Fkc - West Metro Dialysis

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 50411 Based on document review, observation, and interview, the Facility failed to ensure that external transducer protectors (a filter to prevent blood from entering the dialysis machine) were immediately changed when wet, as required. Findings include: 1. The Facility’s policy titled, Maintenance of Transducer Protectors (Published 11/7/2022) included “... The transducer protector must be changed immediately when contaminated with saline or blood...” 2. An observational tour of the dialysis treatment area was conducted on 9/9/2025, between approximately 9:30 AM and 12:00 PM. - At approximately 10:30 AM, the transducer protector at station #7 was wet and contained blood. At approximately 10:45 PM, a Patient Care Technician (E#8) was at station #7 checking on the patient. E#8 did not change the transducer. 3. On 9/9/2025 at approximately 10:53 AM, the Clinical Manager (covering manager - E#2) was interviewed in the treatment area. E #2 stated that the transducer protector should be changed immediately as soon as it is wet with saline or blood. E #2 then instructed E #8 to change the transducer at station #7.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 50411 A. Based on document review, observation and interview, the Facility failed to ensure that clinical record documentation included a physician’s order when reversing CVC (Central Venous Catheter) lines, as required. Findings include: 1. The Facility’s policy titled, “Reversal of Central Venus Catheter Lines” (Published 2/5/2024), was reviewed and required, “... Documentation requirements - Reversal of CVC Lines requires the following documentation in the patient’s medical record - Provider order with frequency (each treatment, x1, etc.) entered in the patient medical record...” 2. During the observational tour of the treatment area on 9/8/2025 at approximately 10:00 AM, Pt. #1 was observed in station #6 receiving dialysis treatment. Pt.#1’s CVC Lines were noted to be reversed (blue catheter limb connected to the red line coming from the dialysis machine and the red catheter limb connected to the blue line coming from the dialysis machine). 3. On 9/10/2025, the clinical record for Pt #1 was reviewed. Pt #1 was admitted on 4/28/2025, with a diagnosis of ESRD (end stage renal disease). - The dialysis treatment flowsheet, dated 9/8/2025, was reviewed and included documentation by the Registered Nurse (E#1) that Pt.#1’s line was reversed. However, Pt #1’s clinical record lacked a physician’s order to reverse the CVC lines of Pt.#1, and E #1’s note did not indicate the reason for the reversal. 4. On 9/9/2025 at approximately 11:00 AM, an interview was conducted with the Clinical Manager (E#3). E#3 stated that when CVC (Central Venous Catheter) lines are reversed, a physicians order should be obtained and documented in the clinical record. 5. On 9/10/2025 at approximately 9:30 AM, an interview was conducted with E#1. E#1 stated that a physician’s order is not required when reversing CVC (Central Venous Catheter) lines as long as the nurse documents the reason in the clinical record. B. Based on Document review and interview, the Facility failed to ensure that monitoring of the patient’s MAP (Mean Arterial Pressure - the average blood pressure throughout one cardiac cycle. It reflects the perfusion pressure, or the force driving blood through the organs and tissues) was documented in the patient’s medical record, as ordered. Findings include: 1. The Facility’s policy titled, “Medical Record Documentation Standards” (dated 2/5/2024), was reviewed and required, “...All treatment information, treatment related events, changes in a patient’s condition or significant care issues must be noted and charted. Documentation must include follow-through. If physician notification is required, all such communication (including attempts at notification) should be charted...” 2. On 9/8/2025, the clinical record of Pt.#2 was reviewed. Pt.#2 was admitted on 8/11/2025, with a diagnosis of AKI (Acute Kidney Injury). Pt.#2 was status post heart transplant on 6/2025. - The clinical record for Pt.#2 included, “Special Attention: MAP>65, Every Treatment ... Ordered by MD#1. Start Date 8/11/2025. Stop Date 8/10/2026...” -The treatment flow sheets from 8/11/2025 to 9/5/2025 were reviewed and lacked documentation of Pt.#2’s MAP. 3. On 9/10/2025 at approximately 9:15 AM, a telephone interview was conducted with the Medical Director (MD#1). MD#1 stated that MD#1 expects that all orders given are to be carried out and updates provided to physicians as needed. 4. On 9/10/2025 at approximately 10:30 AM, an interview was conducted with the Clinical Manager (E#3). E#3 stated that when a physician orders to monitor a patient’s MAP (Mean Arterial Pressure), it should be carried out and documented in the patient’s clinical record.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 50411 Based on document review and interview, it was determined that the Facility failed to ensure that the quality indicators were analyzed and performance actions implemented aimed at the improvement of care in the Facility, as required. Findings include: 1. On 9/10/2025, the Facility’s policy titled, “Quality Assessment and Performance Improvement Policy” (Published 11/4/2024) was reviewed and required, “QAPI (quality assessment and performance improvement) is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes...” 2. On 9/10/2025 at approximately 10:10 AM, the Facility’s QAPI activities were reviewed with the Clinical Area Manager (E #2). Review of the Facility’s quality metrics for 2025 included the following: - Adequacy (the effectiveness of dialysis treatment) [benchmark is 99.4%] - April (95.7%), May (84%), June (85.2%), and July (75%); - Catheters>= 90 days [benchmark is no catheters > 90 days] - April (40.7%), May (48.1%), June (48.1%), and July (42.9%); - No Show Missed Treatments [benchmark is no unexcused missed treatments] - April (25.8%), May (34.5%), June (44.4%), July (41.4%); - Albumin (the body’s own protein, which helps keep fluids inside the blod vessels) [benchmark is albumin >/= 4.0] - April (52.2%), May (64%), June (48.1%), July 44%). No new/additional action plans were initiated or implemented for the above metrics, which were below benchmarks and not trending toward improvement. 3. On 9/10/2025, during the QAPI review, an interview was conducted with the Clinical Manager (covering manager E#2). E#2 stated that action plans should be initiated for areas identified for improvement. E#2 stated that their facility’s poor-quality outcomes is due to the fact that they get a lot of new patients from the hospital (Facility is located in a Hospital) and also they get a number of patients who are non-compliant to dialysis treatment and diet regimen. 4. On 9/10/2025 at approximately 9:15 AM, a telephone interview was conducted with the Medical Director (MD#1). MD#1 stated that the facility’s quality metrics are reviewed and action plans will be started for metrics that need improvement. MD#1 stated that the Facility is struggling with its quality metrics due in part to their location within a hospital wherein the Facility will get a lot of new admissions and these patients start in the Facility and eventually transfer somewhere else.”

“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: 50411 Based on document review, observation, and interview, the Facility failed to ensure that medications were kept under the preparer’s control or locked in a designated medication storage area, as required per policy. Findings include: 1. The Facility’s policy titled, “Medication Preparation and Administration” (Published 7/7/2025), was reviewed on 9/9/2025 and required, “... Medications may be pre-drawn up to 4 hours prior to administration ... These pre-drawn medications shall be labeled and must be kept under the preparer’s control or in a locked designated medication storage area or refrigerated, if necessary, until delivery to the appropriate patient for administration...” 2. During the observational tour of the dialysis treatment area on 9/8/2025, between 9:30 AM and 12:30 PM, the following was observed: - At approximately 10:00 AM, 2 10 cc syringes labeled Heparin (a blood thinner) for 1 patient were observed on the Nurse’s station counter. 1 Vial labeled Heparin was also observed on the counter. 2 boxes labeled Mircera (medication used to treat anemia) were also noted on the counter. - all of these medications were left on top of the counter at the nurse’s station and left unattended by the RN (Registered Nurse). 3. On 9/8/2025 at approximately 10:10 AM, an interview was conducted with the RN (E#1). E#1 stated that all these medications should be placed in a locked cabinet when left unattended. 4. On 9/8/2025 at approximately 10:52 AM, an interview was conducted with the Clinical Manager (covering manager E#2). E#2 stated that medications should not be left unattended on the counter and instead should be placed in a locked cabinet.”

“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: 36774 Based on observation, document review, and interview, it was determined that for 1 of 3 PCTs/patient care technicians (E #4) observed initiating dialysis on a patient with AV/arteriovenous fistula/dialysis access, the facility failed to ensure that the staff performed hand hygiene and donned new gloves, as required. Findings included: 1. On 9/16/2024 between approximately 10:15 AM and 12:50 PM, an observational tour of the dialysis treatment area was conducted. At approximately 10:50 AM, E #4 was observed initiating dialysis on Pt. #5 with an AV fistula. With a gloved hand, E #4 touched and disinfected Pt. #5’s dialysis access. Then, placed the same gloved hand over the site to palpate and cannulate the AV fistula. E #4 did not perform hand hygiene and donned new gloves between disinfection, palpation, and cannulation of the AV fistula. 2. On 9/18/2024, the facility’s policy titled, “Access Assessment and Cannulation” (5/2024) was reviewed and included, “ ... Assessment of Vascular Access ... 9 ... With the ... gloves, staff may perform the full cannulation procedure including skin disinfection ... and cannulation. If any of the steps in the procedure are interrupted, hand hygiene must be performed, and new gloves must be donned ...” 3. On 9/18//2024 at approximately 11:00 AM, findings were discussed with E #1 (Clinic Manager). E #1 stated that the staff should have performed hand hygiene and donned new gloves between disinfection, palpation, and cannulation of the AV fistula.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 36774 Based on observation, document review and interview, it was determined that for 1 of 3 PCTs/patient care technicians (E #3) observed cleaning the dialysis station, the facility failed to ensure that the PCT followed the required process for cleaning and disinfecting the dialysis station. Findings include: 1. On 9/16/2024 between approximately 10:00 AM through 11:00 AM, an observational tour of the facility’s dialysis treatment area was conducted. At approximately 10:20 AM, E #3 was observed cleaning the dialysis station #12. E #3 did not empty and clean the dialysis machine prime waste receptacle. 2. On 9/16/2024, the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station” (9/2023) was reviewed and included, “... to provide guidelines to prevent the spread of infectious disease... Background... a dialysis station must be cleaned and disinfected between dialysis patients... Dialysis Station. Area including the dialysis machine... Cleaning of the Dialysis Machine. Externally disinfect the dialysis machine with 1:100 bleach solution...” 3. On 9/16/2024 at approximately 10:30 AM, an interview was conducted with E #3. E #3 stated that the dialysis machine was ready for use for the next patient. E #3 stated that E #3 forgot to empty and clean the prime waste receptacle. E #3 stated that the waste receptacle should be emptied and cleaned with 1:100 bleach solution to prevent potential contamination from the previous patient.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 36774 Based on document review and interview, it was determined that for 2 of 4 patients’ records (Pt. #7 and Pt. #8) reviewed regarding Hepatitis B vaccination, the facility failed to ensure that the Hepatitis B vaccine was offered, as required. Findings include: 1. On 9/18/2024, the facility’s policy titled, “Patient Vaccination for Hepatitis B” (2/2022) was reviewed and included, “... The Hepatitis B vaccine shall be offered to all susceptible patients... Protection against Hepatitis B is not maintained when antibody titers fall below 10... Declination... Each offering of the vaccine should be documented in the patient’s medical record...” 2. On 9/18/2024, the facility’s Hepatitis B Summary Report (9/16/2024) was reviewed. The report indicated that 2 of the 4 Hepatitis B susceptible patients lacked documentation to indicate that Hepatitis B vaccination was offered or declined: - Pt. #7 was admitted on 8/28/2024. As of 8/28/2024, Pt. #7’s Hepatitis B antibody titer was less than 10. Pt. #7 had dialysis treatments on 8/28/2024, 8/30/2024, 9/4/2024, 9/6/2024, 9/9/2024, 9/11/2024, 9/13/2024, and 9/16/2024. - Pt. #8 was admitted on 9/11/2024. As of 9/11/2024, Pt. #8s’ Hepatitis B antibody titer was less than 10. Pt. #8 had dialysis treatments on 9/11/2024 and 9/16/2024. 3. On 9/18/2024 at approximately 1:00 PM, findings were discussed with E #1 (Clinic Manager). E #1 could not provide documentation in Pt. #7 and Pt. #8’s clinical records to indicate that Hepatitis B vaccination was offered. E #1 stated that the vaccination should be offered as soon as the antibody titer result is known.”

“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: 36774 A. Based on document review and interview, it was determined that for 2 of 4 patients’ (Pt. #1 and Pt. #2) clinical records reviewed regarding management of fluid volume, the Facility failed to obtain a pre- and/or post-dialysis standing blood pressure. Findings include: 1. On 9/18/2024, the facility’s policy titled, “Determination of Blood Pressure” (2/2022) was reviewed and included, “... Responsibility... (Name of Facility) Staff... Background: Blood pressure management in patients with kidney failure are most often indicators of changes in fluid status... Incenter patients. Obtain blood pressure readings pre-and post-dialysis sitting and standing...” 2. On 9/18/2024, the clinical record for Pt. #1 was reviewed. Pt. #1 was admitted on 12/11/2023 with a diagnosis of ESRD (end stage renal disease). The clinical record indicated that Pt. #1 can ambulate without assistance. The pre-and/or post-dialysis standing blood pressures were not obtained on 9/4/2024, 9/6/2024, and 9/9/2024. 3. On 9/18/2024, the clinical record for Pt. #2 was reviewed. Pt. #2 was admitted on 7/4/2022 with a diagnosis of ESRD. The clinical record indicated that Pt. #2 can ambulate without assistance. The pre-dialysis standing blood pressures were not taken on 9/4/2024, 9/6/2024, and 9/9/2024. 4. On 9/18/2024 at approximately 3:30 PM, findings were discussed with E #1 (Clinic Manager). E #1 stated that staff are taught to check the patient’s blood pressure before and after each dialysis treatments. E #1 stated that the pre-and/or post standing blood pressures should have been taken and documented for Pt. #1 and Pt. #2. B. Based on document review and interview, it was determined that for 2 of 4 patients’ (Pt. #1 and Pt. #2) clinical records reviewed regarding management of fluid volume, the facility failed to reassess the patient’s edema after the dialysis treatments. Findings include: 1. On 9/18/2024, the facility’s policy titled, “ Patient Assessment and Monitoring” (5/2023) was reviewed and included, “... Data Collection... The Registered Nurse will assess... Pre-Treatment... 2... the patient for edema: Location... Severity... Post-Treatment... The registered nurse will... reassess post-treatment as indicated...” 2. On 9/18/2024, the clinical record for Pt. #1 was reviewed. Pt. #1 was admitted on 12/11/2023 with a diagnosis of ESRD (end stage renal disease). The dialysis treatment records on 9/4/2024, 9/6/2024, and 9/9/2024 indicated that Pt. #1 had edema on left lower extremity before the dialysis treatments. The records did not include a reassessment of Pt. #1’s edema after the dialysis treatment. 3. On 9/18/2024, the clinical record for Pt. #2 was reviewed. Pt. #2 was admitted on 7/4/2022 with a diagnosis of ESRD. The dialysis treatment records on 9/4/2024, 9/6/2024, and 9/9/2024 indicated that Pt. #2 had edema on bilateral lower extremities before the dialysis treatments. The records did not included reassessments of Pt. #2’s edema after the dialysis treatment. 4. On 9/18/2024 at approximately 3:30 PM, findings were discussed with E #1 (Clinic Manager). E #1 stated that nurse should have reassessed and documented Pt. #1 and Pt. #2’s edema.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 36774 Based on observation, document review and interview, it was determined that for 1 of 3 PCTs/patient care technicians (E #3) observed performing initiation of dialysis on patients with AV (arteriovenous/dialysis access) fistula, the facility failed to ensure that the PCT followed the required assessment of vascular access. Findings include: 1. On 9/16/2024 between approximately 10:00 AM through 11:00 AM, an observational tour of the facility’s dialysis treatment area was conducted. At approximately 10:50 AM, E #3 was initiating dialysis treatment on Pt. #6 who has a right forearm AV fistula. E #3 visually inspected and palpated Pt. #6’s AV fistula. However, E #3 initiated Pt. #6’s dialysis treatment without auscultating the AV fistula for presence of bruit (indicator how well the dialysis access is functioning). 2. On 9/16/2024, the facility’s policy titled, “Access Assessment and Cannulation” (5/2024) was reviewed and included, “... Before each treatment, the internal access must be assessed for patency... and any abnormal findings... Assessment of Vascular Access... 6... Staff/patient care partners who have been trained to auscultate vascular access should listen to the entire length of the access for changes in the sound of the bruit...” 3. On 9/16/2024 at approximately 11:00 AM, findings were discussed with E #3. E #3 stated that E #3 forgot to auscultate Pt. #6’s AV fistula. E #3 stated that E #3 should have auscultated Pt. #6’s vascular access before initiation of the dialysis treatment. 4. On 9/18/2024 at approximately 3:30 PM, findings were discussed with E #1 (Clinic Manager). E #1 stated that the E #3 should have auscultated the patient’s vascular access before initiation of dialysis.”

“POC-TRACK TP REFER/STATUS;CONTACT TP CTR YRLY CFR(s): 494.90(c) The interdisciplinary team must- (1) Track the results of each kidney transplant center referral; (2) Monitor the status of any facility patients who are on the transplant wait list; and (3) Communicate with the transplant center regarding patient transplant status at least annually, and when there is a change in transplant candidate status. This Standard is not met as evidenced by: 36774 Based on document review and interview, it was determined that for 2 of 2 patients (Pt. #1 and Pt. #2’s) clinical records reviewed regarding kidney transplant, the facility failed to track the results of kidney transplant referral/evaluation. Findings include: 1. On 9/18/2024, the facility’s policy titled, “Transplant Responsibilities and Guidelines” (3/2020) was reviewed and included, “Purpose... to guide (Name of the Facility) Staff in their responsibilities regarding... transplant center referral of patients... The Social Worker will perform or coordinate the following... Track the transplant process within the dialysis clinic and routinely keep the attending physician and care team apprised of patients transplant status... Ensure communication between the patient and the transplant center is in place to enhance continuity of care. Document the Transplant Assessment and updates to the Assessment in the electronic medical record...” 2. On 9/18/2024, the clinical record for Pt. #1 was reviewed. On 12/11/2023, Pt. #1 was admitted to the facility with a diagnosis of End Stage Renal Disease (ESRD). On 4/2/2024 and 6/2024, Pt. #1 had kidney transplant referral/evaluation at (Name of Transplant Center). As of 9/18/2024, the electronic medical record lacked documentation regarding results of Pt. #1’s kidney transplant evaluation. 3. On 9/18/2024, the clinical record for Pt. #2 was reviewed. On 7/4/2022, Pt. #2 was admitted to the facility with a diagnosis of ESRD. On 7/25/2024, Pt. #2 had kidney transplant evaluation at (Name of Transplant Center). As of 9/18/2024, the electronic medical record lacked documentation regarding results of Pt. #2’s kidney transplant evaluation. 4. On 9/18/2024 at approximately 11:30 AM, findings were discussed with E #5 (Social Worker). E #5 could not provide documentation regarding communication with the transplant centers, including status or results of the kidney transplant evaluations for Pt. #1 and Pt. #2.”