bicarbonate, 50 ml, expired on 01/01/25. Interview conducted with the Registered Nurse on 06/10/25 during the observation confirmed the items were expired. 2c) Observation of care conducted on 06/10/25 at approximately 09:54 AM revealed Staff H, a Patient Care Technician, taking a dialysate water sample in a disposable cup to the dirty sink to check the conductivity. The staff used the pHoenix meter by aspirating and discarding the solution three times and then read the results with another staff member. Staff H returned the pHoenix meter to the holder without rinsing the unit with RO (Reverse Osmosis) water. It is noted there is no RO water available at the sink where the meter stored. Interview with Staff H conducted on 06/10/25 at 11:35 AM confirmed the Phoenix meter was not rinsed with RO water after use and stated she will ask the nurse for RO water for future use. Facility policy titled “Checking Conductivity of Final Dialysate with the pHoenix Meter Procedure, dated 05/11/22 documents: Testing with the pHoenix Meter 1. Put the end of the sampling tube into the test solution in the sample cup. slowly draw the liquid through the cell. Liquid should be flowing while the measurement is taken. 2. when no air bubbles are present and the readings stabilize, press and release the mode switch to hold the readings on the display. 3 return to the sampled machine and compare the measured conductivity value to the display on the dialysis machine...the conductivity must be within 0.3 mS of the value taken with the meter. 4. Document conductivity and pH results in the medical record. 5. Press the mode switch a second time to release the data and rinse the meter with RO water repeating steps 1, 2, 3 and 4 for subsequent test if required. discard all remaining solution and sample cups into an appropriate dirty sink/drain or labeled waste container. 6. The pHoenix meter’s internal cell must be rinsed between tests with RO water. Attach the meter to the RO water bottle and rinse the cell two times, expel into Dirty sink or waste receptacle.” 2d ) Observation of care conducted on 06/10/25 at 10:57 AM revealed Staff J, a Registered Nurse, checking the conductivity in the isolation room. The staff used the Myron meter, poured the solution into the cell and discarded the solution, then repeated the same steps two more times, and proceeded to insert the plunger once and called a staff member to read the results. The staff then placed the meter back on the counter without rinsing the unit. It is noted there is no RO water in the isolation room counter. Staff J did not follow the steps delineated in the policy for the use of the Myron meter. Interview with Staff J conducted on 06/10/25 at 11:36 AM revealed the staff confirmed the observation documented above and that the meter was not used as per policy or rinse with RO water after use. Facility policy titled “Checking Conductivity of Final Dialysate with the Myron Dialysate Meter Procedure, dated 04/09/24 documents: Fill the cell cup just able the electrode with a sample of dialysate you want to test. the dipper end of the plunger will deliver just the right amount. Drop the plunger into the cell cup. lift it about halfway out of the cell an drop it back in three or four times. Repeat steps 1 and 2 a minimum of three times. Fill the cell cup with sample, drop the plunger in the sample and lift hallway out of the cell and drop it back in three or four times. Press the black button. when the pointer stops, immediately release the button. Repeat step 4 two additional times and record the last reading. Rinse the cell cup with RO water.” 22517 3) An observation was conducted on 06/10/25 beginning at approximately 9:30 AM in the water treatment and supply room revealed the following supplies remained available for use beyond the manufacturer’s use by date: a. a open bottle of Minncare stored on a table near the CWP, expired on 05/03/25 b. an open package of red top BD Vacutainer which had an expiration date of 04/30/25 c. a bottle of Mesa Labs NeoCare Standard Buffer Solution 4.00 pH expiring 05/29/25 An interview was conducted on 06/10/25 at approximately 12:27 PM with the Area Technical Operations Manager (ATOM). The expired Minncare was shown to him, who stated that after the weekly disinfection of the CWP, the BioMed uses the Minncare strips to test for the presence of bleach. He also stated that the facility is no longer using the NeoCare and he would discard. 4) An observation of the Home Training Rooms was conducted on 06/11/25 at 9:25 AM with the Home Therapies Clinical Manager revealed that there were numerous expired supplies stored in the room as follows: a. 3 - Suture Removal Trays expired 12/31/24 b. 26 - BD Vacutainer soft lok blood collection set expired 01/31/25 c. 23 Chlor Prep Single Swabstick expired 04/25 An interview was conducted with the Home Therapies Manager at the time of the observation, who confirmed the continued presence of the expired supplies.”

“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: 29151 Based on clinical record review, policy review and staff interview, it was determined, the clinical staff failed to ensure the appropriate time monitoring during treatments was performed for 3 of 8 sampled patients (Patients #3, #4 and #6). The findings included: Review of the facility’s policy regarding Patient Assessment and Monitoring, published 05/01/2023, documented, “The Registered Nurse will assess/reassess any findings addressed pre or during treatment as needed. Lungs sounds, edema, heart sounds, the Registered Nurse will assess/re-assess post treatment as indicated. During treatment - Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state state regulations. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations. 1) Treatment Records dated 05/15/25 documents Patient #4’s vital signs, arterial and venous pressures, safety checks and access checks, were not monitored every thirty minutes. The staff monitored the patient at 12:30 PM and noted blood pressure 187/92, and the next monitoring was documented at 1:35 PM and noted blood pressure readings of 191/93. 2) Treatment Records dated 05/29/25 documents Patient #3’s vital signs, arterial and venous pressures, safety checks and access checks, were not monitored every thirty minutes. The staff monitored the patient at 10:32 AM and the next monitoring was documented at 11:33 AM. Interview with the Acting Clinical Manager conducted on 06/11/25 starting at 11:20 AM confirmed the patients were not assessed and monitored as per policy and procedures. 22517 Review of the home records for Patient # 6 revealed that the patient was admitted to the facility on 09/06/21 and the physician prescribed for the patient to receive Home Hemodialysis Dialysis five days a week via the NxStage dialysis machine. The 05/18/25 physician order prescribed for the patient to receive 2 hours and 30 minutes treatment at home. Further review of the home records from 05/26/25 through 06/10/25 revealed that the patient failed to consistently monitor his blood pressure throughout the treatment on 7 of 12 treatments. a. 06/09/25 - There was no documented blood pressure after 12:48 PM. The treatment ended 2:09 PM. b. 06/08/25 - Blood pressure not recorded timely c. 06/02/25 - No blood pressure recorded after 11:35 AM, treatment ended 1:15 PM d. 06/01/25, 05/30/25, and 05/29/25 - The blood pressure was not recorded in a timely manner e. 05/27/25 - No blood pressure recorded after 9:15, treatment ended 10:46. An interview was conducted on 06/11/25 beginning at 2:20 PM with the Home Hemodialysis Training Nurse, who confirmed that the patient was not consistently monitoring his blood pressure throughout the treatment. He further confirmed that he had not identified this but he would discuss with the patient. Review of the facility’s policy regarding patient Monitoring During Hemodialysis Treatment (HT), published 02/07/22 documented “Monitoring frequency intervals shall not exceed hourly intervals for home hemodialysis patients, with the exception of nocturnal hemodialysis patients.””

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 29151 Based on record review, policy review and interview, it was determined, the clinical staff failed to ensure the dialysis prescription was consistently followed for 4 of 8 sampled patients. This is evidenced by the failure to follow the prescribed Blood Flow Rate (BFR) and Dialysis Flow Rate (DFR) for Patients #2, #4 and #6 and failure to document the clinical rationale for the deviation from the treatment prescription. In addition, the clinical staff failed to ensure Heparin administration was completed for one home therapy patient (Patient #5). The findings included: 1) Clinical record review conducted on 06/11/25 revealed Patient #4 has physician order prescribing for dialysis treatment, 3 hours and 15 minutes three times a week with Blood Flow Rate 400 and Dialysis Flow Rate of 800. Review of 12 treatments records revealed the staff failed to follow the physician order for the prescribed BFR and/or DFR on 6 of 12 treatments and did not provide an explanation why they were unable to follow the physician order as follows: On 05/15/25, the staff documented a BFR of 350 throughout the treatment. On 05/22/25, the staff documented a DFR of 600 throughout the treatment. On 05/24/25, the staff documented a DFR of 600 throughout the treatment. On 05/29/25, the staff documented a BFR of 350 and DFR of 600 throughout the treatment. On 06/07/25, the staff documented a DFR of 600 throughout the treatment. On 06/03/25, the staff documented a BFR of 350 throughout the treatment. Interview with the Acting Clinical Manager conducted on 06/11/25 starting at 11:20 AM, after review of the treatment records, confirmed the staff did not follow the prescription and did not document the reason for the changes. 51535 2) A review of the clinical record for Patient #2 revealed that the patient was started on Hemodialysis on 02/26/22. A review of the doctor’s orders dated 06/04/25 showed the following order: BFR (Blood Flow Rate) at 450 millimeters (ml) per minute and DFR (Dialysis Flow Rate) autoflow 1.5 (675). A review of the last 10 treatments flow sheets revealed the following: Dialysis treatment flow sheet dated 06/09/25 further revealed that Patient #2 received BFR 420 ml for 1 hour 57 minutes of a three (3) hour treatment. A review of the Dialysis treatment flow sheets dated 06/02/25 revealed that Patient #2 received DFR 800 for 1 hour 52 minutes of a three (3) hour treatment. 3) A review of the clinical record for Patient # 5 revealed that the physician prescribed for the patient to receive hemodialysis at home via NxStage Dialysis Machine. A 04/18/25 physician order prescribed for the patient to self-administer Heparin bolus 5000 units intravenous push (IVP) every treatment. Further review of the home records revealed the patient failed to document the administration of the prescribed Heparin dose on 1 of 12 treatments as follows: A HHD dialysis treatment record revealed on 06/03/25, there was no documentation that the prescribed heparin was administered, and no written explanation of the deviation from the prescribed order. An interview with the Home Hemodialysis Training Nurse, Staff S, was conducted on 06/11/25 at 2:00 PM. The surveyor identified and reviewed with Staff S the missed dose of medication. Staff S confirmed the missed dose and stated that he did not recognize that the patient had missed the dose of heparin. The review of the facility policy Heparin Bolus Administration, published 05/05/2025, documented, “The home therapies staff, hemodialysis patient and/or care partner will administer Heparin as ordered by the provider.” 22517 3) Review of the clinical record for Patient # 6 revealed that the patient was admitted to the facility on 09/06/21 and the physician prescribed for the patient to receive Home Hemodialysis Dialysis five days a week via the NxStage dialysis machine. The 05/18/25 physician order prescribed for the patient to receive 2 hours and 30 minutes treatment at home and prescribed a Blood Flow Rate (BFR) of 350. Further review of the home records from 05/26/25 through 06/10/25 revealed that the home records documented the BFR on the treatment sheets ranged from 380 to 400 on each of the 12 treatments reviewed. However there was no corresponding physician order prescribing a change in the BFR. An interview was conducted on 06/11/25 beginning at 2:20 PM with the Home Hemodialysis Training Nurse, who confirmed that the patient’s KTV (dialysis adequacy) was low, so they were increasing the Blood Flow Rate to see if there would be improvement. He further confirmed that he did not write a physician order or document the change in treatment order.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 51535 Based on clinical record review, administrative record review, and staff interview, the facility failed to ensure that medication prescribed for anemia management is administered as prescribed by the physician. This is evidenced by 1 of 2 sampled home hemodialysis patients (Patient #5) missed administering doses of Venofer medication as prescribed by physician. The findings included: Review of the clinical record for Patient # 5 revealed that the patient was admitted to the facility on 02/06/25. On 04/28/25 the physician prescribed for the patient to self-administer his medications at home, Venofer 100 mg intravenous push (IVP) during dialysis 1 time per week. Further review of the home records revealed that the patient did not administer the medication as prescribed in a timely manner and failed to provide evidence of administration of the weekly dose of Venofer. An interview was conducted on 06/11/25 at 2:00 PM with the Home Hemodialysis (HHD) nurse, Staff S, who confirmed that he did not identify the missed doses and will follow up with the patient concerning the missed doses of medication.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 22517 Based on staff interview, administrative and clinical record review, the facility failed to ensure the home training nurse accurately reviewed home records to identify irregularities for 2 of 3 sampled Home Therapy Patients, 2 of 2 Home Hemodialysis Patients (Patient # 5 and # 6). This is evidenced by the staff failure to identify concerns when the home hemodialysis patient did not perform the appropriate monitoring of their blood pressure throughout treatment, follow the prescribed Blood Flow Rate and administer medication as prescribed. Such review assists staff in monitoring the home patients’ status by determining if patients are following their treatment plans and/or having problems with their dialysis at home. The findings included: 1) The Home Training Nurses failed to identify irregularities with the home record review when home patients failed to perform the appropriate monitoring of their blood pressure during treatment and failed to document a possible change in the Blood Flow Rate prescription orders for Patient # 6. Review of the clinical record for Patient # 6 who the physician prescribed for the patient to receive Home Hemodialysis Dialysis five days a week via the NxStage dialysis machine. The 05/18/25 physician order prescribed for the patient to receive 2 hours and 30 minutes treatment at home and prescribed a Blood Flow Rate of 350. Review of the home records from 05/26/25 through 06/10/25 revealed the following irregularities: a. The BFR on the treatment sheets ranged from 380 to 400 on each of the 12 treatments reviewed. However there was no corresponding physician order prescribing a change in the BFR. b. The patient failed to consistently monitor his blood pressure throughout the treatment on 7 of 12 treatments. Please refer to V 543 and V 544 for specific details. An interview was conducted on 06/11/25 beginning at 2:20 PM with the Home Hemodialysis Training Nurse. He confirmed the above identified irregularities and further confirmed that he did not document a new order for the patient’s BFR and did not identify the concerns with the patient blood pressure monitoring during treatment. 51535 2) A review of clinical records for Patient # 5 revealed the patient had identified irregularities related to missed doses of Heparin and Venofer. However, there is no evidence that the Home Hemodialysis Training Nurse identified these irregularities and educated the patient regarding these concerns. The home records for Patient # 5 failed to provide evidence of administering the prescribed Heparin on 06/03/2025 and failed to provide evidence of administering the Venofer on 05/16/25 and 06/06/2025. Further review of the Nursing Progress Notes does not provide an explanation for the deviation from the physician order for medication administration or education for the patient regarding the same. Please refer to V 544 and V 547 for specific details. An interview with the Home Hemodialysis Training Nurse, Staff S, was conducted on 06/11/25 at 2:00 PM. He acknowledged the patient did not administer the medication as prescribed and he did not identify the missed doses of medication administration. The facility policy CMAB Recommended Anemia Algorithm Venofer (HHD, PD), revised 07/08/2019, documented, “Document communication with patient and care partner in Medical Record.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 29151 Based on record review, policy review, and interview, the facility staff failed to implement Patient Safety policies and procedures for 1 of 8 sampled patients ( Patient #3). The deficient practice is evidenced by the failure to timely respond to sustained abnormal heart rate, failure to notify the physician of the patient’s condition, failure to file a event report with the goal of review, analyze and implement corrective measures if necessary for Patient #3, who required emergency personnel for transfer to the hospital. The findings included: Treatment record dated 05/15/25 documents Patient #3’s pre-dialysis treatment heart rate was 140 beats per minute and a second check documents apical pulse of 110. Documented pre dialysis dialysis assessment documents no unusual findings, despite the abnormal heart rate. The treatment started at 10 AM and the documented vital signs noted pulse 148 and blood pressure 101/72. At 10:30 AM, the pulse was noted as 150 and blood pressure 90/73. At 11:06 AM, the pulse noted 161 and blood pressure 107/51. At 11:18 AM the vital signs noted as pulse 153 with blood pressure of 80/59. At this time the treatment was discontinued, and the patient was transferred to the hospital by paramedics. Further review of the clinical record indicates Patient #3 required cardioversion at the hospital to address the sustained tachycardia. Review of the facility incident reports logs dated 05/29/2024 thru 05/29/25 failed to provide evidence the facility completed a safety event report for Patient #3. There is no evidence of a review addressing if Patient #3 was appropriately monitored during the treatment or evidence the physician was notified of the abnormal readings prior to calling 911. Review of the incident logs dated 05/29/24 through 05/29/25 failed to provide evidence the staff completed an event report to determine if the provision of care prior to the transfer to a higher level of care was appropriate and implement corrective actions as appropriate. Interview with the acting Clinical Manager on 06/11/25 at 12:21 PM revealed after further review of the electronic record there is no evidence the physician was notified of the patient’s condition or evidence that an event report was completed addressing Patient #3’s care on 05/15/25. Interview with the Director of Operations conducted on 06/11/25 at approximately 3:12 PM revealed the facility conducted a review of the event and found no issues, the event did not require the completion of an event report because the patient arrived with elevated heart rate and the documentation on the treatment record may be erroneous. They are trying to reach out to the nurse to clarify the time frame for the event. The investigation determined the clinical staff failed to notify the physician of the patient’s condition; the record indicates the patient had sustained tachycardia from 10 AM thru 11:18 AM with no interventions and the nurse documented an inaccurate assessment. Facility policy “Patient Safety Event Reporting and Documentation, dated 02/06/23 documents: Categories event description and definitions. Cardiac arrhythmia during dialysis greater than 120. Occurrence of an arrhythmia during dialysis with heart rate greater than 120 beats per minute that is new or sustained. Documentation of all patient events shall be: Factual, complotted, timely and concise. Include patient assessment and represent an accurate recording of the events, times, interventions and result of the interventions. Documentation should include that the physician was notified Be consistent in all recorded documents.””