Trinity Dialysis Clinic

“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: 53051 Based on observation, staff interviews, a review of facility Policies and Procedures (P&P), and a review of the Center for Disease Control and Prevention (CDC) Recommendations & Guidelines, it was determined that the Infection Control Committee failed to ensure that two of two nursing staff (Registered Nurse/Charge Nurse [RN/CN] and Licensed Practical Nurse [LPN AA]), and three of three Certified Clinical Hemodialysis Technicians (CCHT AA, CCHT BB and CCHT CC) observed, performed hand hygiene (washed hands or used an alcohol-based hand sanitizer), after removal of contaminated gloves, between glove changes, after touching contaminated equipment, between patients/patient care, after handling body fluids, and when leaving and entering the Patient Treatment Room. Failure to comply with these hand hygiene protocols significantly increased the risk for cross-contamination with the potential to expose patients and staff to bloodborne pathogens in the hemodialysis environment. Hemodialysis patients are particularly vulnerable because they are immunocompromised, leaving them at higher risk for infections. This deficient practice had the potential to negatively affect the health and safety of 15 of 15 patients (P) (P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, and P#16), who were undergoing hemodialysis treatment at the time of this observation, and seven of seven direct patient care staff (RN/CN, LPN AA, CCHT AA, CCHT BB, CCHT CC [an orientee-new to this facility], CCHT DD and CCHT EE), who were present during this observation. The facility census was 67. Findings include: During observation in the Patient Treatment Room on 1/12/26 between 10:23 a.m. and 12:34 p.m., the following was revealed: - There were 15 of 18 Stations (S) S1, S2, S3, S4 (in the Isolation 4), S5, S6, S7, S8, S9, S10, S11, S12, S13, S14, S15) being used, with 15 patients (P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, and P#16), undergoing hemodialysis treatment. - At 11:30 a.m., CCHT AA was observed placing an emesis bag (a plastic container used to collect vomit) near the mouth of P#2, while P#2 was vomiting during her treatment at S8. CCHT AA disposed of the emesis bag (dirty) in the red biohazard bin. Then without performing hand hygiene after glove removal, CCHT AA proceeded to enter data on a laptop (clean) that was on a mobile laptop table/desk. - At 11:35 a.m., CCHT AA put on a new pair of gloves without performing hand hygiene, to address the machine’s (dirty) alarm at S8 (dirty). CCHT AA removed her contaminated gloves, then without performing hand hygiene, CCHT AA returned to the laptop (clean) to continue her documentation. - At 11:39 a.m., CCHT AA silenced the machine’s alarm at S6. Then without performing hand hygiene between glove changes, she grabbed another pair of gloves and fetched a Bicart (a brand name for a dry sodium bicarbonate cartridge used in hemodialysis to help balance blood pH). CCHT AA connected the Bicart to the machine, still wearing the same gloves. After addressing the alarm, CCHT AA removed her contaminated gloves and without performing hand hygiene, CCHT AA continued documentation on the laptop. - At 11:41 a.m., CCHT BB was observed entering data on a laptop. Then without performing hand hygiene, CCHT BB put on a pair of gloves to set up the machine at S10. P#3 came in and sat in the chair at S10. CCHT BB removed her gloves and without performing hand hygiene, CCHT BB put on a new pair of gloves to check P#3’s blood pressure (BP). - At 11:43 a.m., CCHT BB took off her contaminated gloves, then without performing hand hygiene, she went to get an access pack (clean and sterile supplies needed for cannulation), for P#3. CCHT BB grabbed a new pair of gloves without performing hand hygiene, and proceeded access cannulation procedure for P#3. - At 11:46 a.m., CCHT BB removed her contaminated gloves, and without performing hand hygiene, she put on new pair of gloves to connect P#3 to the machine. - Between 11:48 a.m. and 12:00 p.m., LPN AA was observed coming back to the Patient Treatment Room without performing hand hygiene. - LPN AA was observed entering data on the laptop, then without performing hand hygiene, LPN AA put on a pair of gloves to silence the machine’s alarm at S2, then he removed his gloves and without performing hand hygiene, LPN AA continued his documentation on the laptop. - LPN AA was also observed entering the Isolation Room (S4) without first performing hand hygiene before putting on a pair of gloves, to attend to P#4 who was receiving treatment as an isolation patient for Hepatitis B (a serious liver infection caused by the Hepatitis B virus (HBV), that spreads through infected blood and bodily fluids. - At 11:47 a.m., RN/CN was observed leaving the Medication Preparation area, wearing gloves and holding a syringe filled with medication. She proceeded to S3, where she administered the medication through the lines but did not use any alcohol wipes to disinfect the port before administering the medication. RN/CN then removed her contaminated gloves without performing hand hygiene. - At 11:50 a.m., RN/CN, CCHT AA, and CCHT CC were wearing gloves without first performing hand hygiene, to assist P#5, who was seated at S9. All three staff then removed their gloves without performing hand hygiene after glove removal. - At 11:55 a.m., RN/CN was observed entering the Patient Treatment Room without performing hand hygiene and went to the Medication Preparation area, where she put on a pair of gloves and grabbed a syringe with medication and administered it to P#3 at S10. During staff interviews on 1/12/26 between 11:53 a.m. and 12:34 p.m., the following was revealed: - At 11:53 a.m., CCHT BB stated that she had not sanitized or washed her hands in between handling the machine and P#3. She explained that she had only changed her gloves and intended to perform hand hygiene after she had finished connecting P#3 to the machine. - At 11:57 a.m., CCHT AA stated that she had been sanitizing her hands in between glove changes. However, when asked which hand sanitizer she used, she then clarified that she hadn’t been using a hand sanitizer; instead, she had washed her hands. When reminded of the sequence of events that were observed when she didn’t perform hand hygiene, she acknowledged that it had been a mistake, and confirmed that she did not perform hand hygiene between gloves changes but she knew she was supposed to perform hand hygiene before and after every glove change. - At 12:06 p.m., LPN AA stated that he understood the importance of performing hand hygiene when returning to the Patient Treatment Room from outside. He also recognized that he must perform hand hygiene between glove changes, however, he acknowledged that he had not consistently followed these practices. He stated that he had made sure to wash his hands after exiting the isolation room. - At 12:08 p.m., RN/CN stated that she overlooked performing hand hygiene between glove changes or before putting on a new pair of gloves. She also stated that she understood the importance of performing hand hygiene when entering the Patient Treatment Room from outside. - At 12:34 p.m., the Facility Administrator (FA) stated that the direct patient care staff (nurses and patient care technicians) had recently completed hand hygiene in-service training within the past few weeks. She further stated that she would reinforce the training again and ensure that every overhead table was equipped with a hand sanitizer. A review of facility Policy #5-001, titled, “Infection Control for Dialysis Facility”, revised 03/23/2010, stated: Teammate Hygiene: 1. Hand hygiene is to be performed upon entering the facility, prior to gloving, after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients, even if the patient is casual, before touching clean areas such as supplies, and before leaving the patient care area physicians, allied health professionals, social workers and dietitian are to follow the same requirements for glove use and hand hygiene. 10. Gloves should be changed when: - When soiled with blood, dialysate, or other body fluids. - When going from a “dirty” area or task to a “clean” area or task. - When moving from a contaminated body side to a clean body side of the same patient. - After touching one patient or their dialysis delivery system and before arriving to care for another patient or touching another patient’s dialysis delivery system. According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal ...”

“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: 03383 Based on document review and staff interview, it was determined that the facility failed to ensure that the facility conducted exercises to test their Emergency Preparedness Plan (EPP) annually. This deficient practice had the potential to negatively affect the health and safety of all 62 hemodialysis patients who were under the care of this facility. Findings include: A review of the facility’s EPP revealed there were no documented evidences to show that the facility conducted annual exercises to test the facility’s emergency plan that is either community-based or individual, facility-based exercises. The Facility Administrator confirmed this observation on 7/18/24 at 4:30 p.m., and was unable to provide the missing documentary evidence during the survey.”

“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: 03383 Based on observation, a review of Center for Disease Control and Prevention (CDC) recommendations, a review of facility Policies and Procedures, and staff interview, it was determined that the Infection Control Committee failed to ensure that three of three patients, (P), (P#7, P#8, and P#9) observed, sitting at Stations, (A6, B4, and C4), who held pressure to their access sites for hemostasis (stopping of the flow of blood after hemodialysis), performed hand hygiene (wash hands with soap and water or use an alcohol based hand sanitizer) after glove removal and prior to leaving the facility. This deficient practice had the potential for cross contamination and increased risk of infection that could affect all 62 hemodialysis patients who were dialyzing at this facility. Findings include: During observation in the Patient Treatment Room on 7/17/24 between 8:41 a.m. and 11:32 a.m., the following was observed: - P#7, P#8, and P#9, who were seated at Stations, (A6, B4, and C4) respectively, held pressure to their dialysis access sites and left the facility without performing hand hygiene. P#7, P#8, and P#9 were not reminded by the Direct Patient Care (DPC) staff (nurses and Technicians) to wash their hands nor were offered to use hand sanitizer after glove removal. - According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal. - A review of Facility Policy #5-001, titled, “Infection Control for Dialysis Facilities”, with last revision date of 7/20/21, stated: Hand hygiene is to be performed upon entering the facility, prior to gloving, after removal of gloves... before leaving the patient care area. The above findings were discussed with the Charge Nurse (CN) and the Facility Administrator (FA) on 7/18/24 at 4:30 p.m.”

“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: 03383 Based on observation and staff interview, it was determined that the facility failed to maintain a safe environment in one of one Patient Treatment Room, as evidenced by torn leather upholstery on three of 18 hemodialysis chairs at Stations (A3, A4, and A6). This failure could hinder effective cleaning and disinfection of the surfaces, thus had the potential for microbial growth and could negatively affect the health and safety of all patients who used these hemodialysis chairs during their hemodialysis treatment. Findings include: During observation in the Patient Treatment Room on 7/18/24 between 5:00 a.m. and 6:05 a.m., the following was observed: - The hemodialysis chairs at Stations (A3, A4, and A6), had torn upholstery ranging from approximately 2 inches to 8 inches in length and diameter, along the sides and top of the armrests, or on the seats, or on the back rests. - The Facility Administrator, who was present during the tour, confirmed the above findings on 7/18/24 at 5:06 a.m.”

“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: 03383 Based on observation and staff interviews, it was determined that the facility failed to ensure that two of nine patients, (P), (P#1, and P#10) observed, had their vascular access sites uncovered/visible to the Direct Patient Care (DPC)staff (Nurses and Patient Care Technicians), throughout their hemodialysis treatment, to ensure patient safety. This deficient practice could provide an opportunity for accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood), to P#1 and P#10. The facility census was 62. Findings include: During observation in the Patient Treatment Room on 7/17/24 at 10:43 a.m. and at 11:32 a.m., the following was revealed: - P#1, at Station C4, had his access covered by a blanket at 10:43 a.m. - P#10 at Station B1, had his access completely covered by a blanket at 11:32 a.m. - Both P#1’s and P#10’s dialysis access sites were not visible during their treatment. - This surveyor informed Patient Care Technician (PCT CC) about these covered accesses on 7/17/24 at 11:34 a.m. PCT CC stated that staff remind patients to leave access uncovered but patients complained of being cold and will not leave access uncovered. PCT CC uncovered access sites after being informed. The Facility Administrator (FA) was informed of and shown the above findings on 7/18/24 at 4:15 p.m. The Facility Administrator was unable to provide documentary evidence that patients were reminded by staff to keep their dialysis access uncovered, to ensure their safety during dialysis.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 03383 Based on a review of the facility’s Fiscal Year 2024 Quarterly Dialysis Facility Report (FY2024 QDFR), (DFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients), a review of facility records, and staff interview, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to track, trend, analyze, and develop plans of action to improve and sustain the facility’s Dialysis Adequacy, Anemia Management, Nutrition, Mineral Metabolism and Bone Disorder, and Vascular Access Management, for six of six months (December 2023 - June 2024) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of all 62 in-center hemodialysis (ICHD) patients who were receiving dialysis services at this facility. Findings include: A review of the FY2024 QDFR, (third quarter 2023), revealed that the facility was above the United States (US) threshold in: 1. Dialysis Adequacy (Kt/V less than (<) 1.2) - facility was 6.2%, whereas, US was 1.9% 2. Nutrition (Albumin <4.0) - facility was 51.0 %, whereas, US was 50.5% 3. Mineral Metabolism and Bone Disorder - (Phosphorus greater than (>) 7.0) - facility was 32 %, whereas US was 15.6 % and (Calcium Uncorrected > 10.2) - facility was 6.2 %, whereas, US was 1.1 % 4. Anemia - (Hemoglobin <10.0) - facility was 58.6 %, whereas, US was 23.4 % 5. Vascular Access - (Long-Term Catheter Rate) - facility was 92.9 %, whereas, US was 17.2 % In Comparison, a review of the facility’s last six months of QAPI meeting minutes from December 2023 - June 2024, (the Facility Administrator explained that the January and February QAPI meeting was combined), revealed the following outcomes that were greater than (>) the US threshold. Specifically, 1. Dialysis Adequacy - (the effectiveness of dialysis prescriptions to avoid symptoms of uremia measured by Kt/V - a number used to quantify hemodialysis treatments). The % of patients with Kt/V < 1.2 ranged between 3.13% (December) and 11.6% (in June). 2. Nutrition - (Albumin - protein in the blood needed to both maintain growth and repair tissues, and in dialysis, it helps with fluid removal). The % of patients with albumin <4.0 was 64.06 % (December) with the lowest at 45% in May but went back up to 63.33% in June. 3. Mineral Metabolism and Bone Disorder - The % of patients with Phosphorus >7.0 ranged between 24.59 % (lowest in April) and 35% (highest in May), then fluctuated down to 33.33% in June. Calcium Uncorrected >10.2 ranged between 4.69% (lowest in December) and highest both in May and June at 10% 4. Anemia - (Hemoglobin - a protein containing iron that facilitates the transport of oxygen in red blood cells). % of patients with Hemoglobin <10.0, ranged between 39.06 % (lowest in December) and highest at 59.02 % in April, and fluctuated down to 46.67 % in June. 5. Vascular Access - Long Term Catheter Rate, equal to or greater than (=/>) 90 days. The % of patients using a Central Venous Catheter (CVC) =/> 90 days ranged between 24.53 % (lowest in March) and 28.33 % (highest in June). Additionally, the facility’s QAPI meeting minutes from (December 2023 - June 2024) revealed no documentary evidence that the interdisciplinary team (IDT) conducted a comprehensive review of the above outcomes with appropriate action plans, root cause analysis, and follow-up evaluations to ensure and sustain improvement. The Facility Administrator stated on 7/17/24 at approximately 4:00 p.m., that the IDT will work toward improvement of these outcomes.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 03383 Based on a review of medical records and staff interview, it was determined that the medical director failed to ensure that two of three patients, (P), (P#4, P#6) sampled, who experienced high BP readings and one of one patient, (P#1), who experienced access pain during dialysis treatment, received medical care and supervision appropriate to patients’ dialysis needs. This deficient practice had the potential to negatively affect the health and safety of P#1, P#4, and P#6. The facility census was 62. Findings include:: #1: High Blood Pressure Readings: The Facility Administrator provided an undated Standing Order that was valid for all patients receiving treatment at the facility that included the following order: Hypertension: Give Clonidine 0.1 mg sublingual (S.L.) for systolic greater than 190 or diastolic greater than 110. May repeat x 1. Notify physician if BP remains elevated after 30 minutes following second dose. A review of P#4’s treatment flowsheets showed the following: On 7/2/24: - The initiation of P#4’s dialysis treatment began at 9:54 a.m. At 1:01 p.m. BP reading was 203/100 (mmHg) then went up to 203/98 at 1:15 p.m. and nurse was notified. At 1:27 p.m., BP reading was 215/110 and at 1:32 p.m. BP reading was 212/98. At the end of dialysis treatment patient complained of chest pain. The patient took home BP medication and was taken to the nearest hospital. There was a lack of interventions done for the elevated BP readings until patient complained of chest pain. On 7/4/24: - The initiation of P#4’s dialysis treatment began at 10:20 a.m. with a BP reading of 206/102 (mmHg), then continued to go up to 221/108 at 10:51 a.m. P#4 took home BP medication and BP reading improved at 195/108 at 10:55 a.m. BP readings between 11:27 a.m. and 1:50 p.m. ranged between 200/106 and 217/103. Post treatment BP was 202/93 at 1:52 p.m. and 199/96 at 1:54 p.m. There was a lack of documentary evidence that the nurse notified the physician of P#4’s high BP readings. There was a lack of interventions done for the elevated BP readings during dialysis treatment after the patient’s home dialysis medication was taken at 10:51 a.m. and BP continued to be elevated and exceeded parameters per Standing Order for hypertension. On 7/11/24: - P#4’s BP was 195/110 at 10:25 a.m. and went up to 229/118 at 10:56 a.m. The BP readings between 11:59 a.m. and 12:37 p.m. ranged between 200/92 and 216/120. At 1:26 p.m., the BP reading was 237/127. Post treatment BP at 1:57 p.m. was 229/120. There was a lack of documentary evidence that the nurse notified the physician of P#4’s high BP readings. The Patient Care Technician (PCT DD), did not notify the nurse about elevated BP readings until 12:31 p.m. There was a lack of interventions done for the elevated BP readings during dialysis treatment other than readjusting BP cuff and rechecking BP readings. BP readings continued to be elevated and exceeded parameters per Standing Order for hypertension. The record does not show interventions prior to patient leaving the facility with BP of 229/120 post dialysis. P#4’s Plan of Care dated 3/1/24 revealed that P#4 had a history of Cerebro-Vascular-Accident (CVA-stroke) two years ago and hypertension was not well controlled. - A review of P#6’s treatment flowsheets showed the following: On 6/29/24: - Pre-treatment blood pressure (BP) reading was 227/137 and pulse (P) was 108 at 6:26 a.m. The initiation of P#6’s dialysis treatment began at 6:44 a.m. with a BP reading of 223/131 and P was 104. The BP readings between 7:15 a.m. and 10:45 a.m., fluctuated between 182/101 and 224/114. Post treatment BP was 209/121 at 10:47 a.m. There was a lack of documentary evidence that the nurse notified the physician about P#6’s high BP readings nor documentation of interventions done for the elevated BP readings. On 7/1/24: - Pre-treatment blood pressure (BP) was 212/130 at 6:15 a.m. The initiation of P#6’s dialysis treatment began at 6:44 a.m. with a BP reading of 213/119. The BP readings between 7:17 a.m. and 10:48 a.m. ranged between 208/124 (lowest at 10:26 a.m.) and 234/130 (highest at 7:48 a.m.). Post treatment BP was 219/116 at 10:50 a.m. There was a lack of documentary evidence that the nurse notified the physician about P#6’s high BP readings, nor documentation of interventions done for the elevated BP readings during dialysis treatment. The above findings were discussed and reviewed with the Charge Nurse (CN) and the Facility Administrator on 7/18/24 at 8:30 a.m. Additionally, P#6 was currently in the hospital during the survey. #2: Access Pain During an observation on 7/17/24 at 10:43 a.m., P#1 yelled out in pain and stated, “Don’t put the needles in the side [of access] when PCT (Patient Care Tech) CC inserted needle into AVF (arteriovenous fistula). PCT CC stopped insertion while patient continued to display facial grimacing and yelled out in pain. Three additional staff members arrived after the patient yelled out in pain and LPN JJ instructed PCT CC to remove the needle. P#1’s forehead was diaphoretic, and a cool compress was applied. Another PCT inserted needles and the patient tolerated it without yelling out or facial grimacing. During an interview on 7/17/24 at 11:15 a.m., PCT CC stated that this has happened before; the patient only trusts three staff to insert his needles; indicated she has inserted his needles before without any problems; but he goes through this [access pain during needle insertion] with other staff. During an interview with P#1 on 7/17/24 at 11:35 a.m., he stated with frustration that he had been on dialysis for 10 years and has had issues with his access over 10 years. “I had asked them not to stick me on the side [of access] but they kept doing it, it really hurts.” A review of P#1’s Treatment Flowsheet dated 7/17/24 showed that P#1 has a left upper arm AVF that was placed on 6/1/13. PCT CC nor LPN JJ did not document that P#1 experienced severe pain during needle insertion (which was observed by this surveyor). - P#1’s Plan of Care dated 7/17/24 did not address pain in the patient’s access during needle insertion and interventions to minimize or prevent pain from occurring. The above findings were discussed and reviewed with the Charge Nurse (CN) and the Facility Administrator on 7/18/24 at 7:16 a.m. The Facility Administrator confirmed that P#1’s Plan of care did not address access pain and P#1’s complaint of access pain experienced on 7/17/24, was not documented in any of P#1’s medical record and was not reviewed. The Facility Administrator also agreed that documentation and follow up must improve.”