Davita Fond Du Lac Dialysis

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 29963 Based on record review and interview, the facility staff failed to ensure Emergency Preparedness training was completed annually by 2 of 8 staff (Medical Director G and Registered Nurse F) personnel files/training records reviewed in a total of 8 current staff. Findings include: A review of facility’s policy titled, “Facility Emergency Management Plan,” last approved 04/2024 revealed, “Training and Education- Emergency Management Plan (EMP) 1. The FA, (Facility Administrator) or designee, is responsible to provide training of EMP: a. Teammates: ANNUALLY 1. Policy facility Emergency Management Plan 2. Appropriate hazard policies, per HVA (Hazards Vulnerability Assessment) 3. Clinic emergency policies 4. Facility specific emergency response procedures.” A review of the personnel files on 08/13/2024 at 7:00 AM revealed Medical Director G and Registered Nurse F did not complete annual emergency preparedness training within the past year. During an interview on 08/13/2024 at 11:18 AM, Manager of Clinical Services B confirmed that Medical Director G and Registered Nurse F had not completed the annual emergency preparedness training.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 29963 Based on interview, observation, and record review, the staff failed to restrict water room access to only the individuals responsible for monitoring and maintaining the system in 1 of 1 water room in a total sample of 1 water room observed. Findings Include: A review of facility’s policy #8-04-01 titled, “Physical Environment” last revised April 2018 revealed, “9. Systems to assure patient safety will be in place ... Access to patient treatment areas, water treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only.” During an observation of the water room of the dialysis facility on 08/12/2024 at 3:15 PM, the door to entry the water room was not locked. The handle on the door had the capability to be secured. During an interview with Manager of Clinical Services B on 08/12/2024 at 3:15 PM, Manager of Clinical Services B stated, “The water room door is expected to be locked at all times.””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 29963 Based on record review, observation, and interview, the facility staff failed to maintain a physical environment where surfaces are intact, clean, and free from damage to ensure patient safety in 1 of 4 areas observed (Patient Treatment Area), in a total sample of 4 areas observed. Findings Include: Review of facility’s policy #8-04-01 titled, “Physical Environment,” last revised April 2018 revealed, “2. The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public ... 5. The space for treating each patient will be sufficient to provide needed care and services, prevent cross contamination ...” During observations on 08/13/2024 at 1:00 PM, observed the entrance area leading into the patient treatment room. The scale used to weigh patients was in the hallway leading to the treatment area. There is a 3-inch black sticky residue on the floor surrounding the perimeter of the scale. A broken floor tile was also observed next to the scale. Observed in the treatment area a combination of black and white discoloration on the floor throughout the room. There were missing floor tiles noted under the dialysis chairs at stations #1 and #4. The paint was chipped off the walls between dialysis station #5 and #6 and stations #8 and #9, exposing the porous surface of the drywall. The baseboards surrounding the treatment area were discolored with white residue. During an interview with 08/13/2024 at 1:10 PM, PCT C stated, “The cleaning service comes in nightly, we’ve said something to them about cleaning better.” During an interview with Manager of Clinical Services B on 08/13/2024 at 1:50 PM stated, “They are aware of the damaged floor, there has been talk of the floor being replaced.””

“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: 29963 Based on record review and interview, the facility staff failed to ensure the administration of the pre-treatment Heparin bolus was at least 3 to 5 minutes prior to the initiation of dialysis, per facility policy, in 2 of 3 in-center hemodialysis patients (Patients #3, #4) with current active orders for Heparin boluses and failed to ensure the prescribed dose of Heparin was given to 1 of 3 in-center hemodialysis patients (Patients #3) with Heparin infusion orders in a total universe of 5 medical records reviewed. Findings include: A review of the facility’s policy #1-06-02 titled, “Anticoagulation,” last revised April 2024 revealed, “ ...Heparin is administered per physician’s order ...the initial loading dose of heparin is administered ...at least three (3) to five (5) minutes prior to the initiation of the hemodialysis treatment ...A heparin pump is used to deliver a constant infusion of heparin over the course of the hemodialysis treatment in order to avoid heparin fluctuations that occur with intermittent infections ...Post treatment, the following is documented: Total amount of heparin administered ...” Example of Heparin Bolus Not Administered Per Policy: A review of Patient #3’s current in-center hemodialysis orders revealed an order for 2000 units of Heparin bolus. A review of the treatment sheet dated 08/05/2024 revealed Patient #3’s dialysis was started at 6:46 AM. “Medications Administered” revealed the Heparin bolus was documented as given at 6:47 AM, 1 minute after the initiation of dialysis. A review of the treatment sheet dated 08/07/2024 revealed Patient #3’s dialysis was started at 6:37 AM. “Medications Administered” revealed the Heparin bolus was documented as given at 6:41 AM, 4 minutes after the initiation of dialysis. A review of the treatment sheet dated 08/09/2024 revealed Patient #3’s dialysis was started at 6:35 AM. “Medications Administered” revealed the Heparin bolus was documented as given at 6:40 AM, 5 minutes after the initiation of dialysis. A review of Patient #4’s current in-center hemodialysis orders revealed an order for 2000 units of Heparin bolus. A review of the treatment sheet dated 07/31/2024 revealed Patient #4’s dialysis was started at 6:26 AM. “Medications Administered” revealed the Heparin bolus was documented as given at 6:34 AM, 8 minutes after the initiation of dialysis. A review of the treatment sheet dated 08/05/2024 revealed Patient #4’s dialysis was started at 6:25 AM. “Medications Administered” revealed the Heparin bolus was documented as given at 6:30 AM, 5 minutes after the initiation of dialysis. During an interview on 08/13/2024 at 11:44 AM, the medical record review findings were discussed with and confirmed by Manager of Clinical Services B who stated that Heparin boluses should be administered 3 to 5 minutes prior to the initiation of dialysis. Example of Heparin Infusion Not Administered as Ordered: A review of Patient #3’s current in-center hemodialysis orders revealed an order for Heparin infusion of 500 units per hour for 210 minutes (3.5 hours). The total infusion dosage ordered was 1,750 units. The treatment sheet dated 07/30/2024 revealed Patient #3’s treatment ran for 211 minutes (3 hours and 31 minutes). Under medications administered on the “Treatment Details Report” flow sheet, 1,200 units of Heparin infusion was documented as administered, 550 units less than ordered. The treatment sheet dated 08/05/2024 revealed Patient #3’s treatment ran for 234 minutes (3 hours and 54 minutes). Under medications administered on the “Treatment Details Report” flow sheet, 1,200 units of Heparin infusion was documented as administered, 550 units less than ordered. The treatment sheet dated 08/07/2024 revealed Patient #3’s treatment ran for 211 minutes (3 hours and 31 minutes). Under medications administered on the “Treatment Details Report” flow sheet, 1,200 units of Heparin infusion was documented as administered, 550 units less than ordered. The treatment sheet dated 08/09/2024 revealed Patient #3’s treatment ran for 211 minutes (3 hours and 31 minutes). Under medications administered on the “Treatment Details Report” flow sheet, 1,200 units of Heparin infusion was documented as administered, 550 units less than ordered. During an interview on 08/13/2024 at 11:28 AM, the medical record review findings were discussed with and confirmed by Manager of Clinical Services B who stated, “It looks like the patient did not get the ordered dose of heparin.””

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 29963 Based on record review and interview, the facility staff failed to ensure blood pressure readings outside of ordered parameters were reported to the nurse for further assessment or the nephrologist, per policy, in 3 of 5 (Patients #1, #4, #5) in-center medical records reviewed and failed to ensure that nursing assessment documentation addressed patients leaving above or below 1 kilogram (kg) of their target weight in 2 of 5 (Patients #1, #5) in-center medical records reviewed in a total universe of 5 medical records reviewed. Findings include: A review of the facility’s policy #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised April 2024 revealed, “...Data collection includes but is not necessarily limited to ... Measurement of Blood Pressure (BP). Blood pressure...11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record...Abnormal Findings ...Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record ....Fluid Status: Post-treatment: If patient is above or below 1 kg from the target weight...Blood pressure-Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg. Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg.” Examples of Blood Pressures Out of Physician ordered Parameters: A review of Patient #1’s treatment sheet dated 08/09/2024 revealed, Patient Care Technician (PCT) D documented at 12:18 PM a blood pressure of 102/49, at 1:03 PM a blood pressure of 97/49 and at 1:04 PM a blood pressure of 99/46. There was no documentation of blood pressures being noted as outside of ordered parameters or notification of the Registered Nurse of the low diastolic blood pressures. A review of Patient #4’s treatment sheet dated 07/31/2024 revealed PCT J documented at 9:01 AM a blood pressure of 122/37. At 10:01 AM a blood pressure of 156/47 and at 10:31 AM a blood pressure of 142/41. There was no documentation of blood pressure being noted as outside of ordered parameters, a re-check of the blood pressure, notification of the Registered Nurse, that the Registered Nurse assessed Patient #4 following the low diastolic blood pressure. Treatment sheet dated 08/02/2024 revealed Patient Care Technician K documented at 7:31 AM a blood pressure of 135/46. Patient Care technician D documented at 7:37 AM a blood pressure of 133/56 and at 8:03 AM a blood pressure of 119/48. There was no documentation of blood pressure being noted as outside of ordered parameters, a re-check of the blood pressure, or notification of the Registered Nurse of the low diastolic blood pressure. Treatment sheet dated 08/05/2024 revealed Patient Care Technician C documented at 7:31 AM a blood pressure of 125/38. Patient Care Technician D documented at 8:05 AM a blood pressure of 102/41 and a blood pressure of 8:31 AM a blood pressure of 121/22. There was no documentation of blood pressure being noted as outside of ordered parameters, a re-check of the blood pressure, notification of the Registered Nurse of the low diastolic blood pressure. A review of Patient #5’s treatment sheet dated 08/02/2024 revealed, PCT D documented at 8:30 AM a blood pressure of 197/112, at 9:00 AM a blood pressure of 199/105 and at 10:00 AM a blood pressure of 186/103. There was no documentation of blood pressures being noted as outside of ordered parameters, a re-check of the blood pressure or notification of the Registered Nurse of the high diastolic and systolic blood pressures. During an interview on 08/13/2024 at 11:44 AM, the medical record review findings were discussed with and confirmed by Manager of Clinical Services B who stated, “If a blood pressure is out of parameters the Patient Care Technician should document that the blood pressure is noted to be outside of ordered parameters, the blood pressure should be re-checked immediately, and the registered nurse should be notified and complete an assessment. The assessment should be completed within 5 minutes and documented in the medical record.” 43264 Examples of Not Meeting Estimated Dry Weight: A review of Pt. #1’s current in-center hemodialysis orders revealed an EDW of 84.0 kilograms (kgs). The treatment sheet dated 07/29/2024 revealed Pt. #1’s post dialysis weight was documented as 90.5 kgs, 6.5 kgs over the EDW. There was no documented contact of the physician to report the patient leaving above the target weight. The treatment sheet dated 07/31/2024 revealed Pt. #1’s post dialysis weight was documented as 88.1 kgs, 4.1 kgs over the EDW. There was no documented contact of the physician to report the patient leaving above the target weight. The treatment sheet dated 08/02/2024 revealed Pt. #1’s post dialysis weight was documented as 87.2 kgs, 3.2 kgs over the EDW. There was no documented contact of the physician to report the patient leaving above the target weight. The treatment sheet dated 08/05/2024 revealed Pt. #1’s post dialysis weight was documented as 87.5 kgs, 3.5 kgs over the EDW. There was no documented contact of the physician to report the patient leaving above the target weight. Treatment sheet dated 08/07/2024 revealed Pt. #1’s post dialysis weight was documented as 85.6 kgs, 1.6 kgs over the EDW. There was no documented contact of the physician to report the patient leaving above the target weight. A review of Pt. #5’s current in-center hemodialysis orders revealed an EDW of 56.0 kgs. The treatment sheet dated 07/29/2024 revealed Pt. #5’s post dialysis weight was documented as 57.5 kgs, 1.5 kgs over the EDW. There was no documented contact of the physician to report the patient leaving above the target weight. Treatment sheet dated 08/09/2024 revealed Pt. #5’s post dialysis weight was documented as 57.9 kgs, 1.9 kgs over the EDW. There was no documented contact of the physician to report the patient leaving above the target weight. During an interview on 08/13/2024 at 11:15 AM, the medical record review findings were discussed with and confirmed by Manager of Clinical Services B who stated, “There should be documentation in the notes or post-assessment if weights are 1 kg above target weights.””

“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: 29963 Based on record review and interview, the facility staff failed to complete documentation of why physician orders were not followed for prescribed blood flow rates and/or dialysate flow rates for 3 of 5 in-center medical records reviewed (Patients (Pt.) #1, 2, and 5), and failed to contact the Nephrologist regarding shortened/early termination time and complete an “Against Medical Advice (AMA)” form, per policy, for 2 of 2 in-center hemodialysis patients (Pt. #1, #5) with shortened treatment times in a total universe of 5 medical records reviewed. Findings include: A review of the facility’s policy #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised April 2024 revealed, “ ...Intradialytic Data Collection/Assessment ...At a minimum, obtain and document the following ...Blood and dialysate flows ...If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed ...” A review of the facility’s policy #1-01-09 titled, “Prescribed Treatment Time Not Met,” last revised April 2024 revealed, “COMPLETION OF THE EARLY TERMINATION OF TREATMENT AGAINST MEDICAL ADVICE FORM. 1. The RN [Registered Nurse] will verify that a patient signs the ‘Early Termination of Treatment Against Medical Advice’ form any time the patient requests to terminate their treatment earlier than the prescribed run time...5. If the patient refuses to sign...the RN will document the patient’s refusal...B. PRESCRIBED TREATMENT TIME NOT MET 1. If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending Nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs...” Example of BFR/DFR not met: A review of Pt. #1’s medical record revealed a physician order for Blood Flow Rate (BFR) of 300 mL/min (milliliters per minute) and a DFR of 600 mL/min. The treatment sheet dated 07/29/2024 revealed the BFR was set at 350 mL/min for the first 1 hour of treatment. There was no documentation in the medical record for the reason the BFR was greater than the ordered rate. The treatment sheet dated 07/29/2024 revealed the Dialysis Flow Rate (DFR) was set at 650 mL/min for the first 30 minutes of treatment. There was no documentation in the medical record for the reason the DFR was higher than the ordered rate. The treatment sheet dated 07/31/2024 revealed the BFR was set at 350 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was greater than the ordered rate. The treatment sheet dated 08/05/2024 revealed the BFR was set at 350 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was greater than the ordered rate. The treatment sheet dated 08/07/2024 revealed the BFR was set at 350 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was greater than the ordered rate. The treatment sheet dated 08/09/2024 revealed the BFR was set at 350 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was greater than the ordered rate. A review of Patient #2’s medical record revealed a physician order for the blood flow rate of 350 mL/min. The treatment sheet dated 07/29/2024 revealed the BFR was turned down to 300 mL/min after 1 hour into the treatment and for the remainder of the treatment. There was no documentation in the medical record for the reason the BFR was lower than the ordered rate. A review of Pt. #5’s medical record revealed a physician order for the BFR of 350 mL/min and a DFR of 700 mL/min. The treatment sheet dated 07/31/2024 revealed the DFR was set at 660 mL/min after 1 hour and 30 minutes of treatment. There was no documentation in the medical record for the reason the DFR was lower than the ordered rate. The treatment sheet dated 08/05/2024 revealed the BFR was set at 300 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was lower than the ordered rate. During an interview on 08/13/2024 at 11:28 AM, the medical record findings were discussed with and confirmed by Manager of Clinical Services B who stated facility staff were “expected to document a reason for not meeting prescribed blood and dialysate flow rates.” 43264 Examples of Early Termination/AMA form not completed: A review of Pt. #1’s medical record revealed a physician order for the duration of dialysis treatment to be 3 hours and 15 minutes. The treatment sheet dated 07/29/2024 revealed a treatment time of 2 hours and 26 minutes (49 minutes short). The “Reason Rx [Prescribed] Tx [Treatment] Time Not Met” revealed, “...continues to cry and scream; disturbing other patients, ended treatment due to intense pain felt by patient.” There was no AMA form found or documentation that the patient’s attending Nephrologist was notified. A review of Pt. #5’s medical record revealed a physician order for the duration of dialysis treatment to be 3 hours and 30 minutes. The treatment sheet dated 07/29/2024 revealed a treatment time of 2 hours and 31 minutes (59 minutes short). There was no reason documented why the treatment time was shortened, no AMA form found, and no documentation that the patient’s attending Nephrologist was notified. The treatment sheet dated 08/05/2024 revealed a treatment time of 2 hours and 44 minutes (46 minutes short). There was no reason documented why the treatment time was shortended, no AMA form found, and no documentation that the patient’s attending Nephrologist was notified. During an interview on 08/13/2024 at 12:20 PM, the medical record review findings were discussed with and confirmed by Manager of Clinical Services B who stated that an AMA form “was expected to be completed and documentation why treatments are ending early” and Nephrologist notified if needed.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 43264 Based on record review, observation and interview, facility staff failed to assess and document patient vascular access for bruit and thrill after applying clamps for 1 of 1 patients (Patient (Pt.) #8), using a clamp for hemostasis (stopping blood flow) in a total sample of 2 patients observed for discontinuation of treatment with fistula or graft. Findings include: A review of facility’s policy titled, “POST DIALYSIS VASCULAR ACCESS CARE: FISTULA/GRAFT USING SAFETY FISTULA NEEDLES,” last approved 04/2023 revealed, “...11. If clamps are to be used, refer to procedure: Utilizing Vascular Access Clamps...17. Document findings and procedure in patient’s electronic health record...” A review of facility’s policy titled, “UTILIZING VASCULAR ACCESS CLAMPS,” last approved 04/2019 revealed, “...To provide guidance for utilizing vascular access clamps...6. During use, the thrill and bruit of the access will be checked above and below the clamp...” A review of facility’s policy titled, “UTILIZING VASCULAR ACCESS CLAMP PROCEDURE,” last approved 04/2023 revealed, “Procedure...After placement of the clamp, check for thrill and bruit above and below clamp. If thrill cannot be palpated or bruit heard, release clamp slightly and recheck until thrill can be palpated or bruit heard. Rationale: If thrill is not palpable or bruit heard, blood flow in the access is diminished and clotting of the access may occur...” During observation on 08/12/2024 at 10:12 AM, observed PCT D remove Pt. #8’s first needle and applied a clamp for hemostasis. PCT D did not auscultate Pt. #8’s fistula access for bruit after applying the clamp and was not observed palpating the access for thrill. At 10:21 AM, PCT D removed Pt. #8’s second needle and applied the clamp for hemostasis. PCT D did not auscultate Pt. #8’s fistula access for bruit after applying the clamp and was not observed palpating the access for thrill. A review of Patient #8’s treatment sheet dated 08/12/2024 revealed no documentation that clamps were used. During an interview on 08/13/2024 at 11:12 AM, Manager of Clinical Services B stated that the expectation is that if staff are using clamps “they should be checking for thrill and bruit and documenting - it should be a manual entry on the patient’s flowsheet.””

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 29963 Based on record review and interview the facility staff failed to document the follow up completed for 4 of 7 events (involving Patients #5, #6 (had 2 incidents) and #10) recorded on the Adverse Occurrence Log in the Risk Event Management (REM) Reporting System in a total universe of 7 events reviewed. Findings Include: A review of the facility’s policy #13-01-02 titled, “Risk Event Reporting Policy,” last revised July 2023, revealed, “ ...B. Handling Of The Risk Event Management (REM) Report by the Administrator/Manager or designee 1. The Facility Administrator/Manager or designee will receive an email notification that a Risk Event Management (REM) Report has been completed and submitted by a teammate. The Facility Administrator/Manager or designee will review the report for completeness... All additional information pertaining to the Risk Event will be entered in the “Event Reporting Follow Up” in the Risk Event Management (REM) Reporting System ...” A review of the facility’s adverse events log for the past 3 months was completed. The Adverse Occurrence log revealed 4 patient events involving 3 different patients. A review of the adverse event involving Patient #5 revealed a machine alarm for blood leak occurred during dialysis treatment on 05/22/2024. There was no follow-up documented regarding an investigation into the root cause of the event or what interventions were put in place in attempt to prevent incident from re-occurring. A review of the adverse event involving Patient #6 revealed Patient #6’s CVC (central venous catheter) was dislodged by the patient during treatment on 05/25/2024 while repositioning his/her blanket. There was no follow-up documented regarding an investigation into the root cause of the event or what interventions were put in place in attempt to prevent incident from re-occurring. A review of the adverse event involving Patient #6 revealed the blood lines clotted during treatment on 07/29/2024. There was no follow-up documented regarding an investigation into the root cause of the event or what interventions were put in place in attempt to prevent incident from re-occurring. A review of the adverse event involving Patient #10 revealed an infiltration during fistula access on 05/22/2024. There was no follow-up documented regarding an investigation into the root cause of the event or what interventions were put in place in attempt to prevent incident from re-occurring. During an interview on 08/13/2024 at 2:30 PM, when asked about the expectations of documentation of the follow up actions and resolution for REM’s, Manager of Clinical Services B stated the actions of the investigation and plan for resolution should be documented under the “follow up” tab in the REM documentation.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 29963 Based on record review and interview facility staff failed to ensure that quality data is tracked and analyzed to address issues with Infection Control for 1 of 1 dialysis program quality data reviewed (In-Center Hemodialysis), in a total sample of 1 dialysis program reviewed. Findings include: A review of policy #1-14-06 titled, “Continuous Quality Improvement Program” last revised April 2021 revealed, “ ...3. Written documentation and plans of action will be documented within the FHM (Facility Health Meeting) application known as Facility Health Record (FHR)...Copies of the QI (Quality Improvement) meeting minutes will be provided upon request to CMS (Centers for Medicare and Medicaid) ... 7. The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include...Infection Control, including ...Incidence of infections...” A review of the facility’s Quality Assessment and Performance Improvement Program with Manager of Clinical Services B revealed the quality program did not include documentation related to data regarding the incidence of infections other than blood-stream infections. A review of Infection Control log from 2024 revealed the following infections: -On 06/26/2024, +blood cultures- no other information was completed including if an antibiotic was ordered, of if a culture was completed and what organism was present. -On 05/06/2024, bloodstream UTI (Urinary Tract Infection)- no documentation if culture was completed. -On 04/20/2024, CVC exit site infection- no documentation if a culture was completed. -On 03/28/2024, pneumonia- no information was completed including if an antibiotic was ordered, or if a culture was completed and what organism was present. During an interview on 08/13/2024 at 1:45 PM, Manager of Clinical Services B stated, “The correct form is not being used to track facility infections.””