Dialysis Direct - Oak Park

“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: 36774 Based on observation, document review, and interview, for 1 of 2 Patient Care Technicians (PCT/E #4) observed discontinuing dialysis treatment at L #2, the facility failed to ensure staff performed hand hygiene and changed gloves. 1. On 9/10/2025 between approximately 11:30 AM through 1:30 PM, an observational tour of the dialysis treatment area was conducted: - At approximately 12:55 PM, E #4 was wearing gloves on both hands while discontinuing dialysis treatment for Pt. #13 with a CVC (Central Venous Access) in Station #7. E #4 removed glove on E #4’s left hand, went to the nurse’s station, and took a 4 x 4 gauze from a box of gauzes with E #4’s ungloved left hand. Then, E #4 went back to station #7, put a glove on E #4’s left hand, and continued discontinuation of Pt. #13’s dialysis treatment. 2. On 9/11/2025, the facility’s policy titled, “Hand Hygiene Handwashing Policy Procedure” (10/2020) was reviewed and indicated, “... To provide guidelines for effective hand hygiene, in order to prevent transmission of bacteria... Policy... Notes: change gloves and discard after each patient contact... Perform hand hygiene after each glove removal...” 3. On 9/10/2025 at approximately 1:15 PM, findings were discussed with E #3 (Charge Nurse). E #3 stated that E #4 should have removed E #4’s gloves on both hands, performed hand hygiene, then don a new pair of gloves before continuing to perform discontinuation of the dialysis treatment.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 36774 Based on observation, document review, and interview, for 1 of 2 PCTs/Patient Care Technicians (E #4) observed discontinuing patients’ hemodialysis at L #2, the facility failed to ensure that E #4 was wearing appropriate PPE (personal protective equipment). 1. On 9/10/2025 between approximately 11:30 AM through 1:30 PM, an observational tour of the dialysis treatment floor was conducted. At approximately 12:55 PM, E #4 was observed discontinuing dialysis for Pt. #13 with a CVC (Central Venous Catheter). Although E #4 was wearing a face shield and mask, E #4’s nose was exposed. 2. On 9/10/2025, the facility’s policy titled, “Central Venous Catheter Care Policy” (8/2021) was reviewed and indicated, “... To provide guidelines for safe, aseptic hemodialysis treatment for the patient with a Central Venous Catheter ... PPE required for both initiation and termination of treatment: Masks for the patient and staff...” 3. On 9/10/2025 at approximately 1:15 PM, findings were discussed with E #3 (Charge Nurse). E #3 stated that mask should be covering the nose when discontinuing dialysis on a patient with CVC.”

“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: 48264 Based on document review, observation and interview, for 2 of 2 Patient Care Technicians/PCT (E #6 and E #7) at L #5 observed cleaning and disinfecting dialysis stations, the facility failed to ensure the dialysis stations (hemodialysis machine, treatment chair) were disinfected per facility’s policy. Findings include: 1. On 9/10/2025, the facility’s policy titled, “Cleaning and Disinfection of Medical Devices and Equipment” (revised 9/26/2024) was reviewed and included, “...Environmental surfaces shall be cleaned and disinfected after each patient use and at the end of the day. Environmental surfaces to be cleaned and disinfected include: Patient chair ...if equipped, the sides are to be opened in order to clean all potentially contaminated surfaces ...For each station ...disinfection of any equipment in the dialysis station may not begin until the patient has vacated the station ...”. 2. On 9/10/2025 between 9:15 AM and 11:10 AM, an observational tour at L #5 was conducted in the dialysis treatment area. The following was observed: -At approximately 9:45 AM, the PCT (E #6) was observed cleaning the dialysis station #3 after a patient’s treatment. E # 6 did not open the arms of the dialysis chair for cleaning/disinfecting. - At approximately 9:48 AM, the PCT (E #7) was observed cleaning the dialysis machine at station #6, while the patient remained in the chair. -At approximately 10:24 AM, the PCT (E #6) was observed cleaning the dialysis station #1 after a patient’s treatment. E #6 did not open the arms of the dialysis chair for cleaning/disinfecting. -At approximately 10:40 AM, the PCT (E #6) was observed cleaning the dialysis station #4 after a patient’s treatment. E #6 did not open the arms of the dialysis chair for cleaning/disinfecting. -At approximately 10:52 AM, the PCT (E #7) was observed cleaning the dialysis machine at station #7, while the patient remained in the chair. 3. On 9/10/2025 at approximately 10:55 AM, an interview was conducted with the Registered Nurse (E #8). E #8 stated that the arms of the dialysis chairs at stations 1, 3, and 4 have the ability to open and should be opened during cleaning/disinfecting of the stations. E #8 stated that the station should be cleaned after the patient has left the station.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 52591 Based on document review, observation, and interview, for 2 of 3 conventional dialysis locations (L#2 and L#3) observed regarding disinfection of Central Venous Catheter (CVC) ports (catheter access), the facility failed to ensure that the CVC ports were properly disinfected, in order to prevent catheter related infections. Findings include: 1. The facility’s policy entitled “Central Venous Catheter Care Policy” (8/16/2021) was reviewed on 9/11/2025. The policy required, “ ... antimicrobial agent Chlorhexidine (antiseptic) (should be applied) for 30 to 60 seconds; back and forth in a scrubbing motion from the exit site and allowed to dry for 30 seconds. If alcohol is used apply for 60 seconds in a bulls-eye pattern from exit site ...” 2. On 9/9/2025 between 11:30 AM to 1:30 PM, an observational tour of the dialysis treatment area at L#2 was conducted: - At approximately 12:55 PM, E#4 (Patient Care Technician/PCT) was observed disinfecting the two CVC ports with alcohol swabs during discontinuation of dialysis for Pt. #13. E #4 disinfected port #1 for 17 seconds and port #2 was disinfected for 11 seconds. 3. On 9/10/2025 between 9:30 AM and 12:15 PM, an observational tour of the dialysis treatment area at L#3 was conducted: - At approximately 9:55 AM, the Registered Nurse/RN (E#9) was observed disinfecting the two CVC ports with alcohol swabs during discontinuation of dialysis for Pt. #15. E #9 disinfected Pt#15’s CVC port #1 for 20 seconds and disinfecting the second port for 21 seconds. - At approximately 10:00 AM, E#9 was observed disinfecting the two CVC ports with alcohol swabs during discontinuation of dialysis for Pt. #16. E #9 disinfected the two CVC ports for 15 seconds. 4. On 9/9/2025 at approximately 12:20 PM, E#4 (PCT) was interviewed regarding the appropriate process of disinfecting the ports of a patient’s CVC. E#4 stated the facility educator had instructed E#4 to disinfect the CVC hub with chlorhexidine or alcohol for 30 seconds with a 20 second dry time. 5. On 9/10/2025 at approximately 10:10 AM, E#9 (RN) was interviewed regarding procedure for disinfection of CVC ports. E#9 stated “I always disinfect CVC hubs for 30 seconds. I believe that is our policy.””

“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: 52591 Based on observation, document review, and interview, for 2 of 3 conventional dialysis locations (L#3 and L#4) the Facility failed to ensure that pH (measures acidity/alkalinity) testing was completed before the initiation of patient dialysis treatment. Findings include: 1. On 9/10/2025, the manufacturer package insert for K100-0117 E-Z Chek 6.8 - 8.5 pH Test Strips use in testing the pH was reviewed. The insert indicated, “Directions ... 5. Briskly shake off excess solution. Compared test results to color scale on bottle between 5 and 10 seconds ...” 2. On 9/10/2025 between 8:45 AM and 12:30 PM, an observational tour of the dialysis treatment area at L#3 was conducted: - At approximately 9:05 AM, E#10 (Patient Care Technician/PCT) was observed conducting the pH testing of the dialysate prior to dialysis treatment for Pt. #5. E#10 was observed dipping the test strip into the dialysate sample, swishing the strip, and shaking the excess solution. E #10 immediately compared the strip without waiting 5 seconds to 10 seconds before reading the pH. 3. On 9/10/2025 between approximately 1:00 PM to 2:00 PM, an observational tour of the dialysis treatment area at L #4 was conducted. During the tour, there were two patients receiving dialysis treatments at L #4. The dialysate pH prior to initiation of dialysis treatment for the two patients were completed by E #11 and E #12. See interview under findings #5 regarding not following the manufacturer’s recommendation for checking dialysate pH. 4. On 9/10/2025 at approximately 9:30AM and 9:50 AM, E#10 (PCT) and E #9 (Charge Nurse at L #3) were interviewed regarding the proper procedure for conducting the pH testing. E#10 stated “I always read the pH immediately. I was unaware I had to wait 5 seconds to 10 seconds before reading the pH.” E#9 stated, “I always read the pH immediately after I dip the test strip and shake the excess, I was not aware of the requirement for waiting 5 to 10 seconds.” 5. On 9/10/2025 at approximately 1:30 PM, interviews were conducted with E #11 (Charge RN at L #4) and E #12 (PCT at L #4) regarding checking of the dialysate pH. E #11 and E #12 stated that after shaking the excess solution from strip, they immediately compare the strip to the bottle. E #11 and E #12 stated that they do not wait for 5 seconds to 10 seconds before reading the pH.”

“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: 36774 Based on observation, document review, and interview, for 1 of 2 intravenous pump (serial number 9080547FA) observed being used at L #3, the facility failed to ensure the equipment was maintained, as required by the user manual. Findings include: 1. On 9/10/2025 between approximately 9:00 AM through 12:15 PM, an observational tour of the dialysis treatment floor was conducted. During the time, Pt. #6 was observed receiving IDPN/PN (Intradialytic Parenteral Nutrition/Nutritional Supplement) via intravenous pump with serial number 9080547FA. The intravenous pump had a sticker indicating preventive maintenance due date of 6/23/2024 (more than a year past the due date). 2. On 9/11/2025, the document titled, “Intradialytic Parenteral Nutrition Manual” (undated) was reviewed and indicated, “... Servicing of Infusion Pumps... An inspection date is located on each pump. The pump needs to be returned and inspected annually...” 3. On 9/10/2025 at approximately 11:30 AM, findings were discussed with E #9 (Charge Nurse). E #9 stated that the nurse should be checking the date and call the manufacturer when maintenance schedule is due.”

“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: 36774 Based on observation, document review, and interview, for 1 of 6 patients (Pt. #3) observed receiving hemodialysis treatments at L #2, the facility failed to ensure that the dialysis access was visible. Findings include: 1. On 9/10/2025 between approximately 11:30 AM through 1:30 PM, an observational tour of the dialysis treatment area was conducted. Pt. #3 was observed receiving dialysis treatment. However, Pt. #3’s dialysis access was covered with blanket and not visible between 11:35 AM through 11:55 AM (20 minutes). During the time frame, no one was checking to ensure Pt. #3’s access site was visible. 2. On 9/11/2025, the facility’s policy titled, “Intradialytic Patient Observation, Assessment, and Monitoring During Treatment Policy” (8/2025) was reviewed and indicated, “... staff shall routinely monitor the patient’s response to hemodialysis treatment... Staff must be able to visualize each patient’s... vascular access site...” 3. On 9/10/2025 at approximately 11:35 AM, findings were discussed with E #3 (Charge Nurse) and E #5 (Pt. #3’s PCT/Patient Care Technician). E #3 and E #5 stated that dialysis access should be visible. E #3 stated that profuse bleeding may take within few minutes.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 36774 Based on document review and interview, for 3 of 12 patients’ (Pt. #4, Pt. #5, and Pt. #6) clinical records reviewed, the facility failed to follow the prescribed BFR (blood flow rate) of DFR (dialysate flow rate), to ensure that the dialysis prescription was evaluated. Findings include: 1. On 9/11/2025, the facility’s policy titled, “Intradialytic Patient Observation, Assessment, and Monitoring During Treatment Policy” (8/2025) was reviewed and indicated, “...Procedure: The dialysis staff shall be responsible for... performing patient assessment... The steps in this procedure shall be completed... as determined by the RN (Registered Nurse). 1. The following machine parameters shall be checked... Dialysate flow. Blood flow... All intradialytic checks and assessments will be recorded on the dialysis treatment flowsheet...” 2. On 9/11/2025, the clinical record for Pt. #4 was reviewed. On 7/21/2025, Pt. #4 was admitted with a diagnosis of ESRD (End Stage Renal Disease). The clinical record included a hemodialysis prescription for Pt. #4 with a DFR of 200 for 2.5 hours five times a week. The following were noted: - On 8/27/2025, Pt. #4 was dialyzed with a DFR of 167 from 10:03 AM through 12:30 PM (2 hours and 27 minutes) - On 8/28/2025, Pt. #4 was dialyzed with a DFR of 167 from 10:03 AM through 12:30 PM (2 hours and 27 minutes) - On 8/29/2025, Pt. #4 was dialyzed with a DFR of 167 from 10:40 AM through 12:40 PM (1 hours and 20 minutes) 3. On 9/11/2025, the clinical record for Pt #5 was reviewed. On 7/16/2025, Pt. #5 was admitted with a diagnosis of ESRD. The clinical record included hemodialysis prescription for Pt. #5 with a BFR of 350 for 3.5 hours three times a week. The following were noted: - On 8/25/2025, Pt. #5 was dialyzed with a BFR of 300 from 11:35 AM through 2:35 PM (3 hours) - On 8/29/2025, Pt. #5 was dialyzed with a BFR between 200 to 300 from 11:06 AM through 2:30 PM (2 hours and 24 minutes) - On 9/01/2025, Pt. #5 was dialyzed with a BFR between 295 to 300 from 11:05 AM through 2:00 PM (2 hours and 55 minutes) 4. On 9/11/2025, the clinical record for Pt. #6 was reviewed. On 2/07/2024, Pt. #6 was admitted with a diagnosis of ESRD. The clinical record hemodialysis prescription for Pt #6 with a BFR of 350 for 3.5 hours three times a week. The following were noted: - On 8/27/2025, Pt. #6 was dialyzed with a BFR of 300 from 6:30 AM to 9:30 AM (3 hours) - On 8/29/2025, Pt. #6 was dialyzed with a BFR of 330 from 7:00 AM to 9:30 AM (2 hours and 30 minutes) 5. On 9/11/2025, findings were discussed with E #1 (Area Manager). E #1 verified that the dialysis prescription was not being followed. E #1 stated that there should be documentation why the prescription was not followed including physician notification that prescription was not being met.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 36774 Based on document review and interview, for 3 of 12 patients’ (Pt.#3, Pt. #6, and Pt. #8) clinical records reviewed, the facility failed to ensure nursing reassessment of patient’s fluid volume was conducted after dialysis treatment. Findings include: 1. On 9/11/2025, the facility’s policy titled, “Pre-Dialysis Nursing Assessment” (10/2020) was reviewed and indicated, “The Dialysis Direct trained and qualified RN will complete and document a physical assessment of the patient prior to initiation of the treatment... Procedure: The assessment shall include an evaluation of the following... edema, including location and degree...” 2. On 9/11/2025, the facility’s policy titled, “Care and Assessment of Patient Post-Hemodialysis” (10/2021) was reviewed and indicated, “... Procedure: The dialysis RN shall be responsible for completing the post-hemodialysis nursing assessment...” 3. On 9/11/2025, the clinical record for Pt. #3 was reviewed. On 8/01/2025, Pt. #3 was admitted with a diagnosis of ESRD (End Stage Renal Disease). The following were noted: - On 8/27/2025, the nursing assessment before initiation of dialysis indicated that Pt. #3 had 1+ (slight pitting) edema on lower extremities. There was no nursing reassessment of Pt. #3’s edema after hemodialysis treatment. - On 29/2025, the nursing assessment before initiation of dialysis indicated that Pt. #3 had 2+ (moderate pitting) edema on lower extremities. There was no nursing reassessment of Pt. #3’s edema after hemodialysis treatment - On 9/01/2025, the nursing assessment before initiation of dialysis indicated that Pt. #3 had 1+ edema on lower extremities. There was no nursing reassessment of Pt. #3’s edema after hemodialysis treatment. 4. On 9/11/2025, the clinical record for Pt. #6 was reviewed. On 2/07/2024, Pt. #6 was admitted with a diagnosis of ESRD. The following were noted: - On 8/27/2025, the nursing assessment before initiation of dialysis indicated that Pt. #6 had 1+ facial edema. There was no nursing reassessment of Pt. #6’s edema after hemodialysis treatment. - On 8/29/2025, the nursing assessment before initiation of dialysis indicated that Pt. #6 had 1+ facial edema. There was no nursing reassessment of Pt. #6’s edema after hemodialysis treatment. 5. On 9/11/2025, the clinical record for Pt. #8 was reviewed. On 4/21/2025, Pt. #8 was admitted with a diagnosis of ESRD. The following were noted: - On 8/27/2025, the nursing assessment before initiation of dialysis indicated that Pt. #8 had 2+ edema on lower extremities. There was no nursing reassessment of Pt. #8’s edema after hemodialysis treatment. - On 8/29/2025, the nursing assessment before initiation of dialysis indicated that Pt. #8 had 2+ edema on lower extremities. There was no nursing reassessment of Pt. #8’s edema after hemodialysis treatment. - On 9/01/2025, the nursing assessment before initiation of dialysis indicated that Pt. #8 had 2+ edema on lower extremities. There was no nursing reassessment of Pt. #8’s edema after hemodialysis treatment. 6. On 9/11/2025, findings were discussed with E #1 (Area Manager). E #1 stated that when the RN identified presence of edema before initiation of dialysis, the RN should have a reassessment of patients’ edema after the dialysis treatment. E #1 stated that presence of edema would help identify patient’s needs for fluid management.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 48264 Based on document review, observation, and interview, for 2 of 4 (Pt. #17 and Pt. #18) patients observed with clamps at L #5, the facility failed to ensure that only one clamp was used at a time on a vascular access site after dialysis treatment. Findings include: 1. On 9/10/2025 the facility’s policy titled, “Use of Fistula Clamps Policy, Procedure” (effective 7/1/2021), was reviewed and included, “...2. Use only one clamp at a time ...”. 2. On 9/10/2025, approximately between 9:15 AM and 11:10 AM, an observational tour at L #5 was conducted in the dialysis treatment area. The following was observed: -At approximately 10:52 AM, a patient (Pt. #17) was at station #7 after dialysis treatment and had two clamps applied to the AV (arteriovenous) fistula on the right arm at one time. -At approximately 10:52 AM, a patient (Pt. #18) was at station #8 after dialysis treatment and had two clamps applied to the AV (arteriovenous) fistula on the right arm at one time. 3. On 9/10/2025 at approximately 10:55 AM, an interview was conducted with the Registered Nurse (E #8). E #8 stated that when clamps are utilized to achieve hemostasis (bleeding stops) after fistula needle removal, only one clamp should be used at one time, never double clamped. E #8 confirmed observation that Pt. #17 and Pt. #18 had two clamps placed to fistula access site at one time.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 48264 Based on document review and interview, for 8 of 12 patient’s (Pt. #3-Pt. #6, Pt. #9- Pt. #12) care plans reviewed, the facility failed to ensure the interdisciplinary team and patient completed and signed the care plan to demonstrate participation. Findings included: 1. The facility’s policy titled, ‘Patient Plan of Care Policy, Procedure (3/31/2017)’ was reviewed on 9/11/2025 and included, “...The plan of care shall be completed by the interdisciplinary team. ... The complete plan of care shall be signed by team members, including the patient ...”. 2. The clinical record for Pt. #3 was reviewed on 9/11/2025. Pt. #3 was admitted with a diagnosis of ESRD (End Stage Renal Disease/kidney failure) on 8/01/2025. The initial care plan dated 8/20/2025 was not signed by Pt. #3. 3. The clinical record for Pt. #4 was reviewed on 9/11/2025. Pt. #4 was admitted with a diagnosis of ESRD on 7/21/2025. The initial care plan dated 8/20/2025 was not signed by Pt. #4. 4. The clinical record for Pt. #5 was reviewed on 9/11/2025. Pt. #5 was admitted with a diagnosis of ESRD on 7/16/2025. The initial care plan dated 8/05/2025 was not signed by Pt. #5. 5. The clinical record for Pt. #6 was reviewed on 9/11/2025. Pt. #6 was admitted with a diagnosis of ESRD on 2/07/2024. Pt. #6 was identified as unstable on 8/05/2025. The care plan dated 8/05/2025 was not signed by Pt. #6. 6. The clinical record of Pt. #9 was reviewed on 9/11/2025. Pt. #9 was admitted on 11/02/2022 with a diagnosis of unspecified nephritic (related to the kidney) syndrome (inflammation of the kidney). An annual care plan dated 2/04/2025 was not signed by the physician. 7. The clinical record of Pt. #10 was reviewed on 9/11/2025. Pt. #10 was admitted on 6/18/2025 with a diagnosis of Type 2 diabetes mellitus with diabetic chronic kidney disease. An annual care plan dated 7/07/2025 was not signed by the physician. 8. The clinical record of Pt. #11 was reviewed on 9/11/2025. Pt. #11 was admitted on 4/15/2024 with a diagnosis of Type 2 diabetes mellitus with diabetic chronic kidney disease. An annual care plan dated 8/05/2025 was not signed by the patient or the physician. 9. The clinical record of Pt. #12 was reviewed on 9/11/2025. Pt. #12 was admitted on 5/13/2022 with a diagnosis of nephrotic syndrome (related to kidney filtering function). Two monthly care plans dated 4/03/2025 and 5/06/2025 was not signed by the patient or the physician. 10. During an interview on 9/11/2025 at approximately 12:30 PM, the Area Manager (E #1) reviewed the patient’s (Pt. #3-Pt. #6) care plans and confirmed the medical records lacked documentation of patient signature that indicated patient participation in care planning. 11. During an interview on 9/11/2025 at approximately 12:30 PM, the Area Manager (E #2) reviewed the patient’s (Pt. #9-Pt. #12) care plans and stated that the care plans (Pt. #9-Pt. #12) did not indicate physician review by signature and care plans (Pt. #11-Pt. #12) did not include documentation of patient signature to indicate care plan participation. E #2 stated that the nursing staff may have signed on behalf of the physician, however all patient care plans should be reviewed and signed by all members of the interdisciplinary team, including the physician and the patient. 12. During an interview on 9/12/2025 at approximately 9:15 AM, the Medical Director (MD #1) stated that all patient care plans should be reviewed and signed by the physician and the patient.”

“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: 52591 Based on observation, document review, and interview, for 2 of 3 conventional dialysis facilities (L#2 and L#3) observed regarding handling of medications, the facilities failed to ensure that the medications were kept secured, as required by policy. Findings include: 1. On 9/09/2025, an observational tour of the dialysis treatment area at L #2 was conducted between 11:30 PM and 1:30 PM. During the tour, a vial of multidose Heparin (blood thinner) and multiple vials of Mircera (medications for anemia) were seen unattended on top of the medication cart. 2. On 9/10/2025, an observational tour of the dialysis treatment area at L#3 was conducted between 8:45 AM and 12:05 PM: - The Registered Nurse (RN) (E#9) left an open multi-use vial of heparin unattended and unsecured on top of the medication counter. The vial of heparin was accessible to anyone who enters and exits the dialysis treatment area, while E#9 was away from the medication cart. - The medication refrigerator inside the water room containing vials of Heparin, Cathflow (used to dissolve blood clots) and Mircera was unlocked and accessible to the PCT (Patient Care Technician). 3. On 9/11/2025 facility’s policy titled “Medication and Supply Storage in the Long-Term Care Facility Policy and Procedure” dated 1/1/2025 was reviewed. The policy stated “... Medications not requiring refrigeration are to be secured in locked cabinets or drawers. Medications that require refrigeration are to be stored in a dedicated locked refrigerator in the dialysis treatment area.” 4. On 9/09/2025 at approximately 1:15 PM, an interview was conducted with E #3 (Charge Nurse at L #2). E #3 stated that the medications should be kept secured and locked. 5. On 9/10/2025 at 11:00 AM, E#9 (RN) was interviewed regarding the medication and security policy and procedure of the facility. E#9 stated that E#9 was aware of the policy to secure the medications in a locked cabinet. E #9 stated, “I got so busy I forgot to do it (secure medication)”.”

“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: 50702 Based on document review, observation, and interview, it was determined that for 1 of 2 staff observed at L#1(Charge Nurse E#3 and Patient Care Technician E#4), the facility failed to ensure that staff performed hand hygiene after removing gloves/contacting medical equipment/supplies in the patient care area. Findings include: 1. On 9/10/2024, the facility’s policy titled, “Hand hygiene Handwashing policy Procedure” (dated 12/01/2014) was reviewed and included, “All staff will use the hand-hygiene techniques, as set forth in the following procedure: ...After contact with medical equipment/supplies in patient areas, and after removing gloves.” 2: On 9/10/2024, between 9:00 AM and 11:45 AM, an observational tour of the dialysis treatment den at L #1 was conducted. The PCT (Patient Care Technician - E#4) adjusted the dialysis machine at station #5 with gloved hands. Then E#4 removed the gloves and started to type on the computer workstation in between station #4 and #5, without first performing hand hygiene. 3. On 9/10/ 2024 around 11:15 AM, an interview was conducted with the charge nurse (E#3). E#3 stated that E#4 should have performed hand hygiene after glove removal and between going from patient treatment to the workstation. E#3 stated that the workstation is considered a clean area.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 50702 Based on document review, observation, and interview, it was determined that for 2 of 2 Nursing Home facility staff observed transporting patients from the dialysis treatment area, the facility failed to ensure that staff wore personal protective equipment (PPE) when entering the treatment area, where patients were being disconnected from dialysis. Findings include: 1. On 9/11/2024, the facility’s policy titled, “Personal Protective Equipment [PPE] (dated 12/01/2014)” was reviewed, and included: “Staff shall wear personal protective equipment appropriate to the anticipated potential exposure. Staff shall wear PPE during the initiation and termination of dialysis treatment... for times when the spurting or spattering of blood, and body fluid might occur. At those times, staff must wear cover garment that provides an impervious barrier to fluids...” 2. On 9/11/2024 between 9:00 AM and 11:30 AM, an observational tour of the dialysis treatment area at L#3 was conducted. Two nursing home staff were observed entering the treatment area to transport patients at stations #1 and #6 out of the dialysis treatment area, and both staff were not wearing PPE. 3. On 9/11/2024 around 10:50 AM, an interview was conducted with the Charge Nurse (E#7) at L #3. E#7 stated that the nursing home staff [patient transporters] should have worn PPE in the dialysis treatment area during patient transportation.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 27125 Based on document review, observation and interview, it was determined that for 1 of 2 storage rooms at L#3, the facility failed to ensure that supplies were secure and stored off the floor to prevent contamination. Findings included: 1. The facility’s policy titled, “Equipment (4/2/2020)” was reviewed on 9/11/2024 and included, “Dialysis equipment when not in use must be stored in a safe and secure location.” 2. An observational tour of the dialysis storage area was conducted on 9/11/2024 at 10:30 AM at L#3. The storage room was down the hall outside of the dialysis area. The door had a key pad lock. However, the door was not locked, allowing access to anyone walking by. The storage room included a stock of boxes that were located directly on the floor. 3. During an interview 9/11/2024 at 11:00 AM, the nurse (E#7) stated, “The door should be locked to prevent unauthorized people from entering the room. All supplies are supposed to be off the floor.””

“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: 32741 Based on document review, observation and interview, it was determined that for 2 of 2 Patient Care Technicians (E #11 and E # 12) at L #2 observed cleaning and disinfecting dialysis stations, the facility failed to ensure the dialysis chair was disinfected, as required. Findings Include: 1. On 9/10/2024, the Facility’s policy titled, “Cleaning and Disinfection of Medical Devices and Equipment” (effective 9/29/2020) was reviewed and required, “...Environmental surfaces shall be cleaned and disinfected after each patient use and at the end of the day. Environmental surfaces to be cleaned and disinfected include: Patient chair, surfaces of dialysis equipment and adjacent tables and work surfaces...” 2. On 9/10/2024 between 8:30 AM and 11:35 AM, an observational tour at L #2 was conducted in the dialysis treatment area. The following was observed: -At approximately 9:35 AM, the Patient Care Technician (E #11) was observed cleaning the dialysis station #6 after a patient’s treatment. E # 11 did not clean/disinfect the dialysis chair at station #6. E #11 placed a blanket over the dialysis chair (without disinfecting the chair) in preparation for the next patient. -At approximately 10:30 AM, E #12 was cleaning dialysis station #2 after a patient’s treatment. E #12 did not disinfect the dialysis chair at station #2. E #12 placed a blanket over the dialysis chair (without disinfecting the chair) in preparation for the next patient. 3. On 9/10/2024 at approximately 11:15 AM, an interview was conducted with the E #12. E #12 stated that the dialysis chairs should be cleaned and disinfected after each treatment.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 2 of 7 patients (Pts. #1 and #6) reviewed for susceptibility to Hepatitis B (liver infection), the facility failed to ensure that Hepatitis B vaccine was offered and administered. Findings include: 1. The facility’s policy titled, “Vaccination Protocol Policy” (revised 3/17/2017) was reviewed and required, “...Hepatitis B vaccine is to be offered to all ESKD [end-stage kidney disease] patients whose HBsAb [hepatitis B surface antibody] < 10 mIU/mL [less than 10 milli-international units per milliter]...” 2. The clinical record for Pt. #1 was reviewed on 09/10/2024. Pt. #1 was admitted in October 2023 with a diagnosis of end-stage renal disease (ESRD). The Hepatitis B surface antibody results from 2023 and 2024 indicated that Pt. #1 was susceptible to Hepatitis B infection (results less than 10). The record included a signed Hepatitis B vaccination consent form, dated 10/13/2023, that indicated Pt. #1’s guardian consented to Pt. #1 receiving the vaccination series. A nurse’s note, dated 10/14/2023, included “[Pt. #1] was going back and forth to hospital, with unstable condition, hepatitis B vaccination was on hold due to unstable and poor general condition...” The record indicated that Pt. #1 was deemed unstable until February 2024. Physician notes between March 2024-June 2024, indicated that Pt. #1 was medically stable; however, the record lacked documentation that the vaccination was administered. 3. The clinical record of Pt. #6 was reviewed on 09/11/2024. Pt. #6 was admitted on 11/04/2022 with a diagnosis of ESRD. The Hepatitis B surface antibody results indicated that Pt. #6 was susceptible to Hepatitis B infection. The record included a signed consent form indicating that Pt. #6 consented to receiving Hepatitis B vaccination on 01/05/2024. The record lacked documentation that the vaccination was administered. 4. An interview was conducted with the Area Manager (E#2) on 09/11/2024, at approximately 3:45 PM. E#2 stated that staff must offer the vaccination within 30 days of admission. If the patient consents, the patient should start the vaccination series unless there is a contraindication or reason to hold. E#2 stated that Pt. #1 was unstable initially; however, in the months when the patient was documented as stable, E#2 stated that administration of the vaccine should have been revisited and discussed. E#2 stated that Pt. #6 consented to the vaccine in January 2024 but there was no record that the vaccine was administered or any documentation to show why it was not given.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 27125 Based on documentation review, observation and interview, it was determined that for 1 of 2 (E#8) staff observed cannulating (introduce a tube into a vein) an arteriovenous fistula (connection between an artery and vein), the facility failed to ensure that staff did not touch the site after prepping the site, potentially causing contamination. Findings included: 1. The facility’s policy titled, “Cannulation of an Arteriovenous Fistula [AVF] Policy, Procedure (3/2/2020)” was reviewed on 9/11/2024 and required, “Trained dialysis staff is responsible to prepare the access area and to use proper technique in cannulating the AV fistula. ... One area is prepared, do not palpate access unless a repeat prep is done.” 2. During an observation on 9/11/2024 at 10:15 AM at L#3, E#8 (PCT - patient care technician) was observed prepping the dialysis site at station #2. E#8 cleaned the site, placed E#8’s hand over the site to palpate and then cannulated the site. E#8 did not prep the area again after touching the site. 3. During an interview on 9/11/2024 at 10:18 AM, the nurse (E#7) stated that the site is now contaminated and needed to be cleaned again.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 32741 Based on document review, observation and interview, it was determined that for 4 of 5 Patient Care Technicians - PCTs - (E # 11 -L #2, E #12 -L #2, E #15 -L #4 and E #16 -L #4), the Facility failed to ensure that staff demonstrated knowledge of the Facility’s infection control practices for the disinfection of CVC (central venous catheter - used for dialysis access) insertion site for initiation of the dialysis treatment, as required. Findings include: 1. On 9/10/2024, the Facility’s policy titled, “Central Venous CV Catheter Care Policy, Procedure” (dated 8/16/2021) was reviewed and required, “Purpose - to provide safe, aseptic hemodialysis treatment for the patient with a central venous catheter...treatment initiation...Soak two 4 x 4 gauze pads in Alcavis (disinfectant). Scrub each catheter connection cap separately for 1 minute...” 2. On 9/10/2024 between 8:35 AM to 11:50 AM, an observational tour of the dialysis treatment area at L #2 was conducted. -At approximately 9:55 AM, a PCT (E #11) was observed disinfecting CVC hubs prior to connection at station #1. E #11 disinfected/scrubbed each catheter connection cap for 15 seconds, not for 1 minute, as required. -At approximately 11:45 AM, a PCT (E #12) was observed disinfecting CVC hubs prior to connection at station #4. E #12 disinfected/scrubbed each catheter connection cap for 10 seconds, not for 1 minute, as required. 3. On 9/11/2024 between 8:30 AM thru 11:55 AM, an observational tour of the dialysis treatment area at L #4 was conducted. -At approximately 10:30 AM, a PCT (E #15) was observed disinfecting CVC hubs prior to connection at station #7. E #15 disinfected/scrubbed each catheter connection cap for 10 seconds, not for 1 minute, as required. -At approximately 11:10 AM, a PCT (E #16) was observed disinfecting CVC hubs prior to connection at station #2. E #16 disinfected/scrubbed each catheter connection cap for 20 seconds, not for 1 minute, as required. 4. On 9/10/2024 at approximately 11:55 AM, an interview was conducted with E #11. E #11 stated that each catheter connection cap should be scrubbed/disinfected for 1 minute.”

“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: 50702 Based on the document review, observation, and interview, it was determined that for 1 of 5 dialysis treatment chairs observed in the dialysis treatment area at L #1 and 6 of 6 diaysis treatment chairs at L #2, the facility failed to ensure that chairs were maintained to allow effective cleaning/disinfection. Findings include: 1. On 9/10/2024, the facility’s policy titled, “ Cleaning and Disinfection of Medical Devices and Treatment Policy” (dated 12/01/2014) was reviewed and included, “Environmental surfaces shall be cleaned and disinfected after each patient use and at the end of the day ...Environmental surfaces to be cleaned and disinfected included: Patient chair...” 2. On 9/10/2024, between 9:00 AM and 11:50 AM, an observational tour of the dialysis treatment den at L #1 was conducted. The dialysis treatment chair at Station #1 was in disrepair: the chair had clear packing tape covering the entire length of both arms of the chair; clear packing tape was covering a tear in the material on the seat, and the material on the footrest was ripped and torn and was unable to be effectively disinfected. 3. On 09/10/2024, between 8:30 AM and 11:30 AM, an observational tour of the dialysis treatment area at L #2 was conducted. Six of 6 chairs were observed to have torn arm rests which were unable to be effectively disinfected due to tears in the surface material. 4. On 9/10/2024 around 10:10 AM, an interview with the Charge Nurse (E#3) at L #1 was conducted. E#3 stated that the dialysis treatment chair was from the nursing home facility and was used for patient transfer and dialysis treatment. E#3 also stated that E#3 has reported the condition of the chair to the management with several follow up emails, and made a request for a new treatment chair, but has not received any update/response.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 32741 Based on document review and interview, it was determined that for 1 of 10 (Pt #8 at L #2) clinical record reviewed for BFR (blood flow rate) and DFR (dialysis flow rate), the facility failed to monitor the BFR and DFR to ensure that the prescribed BFR was maintained for adequate hemodialysis. Findings include: 1. On 9/10/2024, the Facility’s policy titled, “Intradialytic Assessment and Monitoring Procedure” (dated 3/31/2017) was reviewed and indicated, “Facility shall routinely monitor the patient’s response to hemodialysis treatment and the accuracy of the machine functions...the following machine parameters shall be checked - dialysis flow and blood flow...” 2. On 9/10/2024, Pt #8’s dialysis treatment records (dated 8/20/2024 thru 9/7/2024) were reviewed and indicated: -Pt. #8 was admitted to the facility on 8/16/2024 with the diagnosis of end stage renal disease. -Pt #8’s hemodialysis prescription treatment order (dated 8/20/2024) included “BFR 400 and DFR 700.” -Pt #8’s treatment record dated 8/29/2024 noted BFR 350 (not the prescribed BFR 400). There was no documentation in Pt #8’s clinical record regarding the reason for not following the prescribed BFR. -Pt. #8’s treatment record dated 9/5/2024 noted DFR 600 (not the prescribed DFR 700). There was no documentation in Pt. #8’s clinical record regarding the reason for not following the prescribed DFR. 3. On 9/10/2024 at 9:00 AM, an interview was conducted with the Charge Nurse (E #10 -L #2). E #10 stated that each patient’s prescribed BFR and DFR should be followed.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 1 of 2 (Pt. #1) records reviewed for heparin (blood thinner) administration, the facility failed to ensure that heparin was administered according the police/procedure. Findings include: 1. The facility’s policy titled, “Anticoagulation During Dialysis Policy, Procedure” (approved 03/31/2017), was reviewed and required, “...Administer prescribed dosage and administer via venous needle or venous port of central venous catheter... Wait five (5) minutes for systemic effect to occur, then initiate hemodialysis treatment...” 2. The clinical record of Pt. #1 was reviewed on 09/10/2024. Pt. #1 was admitted in October 2023, with a diagnosis of end-stage renal disease. Dialysis prescription orders, dated 07/04/2024, indicated that Pt. #1 was ordered hemodialysis treatments 3 times per week on Tuesdays, Thursdays, and Saturdays. Physician’s orders for heparin, dated 05/13/2024, included “2000 units intravenously Tuesday, Thursday, Saturday bolus.” Treatment flowsheets from 08/20/2024 to 09/07/2024 were reviewed and included the following: - 08/22/2024: Treatment started at 5:48 AM; heparin bolus was administered at 6:39 AM, after treatment started. - 08/24/2024: Treatment started at 5:35 AM; heparin bolus was administered at 6:54 AM, after treatment started. - 08/27/2024: Treatment started at 5:59 AM; heparin bolus was administered at 6:21 AM, after treatment started. - 09/03/2024: Treatment started at 5:37 AM; heparin bolus was administered at 5:39 AM, after treatment started. - 09/05/2024: Treatment started at 5:30 AM; heparin bolus was administered at 7:03 AM, after treatment started. - 09/07/2024: Treatment started at 5:56 AM; heparin bolus was administered at 6:37 AM, after treatment started. 3. An interview was conducted with the Area Manager (E#2) on 09/11/2024, at approximately 3:45 PM. E#2 stated that heparin bolus should be given before starting hemodialysis treatment. E#2 stated that staff should wait 5 minutes after administration before starting the treatment.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 27125 Based on document review and interview, it was determined that for 1 of 2 (Pt. #5) patients care plans reviewed at L#3, the facility failed to ensure the interdisciplinary team completed and signed the care plan to demonstrate involvement. Findings included: 1. The facility’s policy titled, “Patient Plan of Care Policy, Procedure (3/31/2017)” was reviewed on 9/11/2024 and required, “The plan of care shall be completed by the interdisciplinary team. ... The complete plan of care shall be signed by the team members, including the patient.” 2. The clinical record of Pt. #5 was reviewed on 9/11/2024. Pt. #5 was admitted on 11/9/2021 with a diagnosis of end-stage renal disease. An annual care plan dated 4/17/2024 lacked completion by the registered nurse or physician. The care plan was not signed by the RN, physician or patient. 3. During an interview on 9/11/2024 at 2:00 PM, The lead social worker (E#6) stated that the care plan was not completed. E#6 stated, “The care plan was missed and the nurse and physician never finished it. We will add it on to the October schedule.””

“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: 39802 Based on document review and interview, it was determined that for 53 of 53 deaths between February 2024-July 2024, the facility failed to ensure that a mortality review was completed for each death in order to measure, analyze, and track for possible trends. Findings include: 1. The facility’s policy titled, “Quality Assessment and Performance Improvement (QAPI) Policy” (revised 7/1/2020), was reviewed and required, “Members of the QAPI Committee will be responsible for the implementation of comprehensive data collection, as well as monitoring and improvement activities including, but not limited to, measurement, evaluation, and analysis of the data related to the following items... Health Outcomes: Patient Survival...” 2. Monthly Quality Assessment and Performance Improvement (QAPI) Meeting Minutes from February to July 2024 were reviewed and included that there were the following number of deaths per month: - 5 deaths in February (1 Respiratory Failure, 2 Cardiac Arrest, and 2 Unknown Causes) - 13 deaths in March (1 Cardiac Arrest and 12 Unknown Causes) - 12 deaths in April (4 Cardiac Arrest, 1 Sepsis, 1 Hospice, 1 Fall, and 5 Unknown Causes) - 12 deaths in May (4 Cardiac Arrest, 1 Sepsis, 1 Hospice, 1 Fall, and 5 Unknown Causes). Per the Area Manager (E#2) on 09/12/2024, the minutes included the incorrect number of deaths in May (duplicated April’s deaths). The actual number of deaths was 10 including 7 Cardiac Arrest, 1 Pneumonia, 1 Hospice, and 1 Unknown Cause. - 7 deaths in June (4 Cardiac Arrest and 4 Unknown Causes) - 6 deaths in July (6 Unknown Causes) - The records lacked documentation that each death was analyzed for potential contributing factors. 3. An interview was conducted with the Area Manager (E#2) on 9/11/2024, at approximately 3:45 PM. E#2 stated that the social worker is responsible for trying to obtain the date and cause of death. E#2 stated that besides the number of deaths and the cause of death (if able to obtain), they do not analyze the deaths further to see if there were any contributing factors such as the patient’s most recent labs, if the patient had a recent infection/hospitalization, or if they missed any treatments.”