Univ Dialysis Ctr @ Auburn

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 52920 Based on document review and interview, the facility did not provide documentation that they had reviewed their emergency preparedness plan at least every two years, as required per regulation. This lapse could place patients at risk for untoward outcomes if an emergency were to occur. Findings include: -- Per review of facility’s policy and procedure (P&P) titled “Emergency Preparedness Planning,” reviewed 1/29/2025, the facility should “review the plan at least biennially and after each actual emergency.” -- Per review of the facility’s “Emergency Plan,” undated, there was no documentation that the plan had been evaluated and updated every two years. -- During interview of Staff A, Clinical Staff, on 8/26/2025 at 9:20 am, they acknowledged the above findings.”

“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: 52920 Based on document review and interview, the facility did not provide documentation that they had conducted exercises to test their emergency plan at least annually, as required per regulation. This lapse could place patients and staff at risk to be unable to safely respond to emergencies at the facility. Findings include: -- Per facility’s policy and procedure (P&P) titled “Emergency Preparedness Planning,” reviewed 1/29/2025, the facility should “hold exercises to rehearse emergency procedures required by the emergency disaster plan (EDP) and document these drills.” -- Per review of the facility’s log titled “Emergency Preparedness Plan,” undated, the last emergency drill was documented as completed in 2022. -- During interview of Staff A, Clinical Staff, on 8/26/2025 at 8:50 am, they acknowledged the above finding.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 49512 Based on observation and interview, clean supplies and equipment were stored in the patient hemodialysis treatment area. This could place patients and staff at increased risk of infection. Findings include: -- Per observation on 8/25/2025 at 8:40 am, during the Flash Tour, blood pressure cuffs and patient comfort wedge pads, not in use for patient care, were stored on the ledges in dialysis stations #2, #4, #6, #8, #9, #11, #12, and #13. These items were not cleaned between each patient. Staff B, Clinical Staff, acknowledged these findings at the time of observation. -- Per observation on 8/25/2025 at 3:00 pm, oxygen concentrators, not in use for patient care, were stored in dialysis stations #3, #5, #6, #8, #9, #10, and #12. These items were not cleaned between each patient. Staff C, Clinical Staff, acknowledged these findings at the time of observation. -- Per observation on 8/25/2025 at 3:30 pm, 2 boxes of unopened bottles of LiquaCel (ready to use liquid protein supplement), 1 box of unopened disposable drinking cups, and 1 box of unopened drinking straws were stored on the ledge in dialysis station #1. Staff C, Clinical Staff, acknowledged these findings at the time of observation.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 52920 Based on document review, observation, and interview, the facility did not ensure that regulated medical waste (RMW) was disposed of in compliance with New York State Codes, Rules, and Regulations Title 10 (10NYCRR) Part 70. Specifically, (1) syringes requiring disposal in a sharp’s container were disposed of in the regular trash container and (2) the facility did not ensure that RMW was properly stored after removal from patient care areas. Findings pertaining to (1) include: -- Per review of facility’s policy and procedure (P&P) titled, “Medical Waste Disposal,” last revised 2/2020, “Contaminated sharps shall be discarded immediately or as soon as feasible into containers that are closable, puncture resistant, leakproof, color-coded and labeled with a bio-hazard label.” -- Per observation, on 8/25/2025 at 9:05 am, retractable sharps were found in the regular trash. -- During interview of Staff A, Clinical Staff, on 8/26/2025 at 1:05 pm, they acknowledged these findings. Findings pertaining to (2) include: -- Per review of facility’s P&P titled “Medical Waste Disposal,” last revised 2/2020, “regulated medical waste containers are labeled with the facility’s address and then are stored in a separate storage area while awaiting pick-up.” -- Per observation on 8/25/2025 at 9:30 am, 6 cardboard containers of RMW were stored in the bulk storage area (where clean supplies were also kept), instead of the dedicated RMW storage room. -- During interview of Staff D, Non-clinical Staff, on 8/25/2025 at 9:30 am, they acknowledged the above 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: 49512 Based on document review, observation, and interview, in 4 of 4 observations, facility staff did not clean and disinfect the patient scale between uses per the facilty’s policy and procedure (P&P). These lapses could place patients and staff at risk for potential exposure to infection. Findings include: -- Per review of the facility’s P&P titled “Housekeeping,” reviewed 1/29/2025, the touch screen portion of the patient scale and rails (safety bar) will be wiped down with 1:100 bleach cloths or disinfectant wipes if touched by the patient. -- Per observation on 8/25/2025 at 9:40 am, a patient left Station #7 and independently weighed themselves after treatment. The patient touched the safety bars of the scale. The scale was not wiped down (cleaned and disinfected) by staff after patient use. -- Per interview of Staff B, Clinical Staff, on 8/25/2025 at 9:45 am, the scale should be cleaned after each patient use. Staff B acknowledged the finding at the time of observation. -- Per observation on 8/25/2025 at 9:55 am, a patient left Station #10 and independently weighed themselves after treatment. The patient touched the safety bars of the scale. The scale was not wiped down by staff after patient use. -- Per interview of Staff C, Clinical Staff, on 8/25/2025 at 10:00 am, the scale should be cleaned after each patient use. Staff C acknowledged the finding at the time of the observation. -- Per observation on 8/25/2025 at 3:10 pm, a patient left Station #6 and independently weighed themselves after treatment. The patient touched the safety bars of the scale. The scale was not wiped down (cleaned and disinfected) by staff after patient use. Staff B acknowledged the finding at the time of observation. -- Per observation on 8/25/2025 at 3:30 pm, a patient left Station #3 and independently weighed themselves after treatment. The patient touched the safety bars of the scale. The scale was not wiped down (cleaned and disinfected) by staff after patient use. Staff C acknowledged the finding at the time of the observation.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 32908 Based on document review and interview, (1) in 2 of 3 (Staff E and Staff F) personnel files, the facility lacked documentation that they performed annual Tuberculosis (TB) screening per New York Codes, Rules and Regulations. (2) In 2 of 3 (Staff E and Staff F) personnel files, the facility lacked documentation that they performed annual health assessments per New York Codes, Rules and Regulations. (3) In 1 of 3 (Staff E) personnel files, the facility lacked documentation indicating that annual infection control training was completed. Additionally, the facility lacked a policy and procedure (P&P) requiring staff to complete an annual TB screening and health assessment. These lapses could place staff and patients at risk of exposure to infection. Findings pertaining to (1) include: -- Per review of New York Codes, Rules and Regulations 751.6 (4) annual TB assessment shall include education, individual risk assessment, and follow-up tests as indicated. -- Review of Staff E’s personnel file, revealed a TB test was done 3/12/2024. There was no documentation of an annual TB screening assessment in 2025. -- Review of Staff F’s personnel file, revealed a TB test was done 2/19/2023. There was no documentation of an annual TB screening assessment in 2024 or 2025. Findings pertaining to (2) include: -- Per review of New York Codes, Rules and Regulations 751.6(5) an annual, or more frequent if necessary, health status reassessment is required to assure freedom from a health impairment which is a potential risk to the patients or might interfere with the performance of duties. -- Review of Staff E’s personnel file, (hired 3/11/2024), did not include documentation that an annual health assessment screening was completed in 2025. -- Review of Staff F’s personnel file, (hired 9/4/2023), did not include documentation that an annual health assessment screening was completed in 2024 or 2025. -- During interview of Staff A, Clinical Staff, on 8/26/2025 at 12:30 pm, they acknowledged these findings and acknowledged that the facility lacked a P&P on annual TB screening and annual health assessments. Findings pertaining to (3) include: -- Review of Staff E’s personnel file revealed they last completed “Infection Control” training on 5/30/2024 (15 months prior). Staff A, Clinical Staff, acknowledged this finding at the time of review.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 52920 Based on document review and interview, the facility did not collect bacteria cultures and endotoxin samples from the reverse osmosis (RO) system prior to weekly chemical disinfection of the RO system. Bacteria cultures and endotoxin samples must be collected prior to chemical disinfection of the RO system. Findings include: -- Per review of facility’s policy and procedure (P&P) titled “Non-patient Lab Requirements,” last revised 1/8/2020, “Product water sample(s) will be collected within 48 hours preceding the disinfection of the Reverse Osmosis (RO) Unit or RO distribution system and must be refrigerated immediately.” -- Per review of the facility’s “CWP Disinfection Log,” between 2/1/2025 and 8/25/2025, and “Culture/Endotoxin - Results by Equipment Log,” between 2/1/2025 and 8/25/2025, the facility was not completing monthly bacteria culture and endotoxin sampling of the RO system, prior to chemical disinfection of the RO system, for 5 out of 7 months: - The RO system was chemically disinfected on 2/4/2025 and the RO system was sampled for bacteria cultures and endotoxins on 2/6/2025. - The RO system was chemically disinfected on 3/4/2025 and the RO system was sampled for bacteria cultures and endotoxins on 3/6/2025. - The RO system was chemically disinfected on 3/31/2025 and the RO system was sampled for bacteria cultures and endotoxins on 4/3/2025. - The RO system was chemically disinfected on 6/2/2025 and the RO system was sampled for bacteria cultures and endotoxins on 6/3/2025. - The RO system was chemically disinfected on 7/7/2025 and the RO system was sampled for bacteria cultures and endotoxins on 7/8/2025. -- During interview of Staff D, Non-clinical Staff, on 8/25/2025 at 4:00 pm, they acknowledged the above findings.”

“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: 32908 Based on document review and interview, in 3 of 3 (Staff B, Staff E, and Staff F) personnel records reviewed, each lacked documentation of an Ishihara (a test to determine color blindness) test. This could lead to adverse patient outcomes. Findings include: -- Review of Staff B’s personnel file revealed it lacked documentation of a Ishihara test. -- Review of Staff E’s personnel file revealed it lacked documentation of a Ishihara test. -- Review of Staff F’s personnel file revealed it lacked documentation of a Ishihara test. -- During interview of Staff A, Clinical Staff, on 8/26/2025 at 12:30 pm, they acknowledged the above 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: 52920 Based on observation and interview, facility staff did not ensure proper ventilation requirements were met, per ASHRAE Standard 170, for the janitor’s closet in the bulk storage area. This is an exhaust ventilated space and requires a negative pressure relationship with adjacent rooms. Findings include: -- Per observation on 8/25/2025 at 11:00 am, the facility’s environmental services’ closet door did not have a self-closing device to ensure a negative-pressure air balance relationship between the environmental services closet and the adjacent bulk storage area. Per ASHRAE Standard 170 (2008) requirements, an environmental services closet must maintain a negative-pressure air balance relationship with adjacent spaces. -- Per interview of Staff D, Non-clinical Staff, on 8/25/2025 at 11:00 am, they acknowledged the above 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: 32908 Based on document review, observation, and interview (1) the facility’s emergency evacuation cart and code cart contained expired medications and supplies and the side drawers of the code cart were covered in dust. (2) Expired cleaning/disinfecting wipes and hand sanitizers were available for use in the treatment area. (3) Expired supplies were available for use in the isolation room and boxes of N 95 masks were improperly stored there. (4) Expired supplies were available for use in the point of care testing lab. (5) The specimen refrigerator temperature was not monitored daily. (6) Daily chemical and heat disinfection logs for hemodialysis machines were incomplete. These lapses could put patients at risk for infection. Findings pertaining to (1) include: -- Per review of the facility’s policy and procedure (P&P) titled “Medication Administration,” reviewed 1/29/2025, staff should check for expiration date by the manufacturer and, if opened, the vial/bottle should be checked for staff’s date/initials. Expired medications should be discarded. -- Per review of the facility’s document titled “DCI Code Cart Checklist,” undated, indicated the last time the code cart was checked was June 2025. -- Per observation on 8/25/2025 at 8:55 am, the side drawers of the code cart were covered in thick dust. -- Per observation on 8/25/2025 at 9:05 am, the following expired medications and supplies were in the code cart or emergency evacuation cart: - 1 Epinephrine auto injector, expired 7/2025 - 2 Solu-Cortef vials, expired 6/2025 - 7 10 milliliter (ml) Luer Lock syringes, expired 7/2025 - 2 60 ml Luer Lock syringes, expired 4/2023 - 4 Yankauer suction instruments, expired 9/2020 - 1 Vacutainer blood collection sets, expired 2/2016 - 2 15 gauge Safety Fistula needles, expired 7/2025 - 1 oxygen mask with 7 foot tubing, expired 6/2018 -- During interview of Staff A, Clinical Staff, on 8/26/2025 at 11:30 am, they acknowledged the above findings. Findings pertaining to (2) include: -- Per observation on 8/25/2025 at 8:20 am, the following expired supplies were in patient treatment areas: - 1 container of Sani Cloth Bleach Wipes, expired 4/2023 - 1 container of Sani Cloth Bleach Wipes, expired 6/2023 - 1 container of Sani Cloth Bleach Wipes, expired 1/2023 - 1 container of Sani Cloth Bleach Wipes, expired 4/2023 - 1 container of Sani Cloth Bleach Wipes, expired 4/2021 - 1 container of Sani Cloth Bleach Wipes, expired 11/2020 - 1 container of Purell Hand Sanitizer, expired 2023 -- During interview of Staff A, Clinical Staff, on 8/26/2025 at 11:30 am, they acknowledged the above findings. Findings pertaining to (3) include: -- Per observation on 8/25/2025 at 2:40 pm, the following expired supplies were in the isolation room: - 1 ChloraPrep swabstick, expired 10/2024 - 3 ChloraPrep swabsticks, expired 4/2025 -- 9 boxes of unused/new N 95 masks were improperly stored within the isolation room -- During interview of Staff A, Clinical Staff, on 8/25/2025 at 2:40 pm, they acknowledged the above findings. Findings pertaining to (4) include: -- Per observation on 8/25/2025 at 8:33 am, the following expired supplies were in the point-of-care testing lab: - 1 Bactec Lytic 10 Anaerobic culture vial, expired 5/13/2025 - 1 Bactec Plus Aerobic culture vial, expired 4/22/2025 -- During interview of Staff A, Clinical Staff, on 8/25/2025 at 10:15 am, they acknowledged the above findings. Findings pertaining to (5) include: -- Per review of the facility’s P&P titled “Lab Refrigerator Temperature Monitoring,” reviewed 1/29/2025, “a lab refrigerator temperature log will be kept and filled out daily except when the clinic is closed.” -- Per review of the facility’s specimen refrigerator temperature log titled “University Dialysis Center Refrigerator Temperature Log,” undated, only 6 days from 1/1/2025 - 8/25/2025 had a temperature of the specimen refrigerator recorded on the log. The dates that the temperatures were recorded were 1/1/2025, 1/23/2025, 1/24/2025, 1/27/2025, 1/30/2025, and 2/10/2025. -- During interview of Staff A, Clinical Staff, on 8/25/2025 at 10:15 am, they acknowledged the above findings. Findings pertaining to (6) include: -- Per review of the facility’s P&P titled “Heat Disinfection,” reviewed 1/29/2025, and “Phoenix Bleach Disinfection,” reviewed 1/29/2025, bleach disinfection of the Gambro X36 Phoenix machines must be completed daily, except for Saturdays, where a weekly heat disinfection must be completed at the end of the day. -- Per review of the technical manual for Gambro X36 Phoenix HD machines, dated 2009, a minimum daily disinfection, either chemical or heat, is recommended for the Gambro X36 Phoenix HD machines. -- Per review of the facility’s daily and weekly chemical and heat disinfection logs, dated between 7/2025 and 8/2025, for 4 Gambro X36 Phoenix hemodialysis (HD) machines logs included the following missing fields: - HD #C: Missing 1 day of daily chemical disinfection and next-day confirmation of negative chlorine test. - HD #D: Missing 1 day of next-day confirmation of negative chlorine test, after daily chemical disinfection and 1 weekly heat disinfection of the machine. - HD #E: Missing 4 days of daily chemical disinfection and next-day confirmation of negative chlorine test - HD #F: Missing 1 weekly heat disinfection of the machine. -- During interview of Staff D, Non-clinical Staff, on 8/25/2025 at 1:35 pm, they acknowledged the above findings.”

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 52920 Based on observation and interview, facility staff did not ensure the privacy and confidentiality of their patient’s personal information. Findings include: -- Per observation of the facility’s medical storage room, on 8/25/2025 at 9:00 am, there were filing cabinets containing patient information that were not secured from unauthorized access. -- During interview of Staff A, Clinical Staff, on 8/25/2025 at 4:00 pm, they acknowledged the above findings.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 46619 Based on document review and interview, the facility identified the possibility that their high rate of infiltrations (occurrences where the needle used to access the bloodstream during dialysis accidentally punctures the wall of the fistula or graft, allowing blood to leak into the surrounding tissues) could be related to staff’s technique, but did not take action to address this concerns. This lapse could place patients at increased risk for dialysis-related complications. Findings include: -- Per review of the facility’s policy and procedure (P&P) titled “Quality Assessment Performance Improvement (QAPI),” reviewed 1/29/2025, “the facility must trend any injuries or errors to identify the prevalence of occurrences, commonalities, and causes ... The QAPI committee should analyze both isolated and repeated events in their review. The intent of QAPI is to improve care ... If needed changes are identified, there should be evidence of action taken to implement those changes.” -- Per review of the document titled “February QAPI Data,” dated 3/26/2025, there were 2 infiltrations The facility documented that blood losses seem to be linked to a patient dislodging the needle and infiltrating their site due to movement during treatment. -- Per review of document titled “March QAPI Data,” dated 4/23/2025, there were two infiltrations documented during the month. The facility documented “all blood losses seem to be linked to a patient dislodging the needle or infiltrating their site due to moving during treatment. In most cases this was the venous part of the access. This could be due to poorly secured needles and/or cannulation technique. Plan made to review cannulation policy with team to make sure that accesses are being secured appropriately and to educate patients about access care during treatment.” Additionally, the facility documented they made contact with a Corporate Nurse about their increased number of blood losses this month, most of which were again linked to infiltration. The Corporate Nurse directed staff to information (a handout) that related to occurrence reporting. This handout was shared with facility staff. -- Per review of document titled “May QAPI Data,” dated 6/25/2025, there were 2 infiltrations documented for the month. -- Per review of document titled “June QAPI Data,” dated 7/31/2025, there was 1 infiltration documented for the month. Documentation indicated improvement noted in response to changes in reporting of blood loss. -- Per review of document titled “July QAPI Data,” dated 8/19/2025, there were 4 infiltrations documented. Documentation indicated improvement noted in response to changes in reporting of blood loss. -- Per review of “Occurrence Report,” covering from 2/25/2025 to 8/25/2025, there were 27 incidents that mentioned that a patient’s line had infiltrated: - There were 2 infiltrations reported in February. - There was 1 infiltration reported in March. - There were 6 infiltrations reported in April. - There was 1 infiltration reported in May. - There were 6 infiltrations reported in June. - There were 7 infiltrations reported in July. - There were 4 infiltrations reported in August. -- Per interview of Staff A, Clinical Staff, on 8/26/2025 at 12:30 pm, they (staff member responsible for staff education) were not aware of any plan to provide education to staff regarding cannulation techniques. They were not asked to address the number of infiltrations and were not aware of any action taken to provide education to staff regarding cannulation techniques. No evidence was provided during interview to explain the discrepancy between the numbers of infiltrations identified within the monthly QAPI data documents, as compared to the Occurrence Report. Staff A acknowledged these findings.”