032517 Central Phx 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, and interview, it was determined that the facility failed to ensure state law was followed regarding: 1. The implementation of policies and procedures for receiving, storing, inventorying, tracking, dispensing, and discarding medication which poses the potential risk to patient safety if medications are tampered, contaminated or unable to be accounted for; 2. The nephrologist completing and signing discharge summaries for 3 of 5 patients (Patients #7, 9, and 11) within 30 days of a patient ’ s discharge which poses the potential risk of a disruption of a continuity of care; and 3. The patient ’ s nephrologist reviewed and signed the history and physical completed by another provider for the admission of 2 of 6 patients (Patients #4 and 6) to the dialysis facility which poses the potential risk of inadequate dialysis if a patient ’ s condition is not evaluated by their nephrologist. Findings include: 1. 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 “...Implement procedures for ensuring secure, safe, and accountable medication receipt, storage, handling and delivery. Document medication receipt and delivery of the medication to the patient ....” The facility online log titled “Clinic FRX Delivery Log” reviewed on 07/15/2025 revealed medications for Patients #13 and 14 had been received by the facility on 07/09/2025 and 07/10/2025 respectively, but not yet delivered to the patients. Employee #1 confirmed on 07/15/2025 that the medication for Patient #13 was received by the facility on 07/09/2025 and had been given to the patient on 07/12/2025 but had not been signed off according to facility policy. Employee #1 also confirmed on 07/15/2025 that the medication for Patient #14 was received on 07/10/2025 and had been given to the patient on 07/12/2025 but had not been signed off according to facility policy. Employee #2 confirmed on 07/15/2025 that the FRx logs were not completed according to facility policy. 2. The Arizona Administrative Code (A.A.C.) 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 MS Discharge Assessment in eCC for each discharged patient (permanent and transient) as soon as reasonable possible and within 30 days of a patient being discharged from the facility. The nurse will provide the necessary information to complete the FMS Discharge Assessment. Additional discharge notes will be documented by other disciplines if required by state regulations (ex. AZ)....” The facility policy did not explicitly require the nephrologist to document the patient’s medical condition and dialysis services provided, not the nephrologist’s signature as required by Arizona law. Patient #7 Patient #7 ’ s medical record review on 07/15/2025 revealed a discharge date of 04/10/2025. The discharge summary was completed on 06/17/2025 by the facility secretary but had not been signed by the nephrologist. Patient #9 Patient #9 ’ s medical record review on 07/15/2025 revealed a discharge date of 06/03/2025. The discharge summary was completed on 07/14/2025 by the facility secretary but had not been signed by the nephrologist. Patient #11 Patient #11 ’ s medical record review on 07/15/2025 revealed a discharge date of 03/15/2025. The discharge summary was completed on 07/01/2025 by the facility secretary but had not been signed by the nephrologist. Employee #1 confirmed on 07/15/2025 that Patients #7,9, and 11 did not have the discharge summaries completed by their nephrologist within 30 days of their discharge date. 3. The Arizona Administrative Code (A.A.C.) 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: ...3. If the patient ’ s medical history and physical examination required in subsection (E)(2) is not performed by the patient ’ s nephrologist, the patient ’ s nephrologist, within 30 calendar days after the date of the medical history and physical examination: a. Reviews and authenticates the patient ’ s medical history and physical examination, documents concurrence with the medical history and physical examination, and includes information specific to nephrology ....” The facility policy titled “Patient Admission” requires “...At minimum, the required document to admit a patient include: History and Physical or nephrology consult note or discharge summary or the most recent physician progress note ...” The facility policy did not explicitly require the nephrologist to review and authenticate a history and physical that was completed by another provider. Patient #4 Patient #4 ’ s medical record review on 07/15/2025 revealed an admission date of 05/08/2025. A history and physical was completed in the hospital on 04/24/2025. The attached document titled “Authentication of History and Physical with Nephrology Specific Note” was dated 05/08/2025 but was not signed by the patient ’ s nephrologist. Patient #6 Patient #6 ’ s medical record review on 07/15/2025 revealed an admission date of 05/23/2025. A history and physical was completed in the hospital on 05/12/2025. The attached document titled “Authentication of History and Physical with Nephrology Specific Note” had no date and was not signed by the patient ’ s nephrologist Employee #1 confirmed on 07/15/2025 that Patients #4 and #6 did not have their history and physicals signed by their nephrologist as required by state law.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. 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 at 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. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. 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 (2) of (4) patients (Patients #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: The 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 ....” Observation on 07/14/2025 revealed Employee #11 cleaning Patient #15 ’ s vascular access for cannulation. Employee #11 disinfected the arterial site using isopropyl alcohol for 15 seconds, and then disinfected the venous site with isopropyl alcohol for 25 seconds. Observation on 07/14/2025 revealed Employee #11 cleaning Patient #16 ’ s vascular access for cannulation. Employee #11 disinfected the arterial site using isopropyl alcohol for 17 seconds, and then disinfected the venous site with isopropyl alcohol for 23 seconds. Employees #1 and 4 confirmed on 07/14/2025 that Employee #11 did not disinfect Patients #15 and 16 ’ s vascular access according to facility policy.”

“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: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff appropriately performed hand hygiene which poses the potential risk of cross contamination between patients; and patients and staff. Findings include: The facility policy titled “Hand Hygiene” requires “...Hands Will Be ...Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ... When ... Before and after direct contact with patients ...Entering and leaving the treatment area ...Immediatlye after removing gloves ...After contact with inanimate objects near the patient ....After contact with other objects within the patient station or treatment space ...” Observations on 07/14/2025 revealed the following: Employee #10 with bare hands left the treatment floor to retrieve a patient, opened the door, brought the patient to Station #3, and donned clean gloves. Employee #10 did not perform hand hygiene. Employee #11 with bare hands left the treatment floor to grab supplies from the storage room. Employee #11 returned with a jug of dialysate and labeled it at the nurses station. Employee #11 then brought the dialysate jug to Station #5 and left the treatment floor to grab a portable divider from the storage room. Employee #11 brought the divider to Station #8, adjusted the goggles on their head, and then donned clean gloves. Employee #11 did not perform hand hygiene during this observation. Employee #13 left the nurses station after charting, fixed the patient ’ s blanket at Station #11 without wearing gloves, returned to the nurses station and continued charting. Employee #13 did not perform hand hygiene. Employee #16 with bare hands charting at the nurses station, donned clean gloves, assessed the patient at Station #11, removed the gloves and returned to the nurses station to chart. Employee #16 did not perform hand hygiene. Employee #1 confirmed on 07/14/2025 that Employee #10, 11, 13, and 16 did not perform hand hygiene according to facility policy.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. 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 were able to verbalize training of policies on chlorine testing and breakthrough procedures which poses a potential risk of harm or death to patients in the event staff do not know what actions to take to protect patients if there is chlorine breakthrough in dialysis water. Findings include: The facility policy titled “Total Chlorine Testing using RPC Ultra Low Total Chlorine Test Strips Procedure” requires “...Central Water System ...Rinse sample port to be tested for 2 minutes or longer, to assure sample is representative of the water in the system ....” The facility policy titled “Carbon Filtration Chlorine Breakthrough Action Plan for Central Water Systems” requires “...If ...results of either the polisher carbon filter or polisher bank of carbon filters or the purified water distribution system are equal to or greater than 0.1ppm total chlorine ....Then ... Keep dialysis machines in bypass. All patient treatments must be discontinued at once. Do not return the patient ’ s blood ....” Observation on 07/14/2025 revealed Employee #10 performing a chlorine test on the dialysate water in the water room. Employee #10 was asked to perform the test, explain the results, and explain what actions would be taken if results were out of range. Employee #10 verbalized and rinsed the sample port for 30 seconds before obtaining a water sample for testing. Employee #10 then verbalized returning patient ’ s blood after detecting chlorine breakthrough. Employee #1 confirmed on 07/14/2025 that Employee #10 did not perform the correct process rinsing the system for 2 minutes before obtaining a water sample, or verbalizing the correct procedures of terminating treatments without returning patient ’ s blood in the event of chlorine breakthrough.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. 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 medications were locked or otherwise secured when not in use, which poses the potential risk of unauthorized access to medication and the potential for tampering or other compromise to the integrity of medications being administered to patients. Findings include: The facility policy titled “Medication Preparation and Administration” requires “...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 ....All medications will be kept in a locked cabinet except when in use ....” Observation on 07/14/2025 revealed two bottles of lidocaine spray in a drawer that did not have a lock on it at the nurses station, an unlocked drawer at the nurses station with the key in the lock, the drawer contained 2 vials of heparin and a 3mL syringe of predrawn heparin. Further observation on 07/14/2025 revealed Employee #10 accessing the medication drawer at the nurses station, Employee #10 opened the drawer and then left the drawer open while they tended to the patient at Station 35. Further observation on 07/14/2025 revealed Employee #13 preparing a medication syringe at the medication prep area. Employee #13 then returned the vial of medication to the cabinet and walked away without locking the cabinet. Further observation on 07/14/2025 revealed Employee #10 drawing up a medication at the nurses station and wrapping the medication in a chucks pad containing clean supplies. Employee #10 placed the chucks pad and it ’ s content on the chair at Station #6 and left the treatment floor. The medication was left unsecured. Employee #1 confirmed on 07/14/2025 that Employees #10 and 13 did not secure medication according to facility policy, and that the lidocaine spray was not kept in a secure manner. Observation on 07/15/2025 revealed the lock of the medication drawer at the nurses station did not have the latch component installed on the cabinet, the drawer was unable to be locked. Employee #1 confirmed on 07/15/2025 that the lock on the medication drawer was broken and unable to be latched, leaving medications unsecured.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 52534 Based on document review and interview it was determined that the facility failed to ensure staff performed equipment maintenance as required in the manufacturer ’ s direction for use (DFU) which has the potential for patient injury or harm if equipment is not maintained and normal operation is not verified. Findings include: The document titled “NewLife Family Technical Manual MN240-1” requires “ ...Method of Cleaning and Infection Control ...Clean the air intake gross particle filter with warm soapy water ...Clean this filter at least once per week ...” The facility document titled “FKD Log Readings Grid Report O2 CONCENTRATOR (weekly)” requires weekly filter cleaning of the O2 concentrators used at the clinic. The facility utilizes three (3) NewLife Oxygen Concentrators. The following machines did not have filters cleaned between 06/18/2025 and 07/02/2025: Serial Number: 647904 Serial Number: 664961 Serial Number: 665217 The document titled “Caire Companion 5 Provider Technical Manual” requires “...Clean the bottom gross particle filter weekly ....” The facility document titled “FKD Log Readings Grid Report O2 CONCENTRATOR (weekly)” requires weekly filter cleaning of the O2 concentrators used at the clinic. The facility utilizes eight (8) Caire Companion 5 oxygen concentrators. The following machines did not have filters cleaned between 06/18/2025 and 07/02/2025: Serial Number: CBB6923160444 Serial Number: CBB692317021 Serial Number: CBB6923170349 Serial Number: CBB6924010173 Serial Number: CBB69240110174 Serial Number: CBB6924490033 Serial Number: CBB6925010015 Serial Number: CBB6925010031 Employees #1 and 3 confirmed on 07/15/2025 that the oxygen concentrators were not serviced weekly as required.”

“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 (6) patients (Patients #1, 2, 3, 4, 5 and 6) received hemodialysis treatment as prescribed by their nephrologist. This deficient practices pose the potential risk of inadequate dialysis, decreased clearances, and hospitalizations if hemodialysis treatments are not given as prescribed. Findings include: The facility policy titled “Early Termination or Arriving Late for Treatment” requires “...If a patient requests to leave treatment early ...the RN is responsible to notify the provider, and document on the ’ AMA ’ , or Against Medical Advice form ....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 ....” The facility policy titled “Unable to Achieve Prescribed Blood Flow Rate” requires “...Staff, patient and/or care partner will recognize and report to the nurse in charge the inability to achieve prescribed blood flow rate ....Document in the patient’s treatment record what action taken to address the inadequate blood flow and if unable to resolve. The nurse shall document any physician orders ....” Patient #1 Patient #1 ’ s medical record review on 07/15/2025 revealed the prescribed treatment time of 4 hours. The following dialysis treatment was not delivered as prescribed: 07/12/2025 - treatment time was 3 hours and 30 minutes. No documentation or signed Against Medical Advice (AMA) form was found in the treatment record. Patient #2 Patient #2 ’ s medical record review on 07/15/2025 revealed the prescribed treatment time of 3 hours and 45 minutes and a prescribed Blood Flow Rate (BFR) of 500mL/min. The following dialysis treatment was not delivered as prescribed: 07/11/2025 - BFR was set to 400mL/min for the entirety of the treatment 06/30/2025 - treatment time was 3 hours and 10 minutes. No documentation for the change in BFR or signed Against Medical Advice (AMA) form was found in the treatment records. Patient #3 Patient #3 ’ s medical record review on 07/15/2025 revealed the prescribed treatment time of 4 hours and a prescribed BFR of 450 mL/min. The following dialysis treatments were not delivered as prescribed: 07/11/2025 - the treatment time was 2 hours and 1 minute, the BFR was set to 150 mL/min for the entirety of the treatment 07/09/2025 - the BFR was set to 450 mL/min at 15:48, changed to 400 mL/min at 16:43, and changed to 300 mL/min at 17:41 for the remainder of the treatment 07/07/2025 - the BFR was set to 450 mL/min at 16:03, changed to 400 mL/min at 16:41 for the remainder of the treatment 07/02/2025 - the BFR was set to 450 mL/min at 15:53, changed to 375 mL/min at 16:21 for the remainder of the treatment 06/30/2025 - the BFR was set to 200 mL/min at 15:55, changed to 400 mL/min at 17:42 No documentation for changes in BFR or signed Against Medical Advice (AMA) forms were found in the treatment records. Patient #4 Patient #4 ’ s medical record review on 07/15/2025 revealed the prescribed treatment time of 4 hours and a prescribed BFR of 450 mL/min. The following dialysis treatments were not delivered as prescribed: 07/12/2025 - treatment time was 3 hours and 30 minutes. 07/10/2025 - the BFR was set to 350 mL/min at 15:30, changed to 300 mL/min at 16:25 for the remainder of the treatment 07/08/2025 - the BFR was set to 450 mL/min at 15:21, changed to 400 mL/min at 17:41 for the remainder of the treatment 07/05/2025 - the BFR was set to 450 mL/min at 15:44, changed to 350 mL/min at 16:42, changed to 300 mL/min at 17:21 for the remainder of the treatment 07/03/2025 - the BFR was set to 450 mL/min at 10:22, changed to 400 mL/min at 11:44 for the remainder of the treatment 07/01/2025 - the BFR was set to 450 mL/min at 10:26, changed to 400 mL/min at 10:41, changed to 300 mL/min at 11:49 for the remainder of the treatment No documentation for changes in BFR or signed Against Medical Advice (AMA) forms were found in the treatment records. Patient #5 Patient #5 ’ s medical record review on 07/15/2025 revealed the prescribed BFR of 350mL/min. The following dialysis treatment was not delivered as prescribed: 07/10/2025 - BFR set at 350mL/min at 13:50, changed to 300mL/min at 15:42, and back to 350mL/min at 16:43 No documentation or rationale was found in the treatment record as to why the hemodialysis treatment was not given as prescribed. Patient #6 Patient #6 ’ s medical record review on 07/15/2025 revealed the prescribed BFR of 450mL/min. The following dialysis treatments were not delivered as prescribed: 07/08/2025 - BFR set at 450mL/min at 16:03, changed to 400mL/min at 16:42 for the remainder of the treatment 07/05/2025 - BFR set at 450mL/min at 15:37, changed to 350mL/min at 16:41 for the remainder of the treatment No documentation or rationale was found in the treatment records as to why the hemodialysis treatment was not given as prescribed. Employee #1 confirmed on 07/16/2025 that Patients #1, 2, 3, 4, 5, and 6 did not receive their hemodialysis treatments as prescribed by their nephrologists.”