Davita Chilton Dialysis

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 47413 Based on record review and interview the facility staff failed to ensure all staff are trained in the Emergency Preparedness plan in 1 of 4 personnel files reviewed (Social Worker C) in a total sample of 4 personnel files reviewed. Findings Include: A review of facility’s policy #4-07-01 titled, “Facility Emergency Management Plan” last reviewed April 2024 revealed, “... that teammates will be trained annually and upon hire on the following: “1. Policy facility Emergency Management Plan...2. Appropriate hazard policies...3. Clinical emergency policies...4. Facility specific emergency response procedures.” A review of Social Worker C’s personnel file revealed no evidence of Emergency Preparedness training for the facility. During an interview on 09/19/2024 at 9:33 AM, the personnel file was reviewed with Manager of Clinical Services I who stated, “Emergency Preparedness training needs to be specific to each facility.””

“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: 29963 47413 Based on record review, observation and interview, the facility staff failed to perform glove changes and/or hand hygiene when moving from “dirty” to “clean” tasks while providing cares for 3 of 18 patients (Patients #5, 9, 12); failed to glove their hand when touching the dialysis machine while providing care for 2 of 18 patients (Patient #7, 11); and failed to ensure patients completed hand hygiene after glove removal and holding dialysis access sites until bleeding stopped for 2 of 2 patients (Patients #6, 7) observed holding access sites in a total universe of 18 observations of patient care. Findings Include: A review of the facility’s policy #1-05-01 titled, “Infection Control for Dialysis Facilities,” last revised April 2023 revealed, “1. Hand hygiene is to be performed ...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 contact is casual, before touching clean areas such as supplies...11. Teammates will wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station and will remove gloves and wash hands or perform hand hygiene between each patient and/or station...13. Gloves should be changed when ... going from a ‘dirty’ area or task to a ‘clean’ area or task...72. Gloves are to be removed and hand hygiene performed before and after touching the keyboard... 35. Patients are encouraged to wash their hands ...after treatment before leaving the treatment area ...” During an observation on 09/18/2024 at 9:10 AM, Patient Care Technician J discontinued dialysis on Patient #5 who had a CVC, removed bloodlines, did not remove “dirty gloves” or perform hand hygiene, and proceeded to touch the computer. During an observation on 09/18/2024 at 9:32 AM, Patient Care Technician D discontinued dialysis on Patient #11. Patient Care Technician J wrapped a glove around his/her finger to silence an alarm on the dialysis machine. During an observation on 09/18/2024 at 9:39 AM, Patient Care Technician D initiated dialysis on Patient #9. Patient Care J took off gloves and touched the keyboard on the computer without completing hand hygiene. During an observation on 09/18/2024 at 10:52 AM, Patient Care Technician J discontinued dialysis on Patient #7. Patient Care Technician J wrapped a glove around his/her finger to silence an alarm on the dialysis machine. During an observation on 09/18/2024 at 11:00 AM, Patient Care Technician J touched the dialysis machine during Patient #12’s dialysis treatment to silence an alarm, removed the glove and did not complete hand hygiene. During an observation on 09/18/2024 at 11:05 AM, Patient Care Technician J discontinued dialysis on Patient #7’s fistula. Patient #7 held access sites with his/her gloved hand, removed the glove, and left the treatment area without completing hand hygiene. During an observation on 09/18/2024 at 11:25 AM, Patient Care Technician J discontinued dialysis on Patient #6’s fistula. Patient #6 held access sites with his/her gloved hand, removed the glove, left the treatment area to obtain a weight without completing hand hygiene. During an interview on 09/19/2024 at 10:31 AM, the observation findings were discussed with Facility Administrator B who stated, “Gloves should be on their hands” when touching the dialysis machines and “staff should offer hand gel to the patients before leaving the dialysis station. Hand hygiene and glove changes should be performed.””

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 29963 Based on record review, observation and interview, facility staff failed to ensure that non-disposable items taken into the patient station (pH test strip bottle) were cleaned and disinfected following use in 1 of 2 observations of patient care (Patient #4) in a total of 2 observations of dialysis machine set up. Findings include: A review of the facility’s policy titled, “Infection Control For Dialysis Facilities,” last revised April 2023 revealed, “ ...14.) Non-disposable items are to be disinfected after each patient, prior to removal from treatment area/station and if contaminated between uses. use...” A review of the facility’s policy titled, “Testing pH For Acetate Based Dialysate Using RPC E-Z Check Test Strips,” last revised October 2020 revealed, “2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second OR Using a new syringe obtained dialysate sample from the sample port, then allow fluid to flow over the pad for one (1) second.” During an observation on 09/18/2024 at 8:06 AM, Patient Care Technician D was observed taking the pH test strip bottle into station #1 to check the pH of the final dialysate prior to Patient #4’s initiation of dialysis. Patient Care Technician D then returned the pH test strip bottle to the clean area without cleansing the exterior of the bottle. During an interview on 09/19/2024 at 10:26 AM, the observation findings were discussed with Facility Administrator B who stated the pH bottle should not be taken into the dialysis station.”

“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: 29963 Based on record review, observation, and interview, the facility staff failed to keep the bleach solution containers covered to ensure the bleach solution concentrations are maintained at the correct ratio for cleaning dialysis stations/supplies and failed to label the containers per policy in 2 of 2 mixed bleach containers in a total universe of 2 bleach containers observed. Findings Include: A review of the facility policy #1-05-08B titled, “Preparation of One To One Hundred (1:100) Bleach Solution,” last revised October 2023 revealed, “...12. With indelible marking pen and label container with expiration date, time, and initials. The solution is good for 24 hours. 13. When the solution is not being used, place a lid on the bleach solution container.” During an observation on 09/18/2024 at 8:15 AM, 2 bleach containers (one for chair cleaning and one for clamp cleaning) were not dated and were being stored uncovered. During an interview on 09/19/2024 at 10:29 AM the observation findings were discussed with Facility Administrator B who stated the bleach containers need to be dated and covered.”

“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: 47413 Based on record review, observation and interview, the facility staff failed to perform central venous catheter exit site care using aseptic technique for 1 of 5 patients observed (Patients #12), and failed to cleanse the central venous catheter exit site per facility policy in 1 of 5 patients observed (Patient #4) in a total sample of 5 observations of care of patients with a CVC. Findings Include: A review of the facility’s policy #1-04-02 B titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps and Tegaderm CHG Dressing Procedure” last revised October 2023 revealed, “... Verify patient’s clothing is secured away from the exit site/work area...” A review of the facility’s document titled, “Disinfection Timing” (no last revision date) revealed, “... Wet Contact Time... ExSept... 60 sec (seconds)...” During an observation on 09/18/2024 at 8:25 AM, Patient Care Technician J was observed performing CVC exit site care for Patient #12. Patient #12 was observed to be wearing a button-down shirt. Patient Care Technician J was observed moving the collar of the button-down away from Patient #12’s exit site but did not secure the shirt away from the site. Upon completion of exit site cleansing, Patient #12’s shirt was observed to be touching the right side of the exit site. The shirt continued to touch the exposed site while Patient Care Technician J performed other tasks until Patient Care Technician J placed a new dressing over the exit site without repeat cleansing. During an observation on 09/18/2024 at 8:33 AM, Patient Care Technician D was observed performing CVC exit site care for Patient #4. Patient Care Technician cleansed the CVC exit site using ExSept for 30 seconds. During an interview on 09/19/2024 at 10:28 AM, the observation findings were discussed with Manager of Clinical Services I who stated, “ExSept cleanse should be for 60 seconds.” During an interview on 09/19/2024 at 10:30 AM, the observation findings were discussed with Facility Administrator B who stated, “The site should have been re-sanitized after the clothes touched the exit site.””

“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 47413 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 4 in-center hemodialysis patients (Patients #4, 5) with current active orders for Heparin boluses in a total universe of 5 medical records reviewed. Findings Include:A review of the facility’s policy #12-08-02 titled, “Anticoagulation” last revised April 2024 revealed, “... To anticoagulate the patient, the initial loading dose of heparin is administered through the venous fistula needle or venous port of the central venous catheter (CVC) at least three (3) to five (5) minutes prior to the initiation of the hemodialysis treatment...” A review of Patient #4’s current in-center hemodialysis orders revealed an order for 1,000 units of Heparin bolus. A review of the treatment sheet dated 09/09/2024 revealed Patient #4’s dialysis was started at 8:40 AM. “Medications Administered” revealed the Heparin bolus was documented as given at 8:56 AM, 16 minutes after the initiation of dialysis. A review of Patient #5’s current in-center hemodialysis orders revealed an order for 3,500 units of Heparin bolus. A review of the treatment sheet dated 09/09/2024 revealed Patient #5’s dialysis was started at 6:13 AM. “Medications Administered” revealed the Heparin bolus was documented as given at 7:05 AM, 52 minutes after the initiation of dialysis. Treatment sheet dated 09/11/2024 revealed Patient #5’s dialysis was started at 6:05 AM. “Medications Administered” revealed the Heparin bolus was documented as given at 6:12 AM, 7 minutes after the initiation of dialysis. During an interview on 09/19/2024 at 9:13 AM, the medical record review findings were discussed with Facility Administrator B who stated, “Heparin should be given 3-5 minutes prior.””

“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: 47413 Based on record review and interview, the facility staff failed to ensure intradialytic monitoring was completed per facility policy in 2 of 5 in-center medical records reviewed (Patients #3, 5) and failed to ensure blood pressure readings outside of ordered parameters were reported to the nurse for further assessment or the nephrologist, per facility policy, in 1 of 5 in-center medical records reviewed (Patient #5) 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 pressure; Heart or pulse rate; Blood and dialysate flows, arterial and venous pressures; fluid removal and/or replacement; Vascular access visible and line connections intact...” 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 .... 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 missing intradialytic monitoring: A review of Patient #3’s medical record revealed a treatment sheet dated 08/28/2024 with missing intradialytic monitoring including, “Access visualized” and “Face visualized.” A review of the treatment sheet dated 09/04/2024 revealed missing intradialytic monitoring including, “Access visualized” and “Face visualized.” A review of Patient #5’s treatment sheet dated 09/04/2024 revealed a blood pressure at 6:10 AM, the next blood pressure check was completed at 7:04 AM, 54 minutes later. During an interview on 09/19/2024 at 9:04 AM, the medical record review findings were discussed with Facility Administrator B who stated, “Yes it looks like they are missing and should be documented.” Examples of blood pressures out of physician ordered parameters: A review of Patient #5’s treatment sheet dated 09/06/2024 revealed, Patient Care Technician J documented at 6:17 AM a blood pressure of 159/100, at 6:47 AM a blood pressure of 160/105, at 7:17 AM a blood pressure of 170/102, at 8:17 AM a blood pressure of 171/114, and at 8:47 AM a blood pressure of 181/112. There was no documentation of blood pressures being noted as outside of ordered parameters or notification of the Registered Nurse of the high diastolic blood pressures. Treatment sheet dated 09/11/2024 revealed, Patient Care Technician J documented at 7:40 AM a blood pressure of 161/103, and at 8:10 AM a blood pressure of 170/104. 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 blood pressures. During an interview on 09/19/2024 at 9:42 AM, the medical record review findings were discussed with and confirmed by Facility Administrator B who stated, “If the patient does not have specific blood pressure parameters ordered, then it goes back to the facility policy. The staff should be re-checking the blood pressure immediately, notifying the registered nurse, documenting a note about the blood pressure being out of parameters and the physician should be notified.””

“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 (BFR) and/or dialysate flow rates (DFR) for 2 of 5 in-center medical records reviewed (Patients #2, 5) 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 2021 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 Patient #2’s medical record revealed a physician order for the BFR at 350 mL/min (milliliters per minute) and a DFR at 800 mL/min. The treatment sheet dated 09/04/2024 revealed the BFR was turned down to 300 mL/min. There is no documentation in the medical records for the reason the BFR was lower than ordered. Treatment sheet dated 09/06/2024 revealed the BFR was set to run at 300mL/min for the entire treatment. There is no documentation in the medical record for the reason the BFR was lower than ordered. A review of Patient #5’s medical record revealed a physician order for the BFR of 350 mL/min and a dialysate flow rate was not included in the physician order. The treatment sheet dated 09/06/2024 revealed the DFR was set at 800 mL/min for the entire treatment. There was no documentation in the medical record addressing the incomplete physician order for DFR. The treatment sheet dated 09/09/2024 revealed the BFR was set at 400 mL/min and the DFR was set at 500 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was higher that the ordered rate and why there was not an order for the DFR. The treatment sheet dated 09/11/2024 revealed the BFR was set at 400 mL/min and the DFR was set at 800 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was higher than the ordered rate and why there was not an order for the DFR. The treatment sheet dated 09/13/2024 revealed the DFR was set at 800 mL/min for the entire treatment. There was no documentation in the medical record addressing the incomplete physician order for DFR. The treatment sheet dated 09/16/2024 revealed the DFR was set at 800 mL/min for the entire treatment. There was no documentation in the medical record addressing the incomplete physician order for DFR. During an interview on 09/19/2024 at 9:42 AM, the medical record findings were discussed with and confirmed by Facility Administrator B who stated facility staff were expected to document a reason for not meeting prescribed blood and dialysate flow rates. Facility Administrator B was unsure as to why there was not a DFR included in the physician order for Patient #5.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 29963 47413 Based on record review and interview the facility staff failed to ensure that all in-center dialysis patients were seen by a Registered Nurse once a month in 3 of 5 patients (Patients #3, 4, 5) in a total universe in of 5 medical records reviewed. Findings Include: A review of the facility’s policy #3-02-17 titled, “Progress Note Policy” last revised October 2023 revealed, “... Nurse: Nurses are required to record patient progress notes at least monthly...” A review of Patient #3’s medical record revealed that there was no Registered Nurse documentation of seeing Patient #3 in June 2024, July 2024, and August 2024. A review of Patient #4’s medical record revealed that there was no Registered Nurse documentation of seeing Patient #4 in August 2024. A review of Patient #5’s medical record revealed that there was no Registered Nurse documentation of seeing Patient #5 in July 2024. During an interview on 09/18/2024 at 9:18 AM, the findings were discussed with Facility Administrator B who stated, “Yes, the notes should be monthly.” .”

“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: 47413 Based on record review and interview the facility staff failed to document the follow up completed for 4 of 9 events (involving Patients #2, 9, 14, 15) recorded on the Adverse Occurrence Log in the Risk Event Management (REM) Reporting System in a total universe of 9 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 6 months revealed missing or incomplete follow-up for 4 patient events: A review of the adverse event involving Patient #2 revealed that Patient #2 developed a bloodstream infection on 05/01/2024. 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 #9 revealed Patient #9 received the wrong acid bath during dialysis occurring on 09/13/2024. 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 #14 revealed an infiltration during fistula access on 05/03/2024. 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 #15 revealed an infiltration during fistula access on 04/01/2024. 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 09/19/2024 at 11:43 AM, the adverse events were reviewed with Facility Administrator B who stated, “There should be more follow-up documented.””

“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: 47413 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 the facility’s policy #5-15-06 titled, “Continuous Quality Improvement Program” last revised April 2024 revealed, “ ...3. Written documentation and plans of action will be documented on the Facility Health Meetings (FHM) minutes form... 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 Facility Administrator B revealed the quality program did not include documentation related to data regarding the incidence of infections. A review of the facility’s infection rate revealed 1 infection for 2024 with no infection log completed. During an interview on 09/19/2024 at 11:43 AM, Facility Administrator B stated, “We do not have an infection log and will have one moving forward.””

“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: 47413 Based on record review and interview the facility staff failed to ensure that a comprehensive Registered Nurse assessment was completed prior to initiation of the first treatment at the facility in 2 of 2 newly admitted patients (Patients #1, 13) reviewed in a total sample of 2 newly admitted patient medical records reviewed. Findings include: A review of the facility’s policy #1-03-07 titled, “Initial Patient Nursing Assessment for New Patients” last revised April 2024 revealed, “... A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility...” A review of Patient #1’s medical record revealed Patient #1 was admitted for their first dialysis treatment on 08/02/2024. The first dialysis treatment was started on 08/02/2024 at 7:54 AM. Patient #1’s “Initial Assessment” was completed on 08/02/2024 at 8:03 AM (9 minutes after initiation of first dialysis treatment). A review of Patient #13’s medical record revealed Patient #13 was admitted for their first dialysis treatment on 07/26/2024. The first dialysis treatment was started on 07/26/2024 at 12:48 PM. There was no evidence found that Patient #13 had an “Initial Assessment” completed. During an interview on 09/19/2024 at 8:58 AM, the medical record review findings were discussed with Facility Administrator B who stated, “The notes should be done prior.””