Rochester General Hospital - Bay Creek Dialysis Center

“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 when entering/exiting the dialysis station, after removing dirty/used gloves, and when re-applying clean gloves. Findings include: Review of the policy “Dialysis Infection Prevention Protocols (Supplemental),” effective March 2025, indicated that all personnel must practice hand hygiene. Hand hygiene must be performed upon entering and exiting patient station, after all patient contact, when removing gloves, and whenever hands are soiled. The staff will remove gloves and wash hands when gloves are soiled, after completing a dirty task, and before leaving the station to care for another patient. Observation on 09/09/25 at 11:15 AM at Station #2 for Patient #1 revealed Staff (H), Registered Nurse (RN), prepared to initiate treatment via a fistula access (surgically created permanent access for dialysis). Without removing gloves and performing hand hygiene, Staff (H) exited the station, walked to the medication preparation area, and opened a drawer at the nursing station to retrieve supplies. Staff (H) re-entered Station #2, listened to Patient #1 lungs with a stethoscope, removed their gloves, performed hand hygiene, and reapplied clean gloves. Staff (H) exited and re-entered Station #2 two times to retrieve supplies from the common supply cart approximately 10 feet away from the station without removing gloves or performing hand hygiene. Staff (H) proceeded to disinfect/cannulate (insert needles) the fistula and secure the needles with tape. At 02:40 PM at Station #15 for Patient #20, Staff (L), Patient Care Technician (PCT), prepared to discontinue treatment for Patient #20. Staff (L) removed the glove from their left hand, kept the glove on their right hand, and exited the station to retrieve supplies from the common supply cart approximately 10 feet away from the station. Staff (L) re-entered the station, reapplied a glove to their left hand and proceeded to discontinue the dialysis treatment without performing hand hygiene. At 02:45 PM at Station #20 for Patient #31, Staff (J), Licensed Practical Nurse (LPN), placed the blood pressure (BP) cuff on Patient #31 and touched the machine to start a BP. Staff (J) prepared supplies to initiate treatment via a central venous catheter (CVC- tube inserted into a large vein to provide access for dialysis) access for Patient #31. Without removing their gloves and performing hand hygiene, Staff (J) exited the station to retrieve supplies from the common supply cart approximately 10 feet away from the station, re-entered the station, and continued on with CVC care. Observation on 09/10/25 at 09:55 AM at Station #19 for Patient #25 revealed Staff (Q), LPN, walked Patient #25 to their dialysis chair. Staff (Q) removed their gloves, exited Station #19, and walked to the medication preparation counter to retrieve a heparin (medication used to prevent blood clotting during dialysis treatment) syringe without performing hand hygiene. Staff (Q) entered Station #13, put gloves on without performing hand hygiene, and connected the syringe to the dialysis machine set up for the next incoming patient. Staff (Q) returned to Station #19, performed hand hygiene prior to putting new gloves on and placed the blood pressure cuff on Patient #25. Staff (Q) removed their gloves, exited and reentered the station two times to retrieve supplies from the storeroom and common supply cart approximately 10 feet away from the station without performing hand hygiene. Staff (Q) set up supplies at Station #19, removed gloves but did not perform hand hygiene prior to cannulating Patient #25 and initiating their treatment. At 10:20 AM at Station #18 for Patient #14, Staff (Q) discontinued treatment but did not perform hand hygiene prior to donning gloves. Interview on 09/11/25 at 01:20 PM with Staff (B), Registered Nurse, 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, the facility failed to ensure personal protective equipment (PPE-equipment worn for protection from workplace hazards such as blood) such as gowns, face shields, eye wear, or masks were worn properly when performing procedures during which spurting or splattering of blood may occur. Findings include: Review of the policy “Dialysis Infection Prevention Protocols (Supplemental),” effective March 2025, indicated face protection (fluid barrier mask, goggles, shield, etc.) and an impervious gown must be worn by personnel while handling blood access, initiation or discontinue treatment, dismantling equipment, or whenever the risk of blood contamination is evident. A mask and shield must be worn properly at required times. PPE will be worn while performing procedures during which spurting or spattering of blood might occur. Observation on 09/09/25 at 11:25 AM at Station #12 for Patient #18 revealed Staff (W), Licensed Practical Nurse (LPN), provided central venous catheter (CVC- tube inserted into a large vein to provide access for dialysis) care and initiated treatment for Patient #18. Staff (W) did not completely fasten their PPE gown, utilizing only one snap, which exposed their uniform scrubs from the neck to thigh area. At 11:30 AM at Station #14 for Patient # 4 Staff (L), Patient Care Technician (PCT), cannulated (insert needles) and initiated treatment for Patient #4 while wearing their surgical face mask below their nose with their nostrils exposed. Observation on 09/11/25 at 01:15 PM at Station #4 for Patient #33 revealed Staff (Y), LPN, provided CVC care and initiated treatment for Patient #33 wearing prescription glasses without side shields protecting their eyes. Interview on 09/11/25 at 01:20 PM with Staff (B), Registered Nurse, verified these findings.”

“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: 16136 Based on policy review, document review, and interview, the facility does not document the hemodialysis machines used to treat Hepatitis B positive (Hep B+) patients were disinfected after each treatment. Findings include: Review of the policy “Hepatitis B Patient Isolation in the Dialysis Unit,” last revised December 2022, indicated the dialysis machine that is utilized for Hep B+ patients will be disinfected with bleach after each patient and after the last patient of the day. Review of the “Dialysis Machine Cleaning Log,” from 06/06/25 to 09/10/25, did not provide evidence Machine #93 used to treat Hep B+ patients was disinfected with bleached after each patient treatment: -In 06/2025: On 06/07/25, 06/07/25, 06/09/25, 06/11/25, 06/14/25, 06/15/25, 06/16/25, 06/17/25, 06/21/25, 06/23/25, 06/27/25 and 06/30/25. -In 07/2025: On 07/07/25, 07/08/25, 07/29/25 and 07/31/25. -In 08/2025: On 08/02/25, 08/05/25, 08/07/25, 08/18/25, 08/22/25, 08/26/25, 08/28/25 and 08/29/25. -For 09/01/25 - 09/10/25: On 09/03/25, 09/06/25, 09/07/25, and 09/10/25. Interview on 09/10/25 at 01:10 PM with Staff (B), Administrator, verified this finding. Interview on 09/11/25 at 12:00 PM with Staff (P), Administrator, verified that the facility has four Hepatitis B+ patients and Machine #93 is utilized daily.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 16136 Based on policy review, document review, observation and interview, the facility does not ensure that the water hardness is measured after the last patient treatment daily and that staff perform testing correctly. Findings include: Review of policy “Hardness Testing of Pre-Treatment Water ....,” revised October 2021, indicated the hardness of pre-treated water is checked before the first patient treatment and after the last patient treatment. Review of the “Patient Treatment Schedules,” for July and August 2025, revealed the last patient treatment ends at approximately 09:00 PM, Monday - Saturday. Review of the “Central RO (Reverse Osmosis-water purification system) Log,” from 07/01/25 and 08/31/25, revealed hardness testing was not performed before the last patient finished their hemodialysis treatment on the following days: On 07/02/25, 07/04/25, 07/05/25, 07/07/25,07/08/25, 07/10/25, 07/11/25, 07/15/25, 07/16/25, 07/17/25, 07/18/25, 07/19/25, 07/21/25, 07/22/25, 07/23/25, 07/24/25, 07/29/25, 07/30/25 and 07/31/25. On 08/01/25, 08/02/25, 08/04/25, 08/05/25, 08/06/25, 08/09/25, 08/11/25, 08/12/25, 08/13/25, 08/14/25, 08/15/25, 08/16/25, 08,17,25, 08/21/25, 08/22/25, 08/25/25, 08/26/25, 08/27/25, 08/28/25, 08/29/25 and 08/30/25. Interview on 09/09/25 at 02:30 PM with Staff (K), Administrator, verified these findings. Review of the manufacturer’s recommendations for “Guardian Water Hardness Test Strips,” revised 2021, indicated staff are to immerse the test strip into the water sample for one second and read the result after 10 seconds. Observation on 09/10/25 at 03:10 PM of Staff (G), Nursing Staff, revealed when performing the water hardness test, Staff (G) obtained a water sample for hardness testing, dipped the test strip in the water sample for 10 seconds, and immediately read the result. Interview on 09/10/25 at 03:50 PM with Staff (E), Technical Staff and Staff (O), Administrator, verified this finding.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 16136 Based on policy review, observation, and interview, the facility does not ensure that total chlorine testing is performed correctly. Findings include: Review of the policy “Dialysis-Chloramine Testing of Pre-treated Water ....,” reviewed June 2025, indicated staff performing chlorine testing are to obtain a 20 milliliter (ml) water sample post primary carbon tank, immerse the indicator pad of the test strip into the sample, and move it back and forth vigorously for 10 seconds, remove the test strip, and wait 30 seconds before reading the result. Observation on 09/10/25 at 03:10 PM in the water room revealed that Staff (G), Nursing Staff, obtained a 30 ml water sample post-primary carbon tank, swirled the test pad of the test strip gently for 10 seconds, and immediately read the result. Interview on 09/10/25 at 03:50 PM with Staff (E), Technical Staff, and Staff (O), Administrator, verified this finding.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure staff document the rest time (amount of time disinfectant solution is in contact with the water system) or testing for presence/absence of disinfectant at all sample ports. Findings include: Review of the policy “RO (reverse osmosis- used to purify water) Loop Disinfection (disinfection of the water delivery system) and Rinsing with “Negative Bleach” Verification,” revised November 2023, indicated staff are to add one-half gallon bleach or Minncare (disinfection solution) to 150 gallons of treated water in the storage tank and purge the loop with disinfecting solution. The disinfecting solution must remain in the loop or “rest” for two (2) hours. The water loop must be purged and prove positive for bleach at all sample ports, ultra-filters, pre-loop, post-loop, bicarb mixer supply, auxillary supply drop and at all wall boxes utilizing the Total Chlorine test strips to prove each station is positive for bleach. After the required rest period, the RO is to be restarted to refill the tank and manually turn on the recirculation pumps, allowing the disinfectant in the water loop to be purged to the drain. After the first rinse, begin testing the return loop at the sample port for negative bleach. Once the return loop is negative for bleach, wait two (2) minutes, switch the circulation pump on and wait another (5) minutes and reverify the loop is negative for bleach at the return loop. After an additional 15 minutes retest the loop return for presence of bleach and proceed to test all sample ports, ultra-filter, pre-loop, post-loop, bicarb mixer test, bicarb mixer supply, anxiliary supply drop to ensure that all test ports are negative for bleach. Proceed to the wall boxes, purging each wall for one (1) minute and verify that each wall box is negative for bleach. Review of the “Central Monthly Cleaning Log,” dated January 2025 to August 2025, revealed the following: -The “rest” time is not documented. -The sampling for presence/absence of disinfecting solution was not documented. The presence/absence must be tested at all sample ports, ultra-filters, pre-loop, post-loop, bicarb mixer test and bicarb mixer supply and at each wall box. Interview on 09/10/25 at 11:00 AM with Staff (E), Technical Staff, verified this finding.”

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 16136 Based on policy review, document review, observation, and interview, the facility does not maintain mixing systems. Specifically: 1. Staff do not mix bicarbonate solution properly; 2. The bicarbonate mixing tank was not rinsed before preparing a new batch of solution; 3. A second person did not verify the specific gravity of the acid solution before the acid concentrate was transferred to the holding tank and did not document the transfer hose was connected to the correct acid holding tank; 4.The one-micron filter (filter to remove small contaminants and particles) was not changed after six batches of acid solution was prepared. Findings include: 1. Review of the manufacturer’s recommendations “Naturalyte - Dry Bicarbonate Concentrate for Bicarbonate Hemodialysis,” dated October 2019, indicated the procedure for mixing/preparing bicarbonate solution is to mix one bag of Naturalyte powder with 90 liters (23.78 gallons) of dialysis water for one minute, add additional dialysis water to total 96 liters (25.36 gallons), and mix for 10 minutes. The temperature of the water should be between 20-30 degrees Celsius (68-86 degrees Fahrenheit) to ensure that the bicarbonate powder quickly dissolves in the solution. The pH (measures the acidity or alkalinity of a water-based solution) and conductivity (degree to which a specified material conducts electricity) will be tested before being utilized for dialysis treatment to ensure proper preparation of the solution. Observation on 09/11/25 at 07:45 AM in the water room with Staff (R), Patient Care Technician, revealed preparation of the bicarbonate solution. Staff (R) added 25 gallons of dialysis water to the bicarbonate mix tank, added one bag of powder bicarbonate, and mixed the solution for 30 minutes. After 30 minutes of mixing, Staff (R) obtained the conductivity of the solution but did not perform pH testing. Not following the manufacturer’s recommendations for proper mixing and mixing time can lead to increased pH levels 2. Review of the policy “Bicarb Mixer Rinse Policy (Quick Rinse),” revised December 2021, indicated staff are to rinse the residual bicarbonate solution from the tank prior to mixing a new batch. Review of the “Bicarb Mix Log,” dated June 2025 to August 2025, revealed no evidence the bicarbonate mixing tank was rinsed before preparing a new batch of bicarbonate solution. 3. Review of the policy “Granuflo (an acid concentrate) Mixing Procedure,” revised February 2025, indicated the lot number and concentration of the acid granules must be documented; the temperature of the prepared acid solution must be obtained; and a hydrometer must be used to obtain the specific gravity, and readings are to be documented on the Granuflo log. Before the acid concentrate can be transferred to the holding tank, the specific gravity must be verified by a second person who will also verify the lot number, the concentration of the acid powder used, and that the transfer hose is connected to the correct acid holding tank. Review of the “Acid Log,” dated 05/23/25 to 09/05/25, revealed there was no documentation a second person verified the specific gravity of the acid solution, lot number, concentration of acid granules, and that the transfer hose was connected to the correct acid holding tank prior to transferring the solution. Review of the “Acid Log,” revealed that acid batches prepared from 07/29/25 to 09/05/25 (28 batches) had no evidence that the batches had been verified. 4. Review of the operator’s manual “Dry Acid Dissolution Unit 99 gallons,” revised 2024, revealed the one-micron filter should be changed after six batches of acid have been mixed. Review of the “Acid Log,” dated 05/23/2025 to 09/05/25, revealed no evidence the one-micron filter was changed after six batches of acid solution was prepared. Interview on 09/11/25 at 08:30 AM with Staff (E), Technical Staff, and Staff (O), Administrator, verified these findings.”

“BICARB MIX SYS-STOR/USE TIME/MIN COMBINE CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: storage/use time limits/min combine Once mixed, bicarbonate concentrate should be used within the time specified by the manufacturer of the concentrate. 7 Strategies for bacterial control 7.1 General Storage times for bicarbonate concentrate should be minimized, as well as the mixing of fresh bicarbonate concentrate with unused portions of concentrate from a previous batch. The manufacturer’s instructions should be followed if they are available. This Standard is not met as evidenced by: 16136 Based on policy review, document review and staff interview, the facility does not ensure that bicarbonate solution is utilized within 24 hours of mixing and the delivery system is not rinsed daily. Findings include: Review of the manufacturer’s recommendations for “Dry Bicarbonate Concentrate- Naturalyte,” dated October 2019, indicated bicarbonate solution should be used within 24 hours of mixing and that the bicarbonate loop is drained/rinsed daily. Review of the “Bicarb Mix Log,” dated 06/01/25 to 08/31/25, revealed bicarbonate solution was not utilized within 24 hours of mixing on the following days: Bicarbonate was mixed on 06/01/25 at 08:06 AM, and again on 06/02/25 at 01:00 PM. Bicarbonate was mixed on 06/20/25 at 07:26 PM, and again on 06/22/25 at 02:11 PM. Bicarbonate was mixed on 06/29/25 at 08:20 AM, and again on 06/30/25 at 01:11 PM. Bicarbonate was mixed on 06/30/25 at 08:03 PM, and again on 07/01/25 at 08:52 PM. Bicarbonate was mixed on 07/07/25 at 06:13 PM, and again on 07/08/25 at 08:46 PM. Bicarbonate was mixed on 07/13/25 at 08:12 AM, and again on 07/14/25 at 11:00 AM. Bicarbonate was mixed on 07/18/25 at 07:47 PM, and again on 07/20/25 at 03:21 PM. Bicarbonate was mixed on 06/20/25 at 07:26 PM, and again on 06/22/25 at 02:11 PM. Bicarbonate was mixed on 07/27/25 at 07:54 AM, and again on 07/28/25 at 08:00 AM. Bicarbonate was mixed on 07/29/25 at 09:30 AM, and again on 07/30/25 at 01:00 PM. Bicarbonate was mixed on 08/01/25 at 09:00 AM, and again on 08/03/25 at 01:23 PM. Bicarbonate was mixed on 08/10/25 at 07:57 AM, and again on 08/11/25 at 12:08 PM. Bicarbonate was mixed on 08/24/25 at 07:30 AM, and again on 08/25/25 at 09:00 AM. There was no documentation bicarbonate delivery system was rinsed clear of bicarbonate solution daily. Interview on 09/09/25 at 01:30 PM with Staff (E), Technical Staff, verified these findings.”

“BICARB MIXING SYS-NOT OVERMIXED CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: not overmixed Overagitating or overmixing of bicarbonate concentrate should be avoided, as this can cause CO2 loss and can increase pH. This Standard is not met as evidenced by: 16136 Based on policy review, observation, and interview, the facility does not ensure that the bicarbonate solution is not over mixed. Findings include: Review of the policy “Dialysis Bicarb Mixing,” dated September 2025, indicated to mix the bicarbonate solution for 10 minutes. Observation on 09/11/25 at 07:45 AM in the water room with Staff (R), Patient Care Technician, revealed they mixed the bicarbonate solution for 30 minutes. Overmixing the bicarbonate solution has the potential to decrease the carbon dioxide level and increase the pH level. The facility does not document the pH of the bicarbonate solution. Interview on 09/11/25 at 08:30 AM with Staff (E), Technical Staff, and Staff (O), Administrator, verified this finding.”

“BICARB CONC DISTRIB-WKLY DISINFECT/DWELL/CONC CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: weekly disinfection/dwell times/conc Bicarbonate concentrate delivery systems should be disinfected on a regular basis to ensure that the dialysate routinely achieves the level of bacteriological purity [required by these regulations]. For piped distribution systems, the entire system, including patient station ports, should be purged of bicarbonate concentrate before disinfection. Each patient station port should be opened and flushed with disinfectant and then rinsed; otherwise, it would be a “dead leg” in the system. Appropriate dwell times and concentrations should be used as recommended by the manufacturer of the concentrate system. If this information is not available, bleach may be used at a dilution of 1:100 and proprietary disinfectants at the concentration recommended by the manufacturer for disinfecting piping systems. 6.5 Concentrate distribution: The interval between disinfection should not exceed 1 week. If the manufacturer does not supply disinfection procedures, the user must develop and validate a disinfection protocol. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility did not ensure routine disinfection of the bicarbonate loop is performed and the presence/absence of disinfectant is tested at the required locations weekly. Findings include: Review of the manufacturer’s recommendations “Bicarb Mixing and Distribution Operating Instructions,” revised 02/23/22, indicated the bicarbonate system should be disinfected per facility policy. Each bicarbonate port will be tested for presence and absence of disinfectant. Review of the policy “Bicarb System Disinfection Policy,” approved January 2024, revealed that the staff are to add one-half gallon of bleach to the mix tank, making sure to close the mix tank lid and activate the safety switch, the spray tank mix switch, the fill/mix switch and the spray day tank switch. Purge bleach through the mix tank and the day tank sample ports and activate the loop prime switch. After five to 10 minutes, staff are to check the bicarb loop return for presence of disinfectant. Once the bicarb loop return is positive, the staff are to check the 24 bicarb ports (21 treatment stations, two technical room stations, and one training room station) for presence of disinfectant. The policy does not indicate the requirements of weekly disinfection and port testing for absence of bleach in the loop. Review of the policy, “Dialysis Outpatient - Sunday Duties”, last revised August 2025, indicates to “rinse bicarb systems per policy...” but does not address testing for absence of bleach at any location. Review of the “Bicarb Disinfection Log,” dated 06/01/25 to 08/31/25, revealed that the bicarbonate loop will be disinfected weekly; instillation of disinfection solution on Saturday evenings and the loop rinsed on Sunday. -In June 2025: disinfection was not performed the week of 06/13/25 to 06/14/25. -In July 2025: On 07/06/25, disinfectant tested positive in the mixing tanking and repeat testing was not done; and on 07/19/25, staff did not document disinfectant was present in the loop. There was no documentation to indicate each bicarbonate port was tested for presence/absence of disinfectant. Interview on 09/11/25 at 02:00 PM with Staff (E), Technical Staff, verified these findings.”

“MICROB MONITOR-MO H20 SAMPLES/METHOD CFR(s): 494.40(a) 7.2 Microbial monitoring methods: monthly water samples/method 7.2.1 General Culture water ...weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Monitoring can be accomplished by direct plate counts, in conjunction with the measurement of bacterial endotoxin. 7.2.2 Sample collection Water samples should be collected directly from outlet taps situated in different parts of the water distribution system. In general, the sample taps should be opened and the water should be allowed to run for at least 60 seconds before a sample is collected in a sterile, endotoxin-free container. A minimum of 50 mL of water, or the volume specified by the laboratory performing the test, should be collected. Sample taps should not be disinfected. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that all required water cultures are obtained monthly and sent to the facility in-house lab and approved laboratory (laboratory that has an ELAP - (Environmental Laboratory Approval Program) number, is competent to analyze environmental samples and provides validated, reliable data for regulatory compliance and environmental decision making). Findings include: Review of the policy “Water Testing Policy and Sampling Policy,” revised October 2023, indicated water cultures will be obtained monthly from the central reverse osmosis (water purification system), the loop start and end (water delivery system), post ultrafilter (membrane used to remove contaminants from water), acid feed, bicarbonate feed, the first and last patient stations, and submitted to the facility approved laboratory and to the in-house laboratory. Review of the “Water Culture Sample Reports,” dated January 2025 to August 2025, revealed water cultures were not obtained monthly for the post ultrafilter, and the first and last patient stations. Additionally, the water cultures obtained were not sent monthly to the in-house laboratory and to the facility approved laboratory. Interview on 09/10/25 at 11:25 AM with Staff (E), Technical Staff, verified this finding.”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure 10 percent of hemodialysis machines dialysate cultures are sent to the facility’s approved laboratory monthly (laboratory that has an ELAP - (Environmental Laboratory Approval Program) number, is competent to analyze environmental samples and provides validated, reliable data for regulatory compliance and environmental decision making) and one-third of the hemodialysis machines dialysate cultures are sent to the in-house laboratory quarterly. Findings include: Review of the policy “Water Testing Policy and Sampling Policy,” revised October 2023, indicated dialysate cultures will be obtained monthly from 10 percent of the hemodialysis machines and submitted to the facility’s approved laboratory and one-third of dialysate cultures will be submitted to the in-house laboratory quarterly. Review of the “Dialysate Cultures Sample Report,” dated January 2025 to August 2025, indicated in February 2025 dialysate cultures were not obtained for 10 percent (minimum of 2) of the hemodialysis machines (total of 27 machines) and submitted to the approved laboratory monthly. Additionally, there was no documentation hemodialysis machines dialysate cultures were sent quarterly to the in-house laboratory per the facility policy. Interview on 09/10/25 at 11:25 AM with Staff (E), Technical Staff, 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 observation and interview, the facility does not ensure a safe and functional environment is maintained in the mechanical room. Findings include: Observation on 09/11/25 at 10:15 AM in the mechanical room, revealed a three-foot separation was not maintained around the electrical panel box. A five-gallon bucket with a cardboard box containing miscellaneous supplies, 4 pieces of wood (2 ½ - 3 feet long), and cardboard were stored adjacent to the electrical panel box. Additionally, on top of Automatic Transfer Switch #40 (ATS- electrical device that automatically switches to back up power source in the event of power loss) there was a can of stain sealing ceiling paint and one container of “Spears-LW-5 One-Step Heavy Body CPVC (chlorinated polyvinyl chloride) Cement” (a product used to join CPVC pipes and fittings in hot and cold water plumbing systems, water treatment and industrial applications). The labeling on both of these products indicates that the products are “extremely flammable”. Interview on 09/11/25 at 10:15 AM with Staff (O), Administrator, verified these 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: 16136 Based on observation, document review and staff interview, the facility does not ensure adequate testing of the emergency generator or adequate testing of the fire alarm system. Findings include: Observation on 09/11/25 at 10:25 AM, revealed two Automatic Transfer Switches (ATS-electrical device that automatically switches to back up power source in the event of power loss) were present for the emergency generator. Review of the “Monthly Generator Testing Reports,” dated January 2025 to August 2025, did not indicate which ATS was utilized when testing or transferring a rated load from normal power to the emergency generator and did not document the time delay it took to transfer the load per National Fire Protection Association (NFPA) 110, 2010 edition. NFPA 110, 2010 edition requires that all ATS be tested when the emergency generator is tested every 20-40 days under a rated load. Review of the “Fire Alarm System Reports,” dated September 2023 and June 2024, revealed the fire alarm system was last tested on 06/11/24 and is required to be tested annually per NFPA 72, 2010 edition. There was no evidence sensitivity testing had been performed on the Photoelectric Smoke Detectors (PSD- detector that uses a light beam and sensor to detect smoke) or if the fire alarm system is addressable (how fire alarm devices communicate with the fire alarm panel) per NFPA 72, 2010 edition. Interview on 09/11/25 at 12:45 PM with Staff (O), Administrator, 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 policy review, observation, document review, and interview, the facility does not ensure that the hemodialysis machines are acid cleaned daily, the pHoenix XL meters are disinfected daily, and the pHoenix XL meters are calibrated daily with the standard solution. Findings include: Review of the hemodialysis machines, “2008T- Operator’s Manual”, 2008-2010 edition, revealed the 2008T hemodialysis machines should undergo an acid cleaning daily when using bicarbonate concentrates during dialysis to prevent the buildup of bicarbonate inside the machine that can have detrimental effect on the machine’s performance and treatment efficacy. Interview on 09/10/2025 at 10:00 AM with Staff (E), Technical Staff, revealed that the facility has 27 hemodialysis machines. Review of the “Dialysis Machine Cleaning Log,” from 06/01/25 to 09/09/25, revealed the following: -In June 2025, seven machines were not acid cleaned daily on 06/02/25 and 06/17/25; six machines on 06/03/25, 06/05-06/06/25, 06/13/25, 06/19-06/20/25, 06/24-06/26/25, 06/30/25; five machines on 06/09/25, 06/27-06/28/25; four machines on 06/11/25; and two machines on 06/10/25. -In July 2025, six machines were not acid cleaned daily on 07/02-07/05/25, 07/07/25, 07/10/25, 07/19-07/21/25, 07/23/25, 07/25/25, and 07/30-07/31/25; five machines on 07/12/25, 07/26/25, and 07/28-07/29/25; four machines on 07/09/25 and 07/15/25; and one machine on 07/11/25, 07/16/25 and 07/18/25. -In August 2025, seven machines were not acid cleaned daily on 08/14/25 and 08/20/25; six machines on 08/01-08/13/25, 08/19/25, 08/22-08/26/25, and 08/28/25; five machines on 08/15/25 and 08/30/25; three machines on 08/21/25, 08/27/25, and 08/29/25; and no machines on 08/16/25. -In September 2025, seven machines were not acid cleaned daily on 09/08/25; six machines on 09/01-09/02/25, and 09/10/25; five machines on 09/04/25 and on 09/09/25; and 19 machines on 09/06/25. The log did not indicate which hemodialysis machines were in backup status or which machines were out of service for maintenance issues. Review of the policy “Dialysis-Phoenix XL Dialysate Testing Procedure,” revised June 2025, indicated the phoenix meter must be disinfected with bleach solution and calibration verification must be performed daily before use. Review of the “Phoenix Meter Disinfection Log,” dated 06/01/25 to 08/31/25, for six of six phoenix meters, revealed the meters were not disinfected daily before use on 06/10/25, 06/19/25, 06/23/25, 06/26/25 (isolation room meter was not disinfected), 07/03/25, 07/10/25, 07/24/25, 07/25/25, 08/01/25, 08/02/25, 08/03/25 (meter #4 was not disinfected), 08/04/25, 08/07/25, 08/08/25, 08/16/25, 08/20/25 (Meter #4 was not disinfected), 08/27/25, 08/28/25, 08/29/25 and 08/30/25. Interview on 09/10/25 at 11:55 AM with Staff (K), Administrator, verified these findings. Review of the “Phoenix Meter Calibration Log,” dated 06/01/25 to 08/31/25, for six of six meters, revealed the phoenix meters were not calibrated before use on 06/01/25, 06/02/25, 06/07/25, 06/13/25 (isolation meter and Meter #4 were not calibrated), 06/19/25, 07/18/25, 07/19/25, 07/29/25, 08/04/25, 08/14/25, 08/16/25, 08/20/25 (Isolation room meter not calibrated), 08/27/25, 08/28/25 and 08/30/25. Interview on 09/11/2025 at 11:50 AM with Staff (E), Technical Staff, verified these findings.”

“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: 40430 Based on policy review, observation, and interview, in four of nine patients observed, staff did not ensure patient access sites, bloodline (tubing used to provide hemodialysis treatment) connections, and/or patient faces were visible at all times during treatment (Patient #12, Patient #19, Patient #21 and Patient #22). Findings include: Review of the policy “Dialysis Access Visibility,” approved November 2024, indicated patients receiving dialysis must have their vascular access and connections with dialysis tubing visible at all times to allow staff to be able to visually assess for blood loss. Patients faces must be visible to allow for continuous assessment by the staff. Observation on 09/10/25 in the patient treatment area revealed staff did not ensure access sites and patient faces were visible during treatment for the following patients: -From 08:30 AM to 09:20 AM, Patient #21 at Station #13 had their fistula (surgically created access for dialysis) and bloodline tubing connections covered by their blanket and not visible. -From 08:30 AM to 09:25 AM, Patient #12 at Station #17 had their central venous catheter (CVC-tube inserted into a large vein to provide access for dialysis), bloodline tubing connections, and head completely covered by their blanket and not visible. -From 08:30 AM to 09:40 AM, Patient #22 at Station #14 had their fistula and bloodline tubing connections covered by their blanket and not visible. -From 08:30 AM to 10:55 AM, Patient #19 at Station #21 had their CVC and bloodline tubing connections covered by their blanket and not visible. Interview on 09/11/25 at 11:00 AM with Staff (B), Registered Nurse, verified these findings.”