Fmc Strong Health 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: 40430 Based on policy review, observation, and interview, nursing staff do not follow standard infection control practices regarding the use of gloves and hand hygiene. Specifically, staff do not perform hand hygiene after removing dirty gloves. Findings Include: Review of the policy “Hand Hygiene,” published 11/06/23, indicated hands will be decontaminated using an alcohol-based hand rub or by washing hands with soap and water immediately after removing gloves, and after contact with inanimate objects near the patient. Review of the policy “Personal Protective Equipment,” published 11/06/23, indicated to always perform hand hygiene after glove removal. Observation on 04/23/25 at 11:45 at Station #11 for Patient #3 revealed Staff (H), Patient Care Technician, with gloved hands, cleansed/disinfected Patient #3’s fistula (surgically created permanent access used for dialysis). Staff (H) removed their gloves but did not perform hand hygiene before putting on a new pair of gloves and cannulating (inserting needles) Patient #3’s fistula. Observation on 04/24/25 at 09:35 AM at Station #23 for Patient #26 revealed Staff (O), Patient Care Technician, terminated treatment for Patient #26. Staff (O) removed their gloves and performed hand hygiene prior to applying a clean pair of gloves. Staff (O) touched the handle of the sharps (puncture/leak resistant container for used needles) container, then disconnected the bloodlines and removed the two needles from Patient #26’s fistula. Observation on 04/24/25 at 09:45 AM at Station #21 for Patient #21 revealed Staff (R), Registered Nurse, performed central venous catheter (CVC) care prior to initiating treatment for Patient #21.Staff (R) aspirated/flushed the CVC ports, removed their gloves, but did not perform hand hygiene before putting on a new pair of gloves. Staff (R) drew laboratory specimens from the CVC port, connected the blood lines to the CVC ports, removed their gloves, but did not perform hand hygiene prior to putting on a new pair of gloves to start the treatment. Interview on 04/25/25 at 11:30 AM with Staff (A), Clinical Nurse Manager, and Staff (S), Regional Quality Manager, verified these findings.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 40430 Based on policy review, observation, and interview, staff do not wear face shields and/or eye wear with full side shield to protect themselves while performing procedures which spurting or splattering of blood can occur. Findings Include: Review of the policy “Personal Protective Equipment (PPE),” published 11/06/23, indicated PPE including, but not limited to, full face shield or mask and protective eye wear with full side shield, must be worn to protect employees from blood or other potentially infectious materials. Review of the policy “Initiation of Treatment Using a Central Venous Catheter (CVC- tube inserted into a large vein in the body to provide access for dialysis) and “Optiflux Single Use Ebeam Dialyzer (filter used to clean blood),” published 05/06/24, indicated PPE, including face shield or googles, are required for treatment initiation. Review of the policy “Termination of Treatment Using a CVC and Optiflux Single Use Ebeam Dialyzer (filter used to clean blood),” published 11/04/24, indicated PPE including face shield or googles are required for treatment termination. Review of policy “Initiation of Treatment Using an Arteriovenous Graft or Fistula (surgically created accesses used for dialysis) and “Optiflux Single Use Ebeam Dialyzer,” last published 05/06/24, indicated PPE, including face shield or googles, are required for treatment initiation. Review of policy “Exposure Categories and Determinations,” published 07/01/2024, indicated gloves and full-face shield or mask and goggles are to be worn when using the centrifuge (device used for laboratory specimens/blood tubes to separate the contents for diagnostic tests). Observation on 04/23/25 at 11:25 AM at Station #8 for Patient #1 revealed Staff (I), Licensed Practical Nurse, initiated treatment via a CVC access. Staff (I) connected both blood lines to the CVC ports wearing eye protection that did not have side shields. Observation on 04/23/25 at 11:45 at Station #11 for Patient #3 revealed Staff (H), Patient Care Technician, initiated treatment via a fistula access wearing eye protection that did not have full side shields. Observation on 04/23/25 at 12:15 PM at the lab revealed Staff (H), Patient Care Technician, removed and inspected the blood-filled lab tubes from the centrifuge and placed them in the laboratory specimen refrigerator. Staff (H) was not wearing eye protection. Observation on 04/23/25 at 02:20 PM at Station #20 for Patient #24 revealed Staff (N), Registered Nurse, terminated treatment. Staff (N) was not wearing a face shield or goggles when they disconnected the bloodlines from the CVC ports. Interview on 04/25/25 at 11:30 AM with Staff (A), Clinical Nurse Manager and Staff (S), Regional Quality Manager, verified these findings.”

“HOT H20 DISINF SYS-MONITORING CFR(s): 494.40(a) 6.3.4 Bacterial control devices 6.3.4.3 Hot water disinfection systems: monitoring Hot water disinfection systems should be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Also, hot water disinfection should be performed at least as often as recommended by the manufacturer. The temperature of the water should be recorded at a point farthest from the water heater-that is, where the lowest water temperature is likely to occur ...and measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection should be maintained. Successful completion is defined as meeting temperature and time requirements specified by the equipment manufacturer. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, in four of four months reviewed, the facility does not ensure the hot water return temperature is 85 degrees Celsius on the Central Water Plant (CWP- system to purify the water used for hemodialysis) when utilized to disinfect the water system (January, February, March and April 2025). Findings Include: Review of the manufacturer recommendations “The 2012 Mar Cor Purification CWP 100, Model H/S, Revision B,” indicated the return hot water from the distribution loop from the farthest point should be 85 degrees Celsius. Review of the “CWP RO (reverse osmosis- process used to purify the water used for hemodialysis treatments) Log,” dated from 01/01/25 through 04/23/25, indicated the hot water temperature was not recorded on the following dates: -In January 2025: On 01/02/25, 01/09/25, 01/10/25, 01/11/25, 01/13/25, 01/16/25, 01/17/25, 01/21/25, 01/22/25, 01/24/25, 01/25/25, 01/28/25, 01/29/25, and 01/30/25. -In February 2025: On 02/06/25, 02/08/25, 02/11/25, 02/13/25, 02/15/25, 02/17/25, 02/18/25, 02/20/25, 02/24/25, 02/25/25, 02/26/25, and 02/27/25. -In March 2025: On 03/01/25, 03/04/25, 3/05/25, 03/10/25, 03/11/25, 03/12/25, 03/14/25, 03/17/25 03/21/25, 03/22/25, 03/26/25, 03/27/25, and 03/28/25. -In April 2025: On 04/02/25, 04/04/25, 04/07/25, 04/08/25, 04/09/25, 04/12/25, 04/14/25, 04/17/25, 04/21/25, and 04/23/25. Interview on 04/23/25 at 03:40 PM with Staff (E), Area Technical Operations Manager, verified this finding.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 16136 Based on interview and document review, for four of four months reviewed, staff do not document all bicarbonate solution (used to remove waste products and excess substances from the blood) batches mixed daily to be used for hemodialysis treatments (January, February, March and April 2025) Findings Include: Interview on 04/25/25 at 09:30 AM with Staff (E), Area Technical Operations Manager, verified that all batches of bicarbonate solution are to be documented when the solution is mixed. Review of the document “Bicarbonate Mixer Log,” from 01/01/25 to 04/23/25, revealed staff documented mixing the following number of bicarbonate solution batches: -In January 2025: On 01/13/25, five batches; on 01/15/25, three batches; on 01/17/25, four batches; on 01/21/25, four batches; on 01/25/25, four batches; on 01/29/25, six batches; and on 01/31/25, six batches. -In February 2025: On 02/13/25, four batches; on 02/17/25, four batches; on 02/18/25, four batches; on 02/21/25, six batches; on 02/22/25, three batches; on 02/26/25, four batches; and on 02/27/25, three batches. -In March 2025: On 03/05/25, four batches; on 03/12/25, four batches; on 03/22/25, three batches; and on 03/28/25, four batches. -In April 2025: On 04/01/25, three batches; on 04/19/25, three batches; and on 04/22/25, three batches. Interview on 04/24/25 at 02:30 PM with Staff (Q), Patient Care Technician, revealed a minimum of seven batches of bicarbonate solution is required for Monday, Wednesday, Friday treatments and a minimum of six batches of bicarbonate solution is required for Tuesday, Thursday, Saturday treatments.”

“BICARB MIX SYS-EMPTY/DISINFECT/PREV CORROSION CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: empty/ disinfect/prevent corrosion Bicarbonate concentrate mixing tanks should be designed to drain completely. Mixing tanks should have a tight-fitting lid and should be designed to allow all internal surfaces to be disinfected and rinsed. Because concentrate solutions are highly corrosive, mixing systems should be designed and maintained to prevent corrosion. This Standard is not met as evidenced by: 16136 Based on document review and interview, in four of four months reviewed, the facility does not ensure staff utilize a one-hour disinfection dwell time for the bicarbonate tank and the loop with bleach (January, February, March and April 2025) and did not ensure the bicarbonate system was disinfected weekly in March 2025. Findings Include: Review of the operator’s manual “Dual Tank Mix & Delivery Bicarb System,” effective 12/29/17, indicated the recommended total contact time (dwell time- time the disinfectant is left in the bicarbonate loop) is one-hour for the disinfection of the bicarbonate loop with bleach. The contact time begins when the disinfecting solution is introduced into the system. Review of the policy “Disinfection of Bicarbonate Mixers Using Bleach as the Disinfectant,” published 10/14/20, indicated bleach disinfection will be consistent with the manufacturer’s instructions and the minimum dwell time for bleach will be five minutes. (This policy does not reflect the manufacturer’s recommendations of a one hour contact/dwell time). Review of the “Bicarb Mixer with Loop Disinfect Log,” from January 2025 to April 2025, revealed staff documented a bleach disinfectant dwell time of five minutes before rinsing the loop, instead of one hour, as recommended by the manufacturer. There was no evidence found in the log to indicate the bicarbonate system was disinfected during the weeks of 03/16/25 and 03/23/25. Interview on 04/24/25 at 03:00 PM with Staff (E), Area Technical Operations Manager, verified this finding.”

“H20 TEST-DEVIATIONS REQUIRE RESPONSE CFR(s): 494.40(c) Water testing results including, but not limited to, chemical, microbial, and endotoxin levels which meet AAMI action levels or deviate from the AAMI standards must be addressed with a corrective action plan that ensures patient safety. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, in four of four months reviewed, the facility does not ensure that the daily water reading results are within established parameters (January, February, March and April 2025). Findings Include: Review of the policy “Central Reverse Osmosis (RO-process used to purify the water used for hemodialysis treatments) Water Purification Operation and Maintenance Policy,” published 02/03/25, indicated readings must be established and an acceptable reference ranges or limits and the ranges/limits will be in accordance with manufacturer instruction for use or Fresenius policy. Review of the “Reverse Osmosis Log,” revealed the following: - For the CWP (circulating water pump/part of the water system) Rejection Flow Rate: The parameters listed on the log are between 0.2 to 15 liters per minute (based on the manufacturers recommendations). In January 2025, the reading was out of range on 01/04/25, 01/14/25, 01/18/25, and 01/23/25; and in February 2025, the reading was out of range on 02/07/25, 02/10/25, 02/19/25, and 02/24/25. - For the CWP Return Flow Rate from Loop: The parameters listed on the log are if the reading is 0.0 liters per minute, staff are to contact technical services. In January 2025, the readings were 0.0 liters per minute on 01/04,25, 01/06/25, 01/08/25, 01/14/25, 01/16/25, 01/18/25, 01/27/25 and 01/28/25 (eight of 26 days); in February 2025, readings of 0.0 liters per minute on for 02/01/25, 02/05/25, 02/07/25, 02/10/25, 02/12/25, 02/18/25, 02/19/25, 02/24/25 and 02/28/25 (nine of 24 days); in March 2025, readings were 0.0 liters per minute on 03/07/25, 03/08/25, 03/13/25, 03/14/25, 03/15/25, 03/19/25, 03/20/25, 03/26/25, 03/29/25 and 03/30/25 (10 of 26 days); and in April 2025, readings were 0.0 liters per minute on 04/02/25, 04/04/25, 04/07/25, 04/08/25, 04/09/25, 04/12/25, 04/14/25, 04/17/25, 04/21/25, and 04/23/25 (10 of 20 days). No documentation was found to indicate staff had contacted technical services. Interview on 04/24/25 at 10:00 AM with Staff (E), Area Technical Operations Manager, verified this finding.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 16136 Based on observations, document review, and interview, for two of two eye wash stations observed, the facility was not maintained to provide a safe and functional treatment environment in the following areas: an eye wash station was not present in the clinic area; the emergency eye wash stations were not tested weekly and/or maintained; the emergency shower (drench) was not tested weekly; and the fire doors were not inspected annually. Findings Include: Observation on 04/24/25 between 02:15 PM and 02:30 PM in the patient care area revealed no eye wash station was present in the clinic area. Eye wash stations are required where there is a possibility of eye exposure to hazardous materials, corrosive chemicals, or solutions and must be accessible within 10 seconds or 55 feet in a pathway that is unobstructed according to American National Standards Institute (ANSI) Z358.1 The caps on the eye wash stations located in the water room and the supply area did not come off when the units were activated. The eyewash station in the supply area was activated and the water was orange/brown. Review of the “Emergency Eyewash Log,” dated January 2025 to April 2025 for the two eyewash stations revealed no evidence the two eye wash stations were tested the weeks of 02/16/25 and 03/09/25. Interview on 02/24/25 at 02:30 PM with Staff (Q), Patient Care Technician, verified these observations regarding the eye wash units. Review on 02/24/25 of the “Drench Shower Log,” dated January 2025 to April 2025 revealed no evidence the drench shower was tested the weeks of 02/16/25 and 03/09/25. From 04/23/25 to 04/25/25, the facility failed to provide documentation to verify the fire doors had been inspected annually by a qualified person and/or provide a written record of the inspection per National Fire Protection Association (NFPA) 80-2010 edition. Interview on 04/25/25 at 11:00 AM with Staff (E), Area Technical Operations Manager, verified these findings.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 16136 Based on observation, and interview, the facility does not ensure wall boxes (a fixture recessed into the wall at each patient’s dialysis station that houses connections for the dialysis machine to receive purified water, acid, and bicarbonate concentrates, and to dispose of waste products) are maintained. Findings Include: Observation on 04/24/25 at 09:05 AM in the patient treatment area revealed wall boxes were not maintained. At Station #5, Station #13, and Station #24, there was a buildup of dried bicarbonate on the wall boxes; at Station #18, there was a buildup of dried acid concentration on the wall box; and at Station #20, there was a buildup of dried bicarbonate solution and dried acid on the wall box. Interview on 04/24/25 at 09:30 AM with Staff (H), Patient Care Technician, and at 01:00 PM with Staff (E), Area Technical Operations Manager, verified these findings.”

“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: 34528 Based on policy review, document review, and interview, the facility Quality Assessment and Performance Improvement (QAPI) program did not ensure that all health outcome data was analyzed and trended to determine if a corrective action plan will be implemented when needed in the areas of blood loss, hospitalizations and adverse events. Findings Include: Review of the policy “Quality Assessment and Performance Improvement,” published 11/04/24, indicated an effective and successful review of the QAPI meeting and program activities will include review of aggregate patient data by utilizing the Electronic Quality Improvement Platform (EQUIP) as the primary electronic data dashboard to be displayed and utilized by the QAPI committee to review indicators, trends, data, action plans and document meeting minutes and activities. Review of the “EQUIP Dashboard,” revealed the following patient indicators: “Patient Safety (includes blood loss),” “Hospital Readmissions (includes Hospital Admissions),” and “Crude Mortality Rate (includes patient deaths).” Review of the “Adverse Event Log,” for February 2025 revealed blood loss events for Patient #17, Patient #35, Patient #36, Patient #37, and Patient #38. Review of the “Hospitalization Log,” for 02/2025 revealed hospitalizations for Patient #1, Patient #2, Patient #3, Patient #9, Patient #16, Patient #21, Patient #32, Patient #33, and Patient #34. Review of the “Mortality Log,” for February 2025 revealed the death of Patient #4, the cause of death was unknown. Review of the “QAPI Meeting Minutes,” for March 2025 (where February 2025 data would be reviewed) revealed no evidence the Feburary 2025 data for adverse events for blood loss and patient hospitalizations were reviewed and analyzed for trends to determine if any corrective action was required. There was no evidence to indicate Patient #4’s death was reviewed and analyzed to determine if the death was dialysis related and required corrective actions. Interview on 04/25/25 at 03:00 PM with Staff (A), Clinical Nurse Manager and Staff (S), Regional Quality Manager, verified findings.”