Valleywise Comprehensive Health Center- Phoenix Outpatient Dialysis Unit.

“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 (5) of (6) patient ’ s (Patients #11,12,13,14, and 15) vascular access which poses the potential risk of vascular access and/or blood stream infection. Findings include: The facility protocol titled “Outpatient Dialysis: Hemodialysis Procedure - Patient” requires “...Approved cleanser for AVF/AVG or CVC access ...Alcohol swabs: apply using rubbing motion for 30 sec (sic), allow to dry ....” Observation on 08/26/2025 revealed the following: Employee #8 disinfecting the Patient #11 ’ s vascular access with alcohol swabs. Employee #8 disinfected the arterial site for 31 seconds prior to cannulating the site with a fistula needle. Employee #8 then disinfected the venous site for 22 seconds prior to cannulating the site with a fistula needle. Employee #11 disinfecting the Patient #12 ’ s vascular access with alcohol swabs. Employee #11 disinfected the arterial site for 23 seconds prior to cannulating the site with a fistula needle. Employee #11 then disinfected the venous site for 26 seconds prior to cannulating the site with a fistula needle. Employee #8 disinfecting the Patient #13’s vascular access with alcohol swabs. Employee #8 disinfected the arterial site for 21 seconds prior to cannulating the site with a fistula needle. Employee #8 then disinfected the venous site for 23 seconds prior to cannulating the site with a fistula needle. Employee #11 disinfecting the Patient #14 ’ s vascular access with alcohol swabs. Employee #11 disinfected the arterial site for 31 seconds prior to cannulating the site with a fistula needle. Employee #11 then disinfected the venous site for 22 seconds prior to cannulating the site with a fistula needle. Employee #8 disinfecting the Patient #15 ’ s vascular access with alcohol swabs. Employee #8 disinfected the arterial site for 33 seconds prior to cannulating the site with a fistula needle. Employee #8 then disinfected the venous site for 24 seconds prior to cannulating the site with a fistula needle. Employee #1 and 2 confirmed on 08/26/2025 that Employees #8 and 11 did not disinfect Patients #11, 12, 13, 14, and 15 ’ s vascular access according to facility protocol.”

“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: 52534 Based on document review, documentation, and interview, it was determined that the facility failed to ensure staff appropriately disinfected their stethoscopes. This deficient practice poses the potential risk of cross contamination if medical equipment is not disinfected correctly. Findings include: The facility policy titled “Ambulatory Services (Hemodialysis): Infection Control Guidelines for Outpatient Dialysis” requires “...To reduce opportunities for patient-to-patient transmission of infectious agents, directly or indirectly through contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel ....Clean and disinfect...equipment used in the dialysis station per manufacturer ’ s guidelines using a Valleywise Health approved disinfectant between patients ....Prevent cross contamination between patients ....” The document titled “Dialysis In Service: Stethoscope Care and Cleaning” revealed “...Stethoscopes come into direct contact with patients ’ skin making them potential carriers of bacteria, viruses, and other pathogens. Regular cleaning helps minimize the risk of transmitting infections between patients ....Regular cleaning ensures compliance with these regulations ....Clean it with an alcohol wipe, or a wipe dipped in an appropriate cleaning solution ....Ensure that all parts and surfaces are dried thoroughly before reassembly ....” Observation on 08/26/2025 revealed Employee #11 with their stethoscope around their neck. Employee #11 went to Station 9 to retrieve an empty acid jug. Employee #11, with their stethoscope around their neck, took the empty jug to the soiled utility room. Employee #11 disposed of the jug and returned to the treatment floor. Employee #11 then charted at the mobile charting station, walked to Station 9 and terminated the patient ’ s treatment. Employee #11 then picked up the patient ’ s blanket to fold and put in the patient’s bag. The patient ’ s blanket touched the stethoscope around Employee #11 ’ s neck. Employee #11 then walked the patient from Station 9 to the lobby. Employee #11 returned from the lobby and went to Station 6 to terminate the patient ’ s treatment. Employee #11 then returned to the mobile charting station with the stethoscope around their neck. Employee #11 did not disinfect their stethoscope during this observation. Observation on 08/26/2025 revealed Employee #6 with their stethoscope around their neck. Employee #6 went to Station 2 to assess the patient, returned to the nurses station, and wiped the bell and diaphragm of the stethoscope with an alcohol pad, and placed the stethoscope around their neck. Employee #6 returned to the mobile charting station and charted the patient assessment. Employee #6 then went to Station 1 with the stethoscope around their neck, assessed the patient, placed the stethoscope around their neck and returned to the nurses station. Employee #6 then disinfected the bell and diaphragm of the stethoscope with an alcohol pad while the stethoscope was around their neck. Employee #6 then charted at the mobile charting station with the stethoscope around their neck. Employee #6 then went to Station 3 and assessed the patient and returned to the nurses station. Employee #6 then disinfected the bell and diaphragm of the stethoscope with an alcohol pad, and placed it around their neck. Employee #6 did not disinfect the earpieces or tubing of the stethoscope during this observation. Observation on 08/26/2025 revealed Employee #3 wearing their stethoscope with the earpieces around their neck, and the bell and diaphragm hanging at the employee ’ s waist. Employee #3 went to Station 9 to assess the patient, and placed the stethoscope around their neck. Employee #3 returned to the mobile charting station and placed the stethoscope on the keyboard. Employee #6 then placed the earpieces of the stethoscope around their neck, with the bell and diaphragm hanging at their waist and went to Station 10 to assess the patient. Employee #3 then terminated the treatment at Station 10 and escorted the patient to the lobby. Employee #3 then started to disinfect Station 10. Employee #3 ’ s stethoscope was dangling from their neck, and Employee #3 swung the stethoscope with their arm to their back. The bell and diaphragm of the stethoscope fell between the gap of Employee #3 ’ s gown and was resting on their scrubs underneath their gown. Employee #6 continued to disinfect Station 10 with the part of the stethoscope beneath their gown. Employee #6 then left Station 10 to retrieve clean supplies, and pulled the bell and diaphragm off their back, and it hung at their waist. Employee #3 then returned to Station 10 with clean supplies. Employee #3 began setting up the station with clean supplies, with the bell and diaphragm of the stethoscope swinging from Employee #3 ’ s neck and hitting the clean chair and blood pressure cuff. Employee #3 finished setting up Station 10 and returned to the mobile charting station with the stethoscope still hanging from their neck. Employee #3 did not disinfect their stethoscope during this observation. Employees #1, 2, and 19 confirmed on 08/26/2025 that stethoscopes should be cleaned before and after being brought into the dialysis station and between clean and dirty areas. Employees #1, 2, and 19 further confirmed on 08/26/2025 that Employees #3, 6, and 11 did not disinfect their stethoscopes as required by facility policy.”

“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: 52534 Based on document review, documentation, and interview, it was determined that the facility failed to ensure staff appropriately disinfected the dialysis station following patient treatment. This deficient practice poses the potential risk of cross contamination if the dialysis station is not properly disinfected between patients. Findings include: The facility policy titled “Ambulatory Services (Hemodialysis): Infection Control Guidelines for Outpatient Dialysis” requires “...Clean and disinfect the treatment station at the end of each patient treatment ....Prevent cross contamination between patients ....” Observation on 08/26/2025 revealed Employee #8 at Station 1. Employee #8 helped the patient put their belongings in their bag, and assisted the patient to stand and started taking a blood pressure. While the blood pressure was being taken, Employee #8 left the station to retrieve Super Sani-Cloth Sanitizing Wipes to disinfect the station. Employee #8 returned to Station 1 with a handful of Super Sani-Cloth Sanitizing Wipes and placed them on the machine. Employee #8 removed the blood pressure cuff from the patient, escorted the patient to the scale, and then escorted the patient to the lobby. Employee #8 returned to Station 1 and started to disinfect the station with the wipes that were placed on the machine. Employee #8 did not disinfect the acid jugs that were stored on the bottom of the machine. Further observation on 08/26/2025 revealed Employee #8 disinfecting Station 2. Employee #8 did not disinfect the acid jugs that were stored on the bottom of the machine. Further observation on 08/26/2025 revealed Employee #8 at Station 3. Employee #8 adjusted the blood pressure cuff on the patient’s arm and started taking a blood pressure. While the blood pressure was being taken, Employee #8 left the station to retrieve Super Sani-Cloth Sanitizing Wipes to disinfect the station. Employee #8 returned to Station 3 and placed the Super Sani-Cloth Sanitizing Wipes on the machine, while the patient was still in the chair. Employee #8 then assisted the patient to stand, escorted them to the scale, and then escorted the patient to the lobby. Employee #8 returned to Station 3 to disinfect the machine. Employees #1 and 19 confirmed on 08/26/2025 that patients should fully vacate the treatment station before disinfection of the station can begin, and that all items at the dialysis stations are required to be disinfected. Employees #1 and 19 further confirmed on 08/26/2025 that Employee #8 did not disinfect the dialysis stations 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. This deficient practice 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 “Out-Patient Dialysis and In-Patient Dialysis: Total Chlorine Testing, RPC Ultra-Low Total Chlorine” requires “...Two qualified staff members are to take part in determining that the level of Total Chlorine in water used to prepare dialysis fluid is within the ’ standard ’ of less than 0.1 ppm Total Chlorine ...Perform a total chlorine test post carbon tank #1. Post Carbon tank #1 test result should be less than or equal to 0.1 ppm total chlorine using the color comparator supplied with the RPC Ultra-Low Total Chlorine Test Strip package. If the value post carbon tank #1 is greater than 0.1 ppm, retest post carbon tank #1 to verify the test result was not a false positive. If the second test is still greater than 00.1 ppm, you must test after the secondary carbon tank #2 for a value of less than 0.1 ppm ....If post-secondary carbon tank #2 test results are less than 0.1 ppm, dialysis treatments may be performed. Total chlorine testing post-secondary carbon tank must continue to be completed every 30 minutes until all dialysis treatments are completed for that day ....” Observation on 08/25/2025 revealed Employees #7 and 10 performing a chlorine test in the water room. When asked what actions the employees would take if the initial chlorine test came back above allowable levels, Employee #7 verbalized retesting the primary tank and then corrected themselves and said test the secondary tank. Employee #10 verbalized notifying the medical director and waiting for direction. Observation on 08/26/2025 revealed Employees #2 and 8 performing a chlorine test in the water room. When asked what actions the employees would take if the initial chlorine test came back above allowable levels, Employee #8 verbalized retesting primary, then retesting secondary. If the secondary tank was within acceptable limits then testing would resume every 2 hours. Employee #2 corrected Employee #8, that testing would resume every 30 minutes. Employee #17 confirmed on 08/26/2025 that Clinical Staff would be required to re-test the primary carbon tank, then if results are still high, test the secondary carbon tank. If the secondary tank is within acceptable limits, the clinic staff should proceed with chlorine testing every 30 minutes. Employee #17 further confirmed on 08/26/2025 that Employees # 7,8 and 10 did not provide steps for chlorine breakthrough as outlined in facility policy.”

“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 (2) of (5) patients (Patients #8 and 9) received hemodialysis treatments as ordered by their nephrologist. Failure to follow physician orders poses the potential risk of inadequate dialysis, decreased clearances and hospitalizations. Findings include: The facility protocol titled “Outpatient Dialysis: Hemodialysis Procedure - Patient”” requires “...Administer the prescribed hemodialysis treatment ...Components of the hemodialysis prescription include:...Blood flow rate ...Initiation of Hemodialysis ...After 2-5 minutes increase the blood pump to the ordered blood flow rate (BFR)....Intradialytic Patient Assessment and Management ...The RN will reassess the patient within 1 hour of treatment initiation to assure chronic hemodialysis physician orders are being followed ...” The facility policy titled “Outpatient Dialysis: Physician Notification of Changes in Dialysis Patient Condition” requires “...Reasons to notify the physician include ...Variance from physician orders ....” Patient #8 Patient #8 ’ s medical record review on 08/25/2025 revealed a prescribed Blood Flow Rate (BFR) of 500 mL/min. The treatment sheet dated 08/12/2025 revealed the BFR was changed from 500 mL/min to 450 mL/min at 0530. No documentation or rationale for the change was documented in the medical record. Patient #9 Patient #9 ’ s medical record review on 08/25/2025 revealed a prescribed BFR of 400 mL/min. The following treatments were not delivered as prescribed: 08/23/2025: BFR was set to 450 for the entirety of the treatment 08/21/2025: BFR was set to 450 for the entirety of the treatment 08/12/2025: BFR was set to 450 for the entirety of the treatment 08/09/2025: BFR was set to 450 for the entirety of the treatment No documentation or rationale for the changes were documented in the medical record for the above dates. Employees #1, 2, and 7 confirmed Patients #8 and 9 did not receive their hemodialysis treatments as prescribed by their nephrologist, and the documentation required by facility policy and protocol for the deviation from physician orders was not present in the medical records.”