Fmc Bristol

“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: 51389 Based on facility policy review, observation and interview, the facility failed to ensure hand hygiene to prevent the patient from potentially spreading infectious bacteria for 3 patients (#4, #9 and #10) out of seven patients observed. The findings include: Review of a policy, “Hand Hygiene,” dated 11/6/2023, showed “The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination...hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content...hands will be...decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water when...before and after direct contact with patients...entering and leaving the treatment area...before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications...immediately after removing gloves...after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings...after contact with inanimate objects near the patient...when moving from a contaminated body site to a clean body site on the same patient...after contact with the dialysis wall box, concentrate, drain, or water lines...after contact with other objects within the patient station or treatment space...Alcohol based hand rubs dispensers should be strategically placed throughout the facility...” During an observation on 7/28/2025 at 11:30 AM, the Patient Care Technician (PCT #1) touched Pt (Patient) #4’s dialysis machine with an ungloved hand. During an observation on 7/28/2025 at 2:35 PM, PCT #1 did not sanitize their hands, placed 1 glove on, and touched Pt #9’s dialysis machine. Continued observation revealed the PCT proceeded to Pt #10’s dialysis station and typed on the dialysis machine screen without sanitizing their hands or changing gloves. During an interview on 7/29/2025 at 9:00 AM, PCT #2 confirmed all staff should sanitize their hands and don new gloves when going from one patient to another patient. During an interview on 7/29/2025 at 9:45 AM, RN #2 confirmed all staff should sanitize their hands and don new gloves when going from one patient to another patient. During an interview on 7/30/2025 at 11:00 AM, the Interim Manager confirmed the staff must sanitize their hands and wear gloves when they are touching a machine or a patient, “...The staff must remove their gloves and wash their hands and place new gloves between patients.” Continued interview confirmed the observations was not following the Hand Hygiene policy.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 51389 Based on facility policy review, observation and interview, the facility failed to ensure the staff followed appropriate infection control measures when accessing a central venous catheter (CVC- a surgically inserted dialysis access) for 2 patients (#7 and #9) out of 3 patients observed during discontinuation of dialysis using a CVC catheter. The findings included: Review of a policy, “Termination of Treatment Using a Central Venous Catheter and Optflux Single Use Ebeam Dialyzer,” dated 11/4/2024, revealed “The purpose of this policy is to provide direction to reinfuse blood in the extracorporeal system to the patient at completion of hemodialysis treatment using a Central Venous Catheter (CVC)...Don gown and full face shield with mask...place mask on patient, perform hand hygiene, then don new gloves....ensure that a clean under pad is below the catheter limbs to protect the work area and the clothing...Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad...for 10-15 seconds any time caps are removed, or bloodlines are disconnected...to reduce risk of contamination...disconnect the arterial bloodline from the catheter limb. Using a sterile alcohol pad...scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue [blood]...Note: Do no place uncapped catheter limbs on under pad to prevent contamination. Hold the limb while allowing the antiseptic to dry. Immediately attach a prefilled saline syringe to the catheter limb. Repeat steps...for the venous end of the catheter...apply a sterile cap on the end of the lumen maintain aseptic technique. Tighten the end caps securely...” During an observation on 7/29/2025 at 2:50 PM, RN #1 (Registered Nurse) was observed discontinuing a dialysis treatment on Patient (Pt) #9’s CVC. Continued observation revealed, after removing the CVC from the dialysis machine tubing, RN #1 placed a syringe on the end of the catheter limb, disconnected the syringe and scrubbed the hub of the catheter limb with alcohol for 15 seconds. Further observations showed RN #1 laid the open and uncapped end of the CVC limb down on the clean barrier beneath the catheter. Observations revealed the catheter limb was left open to air as RN #1 reached over to get a cap to place on the end of the CVC limb. Continued observation revealed the observed practice occurred with both limbs of the CVC. During an observation on 7/30/2025 at 10:15 AM, RN #1 was observed discontinuing a dialysis treatment on Pt #7’s CVC. Continued observation revealed, after removing the CVC from the dialysis machine tubing, RN #1 placed a syringe on the end of the catheter limb, disconnected the syringe and scrubbed the hub of the catheter limb with alcohol for 15 seconds. Further observations showed RN #1 laid the open and uncapped end of the CVC limb down on the clean barrier beneath the catheter. Observations revealed the catheter was left open to air as RN #1 reached over to get a cap to place on the end of the CVC limb. Continued observations revealed this observed practice occurred on both limbs of the CVC. During an interview on 7/30/2025 at 11:00 AM, the Interim Manager confirmed the ends of the CVC should not be laid down or left open to air, on the clean barrier underneath the catheter.”

“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: 27405 Based on facility policy review, medical record review and interview, the facility failed to ensure patient involvement in the Plan of Care (POC) for 6 of 6 patients (Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, and Patient #6) of sampled incenter hemodialysis patients. The findings include: Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 7/03/2023, revealed “...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 refusal must be documented in the patient’s medical record...” Medical record review revealed Patient #1 was admitted to the facility on 10/6/2023 with diagnoses including End Stage Renal Disease, Hypertension and Anemia. During a review of Patient #1’s POC revealed the last Interdisciplinary Team (IDT) meeting dated 2/28/2025, with the absence of the patient’s signature, indicating the POC was reviewed without participation by Patient #1. Continued review revealed no documentation of a reason why the patient signature was absent. Medical record review revealed Patient #2 was admitted to the facility on 4/19/2022, with diagnoses including End Stage Renal Disease, Hypocalcemia and Anemia. During a review of Patient #2’s POC revealed the last IDT meeting date of 2/28/2025, with the absence of Patient #2’s signature, indicating the POC was reviewed without participation by Patient #2. Continued review revealed no documentation of a reason why the patient signature was absent. Medical record review revealed Patient #3 was admitted to the facility on 5/13/2024, with diagnoses including End Stage Renal Disease, Anemia and Shortness of Breath. During a review of Patient #3’s POC revealed the last IDT meeting date of 6/25/2025, with the absence of Patient #3’s signature, indicating the POC was reviewed without participation of Patient #3. Continued review revealed no documentation of a reason why the patient’s signature was absent. Medical record review revealed Patient #4 was admitted to the facility on 2/14/2019, with diagnoses including End Stage Renal Disease and Anemia. During a review of Patient #4’s POC revealed the last IDT meeting date of 4/30/2025, with the absence of Patient #4’s signature, indicating the POC was reviewed without participation by the patient. Continued review revealed no documentation of a reason why the patient signature was absent. Medical record review revealed Patient #5 was admitted to the facility on 3/11/2025, with diagnoses including Hypertension, End Stage Renal Disease and Anemia. During a review of Patient #5 Plan of Care revealed the last IDT meeting date of 6/25/2025 with the absence of patient signature indicating the POC was reviewed and/or participation by patient. Continued review revealed no documentation of reason why the patient signature was absent. Medical record review revealed Patient #6 was admitted to the facility on 4/1/2025 with diagnoses including Hypertension, End Stage Renal Disease and Anemia. During a review of Patient #6 POC revealed the last IDT meeting date of 4/30/2025, with the absence of Patient #6’s signature, indicating the POC was reviewed without participation by the patient. Continued review revealed no documentation of a reason why the patient signature was absent. During an interview with concurrent review of the POC’s for Patient #1, Patient #2, Patient #3, Patient #4, Patient #5 and Patient #6 on 7/29/2025 at 12:45 PM, the Social Services Director stated she was unsure who’s responsibility of reviewing and obtaining patient participation and/or signature. “...not sure if that has been delegated out yet...” During an interview and review of the POC’s for Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, and Patient #6 on 7/30/2025 at 10:05 AM, the Interim Dialysis Center Manager confirmed the policy for Comprehensive Plan of Care was not followed.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 18784 Based on review of facility policy, review of facility documentation and interview, the facility’s Quality Assessment Performance Improvement (QAPI) committee failed to develop and implement performance improvement action plans to address non-reporting of patient safety events during 5 of the previous 12 months, in an effort to capture adverse events to identify trends; and the QAPI committee failed to perform an investigation and root cause analysis of all the patient safety events, reported in 7 of the previous 12 months, to determine areas for improvement and develop action plans. This failure resulted in the health and safety of all patients on the census potentially being affected. In addition, this is the second consecutive survey (prior recertification 8/22/2022) with the facility cited for failure to investigate adverse events. This failure resulted in the Condition of Coverage (494.110) Quality Assessment Performance Improvement not met. The findings include: V628 - Based on review of facility policy, review of facility documents and interview, the facility failed to address non-reporting of patient safety events in 5 of the previous 12 months, preventing tracking and trending of data related to clinical variances, occurrence and adverse events. This failure resulted in the quality assessment performance improvement (QAPI) committee not addressing all aspects of patient safety and quality of care. V634- Based on review of facility policy, review of facility documents and interview, the facility failed to investigate patient safety events reported that occurred with 12 patients, in the previous 12 months, an effort to prevent similar adverse events and improve the quality of care for all patients receiving services at the facility. Refer to V628 and V634”

“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: 40606 Based on policy review, observation and interview, the facility failed to ensure proper hand hygiene to prevent the spread of potentially infectious bacteria was performed by 2 (Patient’s #6 and #7) of 8 patients observed during 1 of 2 days of observations of direct patient care. The findings include: Review of the facility policy titled, “Hand Hygiene,” dated 11/6/2023, revealed “...All staff, patients, patient care givers... must follow the same requirements for hand hygiene...Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub... Hands will be... Washed with antimicrobial soap and water When Hands are visibly dirty or contaminated with proteinaceous material, blood, or other body fluids... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water... Immediately after removing gloves...” Observations were conducted of the treatment floor on 7/29/2024 from 10:35 AM through 12:30 PM, the following staff were present during the observation: 4 Registered Nurses’ (RN) and 1 Patient Care Technician (PCT). A total of 20 patients were present in the treatment area during the time period. The following concerns were observed: At 10:40 AM, PCT H was in station 16 with Patient #6 who had finished holding his dialysis access site with gloved hand. He removed his glove and exited station16 with PCT H following him. Patient #6 proceeded through the exit door without sanitizing his hands, before exiting the treatment area. At 11:36 AM, Patient #7 had completed her dialysis treatment and gathered her belongings from station 15. Patient #7 exited the station accompanied by RN C, Patient #7 proceeded through the exit door without sanitizing her hands before exiting the treatment area. During an interview on 7/31/2024 at 8:47 AM, RN C confirmed hand hygiene should be performed according to facility policy by patients as well as staff before exiting the dialysis treatment area.”

“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: 40606 Based on review of the facility policy, medical record review, Hepatitis Summary Report review and interview, the facility failed to vaccinate 2 susceptible patients (#8 and #9) of 53 patients reviewed on the Hepatitis Summary Report. The findings include: Review of the facility policy titled, “Patient Vaccination for Hepatitis B,” dated 2/7/2022, revealed “...The Hepatitis B vaccine shall be offered to all susceptible patients...” Medical record review revealed Patient #8 was admitted to the facility on 6/26/2024, with diagnoses including Type II Diabetes and End Stage Renal Disease. Review of the Hepatitis B Summary report revealed Patient #8 was susceptible and had not began a vaccination series for Hepatitis B. Medical record review revealed Patient #9 was admitted to the facility on 6/13/2024, with diagnoses including Hypertensive Chronic Kidney Disease and End Stage Renal Disease. Review of the Hepatitis B Summary report revealed the Patient #9 was susceptible and had not began a vaccination series for Hepatitis B. During an interview on 7/31/2024 at 10:47 AM, the Interim Clinical Manager confirmed the facility had failed to offer Patients #8 and #9 the Hepatitis B vaccine in a timely manner.”

“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: 27405 Based on policy review, facility record review, observation and interview, the facility failed to ensure annual training and evaluations were conducted to maintain the operator’s knowledge and skills related to chlorine and water testing for 1 of 5 staff members, RN (Registered Nurse B) was unaware of an immediate action step required in case of a chlorine breakthrough. The findings include: Review of the facility policy “Knowledge, Skills and Competency Evaluation for Clinical Staff’, dated 6/4/2024 revealed “...the following are the clinical topics covered during the required training for...clinical field employees...initial, annual...Role Specific Skills Evaluation...” Observation and interview of RN B on 7/29/2024, at 11:15 AM, as the third chlorine test for the treatment day was conducted, the RN failed to recognize one of two facility steps required to immediately address a chlorine breakthrough of the first carbon tank. RN B voiced the immediate need to place the patients’ dialysis machines into bypass, but did not include the immediate need to test behind the second carbon tank for chlorine. Review of Staff #1 personnel file revealed the last annual evaluation for water skills related to chlorine and water testing was conducted on 5/10/2023. During an interview on 7/29/2024 at 3:15 PM, the Director of Operations stated it was his expectation for the annual evaluations to be completed. Continued interview confirmed Staff #1’s annual training and evaluation expired in May 2023.”

“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: 18784 Based on review of facility policy, review of facility documents and interview, the facility failed to address non-reporting of patient safety events in 5 of the previous 12 months, preventing tracking and trending of data related to clinical variances, occurrence, and adverse events. This failure resulted in the quality assessment performance improvement (QAPI) committee not addressing all aspects of patient safety and quality of care. The findings include: Review of the facility’s policy, “Patient Safety Event Reporting and Documentation,” dated 2/6/2023, showed “...Through promotion of a Culture of Safety...create best practice guidelines by identifying human, technical and environmental factors that impact the safety of our patients. Staff are encouraged to report patient events without blame or shame...event review is focused on opportunities for...improving the quality and safety of patient care...” Review of Patient Safety Event reports from 8/1/2023 - 7/3/2024, revealed there were no reports filed in September 2023 or the 4 consecutive months of March, April, May, and June of 2024. During an interview with RN (registered nurse C) on 7/31/2024 at 9:25 AM, revealed she had been employed at the facility as a dialysis nurse for 9 months. RN C stated she had not filed an incident (patient safety report) during the previous 9 months and “would get together with someone and figure it out.” During an interview with the Director of Operations on 7/31/2024 at 11:00 AM, he stated “...there isn’t a tile [reference to a designated area] in the QAPI meetings for reviewing the incident reports...””

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 18784 Based on review of facility policy, review of facility documents and interview, the facility failed to investigate 13 patient safety events in the previous 12 months, an effort to prevent similar adverse events and improve the quality of care for all patients receiving services at the facility. The findings include: Review of the facility’s policy, “Patient Safety Event Reporting and Documentation,” dated 2/6/2023, showed “...successful review of patient events performed by the QAPI Committee during QAPI will...Identify facility Identify facility trends including preventability and severity...Determine opportunities for improvement...Cultivate a Culture of Safety by performing a Root Cause Analysis to determine What happened, Why it happened and How to prevent it from happening again...Develop appropriate action plan with a specific goal...” Review of the facility’s list of patient safety (adverse) events from 8/1/2023 through 7/30/2024 included 13 events recorded as follows: 8/17/2023 - Blood Loss-Clotted Dialyzer/Extracorporeal Circuit 8/22/2023 - Sustained Loss of Consciousness...recovered onsite 8/28/2023 - Access...Clotting During the Dialysis Treatment... Blood Loss 10/10/2023 - Dialysis Weight/UF Goal Variance 11/6/2023 - Blood Loss-Vascular Access...recovered onsite 11/16/2023 - Fall...no injury 12/8/2023 - Access Infiltration 1/30/2024 - Incorrect Dialysate Formula Used 2/12/2024 - Blood Loss-Clotted Dialyzer/Extracorporeal Circuit 2/26/2024 - Access Infiltration 2/26/2024 - Blood Loss-Vascular Access 2/27/2024 - Blood Loss- Needle Dislodgement 7/20/2024 - Medication Error- Wrong Dose During an interview on 7/30/2024 at 4:00 PM, with the Director of Operations (DO), he brought 6 patient safety “incident reports” requested by the survey and stated there weren’t any investigations of the events to share. Interview continued and the DO confirmed investigations of the adverse events were not being done. During an interview on 7/31/2024 at 8:30 AM, with the nurse in charge, RN (registered nurse B) stated “...I haven’t been asked to participate in anything past filing the incident report.” During an interview on 7/31/2024 at 8:55 AM, with RN F she stated she had been employed here for the previous 11 months and “...was oriented to filing incident reports...not taught about investigations or how to participate in one.” The RN reviewed the list of incidents (patient safety events) and referred to the 10/10/2023 incident with Dialysis Weight/UF Goal Variance. She stated this was unexpected and related the error to the automated function of the dialysis machine to begin ultrafiltration (UF) at the start of the dialysis treatment. She stated the teammates spoke among themselves to alert each other to check the “green light was on” (indicating the UF had engaged) at start of treatment. She stated that it was her understanding something had happened with some of the dialysis machines during preventative maintenance. Interview confirmed she had not been asked to participate in an investigation of the incident. During an interview on 7/31/2024 at 10:00 AM, with the Medical Director, he stated the QAPI committee had not been doing root cause analysis of the facility’s patient safety events.”