Tri State Dialysis

“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: 29963 Based on record review, observation and interview, the facility staff failed to ensure patients completed hand hygiene after glove removal and holding dialysis access sites until bleeding stopped for 2 of 2 patients (Patients #3, 9) observed holding access sites in a total universe of 16 observations of patient care. Findings include: A review of the facility’s policy titled, “Fistula/Graft Guidelines and Initiating Hemodialysis” last revised 01/30/2025 revealed, “... Discontinuation of Dialysis... 11. Verify bleeding has stopped... apply post-dialysis dressing. Remove gloves. Patient and staff wash hands...” During an observation on 03/26/2025 at 9:15 AM, Patient #9 was observed holding her dialysis access site with a glove, removed the glove, and did not perform hand hygiene prior to exiting the treatment area. During an observation on 03/26/2025 at 9:40 AM, Patient #3 was observed holding his dialysis access site with a glove, removed the glove, and did not perform hand hygiene prior to exiting the treatment area. During an interview on 03/26/2025 at 5:29 PM, the observation findings were discussed with Nurse Manager B who stated it is an expectation that staff offer hand gel to the patients before they leave the treatment area.”

“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: 29963 Based on record review and interview, the facility staff failed to ensure intradialytic blood pressure monitoring was completed per facility policy in 1 of 5 (Patient #2) and the facility staff failed to ensure abnormal findings during the course of Hemodialysis treatments were assessed and documented by nursing staff in 2 of 5 (Patients #4, 5) in-center medical records in a total universe of 5 medical records reviewed. Findings include: A review of the facility’s policy titled, “Assessment of Patient” last revised 03/26/2018 revealed, “... Monitoring During Treatment: Patient Monitoring: Check vital signs (BP, HR) every 30 minutes during treatment... Post Treatment Assessment: The nurse will assess the patient post treatment for the abnormalities found... that developed during treatment...” A review of Patient #2’s medical record revealed on the treatment sheet dated 03/21/2025, an intradialytic blood pressure was documented at 9:30 AM and then again at 10:30 AM (60 minutes later). A review of Patient #4’s medical record revealed on the treatment sheet dated 03/17/2025 at 1:00 PM a blood pressure of 219/95 and at 1:30 PM a blood pressure of 247/101 and on the treatment sheet dated 03/24/2025 at 12:00 PM a blood pressure of 204/94, 12:30 PM a blood pressure of 202/90, 1:00 PM a blood pressure of 197/80, 1:30 PM a blood pressure of 207/87, 2:30 PM a blood pressure of 217/95, and at 3:00 PM a blood pressure of 244/95 without a recheck or documentation that the blood pressure was elevated. A review of Patient #5’s medical record revealed on the treatment sheet dated 03/19/2025 at 9:30 AM a blood pressure of 203/107 and at 10:00 AM a blood pressure of 205/107 without a recheck or documentation that the blood pressure was elevated. During an interview on 03/27/2025 at 7:45 AM, the medical record review findings were discussed with and confirmed by Director of Dialysis A who stated the blood pressures should be checked and documented every 30 minutes and that there should be some documentation about an elevated blood pressure and/or a recheck blood pressure. 47413”

“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: 29963 Based on record review and interview, the facility staff failed to complete documentation of why physician orders were not followed for prescribed blood flow rates for 2 of 5 in-center medical records reviewed (Patients #2, 3) in a total universe of 5 medical records reviewed. Findings include: A review of the facility’s policy titled, “Initiating Hemodialysis” last revised 02/14/2023 revealed, “... Initiating Hemodialysis: ... Turn BFR to prescribed blood flow rate...” A review of Patient #2’s medical record revealed a physician order for the blood flow rate (BFR) of 300-400 mL/min (milliliters per minute). The treatment sheet dated 03/14/2025, 03/19/2025, 03/24/2025, and 03/21/2025 revealed the BFR was set at 450 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was greater than the ordered rate. A review of Patient #3’s medical record revealed a physician order for the BFR of 350-450 mL/min. The treatment sheet dated 03/12/2025 revealed the BFR was set at 250 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was lower than the ordered rate. During an interview on 03/27/2025 at 7:30 AM, the medical record findings were discussed with and confirmed by Director of Dialysis A who stated facility staff are expected to document a reason for not meeting prescribed blood flow rates. 47413”

“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: 29963 Based on record review and interview, the facility staff failed to ensure the prescribed dose of Micera (used to treat a low red blood cell count) was given to 1 of 5 in-center hemodialysis patients (Patient #1) with anemia management orders in a total universe of 5 medical records reviewed. Findings include: A review of facility policy titled, “Medications (Parenteral) last revised 06/25/2024 revealed, “... 12. The time medication was given along with the initials of medication administrator will be documented with every medication...” A review of Patient #1’s current in-center hemodialysis orders revealed an order for Micera 150 mcg (micrograms) IV (intravenous) 2 x month (give on 03/12 and 03/26). In the “Medications” column on the dialysis treatment flow sheet dated 03/26/2025, there was no documentation that Micera had been given per order. During an interview on 03/27/2025 at 8:00 AM, the medical record review findings were discussed with and confirmed by Director of Dialysis A who stated “It looks like the Micera should have been given and it was missed.””

“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: 47413 Based on record review, observation and interview, the facility staff failed to perform skin antisepsis prior to cannulation per policy for 1 of 2 patients (Patient #12) observed for initiation of dialysis with an AV Fistula/Graft in a total of 16 observations of patient care. Findings Include: A review of the facility’s policy titled, “Fistula/Graft Guidelines and Initiating Hemodialysis” last revised 01/30/2025 revealed, “... Always do hand hygiene and don new gloves prior to contacting the access.” During an observation on 03/26/2025 at 10:02 AM, Director of Dialysis A was observed initiating dialysis for Patient #12. Director of Dialysis A cleansed Patient #12’s AVF site, touched the TV arm with the same gloves, and then cannulated Patient #12’s access without changing gloves or performing hand hygiene. During an interview on 03/27/2025 at 8:15 AM the observation findings were discussed with Director of Dialysis A who stated accessing the fistula should be done with clean gloves and after the arm of the TV was touched, gloves should have been changed and hand hygiene should have been completed.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 30177 Based on an interview and review of the facility’s “Emergency Preparedness Plan,” the facility failed to ensure that it included strategies to address interruptions in communication, including cyber-attacks. This failure to ensure that the “Emergency Preparedness Plan” contained all of the required elements had the potential to hinder the facility’s ability to prepare and respond timely to interruptions in communication. The failed practice had the potential to impact the safety and care of the 19 in-center hemodialysis patients receiving care at this facility. Findings include: A review of the facility’s undated “Emergency Preparedness Plan” revealed that it did not include strategies to address communication interruptions, including cyber-attacks. During a joint interview on 07/16/24 at 8:45 AM with the Dialysis Director and Nurse Manager, the Dialysis Director was asked if the facility utilized any electronic or technological systems; the Dialysis Director stated, “Yes.” The Nurse Manager was asked to identify the potential hazards identified in the facility’s risk assessment and describe how the facility would handle interruptions in communication, including cyber-attacks. The Nurse Manager stated that he/she was unable to explain the facility’s process for managing interruptions in communications, including cyber-attacks. He/she confirmed there was no process to mitigate cyber-attacks or interruptions.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 30177 Based on interview and review of the facility’s “Emergency Preparedness Plan,” the facility failed to address, via policy, how the facility would obtain emergency drugs in the event of shortages. The failed practice posed a risk to the facility’s capacity to promptly provide life-saving medication to patients requiring urgent medical attention. The failure had the potential to negatively affect all 19 in-center hemodialysis patients receiving care at this facility. Findings Include: Record review of the facility’s Emergency Preparedness Plan revealed there was no policy to address how the facility would obtain emergency drugs in the event of shortages. During a joint interview on 07/16/24 at 8:45 AM, the Nurse Manager and the Dialysis Director were asked how the facility would obtain emergency drugs in the event of shortages. The Nurse responded that he/she was unaware of the facility’s process for obtaining emergency drugs in the event of shortages. A policy was requested for the facility’s process of acquiring emergency drugs in the event of a shortage. On 07/16/24 at 8:56 AM the Dialysis Director confirmed that the facility had not developed a policy to address obtaining emergency drugs in the event of shortages and provided no additional documentation.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 30177 Based on staff interviews and observations, the facility failed to label bulk storage/dispensing tanks to identify the chemical composition or formulation of their contents. The failure to permit identification of the bulk storage/dispensing tanks’ contents had the potential to lead to inadvertently mismatching dialysate components. The failed practice had the potential to negatively affect the 19 in-center hemodialysis patients at this facility. Findings Include: During a tour of the Water Treatment/Dialysis Preparation Area with the Dialysis Director on 07/15/24 at 1:55 PM, two 240-gallon acid bulk storage/dispensing tanks were observed without proper identification of their contents. In a joint interview on 07/15/24 at 2:00 PM, the Dialysis Director confirmed the two 240-gallon acid bulk storage/dispensing tanks were not labeled indicating their contents. The Biomedical Technician stated he/she was aware that the tanks should be labeled to identify the contents but failed to do so. The Biomedical Technician revealed the bulk storage tanks dispensed two potassium (2K)/two. five (2.5) calcium (ca) and 3K/2.5 ca. A policy indicating the need to label the storage/dispensing tanks was requested. The facility failed to provide a policy by the survey’s exit date.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 30177 Based on observation, staff interview, and policy review, the facility failed to develop and implement an ongoing training program designed to evaluate staff’s compliance in collecting water and dialysate samples for bacteria and endotoxin in that one staff member (Certified Care Hemodialysis Technician (CCHT)1 who was assigned the responsibility of collecting water and dialysate samples for bacteria and endotoxin had not been trained and verified. In addition, the facility failed to train four Registered Nurses (RN) (Nurse Manager, RN1, RN2, and RN3) and periodically evaluate compliance by actual observation of safely adding calcium and/or potassium chloride to increase the calcium and/or potassium content of the acid concentrate. Failure to ensure staff responsible for collecting water and dialysate samples and concentrate additives were trained and competent in the execution of procedures placed all 19 in-center patients at risk of adverse outcomes. Findings Include: During observations and interview with the Dialysis Director on 07/16/24 at 12:30, a two-gallon container labeled as four (4) potassium (k), 2.4 ca which included a label indicating potassium had been added to the acid concentrate to increase the potassium was noted on a cart. The Dialysis Director confirmed that the RNs added additives to the acid concentrate to increase the potassium or calcium. He/she also confirmed that this was completed by the RNs only. A review of the facility’s policy and procedure titled “Potassium Chloride to Acid Concentrate” revealed, “. . .It is the responsibility of the dialysis Registered Nurse (RN) to correctly add potassium chloride to the acid concentrate bath to increase the potassium content according to physician’s orders.” A review of the facility’s policy and procedure titled “Calcium Chloride to Acid Concentrate” revealed, “. . .It is the responsibility of the dialysis Registered Nurse (RN) to correctly add calcium chloride to acid concentrate to increase the calcium content according to physician’s orders.” A request was made in a joint interview with the Nurse Manager, Biomedical Technician, and the Nurse Manager on 07/16/24 at 2:53 PM for the training and competencies for CCHT1 where actual observations for his/her compliance in collecting water and dialysate samples for bacteria and endotoxin. A request was also made for training and actual observation for the Nurse Manager, RN1, RN2, and RN3 competencies for concentrate additive. The Dialysis Director revealed that the staff had not been trained in such procedures and that no training and competencies were available. The Biomedical Technician was asked who was responsible for ensuring staff members assigned responsibility for collecting water and dialysate samples for bacteria and endotoxins were competent to perform the skills. The Biomedical Technician replied, “It’s our responsibility.” The Dialysis Director and Biomedical Technician were asked if the facility had developed and implemented a training program with periodic audits to ensure staff remain knowledgeable with training and competency testing of personnel responsibility in collecting water and dialysate samples and concentrate additives. The Dialysis Director and the Biomedical Technician replied, “No.””