032516 Chandler Dialysis (Fmc)

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure state rules were followed regarding: 1. (2) of (5) patient (Patients 10 and 11) had discharge summaries signed by the patient ’ s nephrologist within 30 days of discharge, which has the potential risk of affecting the patient ’ s continuity of care; 2. (3) of (7) patients (Patients #2, 5, and 7) had monthly progress notes documented by the patient ’ s nephrologist or designee, which poses the potential risk to patient outcomes by a lack of coordination of care if the patient ’ s nephrologist is not documenting the patient ’ s status; 3. Staff members had their name and role displayed on their gown, which poses the potential risk of inadequate patient care if team members are not identifiable; and 4. Policies and procedures were implemented for receiving, storing, inventorying, tracking, dispensing, and discarding medication. Failure to implement policies and procedures for medication chain of custody poses the potential risk to patient safety if medications are tampered, contaminated or unable to be accounted for. Findings include: 1. Arizona Administrative Code requires “...R9-10-1018. Dialysis Services ...L. For a patient who received dialysis services, an administrator shall ensure that after the patient ’ s discharge from an outpatient treatment center that is authorized to provide dialysis services, the nephrologist responsible for the dialysis services provided to the patient documents the patient ’ s discharge in the patient ’ s medical record within 30 calendar days after the patient ’ s discharge and includes: 1. A description of the patient ’ s medical condition and the dialysis services provided to the patient, and 2. The signature of the nephrologist ....” The facility policy titled “Documenting Progress Notes, Transfers, Transplants, Discharges and Order Review” requires “...The nurse or designee will complete the FMS Discharge Assessment in eCC for each discharged patient (permanent and transient) as soon as reasonably possible and within 30 days of a patient being discharged from the facility .... Additional discharge notes will be documented by other disciplines if required by state regulations (ex. AZ)....” The facility policy does not require the nephrologist to sign the patient ’ s discharge summary as required by Arizona State Rules. Patient #10 ’ s medical record review on 09/02/2025 revealed a discharge date of 12/10/2024. The patient ’ s discharge summary was signed by the patient’s nephrologist on 01/20/2025. Patient #12 ’ s medical record review on 09/02/2025 revealed a discharge date of 03/13/2025. The patient ’ s discharge summary was signed by the patient ’ s nephrologist on 04/25/2025. Employees #1 and 22 confirmed on 09/02/2025 that Patients #10 and 12 did not have their discharge summaries signed according to Arizona State Rules. 2. Arizona Administrative Code requires “...R9-10-1018. Dialysis Services ...E. An administrator of an outpatient treatment center that is authorized to provide dialysis services shall ensure that for a patient receiving dialysis services...4. The patient ’ s nephrologist or the nephrologist ’ s designee ...b. Documents monthly notes related to the patient ’ s progress in the patient ’ s medical record ...” The facility policy titled “Arizona State Specific - Monthly Progress Notes” requires “...A progress note shall be completed and placed in the patient ’ s medical record by the physician, advanced practice nurse or physician assistant at least monthly ...” Patient #2 ’ s medical record review on 09/02/2025 revealed no monthly progress from the patient ’ s nephrologist or designee for the months of June, July and August of 2025. Patient #5 ’ s medical record review on 09/02/2025 revealed no monthly progress from the patient ’ s nephrologist or designee for the months of June, July and August of 2025. Patient #7 ’ s medical record review on 09/02/2025 revealed no monthly progress from the patient ’ s nephrologist or designee for the months of June, July and August of 2025. Employees #1, 2, and 22 confirmed on 09/03/2025 that Patients #2, 5, and 7 did not have monthly progress notes documented by their nephrologist or designee. 3. R9-10-1018.C.4 Arizona Administrative Code requires “...R9-10-1018. Dialysis Services ...C. An administrator of an outpatient treatment center that is authorized to provide dialysis services shall ensure that ...4. A personnel member wears a name badge that displays the individual ’ s first name, job title, and professional license or certification ...” A facility policy regarding staff wearing a name badge that includes the employee ’ s name and role was requested but not provided. Observation on 09/03/2025 revealed two staff members on the treatment floor wearing a gown, face mask, and face shield. The two staff members did not have their name or role visible on their gowns and were unable to be identified without asking the staff to identify themselves. Employees #1 confirmed on 09/03/2025 that the two staff members did not have their name or role displayed. Employee #22 confirmed on 09/03/2025 that while the Arizona State Rules require staff members to wear a badge that displays their name and role, the facility does not have a policy that requires staff member ’ s name and role to be displayed. 4. Arizona Administrative Code requires “...R9-10-1010. Medication Services ...E. When medication is stored at an outpatient treatment center, an administrator shall ensure that ...3. Policies and procedures are established, documented, and implemented for ... a. Receiving, storing, inventorying, tracking, dispensing, and discarding medication including expired medication ...” The facility policy titled “FreseniusRx Medication Shipment to FKC Facilities - Receipt Storage and Delivery to Patients” requires “...All pharmacy medication packages received at the facility will be tracked using the Clinic FRx Delivery log ....The receiving staff member will: 1 Access the electronic Clinic FRx Delivery Log. 2 Navigate to the ’ Received Package(s) Tab ’ . 3 Locate the delivered packaged on the Clinic FRx Delivery Log by matching the displayed shipping carrier tracking number on the log with the tracking number on the package itself. 4 Mark the package(s) as received and click the ’ Sign Selection(s) Button ’ to complete the receiving process ....” Review of the facility document titled “Clinic FRx Delivery Log” on 09/04/2025 revealed four (4) medications shipped from Fresenius RX between the dates 08/19/2025 and 08/28/2025. The FedEx tracking numbers associated with these four (4) medications revealed the medication packages were signed as received by a clinic employee between the dates 08/22/2025 and 09/03/2025. The “Clinic FRx Delivery Log” revealed the four (4) medication packages had not been marked as received by the clinic. Employees #1 and 2 confirmed on 09/04/2025 that the signature of receipt on the FedEx tracking number was a clinic employee, and the four (4) medication packages had not been tracked in the Clinic FRx Delivery Log as required by facility policy.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff appropriately disinfected (4) of (5) patients (Patients #13, 14, 15, and 16) vascular access prior to cannulation, which has the potential risk of blood stream infection and vascular access infection if the site is not disinfected properly. Findings include: Facility policy titled “Access Assessment and Cannulation” requires “...Disinfect cannulation site as follows using any of the disinfectants below: 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating ....Perform skin antisepsis on one site at a time, allow to dry and then cannulate ....” Observation on 09/03/2025 revealed Employee #7 cleaning Patient #13 vascular access for cannulation. Employee #7 disinfected the arterial site using isopropyl alcohol for 16 seconds, and then disinfected the venous site with isopropyl alcohol for 18 seconds. Observation on 09/03/2025 revealed Employee #7 cleaning Patient #14 vascular access for cannulation. Employee #7 disinfected the arterial site using isopropyl alcohol for 15 seconds, and then disinfected the venous site with isopropyl alcohol for 18 seconds. Observation on 09/03/2025 revealed Employee #33 cleaning Patient #15 vascular access for cannulation. Employee #33 disinfected the arterial and venous site using isopropyl alcohol for 39 seconds, and then cannulated the arterial site and then the venous site. Observation on 09/03/2025 revealed Employee #7 cleaning Patient #16 vascular access for cannulation. Employee #7 disinfected the arterial site using isopropyl alcohol for 24 seconds, and then disinfected the venous site with isopropyl alcohol for 11 seconds. Employee #1 confirmed on 09/03/2025 that Employees #7 and 33 did not perform access disinfection according to facility policy.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 52534 Based on document review, observation and interview, it was determined that the facility failed to ensure staff appropriately disinfect the rubber diaphragm before accessing a multi-dose vial of Heparin which has the potential risk of infections and patients receiving contaminated medication. Findings include: The facility policy titled “Medication Preparation and Administration” requires “...Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol ....” Observation on 09/03/2025 revealed Employees #7 and 33 drawing up medications from multidose vials. Neither Employee #7 or 33 cleaned the diaphragm of the vial with alcohol before accessing the vial with the syringe. Employee #1 confirmed on 09/03/2025 that Employees #7 and 33 did not disinfect the diaphragm of the medication vial before drawing up the medication as required by facility policy.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff correctly perform central venous catheter (CVC) dressing change and cannulation for (1) of (5) patients (Patient #7). This deficient practice poses the potential for CVC and/or bloodstream infection if catheter care and dressing changes are not performed aseptically. Findings include: The facility policy titled “Changing the Catheter Dressing Procedure” requires “...Follow the steps below to clean the catheter exit site ... 2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward the are of the size of the dressing to be applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds ....” Observation on 09/03/2025 revealed Employee #33 performing a CVC dressing change on Patient #7. Employee #33 removed the old dressing, disinfected the exit site for 14 seconds, allowed to dry for 18 seconds, and then applied the new dressing. Employee #1 confirmed on 09/03/2025 that Employee #33 did not perform the CVC dressing change according to facility policy.”

“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: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure: 1. Staff secured pre-drawn syringes of Heparin Sodium for injection when not in use; and 2. Staff labeled pre-drawn medication syringes according to facility policy. These deficient practices pose the potential risk that a patient will receive contaminated, tampered with, or compromised medications. Findings include: 1. And 2. The facility policy titled “Medication Preparation and Administration” requires “...All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time and initials of the person who prepared the medication ....Medications may be pre-drawn up to 4 hours prior to administration ...These pre-drawn medications shall be labeled and must be kept under the preparer ’ s control or in a locked designated medication storage area or refrigerated, if necessary, until delivery to the appropriate patient for administration ....” 1. Observation on 09/04/2025 at 0820 revealed two (2) 3-mL syringes of predrawn Heparin Sodium. The labels on both syringes did not contain the initials of the employee who drew up the medication, nor the time the medication was drawn up. Further observation on 09/04/2025 at 1154 revealed an additional two (2) 3-mL syringes of predrawn Heparin Sodium. The labels on both syringes did not contain the initials of the employee who drew up the medication, nor the time the medication was drawn up. Employee #1 confirmed on 09/04/2025 that the four medication syringes were not labeled according to facility policy. 2. Observation on 09/04/2025 revealed Employee #32 retrieving a syringe of predrawn Heparin Sodium from the medication cabinet. Employee #32 brought the medication syringe to Station 18 and placed it on the chairside table. Employee #32 then left the floor to escort a patient from the lobby to the treatment floor. The medication was left unattended and unsecured. Further observation on 09/04/2025 revealed Employee #12 retrieving a syringe of predrawn Heparin Sodium from the medication cabinet. Employee #12 brought the medication syringe to Station 23 and placed it on the chairside table. Employee #32 then left the station to assess the patient at Station 24, and then went to Station 21 to disinfect the station. Employee #12 then left the floor to escort the patient from the lobby to Station 21. The medication was left unattended and unsecured during this observation. Employee #1 confirmed on 09/04/2025 that Employees #12 and 32 did not secure predrawn medications as required by facility policy.”

“PE-INCORPORATION BY REFERENCE CFR(s): (f) Incorporation by reference. The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material from the sources listed below. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov, or go to: www.archives.gov/federal__register/cfr/ibr-locations.html. If any changes in the editions of the Codes are incorporated by reference, CMS will publish a document in the Federal Register to announce the changes. (1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1-617-770-3000. (i) NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11 2011. (ii) TIA 12-2 to NFPA 99, issued August 11, 2011. (iii) TIA 12-3 to NFPA 99, issued August 9, 2012. (iv) TIA 12-4 to NFPA 99, issued March 7, 2013. (v) TIA 12-5 to NFPA 99, issued August 1, 2013. (vi) TIA 12-6 to NFPA 99, issued March 3, 2014. (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011. (viii) TIA 12-1 to NFPA 101, issued August 11, 2011. (ix) TIA 12-2 to NFPA 101, issued October 30, 2012. (x) TIA 12-3 to NFPA 101, issued October 22, 2013. (xi) TIA 12-4 to NFPA 101, issued October 22, 2013. (2) [Reserved] This Standard is not met as evidenced by: 52534 Based on docuemnt review, observation and interview, it was determined that the the facility failed to maintain a comfortable temperature in the dialysis treatment area which poses a potential risk of patient discomfort and adverse outcomes during treatment if patients are not able to maintain a comfortable body temperature. Findings include: NFPA 101: Life Safety Code, 2012 Edition - Chapter 21 Existing Ambulatory Health Care Occupancies1.5.2 Heating, Ventilating, and Air-Conditioning. 21.5.2.1 Heating, ventilating, and air-conditioning shall comply with the provisions of Section 9.2 and shall be in accordance with the manufacturer ’ s specifications, unless otherwise modified by 21.5.2.2. NFPA 99: Health Care Facilities Code, 2012 Edition - Chapter 9 Heating, Ventilation, and Air Conditioning (HVAC) 9.3.1 Heating, Cooling, Ventilating, and Process Systems. 9.3.1.1 Heating, cooling, ventilating, and process systems serving spaces or providing health care functions covered by this code or listed within ASHRAE 170, Ventilation of Health Care Facilities, shall be provided in accordance with ASHRAE 170. ASHRAE Standard 170- 2008 Table 7.1 Dialysis Treatment areas must be maintained between 72-78 deg F. Observation on 09/03/2025 revealed the treatment floor temperature was controlled by four thermostats mounted on the back wall of the treatment area by the medication preparation area. The thermostats were labeled RTU6, RTU7, RTU8, and RTU9. Observations on 09/03/2025 revealed the following: At 09:10 - RTU8 at 73.5°F, RTU7 at 73°F, RTU6 at 68°F, RTU9 at 70°F At 09:58 - RTU8 at 73.5°F, RTU7 at 73°F, RTU6 at 68.5°F, RTU9 at 70.5°F At 10:56 - RTU8 at 73.5°F, RTU7 at 73°F, RTU6 at 69°F, RTU9 at 71°F At 11:33 - RTU8 at 74°F, RTU7 at 73.5°F, RTU6 at 68°F, RTU9 at 71.5°F At 12:09 - RTU8 at 74°F, RTU7 at 73°F, RTU6 at 68°F, RTU9 at 71.5°F The following temperatures were taken with a Raytek MiniTemp Temperature gun at various places on the treatment floor: The Northwest corner of the treatment floor facing East was 66.5°F The Northwest corner of the treatment floor facing South was 70°F The Northeast corner of the treatment floor facing West was 72°F The Northeast corner of the treatment floor facing South was 69°F The Southeast corner of the treatment floor facing North was 68°F The Southeast corner of the treatment floor facing West was 71°F The Southwest corner of the treatment floor facing East was 75°F The Southwest corner of the treatment floor facing North was reading 76°F The Center of the treatment floor facing West was reading 61.5°F The Center of the treatment floor facing East was reading 60°F Patient #17 stated the treatment floor is often cold and sometimes requires 3 blankets to be worn during treatment to maintain a comfortable temperature. Employees #3 and 8 stated on 09/03/2025 that the treatment floor is often kept at a temperature that is uncomfortable for staff and patients. Employees #1 and 2 confirmed on 09/03/2025, that the facility temperature is a pre-set range set by the corporate offices in Massachusetts and that the facility has a few degree range in which to adjust temperatures. Additionally, when the facility does adjust the temperature, the system reset to the temperature set by the corporate offices after about an hour. Additionally, Employees # 1 and 2 confirmed that the temperature maintained on the treatment floor was below the required 72° minimum requirement for ASHRAE standard.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 52534 Based on document review and interview, it was determined that the facility failed to ensure (6) of (7) patients (Patients 2, 3, 4, 5, 6, and 7) received hemodialysis treatment as prescribed by their nephrologist. This deficient practice poses the potential risk of inadequate dialysis, decreased clearance, and increased hospitalizations if hemodialysis treatments are not given as prescribed. Findings include: The facility policy titled “Patient Assessment and Monitoring” requires “...Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered ....Document any findings and interventions in the medical record ....” The facility policy titled “Early Termination or Arriving Late for Treatment” requires “...Against Medical Advice forms are ...Signed by the patient and witnessed by the supervising nurse. Signed with each early termination event and filed in the patient’s medical record ....” Patient #2 Patient #2 ’ s medical record review on 09/02/2025 revealed a prescribed hemodialysis treatment time of 4 hours. The following dialysis treatments were not delivered as prescribed: 08/25/2025 - The treatment time was 2 hours and 59 minutes 08/06/2025 - The treatment time was 3 hours and 34 minutes No rationale for the shortened treatment or signed Against Medical Advice (AMA) forms were found in the treatment record. Patient #3 Patient #3 ’ s medical record review on 09/02/2025 revealed a prescribed hemodialysis treatment time of 3 hours and 30 minutes. The following dialysis treatment was not delivered as prescribed: 06/27/2025 - The treatment timed was 3 hours and 7 minutes No rationale for the shortened treatment or signed AMA form was found in the treatment record. Patient #4 Patient #4 ’ s medical record review on 09/02/2025 revealed a prescribed hemodialysis treatment time of 4 hours and 15 minutes, and a prescribed Blood Flow Rate (BFR) of 550 mL/min. The following dialysis treatments were not delivered as prescribed: 08/28/2025 - The treatment timed was 2 hours and 59 minutes 07/29/2025 - The BFR was set to 400 from 07:16 to 09:02 07/22/2025 - The BFR set to 450 for the entirety of the treatment 07/15/2025 - The treatment time was 3 hours and 58 minutes No documentation for the reason for the change in BFR, or signed AMA forms were found in the treatment record. Patient #5 Patient #5 ’ s medical record review on 09/02/2025 revealed a prescribed hemodialysis treatment time of 3 hours and 45 minutes. The following dialysis treatments were not delivered as prescribed: 08/05/2025 - The treatment timed was 3 hours and 1 minute 07/03/2025 - The treatment time was 2 hours and 31 minutes No rationale for the shortened treatment or signed AMA forms were found in the treatment record. Patient #6 Patient #6 ’ s medical record review on 09/02/2025 revealed a prescribed hemodialysis treatment time of 3 hours. The following dialysis treatments were not delivered as prescribed: 05/27/2025 - The treatment timed was 2 hours and 37 minutes 05/14/2025 - The treatment time was 2 hours and 7 minutes No rationale for the shortened treatment or signed AMA forms were found in the treatment record. Patient #7 Patient #7 ’ s medical record review on 09/02/2025 revealed a prescribed hemodialysis treatment time of 4 hours, a prescribed BFR of 500 mL/min, and a prescribed Dialysate Flow Rate (DFR) of 800 mL/min. The following dialysis treatments were not delivered as prescribed: 08/08/2025 - The DFR changed from 800 to 500 at 11:11 and remained at 500 for the remainder of the treatment 08/06/2025 - The note in Patient #7 ’ s treatment sheet revealed patient was set to run on a profile, the order sheet for Patient #7 states “UFR Profile Type: None”. No special orders were present that allow the patient to run on a profile. 07/30/2025 - The treatment time was 3 hours and 34 minutes. The BFR was set to 400 mL/min for the entirety of the treatment. 07/28/2025 - The BFR was set to 400 mL/min for the entirety of the treatment. No documentation for the changes in BFR or DFR, or signed AMA form was found in the treatment record. Employees #1, 2, and 22 confirmed on 09/03/2025 that the documentation revealed Patients #2, 3, 4, 5, 6, and 7 did not receive their hemodialysis treatments as prescribed by the nephrologist.”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 52534 Based on document review and interview, it was determined that the facility failed to ensure cultures and endotoxin tests were presented accurately at the facility ’ s Quality and Improvement (QAI) meetings. This deficient practice poses the potential risk of patient harm if the water used for hemodialysis is not monitored and problems are addressed. Findings include: The document titled “Chandler JV Facility Summary By Date” revealed “Water Colony Count: Action Level: 20 - Allowable Limit: 100 ... Endotoxin: Action Level: 0.125 - Allowable Limit 0.250 ... Dialysate Colony Count: Action Level: 20 - Allowable Limit: 100 ... Endotoxin Action Level 0.060 - Allowable Limit: 0.250 ...” The document titled “ICHD QAI Agenda W/ EQUIP” dated 05/21/2025 revealed the Bicarbonate Distribution System was tested on 04/10/2025 and the results came back under action level. The document titled “Chandler JV Facility Summary By Date” containing the results from the lab revealed the Bicarb Distribution System was tested on 04/14/2025 and the Endotoxin result came back above action level. The test date of the Bicarbonate Distribution System documented by the lab on 04/14/2025 did not match the test date of 04/10/2025 documented in the Quality meeting minutes. The Endotoxin test results for the Bicarbonate Distribution System documented by the lab were above action level, the test results documented in the Quality meeting minutes did not reflect the elevated test results. The dates and results were not presented accurately in the Quality meeting minutes. The document titled “ICHD QAI Agenda W/ EQUIP” dated 06/18/2025 revealed the Bicarbonate Distribution System was tested on 05/14/2025. The document titled “Chandler JV Facility Summary By Date”containing the results from the lab revealed the Bicarb Distribution System was tested on 05/19/2025. The test date of the Bicarbonate Distribution System was documented by the lab on 05/19/2025 did not match the test date of 05/14/2025 documented in the Quality meeting minutes. The test dates were not presented accurately in the Quality meeting minutes The document titled “ICHD QAI Agenda W/ EQUIP” dated 07/23/2025 revealed the Bicarbonate Distribution System, RO Distribution Loop, and RO Permeate were tested on 06/10/2025 and that the hemodialysis machine with serial numbers 4T0S-279644 had endotoxin results of = 0.040 EU/ml and the hemodialysis machine with serial number 4T0S-279875 had a colony count result of < 2 CFU/ml. The document titled “Chandler JV Facility Summary By Date” containing the results from the lab revealed the Bicarbonate Distribution Loop was tested on 06/16/2025, and that the RO Distribution Loop and Permeate was tested on 06/18/2025. The document further revealed that the hemodialysis machine 4T0S-279644 had endotoxin results on < 0.010 EU/ml and the hemodialysis machine 4T0S-279875 had a colony count of 20 CF/ml which is above action level. The test date of the Bicarbonate Distribution System was documented by the lab on 06/16/2025 and the RO system was documented by the lab on 06/18/2025. These test dates did not match the date of 06/10/2025 documented in the Quality meeting minutes. The endotoxin test results of the hemodialysis machine 4T0S-279644 documented by the lab was < 0.010 EU/ml did not match the results of = 0.040 EU/ml documented in the Quality meeting minutes. The colony count test results of the hemodialysis machine 4T0S-279875 documented by the lab as 20 CFU/ml, which is at action level, did not match the results of <2 CFU/ml documented in the Quality Meeting minutes. The test results and test dates were not presented accurately in the Quality meeting minutes. A facility policy for information required to be presented in QAI meetings was requested but not provided. Employees #20 and 22 confirmed on 09/04/2025 that information documented in QAI meeting minutes comes from a template where values are inputted and errors may have occurred when inputting data into the standardized template. Employee #20 further confirmed on 09/04/2025 that the information presented in the QAI meeting minutes was not accurate compared to the test results from the lab report.”