Dialysis Center of Rhode Island Hospital - Warren Avenue

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 46539 Based on record review and staff interview, it has been determined that the facility failed to conduct all required exercises to test the facility’s emergency plan. This deficient practice has the potential to impact 39 of 39 patients, as well as an indeterminable number of staff and visitors. Findings are as follows: Record review failed to reveal evidence that the facility conducted a full-scale emergency preparedness exercise that was facility based, or a tabletop exercise that includes a group discussion designed to challenge the emergency plan, during the 2023 and 2024 calendar years. During a surveyor interview on 1/24/2025 at 11:35 AM with the Director of Dialysis Services, she was unable to provide evidence of a full-scale emergency preparedness exercise or a tabletop exercise to challenge the emergency plan. Additionally, she acknowledged that a full-scale emergency preparedness exercise or a tabletop exercise were not completed during the 2023 and 2024 calendar years.”

“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: 46539 Based on surveyor observation, record review, and staff interview, it has been determined that the facility failed to ensure that proper glove use, hand hygiene and infection control practices were maintained relative to accessing a arteriovenous graft (AV graft; a connection that is made between an artery and a vein for dialysis access) for the initiation of dialysis, Patient ID #1 and during 1 of 2 observations relative to the disinfection of a dialysis station, Station #7. Findings are as followings: Review of a policy titled “Hand Hygiene” last reviewed on 7/2024 states in part, “...When to use Alcohol-based Hand Rub...Before donning [putting on] gloves...after removal of gloves...after contact with inanimate objects (including medical equipment) and environmental surfaces in the immediate area of the patient (e.g., patient furniture)...change gloves during patient care if moving from a contaminated body site to a clean body site...” 1. Record review revealed Patient ID #1 was admitted to the facility with a diagnosis of end stage renal disease and is receiving hemodialysis (a procedure where a dialysis machine and a special filter called an artificial kidney are used to clean the blood three times a week). During a surveyor observation on 1/22/2025 at 12:12 PM, Registered Nurse (RN), Staff A, was observed wearing gloves while accessing the AV graft on the patient’s right upper arm. Staff A then cleaned the access sites with an antiseptic product, inserted both needles into the access sites, and then secured them with tape. Staff A proceeded to dispose of the items in the biohazard bin by sliding back the top of the bin to throw away the items. Staff A then evaluated the cannulation (the insertion of a small plastic tube into a vein) sites by palpating (a physical examination performed by applying pressure by the hand or fingers to a surface of the body). Staff A then removed her gloves, without performing hand hygiene and proceeded to rest her arm and bare hand on the dialysis machine. Staff A failed to change her gloves, perform hand hygiene during the above observations and failed to reapply gloves prior to touching the dialysis machine. 2. During a surveyor observation on 1/22/2025 at 10:55 AM, Staff A was observed cleaning and disinfecting Dialysis Station #7, after it had been used for a patient’s treatment. Staff A removed her gloves and did not perform hand hygiene. She then proceeded to obtain a pen and a piece of paper from her workstation, she then touched her computer and keyboard. Staff A then failed to perform hand hygiene prior to the donning of a pair of clean gloves. During a surveyor interview on 1/22/2025 at 1:36 PM with Staff A, she questioned which surveyor witnessed these observations and she was unable to explain why she did not follow the hand hygiene policy. During a surveyor interview with the Director of Dialysis Services on 1/23/2025 at approximately 2:35 PM, she was unable to explain why Staff A did not follow the hand hygiene policy. 41729”

“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: 41729 46539 Based on surveyor observation and staff interview, it has been determined that the facility failed to ensure the staff thoroughly disinfect all surfaces of the dialysis stations and treatment areas for 1 of 2 staff observed during cleaning and disinfection of the treatment areas, Registered Nurse (RN) Staff A. Additionally, it has been determined that the facility failed to ensure that the staff thoroughly disinfect multiuse equipment between Patients for 1 of 1 staff observed utilizing a multiuse stethoscope on an access site, RN, Staff B. Findings are as follows: 1. During a surveyor observation on 1/22/2025 at 10:55 AM of the patient treatment area, after the dialysis treatment was terminated and the patient had vacated the treatment area, RN, Staff A, was observed cleaning and disinfecting Station #7. Staff A failed to clean the TV and the counter. During a surveyor interview on 1/22/2025 at approximately 1:30 PM with Staff A, she acknowledged that she did not clean the counter or the TV after the dialysis treatment was terminated, and the patient had vacated the station. 2. Record review revealed Patient ID #1 was admitted to the facility with a diagnosis of end stage renal disease and is receiving hemodialysis (a procedure where a dialysis machine and a special filter called an artificial kidney are used to clean the blood) three times a week. A surveyor observation on 1/22/2025 at 12:42 PM revealed Staff B at Station #9 assisting Staff A attempting to insert the needles into Patient ID #1’s access site. Staff B auscultated (the medical practice of listening to internal sounds of the body with a stethoscope) the insertion site which had been bleeding, with her stethoscope and then placed the stethoscope around her neck without disinfecting the stethoscope prior to leaving Station #9. During a surveyor interview on 1/22/2025 at 12:50 PM with Staff B, she acknowledged that she utilizes a multiuse stethoscope and that she had completed her assessment at Station #9. She also acknowledged that she did not disinfect her stethoscope after it was used on Patient ID #1’s access site. Staff B then proceeded to disinfect her stereoscope after it was brought to her attention by the surveyor. During a surveyor interview with the Director of Dialysis Services on 1/23/2025 at approximately 2:35 PM, she revealed that she would expect staff to clean the dialysis station and treatment areas including the TV’s and counters. Additionally, she revealed that she would expect staff to disinfect their stethoscopes after they have been utilized on a patient.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 47279 Based on surveyor observation, record review, and staff interview, it has been determined that the facility failed to ensure that the pHoenix XL Meter (a tool used for independent verification of dialysate [a solution used during dialysis to help maintain the body’s electrolyte balance] conductivity and pH [a measure of acidity]) was properly calibrated (the process of a comparison of a device with unknown accuracy to a solution with a known, accurate standard to eliminate any variation in the device being tested) prior to daily use for 2 of 2 meters reviewed. Findings are as follows: Review of a facility policy titled, “Phoenix Meter Usage” last reviewed on 5/2022, states in part, “...TESTING EQUIPMENT REQUIRED...Phoenix Meter...Calibration...Solutions...14.0 ms [milli Siemens; a unit of conductivity measurement]/cm [centimeter] Conductivity...7.0 pH...The conductivity reading of the phoenix meter(s) shall be verified to be + or - [plus or minus] 0.1 ms/cm...The pH reading of the phoenix meter(s) shall be verified to be + or - 0.1 pH unit compared to a pH control solution...The pH and conductivity readings from each Phoenix meter of the control solutions shall be recorded in the Phoenix Meter Daily Log sheet for that meter...Any meter, which reads outside of the acceptable limits for either pH or conductivity, compared to the control solutions, must not be used to verify dialysate of the dialysis machines, but shall be temporarily removed from service. That meter must be recalibrated, and verified to read the control solutions within acceptable limits before being returned to service. Any such calibration, and subsequent verification, shall be recorded on the Phoenix Meter Daily Log sheet for that meter...” Review of the pHoenix XL User Guide dated 2019 revealed, the manufacturer recommends that users verify meter values against the control solutions daily and calibrate the meter when the verifications are out of tolerance. Additionally, the daily verifications and calibrations are to be 14.0 mS and 7.0 pH. Review of the documents titled, “Phoenix Meter Daily Log” revealed, the conductivity and/or pH readings compared to the control solutions were not within an acceptable range per the manufacturer’s guidelines and the facility policy. Additionally, there were no calibrations performed on the following dates: Meter 1: -9/2/2024 7.3 pH, 14.2 mS -9/4/2024 13.8 mS -9/12/2024 7.2 pH -9/13/2024 14.4 mS -9/16/2024 14.5 mS -9/27/2024 7.4 pH, 14.2 mS -9/28/2024 7.2 pH -10/5/2024 7.2 pH, 14.2 mS -10/18/2024 7.2 pH, 14.6 mS -10/24/2024 13.8 mS -10/25/2024 7.2 pH, 13.8 mS -10/26/2024 13.8 mS -10/28/2024 7.2 pH, 14.7 mS -10/30/2024 13.8 mS -10/31/2024 13.8 mS -11/7/2024 7.2 pH, 14.3 mS -11/12/2024 14.2 mS -11/14/2024 7.3 pH, 14.2 mS -11/18/2024 14.4 mS -11/22/2024 7.3 pH, 14.4 mS -11/23/2024 14.4 mS -11/27/2024 7.4 pH, 14.4 mS -11/29/2024 7.3 pH -12/4/2024 7.2 pH, 14.4 mS -12/5/2024 14.2 mS -12/6/2024 7.2 pH, 14.4 mS -12/9/2024 7.4 pH -12/11/2024 14.4 mS -12/12/2024 7.2 pH, 14.3 mS -12/13/2024 7.2 pH, 14.3 mS -12/17/2024 7.2 pH, 14.2 mS -12/21/2024 7.2 pH -12/22/2024 7.2 pH -12/23/2024 7.2 pH, 14.2 mS -12/24/2024 7.4 pH, 14.2 mS -12/29/2024 7.2 pH, 14.2 mS -12/31/2024 7.2 pH -1/4/2025 7.2 pH, 14.2 mS -1/7/2025 7.2 pH, 14.3 mS -1/8/2025 7.2 pH, 14.2 mS -1/11/2025 14.2 mS -1/18/2025 7.2 pH -1/22/2025 14.6 mS Meter 2: -9/2/2024 7.4 pH, 14.4 mS -9/4/2024 13.8 mS -9/5/2024 13.8 mS -9/13/2024 14.4 mS -9/16/2024 7.2 pH, 14.5 mS -9/27/2024 7.3 pH, 14.2 mS -9/28/2024 7.2 pH, 13.8 mS -10/5/2024 7.3 pH, 14.4 mS -10/7/2024 7.2 pH, 14.2 mS -10/18/2024 7.4 pH, 14.5 mS -10/19/2024 7.2 pH -10/24/2024 13.8 mS -10/25/2024 13.8 mS -10/28/2024 7.4 pH, 14.5 mS -10/31/2024 13.8 mS -11/1/2024 14.2 mS -11/14/2024 7.2 pH -11/18/2024 7.2 pH, 14.4 mS -11/22/2024 7.2 pH, 14.3 mS -11/23/2024 7.2 pH, 14.3 mS -11/26/2024 14.2 mS -11/27/2024 7.2 pH -12/4/2024 7.5 pH, 14.2 mS -12/6/2024 7.3 pH -12/7/2024 7.3 pH -12/11/2024 7.3 pH, 14.4 mS -12/12/2024 7.3 pH, 14.2 mS -12/13/2024 7.4 pH -12/17/2024 7.5 pH, 14.2 mS -12/21/2024 7.4 pH, 14.3 mS -12/23/2024 7.3 pH, 14.2 mS -12/24/2024 7.2 pH, 14.4 mS -12/29/2024 7.3 pH, 14.4 mS -12/31/2024 7.3 pH, 14.5 mS -1/2/2025 7.2 pH -1/4/2025 7.2 pH -1/7/2025 7.2 pH -1/8/2025 7.2 pH -1/11/2025 7.2 pH -1/13/2025 7.2 pH -1/14/2025 7.3 pH, 14.2 mS -1/18/2025 7.2 pH -1/22/2025 14.2 mS Additional review of the “Phoenix Meter Daily Log” for January 2025 for meters 1 and 2 revealed the daily calibration for both devices were not completed on 1/23/2025. During a surveyor observation and simultaneous interview on 1/23/2025 at approximately 1:15 PM with the Certified Clinical Hemodialysis Technician (CCHT), Staff C, she indicated that she was responsible for verifying both meters with the control solutions on 1/23/2025 and acknowledged that nothing was documented. At the request of the surveyor, in the presence of a second surveyor, Staff C was asked to verify both meters using the control solutions. Meters 1 and 2 both registered with a pH of 7.2 and Staff C indicated that both meters required calibration and that she would inform the Director of Dialysis Services. During a surveyor interview on 1/23/2025 at approximately 2:15 PM with the Director of Dialysis Services, she acknowledged that the pH and conductivity levels on the above-mentioned dates required calibration of the meters and revealed that she was unaware that both pHoenix Meters verifications have been out of tolerance. Additionally, she revealed that she would expect staff to have notified her, so that the meters could be calibrated and/or she could contact the manufacturer.”

“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: 46539 Based on record review and staff interview, it has been determined that the facility failed to conduct periodic audits to assess the compliance of procedures for staff responsible for disinfection and quality mixing and testing of the water and dialysate (a solution used during dialysis to help maintain the body’s electrolyte balance) systems for 5 of 5 staff reviewed, Staff A, B, C, D, and E. Findings are as follows: Record review failed to reveal evidence any audits were completed during the 2023 and 2024 calendar years for Staff A, B, C, D, and E that includes, but is not limited to, conducting water and dialysate testing, dialysate mixing, dialysate pH (a measure of acidity), and conductivity testing at the point of use. During a surveyor interview on 1/23/2025 at approximately 10:00 AM with the Director of Dialysis Services, she revealed that she does not conduct periodic audits of staff to assess compliance of procedures including the above-mentioned tasks.”

“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: 47279 Based on record review and staff interview, it has been determined that the facility failed to implement corrective actions when required for deviations in microbial (relating to or characteristic of a microorganism) and endotoxin (a toxin released by a living bacterial cell into its surroundings) levels during testing of bicarbonate solution (a solution used to maintain a patient’s blood acid-base balance) used during dialysis (a treatment that filters your blood through a machine when your kidneys can not) that are outside expected parameters for 2 of 6 opportunities reviewed. Findings are as follows: Review of a facility policy titled, “Water / Dialysate [a solution used during dialysis to help maintain the body’s electrolyte balance] Sampling” last revised 5/2022 states in part, “...It is extremely important all fluids contacting the patient’s blood are within AAMI [The Association for the Advancement in Medical Instrumentation] standards. Dialysate is one such fluid that is in direct contact with the patient’s blood and must be closely monitored. Treated water is a major component of dialysate, and therefore monitored as well. Routine testing of dialysate and treated water to determine endotoxin levels and microbial load is vital to ensure safe hemodialysis treatments for all patients...Frequency...Monthly...Random stations...” Review of two microbiology reports dated 9/6/2024 and 10/5/2024 indicate that there are minimum requirements for dialysis fluid used for dialysis microbial counts and endotoxin levels. Additionally, the reports indicate that the dialysis fluid should contain a total viable count of less than 100 Colony Forming Units per Milliliter (CFU/ML) and the action level for the total viable microbial count in the dialysis fluid shall be 50 CFU/ML. Further, the reports state, “...If these action levels are observed in the dialysis fluid, corrective measures shall be taken promptly to reduce the levels into an acceptable range...” Record review failed to reveal evidence of a facility policy that includes requirements to develop and implement a corrective action plan that ensures patient safety if water testing results are outside accepted limits or action levels. Additional review of the reports revealed that the bicarbonate fluid samples exceeded the action level of 50 CFU/ML on the following dates: - 9/6/2024, Station 4: 92 CFU/ML - 10/5/2024, Station 11: 112 CFU/ML Record review failed to reveal evidence that corrective actions were implemented to promptly to reduce the levels into an acceptable range to ensure patient safety. During a surveyor interview on 1/23/2025 at approximately 2:15 PM with the Director of Dialysis Services, she revealed that they do not have a policy on implementing corrective measures when microbiology and endotoxin action levels are exceeded. She further revealed that routine microbiology testing is conducted monthly and is reviewed by herself and the Medical Director. Additionally, she revealed that corrective action measures are only implemented once levels exceed 100 CFU/ML and was unable to provide evidence of any corrective action measures implemented following the 9/6/2024 and 10/5/2024 reports that required corrective actions to promptly reduce the levels into an acceptable range. During a surveyor interview on 1/24/2025 at 9:08 AM with the Medical Director, he revealed that he is unaware of the what the facility’s protocol is for corrective action but would expect the staff to promptly re-culture the stations as soon as the reports were received.”

“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: 41729 Based on surveyor observation, record review, and staff interview, it has been determined that the facility failed to ensure that each patient’s vascular access site and bloodline connections (two tubes that are connected to the patient to clean the blood and return the blood to the patient) were able to be seen by staff throughout the hemodialysis treatment (a treatment that removes waste and excess fluid from the blood when the kidneys are not functioning to perform this task) for 6 of 6 patients observed receiving hemodialysis, Patient ID #’s 2, 3, 4, 5, 6 and 7. Findings are follows: 1. Record review revealed Patient ID #2 was admitted to the facility in September of 2014 with a diagnosis of end stage renal disease (ESRD) and is receiving hemodialysis (HD). 2. Record review revealed Patient ID #3 was admitted to the facility in March of 2023 with a diagnosis of ESRD and is receiving HD. 3. Record review revealed Patient ID #4 was admitted to the facility in September of 2016 with a diagnosis of ESRD and is receiving HD. 4. Record review revealed Patient ID #5 was admitted to the facility in September of 2022 with a diagnosis of ESRD and is receiving HD. 5. Record review revealed Patient ID #6 was admitted to the facility in June of 2021 with a diagnosis of ESRD and is receiving HD. 6. Record review revealed Patient ID #7 was admitted to the facility in May of 2019 with a diagnosis of ESRD and is receiving HD. A. During a surveyor observation on 1/22/2025 at 8:27 AM, Patient ID #s 2, 3, and 7 were receiving dialysis treatments and their vascular access sites and bloodline connections were not visible to the staff as they were fully covered with blankets. During a surveyor observation and interview on 1/22/2025 at 8:34 AM with Certified Clinical Hemodialysis Technician (CCHT), Staff D, she acknowledged that Patient ID #s 2, 3, and 7 were receiving dialysis treatments and their access sites and connections were unable to be seen by the staff. She further indicated that the access sites and connections should be visible to the staff at all times while receiving treatment. B. During a surveyor observation and interview on 1/22/2025 at 1:30 PM, Patient ID #s 4, 5, and 6 were observed receiving dialysis treatments and their vascular access sites and bloodline connections were not visible to the staff as they were fully covered with blankets. During a surveyor observation and interview on 1/22/2025 at 1:40 PM with CCHT, Staff F, she acknowledged that Patient ID #s 4, 5, and 6 were receiving dialysis treatment and their access sites and connections were unable to be seen by the staff. During a surveyor interview on 1/23/2025 at 2:40 PM with the Director of Dialysis Services, she revealed that she would expect that the patients’ access sites and connections are visible during the patients’ treatment.”

“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: 41729 Based on record review and staff interview, it has been determined that the facility’s Quality Assurance Performance and Improvement (QAPI) program failed to ensure that routine audits are completed at least annually of all staff conducting water and dialysate (an electrolyte solution) testing, dialysate mixing, dialysate pH (a measure of acidity), and conductivity testing (measures the electrical current a dialysis solution conducts) at the point of use. Additionally, the facility failed to review and monitor the daily pHoenix meter (a tool used for independent verification of dialysate [an electrolyte solution] conductivity and pH [a measure of acidity]) log for 2 of 2 reviewed, Meter 1 and 2. Findings are as follows: 1. Record review of the facility’s QAPI program failed to ensure that audits were completed at least annually during the 2023 and 2024 calendar years of the facility’s staff that includes, but is not limited to, conducting water and dialysate testing, dialysate mixing, dialysate pH, and conductivity testing at the point of care. During a surveyor interview on 1/24/2025 at 10:37 AM with the Director of Dialysis Services, she acknowledged that the facility’s QAPI program does not conduct audits of the staff at least annually, as required. 2. Record review of the facility’s monthly QAPI committee meeting data for the last 6 months revealed monthly QAPI meetings were held on the following dates, January 15, 2025, December 18, 2024, November 20, 2024, October 16, 2024, September 18, 2024 and August 21, 2024. Additional review of the monthly QAPI meeting data indicated that the daily pHoenix meter logs were being reviewed at the meeting. Record review failed to reveal evidence that the daily pHoenix meter logs were reviewed during the monthly meeting as evidenced by the facility’s failure to identify that both Meter and Meter 2’s conductivity levels were not within the manufactures recommended ranges for following months: A. Meter-1: - January 2025: 4 out of 18 opportunities for pH level and 5 out of 18 opportunities for conductivity level. - December 2024: 13 out of 27 opportunities for pH level and 11 out of 27 opportunities for conductivity level. - November 2024: 5 out of 26 opportunities for pH level and 7 out of 26 opportunities for conductivity level. - October 2024: 4 out of 27 opportunities for pH level and 8 out of 27 opportunities for conductivity level. - September 2024: 4 out of 25 opportunities for pH level and 5 out of 25 opportunities for conductivity level. B. Meter-2: - January 2025: 8 out of 18 opportunities for pH level and 2 out of 18 opportunities for conductivity level. - December 2024: 12 out of 27 opportunities for pH level and 9 out of 27 opportunities for conductivity level. - November 2024: 5 out of 26 opportunities for pH level and 7 out of 26 opportunities for conductivity level. - October 2024: 5 out of 27 opportunities for pH level and 7 out of 27 opportunities for conductivity level. - September 2024: 4 out of 25 opportunities for pH level and 7 out of 25 opportunities for conductivity level. During a surveyor interview on 1/24/2025 at 10:40 AM with the Director of Dialysis Services, she acknowledged that the pHoenix meters’ logs were not monitored monthly as indicated in the facility’s QAPI plan. She further acknowledged that the pHoenix meters’ logs revealed that the meters were not within the manufacturer’s recommended ranges for the above-mentioned months.”