Fmc Dialysis - University

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 38304 Based upon record review and interview, the facility failed to document facility wide training and testing drills for the last two years, potentially affecting staff and all 86 patients currently receiving services, resulting in an increased potential for harm in the event of an emergency. Findings include: On 1/24/24, review of the facility’s EP (Emergency Preparedness) binder found no evidence of staff sign in sheets, staff participation, or documentation of an AAR (After Action Report) concerning the required facility-wide testing drill(s) within the last two years. During an interview with the Director of Operations (Staff B) on 1/24/24 at 1115, the above findings were reviewed and acknowledged. Staff B was noted this did not meet facility expectations or its policy referenced below. Facility Policy: “Guidelines for Emergency Preparedness” Pub. 07/03/2023, Reference No. 25907 stated, “In addition to the community drills, facilities must select an event of high likelihood and conduct a table-top drill. It is recommended a different drill be completed annually. The DO (Director of Operations) must complete an after-action review and make any revision to the emergency plan as needed.””

“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: 47976 Based on observation, interview, and record review, the facility failed to ensure staff performed hand hygiene between all glove changes per facility policy, resulting in the potential for spread of infectious agents to all 86 patients being served by the facility. Findings include: **Policy titled “Hand Hygiene” (revised 11/6/23) stated, “Hands will be ....Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ....Immediately after removing gloves.” During dialysis floor observation on 1/22/24 and 1/23/24, the following observations were made: On 1/22/24 at 1030, Staff X was observed disconnecting a patient from dialysis at station #22. Throughout the procedure, Staff X missed 4 opportunities for hand hygiene between glove changes. On 1/22/24 at 1053, Staff O was observed initiating dialysis on a patient at station #8. During the procedure, Staff O was observed leaving the dialysis station with gloved hands to get supplies without removing her gloves. When she returned to the station with the supplies, she removed her gloves and donned new gloves without performing hand hygiene first. Findings were reviewed with and acknowledged by the Facility Administrator (Staff C) and the Director of Operations (Staff B) during an interview on 1/23/24 at 1600. 46476 On 1/22/24 during incenter hemodialysis floor observation of staff, the following observations were noted: At 1110, Staff L, a registered nurse, was observed while discontinuing dialysis blood lines for the patient at station #23. During the multi-step procedure, Staff L removed gloves 3 times and did not perform hand hygiene prior to donning a new pair of gloves. These findings were reviewed and acknowledged during interview with the Director of Operations (Staff B), and the Medical Director (Staff A) on 1/24/24 at 1000. Staff A stated that all staff are expected to adhere to facility policies and procedures.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 46476 Based on observation, interview, and record review, the facility failed to ensure items taken into the dialysis station were disinfected before removal from the station resulting in the potential to spread infectious diseases to all 86 patients receiving in-center dialysis at this facility. Findings include: Facility policy titled “Cleaning and Disinfecting the Dialysis Station”; Published: 09/05/2023, was reviewed on 1/23/24. On page 2., under “General Cleaning”, it stated, “ ... After use, any non-disposable equipment and supplies brought into the dialysis station ... must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station. On 1/22/24 during incenter hemodialysis floor observation of staff, the following observations were noted: At 1030, Staff X, a patient care technician, was observed while disconnecting the patient at station #22 from hemodialysis blood lines. Staff X brought a wheeled stool into the treatment station and sat on it while performing the procedure. After the procedure, the stool was wheeled back out of the station without first being disinfected. At 1110, Staff L, a registered nurse, was observed while disconnecting the patient at station #23 from hemodialysis blood lines. Staff L brought a wheeled stool into the treatment station and sat on it while performing the procedure. After the procedure, the dialysis treatment station was disinfected but the stool was wheeled out of the station and was not disinfected. On 1/23/24 during incenter hemodialysis floor observation of staff, the following observation was noted: At 1020, Staff Q, a certified clinical hemodialysis technician, was observed while initiating dialysis for the patient at station #2. Staff Q brought a wheeled stool into the treatment station and sat on it while performing the procedure. After the procedure, the stool was moved out of the station without being disinfected. These findings were reviewed and acknowledged during interview with the Director of Operations (Staff B), and the Medical Director (Staff A) on 1/24/24 at 1000.”

“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: 47976 Based on observation, interview, and policy review, the facility failed to ensure that expired medications were not available for patient use, resulting in the potential for poor patient outcomes for the 85 patients receiving dialysis at this facility. Findings include: **Policy titled “Expiration Date Sterile Supplies” (revised 7/4/12) stated, “Expiration dates of sterile supplies contained in emergency boxes or code carts should be noted and logged as per facility protocol.” During dialysis floor observation on 1/22/24 at 1015, the contents of the emergency crash cart were examined. During review of the items in the cart, the following expired supplies were found: 2 syringes of 10% Calcium Chloride 1000 milligrams/10 milliliter (mg/mL) (expired 1/1/2024) 4 1 mL vials of Naloxone HCl 0.4 mg/mL (expired 12/23) During an interview on 1/24/24 at 1130, the Facility Administrator (Staff C) was queried regarding when supplies are checked for expiration dates. Staff C stated these supplies are checked monthly to remove items with upcoming expiration dates. She reported these items should have been removed already and acknowledged the findings.”

“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: 47976 Based on observation, interview, and record review, the facility failed to ensure staff maintained aseptic technique when providing care to patients with intravascular catheters during 1 of 4 observations, resulting in an increased risk for infection and potential for poor patient outcomes. Findings include: **Policy titled “Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer” (revised 7/6/21) stated on page 4, “Threads and end of the luer (hub) must be scrubbed with 70% sterile alcohol pad (or other antiseptic such as chlorhexidine povidone if required by the hospital) for 10-15 seconds and any time caps are removed, or bloodlines are disconnected (i.e. end of treatment or treatment interruption) to reduce risk of contamination.” During dialysis floor observation on 1/22/24 at 1445, Staff R was observed disconnecting a patient with a central venous catheter (CVC) from dialysis at station #2. It was noted that Staff R scrubbed one hub for 9 seconds and the other for 7 seconds after disconnecting the bloodlines. Findings were reviewed with and acknowledged by the Facility Administrator (Staff C) and the Director of Operation (Staff B) during an interview on 1/23/24 at 1600.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 46476 Based on interview and record review, the facility failed to ensure the pH (acidity or basicity level) of the dialysate was properly tested prior to initiation of dialysis treatment per facility policy in 2 (P# 1 and 3) of 7 sample records reviewed potentially resulting in unsafe treatment conditions for all 86 patients receiving care at this facility. Findings include: Facility policy titled “Checking pH of Final Dialysate with Precision pH Control Paper”; Published: 06/19/2013, was reviewed on 1/23/24. On page 4., under “Step 7” it stated, “Interpret results as follows: If ... Results are equal to or within 6.9 to 7.6 Then ... Machine is acceptable for use ...” On page 4., under “Step 8” it stated: Document pH results in the electronic medical record ...” P-3: This 49-year-old was admitted to the facility on 11/18/16 with end stage kidney disease; high blood pressure; and paranoid schizophrenia. The medical record was reviewed on 1/23/24 and included 6 hemodialysis treatment sheets between the dates of 1/5/24 and 1/17/24. During review of the treatment sheets dated 1/10/24, 1/12/24, and 1/17/24, it was noted the machine set up check prior to initiating dialysis did not have a numerical value entered for pH. A “p” was marked next to the section “pH (p/f):” indicating the pH “passed” the test. It is unknown if the pH was tested properly and machine was acceptable for use because a numerical value was not documented. These findings were reviewed and acknowledged during interview with the Facility Administrator (Staff C) and the Director of Operations (Staff B) on 1/24/24 at 1030. Staff B stated that staff should not be documenting “p” for pass or “f” for fail unless they also included a numeric reading. Staff B stated that the “p” and “f” boxes should be used for another type of machine that does an automated check of pH. Staff B stated that staff are expected to document the numerical reading of the pH (and not “p” or “f”) on the treatment sheet at this facility. 47976 P-1: This 77-year-old patient was admitted to dialysis on 11/3/23 with the diagnosis of acute kidney failure and was receiving dialysis treatment 3 times per week. On 1/23/24, the last 6 treatment sheets were reviewed. During review of the machine set up check prior to initiating dialysis, it was noted there was no numerical value entered for pH on 1/10/24, 1/15/24 and 1/17/24. Instead, there was a “p” marked next to the “pH (p/f):” section to indicate the pH “passed” the test. On 1/23/24 at 1600, the Facility Administrator (Staff C) and Director of Operation (Staff B) were queried as to when a machine check list should have an “p” or “f” instead of a number. Staff B noted there would be a “p” or “f” entered automatically by the machine if it was tested internally, however, she reported this clinic does not have any machines with that capability. Staff B was also asked if there was any reason a “p” or “f” would be documented instead of a number. Staff B states that they should be entering a number according to facility policy. Staff B and Staff C acknowledged the findings.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 38304 Based on observation and interview, the facility failed to ensure that 4 of 6 dialysis station wall boxes were free from excessive build-up and potential corrosion, resulting in the potential for less-than-optimal outcomes for the 23 patients receiving dialysis treatments at the time of observation. Findings include: During the facility treatment floor inspections on 1/22/2024 at 1050, it was observed that four wall boxes associated with stations numbered 17 through 22 contained excessive build-up surrounding dialysis line connections. The build-up varied from pure white to rust-colored/light brown. The Area Technical Operations Manager (Staff E) and the Director of Operations (Staff B) were visually made aware of the findings during an interview on 1/22/24 at 1320. Staff E was unsure of when the wall boxes were last maintained, and the rust-colored build-up resulted from potential corrosion or becoming “darker” over time. Both agreed this did not meet facility expectations, or its policy referenced below. Facility Policy: “Cleaning and Disinfecting the Dialysis Station” Pub. 09/05/2023, Reference No. 47806 stated, “Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. Special attention should be given to removing build-up... If concentrate leaks are noted at the wall box, staff should notify biomedical services for repair.””

“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: 47976 Based on record review, observation, and interview, the facility failed to ensure that patient access sites were in view of staff during dialysis treatment at 1 (#29) of 31 stations, resulting in the potential for needle dislodgement or line disconnection to go undetected and for significant bleeding to occur. Findings include: **Policy titled “Patient Assessment and Monitoring”; Published: 05/01/2023, was reviewed on 1/23/24. On page 5., under “During Treatment”, it stated: “Follow the steps below for monitoring patient ... during treatment ... General Observation/Mental Status ... Ensure each patient ’ s face is visible and uncovered ... Access ... Ensure access remains uncovered throughout the treatment.” During dialysis floor observation on 1/22/24 at 1028, it was noted the access site for the patient at station #29 was completely covered. Several staff members were observed walking past the patient without uncovering it. At 1048, Staff K was asked if she was able to see that patient’s access site. Staff K stated she was unable to see it and reported it is on his leg. Staff K then went to uncover the patient’s access site. At 1115, it was noted that although the access site was uncovered, it could not actually be visualized from anywhere besides right next to the treatment chair due to the location of the graft (right leg), the location of the treatment chair (next to a half wall on the right side of the patient’s body), and the size of the blanket blocking the view. Staff K was asked if she could actually see the access site and if she felt she would be able to see if the patient’s needle dislodged from where she was standing. Staff K admitted that she would not likely be able to see if the patient’s needle dislodged and he started to bleed. During dialysis floor observation on 1/23/24 at 1005, it was noted the patient’s face and access site at station #29 were completely covered by a very large blanket. At this time, there were 2 staff members at the nurses station in this pod and other patient who were observed at the stations on either side of #29. At 1013, Certified Clinical Hemodialysis Technician (Staff V) was observed at station #29 pressing buttons on the dialysis machine. She did not uncover the patient at this time. Staff V was asked if she was able to see the access site or face of the patient at #29. Staff V acknowledged she could not and went uncover the patient. Findings were reviewed with and acknowledged by the Facility Administrator (Staff C) and Director of Operations (Staff B) during an interview on 1/23/24 at 1600.”

“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: 46476 Based on record review and interview, the facility failed to provide medication services as outlined in the patients plan of care in 2 (P# 4 and 7) of 7 sample records reviewed resulting in a medication being administered outside of what was prescribed and potentially leading to a poor patient outcome. Findings include: P-4: This 66-year-old was admitted to the facility on 6/10/13 with end stage kidney disease; high blood pressure; and type 2 Diabetes. The medical record was reviewed on 1/23/24 and included 6 hemodialysis treatment sheets between the dates of 1/10/24 and 1/22/24. The plan of care included an active physician order for Heparin (a strong blood thinner) 1000 Units/hour to be infused over 3 hours and 30 minutes each treatment. The total Heparin dose would be 3500 Units if the patient stays for the entire duration of the treatment. During review, the following were noted: On the treatment sheet dated 1/12/24, the documentation reflected that 1200 Units of Heparin were infused during the 3 hour and 41-minute treatment (2300 Units less than prescribed). On the treatment sheet dated 1/19/24, the documentation reflected that 1000 Units of Heparin was infused during the 3 hour and 27-minute treatment (2500 Units less than prescribed). This finding was reviewed and acknowledged during interview with the Facility Administrator (Staff C) and the Director of Operations (Staff B) on 1/24/24 at 1030. Staff B stated that staff must manually put in the amount of Heparin infused and agreed that the documentation reflected a medication error. 38304 P-7: This patient was admitted to the facility on 9/20/2016 with diagnoses which included end-stage renal disease, atrial fibrillation, hypotension, and fluid overload-unspecified. P-7 was receiving treatments 3 times per week (Tues-Thu-Sat) for an ordered duration of 240 minutes each treatment. On 1/23/2024, review of P-7’s medical record noted treatment orders for Heparin (medication used for blood thinning) to be administered at 1000 Units/ml. (milliliter), with 500 Units/Hour or 0.5 ml./hour and stopped 60 minutes before the end of treatment. Further record review of P-7’s six most recent dialysis treatment sheets (12/28/23 through 1/20/24) found the following concerning Heparin administered by the patient-care-technicians (PCT’s): On the treatment dated 1/20/2024, dialysis treatment duration was 243 minutes (0707-1110). Heparin pump was on at 0707 and stopped at 1016. Total Heparin infused was 1.5 ml. or 1500 Units. On the treatment dated 1/18/2024, dialysis treatment duration was 229 minutes (0749-1138). Heparin pump was on at 0738 (prior to the start of dialysis) and stopped at 1138. Total Heparin infused was 2 ml. or 2000 Units. This equates to 4 hours of Heparin administration for a 4-hour dialysis treatment. No discontinuation of Heparin 60 minutes prior to the end of treatment was evidenced. On the treatment dated 1/16/2024, dialysis treatment duration was 248 minutes (0721-1129). Heparin pump was on at 0721 and stopped at 1127. Total Heparin infused was 2 ml. or 2000 Units. This equates to over 4 hours of Heparin administration for a 4-hour treatment. No discontinuation of Heparin 60 minutes prior to the end of treatment was evidenced. On the treatment dated 1/13/2024, the facility’s EMR (electronic medical record) system went down and was unable to capture the intra-dialytic information for review. The Director of Operations (Staff B) noted the system was fixed later that day after P-7’s dialysis treatment had been completed. On the treatment dated 1/2/2024, dialysis treatment duration was 157 minutes (0704-0941). Heparin pump was on at 0704 and stopped at 1008. Total Heparin infused was 1.3 ml. or 1300 Units. The treatment noted documented at 0941 the following: “Treatment Discontinued Without Problem; tx (treatment) ended with 1:24 minutes left. No explanation was found in the medical record why treatment was shortened, subsequently failing to have P-7’s Heparin administered as ordered, and why the Heparin pump continued with its administration until 1008, after P-7’s dialysis treatment had been completed at 0941. On the treatment dated 12/28/2023, dialysis treatment duration was 244 minutes (0722-1126). Heparin pump was on at 0722 and stopped at 1030. Total Heparin infused was 1.5 ml. or 1500 Units. Based on the above findings, 3 of 5 treatment sheets for P-7 reflected a Heparin dose that was not administered in accordance with physician orders. These findings were reviewed with and acknowledged during interview on 1/24/24 at 1105 with the Director of Operations (Staff B) and the Facility Administrator (Staff C). Both agreed this did not meet facility expectations and was considered a medication error.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to respond timely to 1 (P-6) of 1 patient reviewed with severe anemia (lack of red blood cells), out of a total sample of 7 records reviewed, resulting in a poor clinical outcome and unmet patient needs. P-6: This patient was admitted to the facility on 5/29/2020 with diagnoses which included end-stage renal disease, anemia, and hypertension. On 1/23/2024, review of P-6’s medical record noted P-6’s baseline hemoglobin (Hgb./oxygen carrying component of blood) was between 9.1 g/dL. (grams/deciliter) and 9.9 g/dL. from 7/13/23 through 9/7/23. Normal Hgb. levels for women are between 11.6 to 15.0 g/dL. (grams/deciliter). A further decline of P-6’s Hgb. levels was noted with the following dates and interventions: 09/07/23: 9.9 g/dL. 09/14/23: 8.9 g/dL. 09/21/23: 8.6 g/dL. 09/28/23: 7.8 g/dL. 10/10/23: 7.9 g/dL. 10/12/23: 7.3 g/dL. with hospitalization for severe anemia 10/15/23 through 10/21/23. Diagnosed with GI (gastro-intestinal) bleed. 10/26/23: 7.2 g/dL. 11/02/23: 7.2 g/dL. 11/09/23: 6.9 g/dL. 11/14/23: 6.3 g/dL. 11/21/23: 6.2 g/dL. with another hospitalization due to severe anemia. All clinical note entry(s) for the above findings after P-6 was discharged from the hospital are as follow: 10/30/23 at 1112: “Consult physician for Mircera (medication used to improve Hgb. levels) order with notification of very low Hgb. (<8g/dL). Latest Hgb Available: 10/26/2023 7.2 g/dL. Latest Mircera Admin: 09/19/2023 150 mcg. Patient Weight: 60.1 (end of note).” 11/06/23 at 1052: “Consult physician for Mircera order with notification of very low Hgb. (<8g/dL). Latest Hgb Available: 11/02/2023 7.2 g/dL. Latest Mircera Admin: 09/19/2023 150 mcg. Patient Weight: 60 (end of note).” 11/09/2023 at 00:00: “HGB - Result relayed to (physician). Will start patient on Mircera 100 mcg every 2 weeks and will repeat Hemoglobin on 11/14/2023 as ordered. (end of note)” 11/16/23 at 1818: “10:26 reached out to (physician) to alert of low Hgb. (end of note)” 11/17/23 at 1245: “Consult physician for Mircera order with notification of very low Hgb. (<8g/dL). Latest Hgb Available: 11/14/2023 6.3 g/dL. Latest Mircera Admin: 11/14/2023 100 mcg. Patient Weight: 58.6 (end of note).” 11/21/23 at 1227: “STAT HGB, and hematocrit ordered, resulted at 6.2. and 20.2. (Physician) notified; patient notified and informed to go to (hospital) per (physician) for a blood transfusion (end of note).” Based on the findings above, the facility sent P-6 to the hospital when Hgb. levels dropped from 7.9 g/dL to 7.3 g/dL. However, the facility failed to note per documentation, that P-6’s first Hgb. level after hospital discharge (10/26/23) was below the level that sent P-6 to the hospital in the first place. Further, the facility failed to act (another hospitalization) as P-6’s Hgb. levels continued to decline over the next 26 days. These findings were reviewed and acknowledged by the Director of Operations (Staff B) and Facility Administrator (Staff C) during an interview on 10/24/24 at 1118. Both agreed this did not meet facility expectations, or its policy referenced below. Facility Policy: “Patient Assessment and Monitoring” Pub. 05/01/2023, Reference No. 45284 stated, “Data Collection: Gathering of objective and subjective information related to the patient’s health status... Contact the physician as needed for additional orders based on assessment findings and clinical judgement.””

“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: 46476 Based on record review and interview, the facility failed to ensure patient blood pressure (BP) monitoring and assessment was performed per facility policy in 1 (P# 3) of 7 sample records reviewed resulting in unmanaged fluid volume status and the potential for poor patient outcomes. Findings include: Facility policy titled “Patient Assessment and Monitoring”; Published: 05/01/2023, was reviewed on 1/23/24. On page 1., under “Data Collection”, it stated “ ... If the PCT/LPN note any changes or abnormal findings ... the registered nurse must assess the patient. The RN will notify the patient’s physician ... of any abnormal findings, if necessary ... The Registered Nurse will assess/re-assess any findings pre or during treatment as needed.” On page 5., under “During Treatment”, it stated: “Follow the steps below for monitoring patient ... Blood Pressure ... Report to nurse: Systolic blood pressures greater than 180 mm/Hg ... Diastolic blood pressure greater than 100 mm/Hg ...” P-3: This 49-year-old was admitted to the facility on 11/18/16 with end stage kidney disease; high blood pressure; and paranoid schizophrenia. The medical record was reviewed on 1/23/24 and included 6 hemodialysis treatment sheets between the dates of 1/5/24 and 1/17/24. The active physician orders for the period reviewed included Clonidine HCL 0.1 milligram (mg) to be given during dialysis as needed for high blood pressure (and could be repeated once). All 6 treatment sheets were noted with elevated BP readings throughout the treatments (Systolic BP over 180 and/or Diastolic BP over 100). The following are examples of what was noted during review: On the treatment sheet dated 1/5/24, the BP was recorded during the 3 hour, 34-minute treatment by 1 of 3 different staff members including a patient care technician (PCT), a certified hemodialysis technician (CHT), and a registered nurse (RN). The following BP’s were documented: Pre-dialysis, the BP entered by the PCT: sitting: 194/115 millimeters of mercury (mm/Hg) At 0901, the BP entered by the CHT was 199/117 mm/Hg At 0931, the BP entered by the RN was 199/137 mm/Hg At 1001, the BP entered by the CHT was 203/140 mm/Hg At 1031, the BP entered by the PCT was 203/134 mm/Hg At 1100, the BP entered by the CHT was 193/120 mm/Hg At 1130, the BP entered by the CHT was 173/114 mm/Hg Post-dialysis, the BP entered by the CHT: sitting: 173/114 mm/Hg The RN did not document an assessment related to the elevated BP readings. There was no documentation that an intervention was given, or why it was not given. There was also no other documentation after 0931 by any staff member indicating that the RN was aware that the BP continued to stay elevated throughout the treatment. On the treatment sheet dated 1/8/24, the BP was recorded during the 3 hour, 53-minute treatment by 2 different PCT’s. The following BP’s were documented: Pre-dialysis: sitting- 209/118 mm/Hg At 0811, the BP was 190/122 mm/Hg At 0901, the BP was 185/103 mm/Hg At 0939, the BP was 183/117 mm/Hg At 1015, the BP was 183/117 mm/Hg At 1036, the BP was 209/129 mm/Hg At 1111, the BP was 190/119 mm/Hg Post-dialysis: sitting- 190/115 mm/Hg There was no documentation by either PCT regarding the nurse being notified of the elevated BP readings, but the RN documented that a dose of Clonidine 0.1 mg was given at 1141 (3 hours and 30 minutes into the treatment). Dialysis was concluded at 1204 (23 minutes after dose was given). It was also noted that the RN documented a response to the intervention at 1451 (2 hours 46 minutes after the patient was done with dialysis) as “Relieved”. There were no additional BP readings recorded after the post-dialysis reading which was still elevated above parameters set by facility policy. On the treatment sheet dated 1/17/24, the BP was recorded during the 3 hour, 44-minute treatment by a PCT. The following BP’s were documented: Pre-dialysis: sitting-191/103 mm/Hg At 0832, the BP was 178/108 mm/Hg At 0912, the BP was 187/108 mm/Hg At 0931, the BP was 179/108 mm/Hg- the PCT documented that the RN was aware of the high BP At 1001, the BP was 198/114 mm/Hg- the PCT again documented the RN was aware of high BP At 1102, the BP was 182/124 mm/Hg At 1201, the BP was 187/111 mm/Hg Post-dialysis: sitting- 176/103 mm/Hg The RN did not document any assessment related to elevated BP. There was no intervention given, and no documentation regarding why an intervention was not given for the elevated BP. These findings were reviewed and acknowledged during interview with the Director of Operations (Staff B) and the Medical Director (Staff A) on 1/24/24 at 1000.”

“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: 47976 Based on record review and interview, the facility failed to ensure adequacy of dialysis was properly addressed by the interdisciplinary team (IDT) in 1 (P# 2) of 7 records reviewed; and failed to ensure the dialysate flow rate (DFR) was run as prescribed in 2 (P# 1 and 5) of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-2: This 93-year-old patient was admitted to dialysis on 1/9/20 with the diagnosis of end stage renal disease secondary to hypertension (high blood pressure). During record review on 1/23/24, it was determined the patient’s adequacy (Kt/v) was measured at 0.87. Adequacy measures how well toxins are removed from the patient’s blood. According to the patient’s most recent plan of care (dated 9/19/23), the patient’s goal for Kt/v is 1.4. Notes were requested to support interventions by the IDT to address this value. A nutritional note dated 1/17/24 by the registered dietician was reviewed. The note recognized the poor adequacy and stated the intervention was to “dialyze as prescribed”. During review of the last 6 treatments visits, it was noted the patient did not miss any treatments and that each visit was run for the prescribed time. The Director of Operation (Staff B) was queried on 1/24/24 at 1045 regarding the patient’s attendance record prior to this note. Staff B reported P-2 does not have a history of missed or shortened treatments. She agreed this is not an appropriate intervention to determine and address the root cause of the patient’s low adequacy. She acknowledged the findings. __ **Policy titled “Patient Assessment and Monitoring” (revised 5/1/23) stated on page 6, “Check dialysate flow rate setting is correct, and prescribed flow is being delivered” and “Document any findings and interventions in the medical record.” P-1: This 77-year-old patient was admitted to dialysis on 11/3/23 with the diagnosis of acute kidney failure and was receiving dialysis treatment 3 times per week. During record review on 1/23/24, it was determined the DFR was ordered at 80 milliliters per minute (mL/min). Upon the review of the last 6 treatment sheets, it was noted the DFR was run incorrectly as follows: On 1/19/24, the DFR was run at 500 mL/min at 0637 and at 600 mL/min from 0701 to 1010 (the remainder of the treatment). There was no documentation of the reason the DFR was not met. The Director of Operation (Staff B) acknowledged the findings during an interview on 1/24/24 at 1045. 46476 P-5: This 78-year-old was admitted to the facility on 6/23/22 with end stage kidney disease and high blood pressure. The medical record was reviewed on 1/23/24 and included 6 hemodialysis treatment sheets between the dates of 1/10/24 and 1/22/24. The active physician orders for the period reviewed included that the DFR be run at 800 milliliters/minute (mL/min) each treatment. During review of the treatment sheet dated 1/22/24, it was noted that the DFR was ran at 500 mL/min (300 mL/min less than prescribed) for the entire duration of the treatment (3 hours, 56 minutes). There was no documentation which indicated why the treatment was not given as prescribed. This finding was reviewed and acknowledged during interview with the Facility Administrator (Staff C) and the Director of Operations (Staff B) on 1/24/24 at 1030.”

“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: 47976 Based on record review and interview, the agency failed to ensure the patient and all members of the Interdisciplinary Team (IDT) signed the Plan of Care in 3 (P-1, P-2, and P-7)) of 7 records reviewed, resulting in the potential for unmet patient care needs. Findings include: Policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” (revised 7/3/23) stated, “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.” It also stated, “Each patient’s plan of care must be signed by all members of the IDT,” and “The Attending Physician reviews CIA and indicates with his/her signature on the POC, their oversight of the patient’s Plan of Care within 30 days.” P-1: This 77-year-old patient was admitted to dialysis on 11/3/23 with the diagnosis of acute kidney failure and was receiving dialysis treatment 3 times per week. During record review on 1/23/24, it was determined the following signatures were missing from Plans of Care: Plan of Care dated 11/20/23 was missing a signature by the patient. Plan of Care dated 12/20/23 was missing a signature by the patient, doctor, social worker and registered dietician. P-2: This 93-year-old patient was admitted to dialysis on 1/9/20 with the diagnosis of end stage renal disease secondary to hypertension (high blood pressure). During record review on 1/23/24, it was determined the following signatures were missing from Plans of Care: Plan of Care dated 4/15/21 was missing a signature by the doctor. Plan of Care dated 10/14/21 was missing a signature by the registered dietician. Plan of Care dated 11/11/21 was missing a signature by the registered dietician. Plan of Care dated 10/17/22 was missing a signature by the patient. Plan of Care dated 9/19/23 was missing a signature by the doctor, social worker, and registered dietician. During an interview on 1/23/24 at 1500, the Director of Operation (Staff B) was queried whether there was another place in the chart where patient and staff signatures on Plans of Care could be found. Staff B stated that if there isn’t a signature on the printed forms, then it wasn’t done. She acknowledged the findings. 38304 P-7: This patient was admitted to the facility on 9/20/2016 with diagnoses which included end-stage renal disease, atrial fibrillation, hypotension, and fluid overload-unspecified. The most recent Plan of Care (POC) dated 7/13/23, was reviewed on 1/23/24. It was determined the following required elements were missing from P-7’s POC: 1) Physician: No date or time evidenced within the POC. 2) Social Worker: No date or time evidenced within the POC. 3) Physician Extender: No date or time evidenced within the POC. 4) Patient: POC signature undated. The two lone examples of compliance were noted as follow: 07/13/2023 20:00 (RN/Staff B) and 07/14/2023 10:53 (RD/Registered Dietician/Staff H). During an interview on 1/24/24 at 1100, the Director of Operations (Staff B) reviewed and acknowledged the above findings. Staff B was noted this did not meet facility expectations which were represented by the two lone examples above.”