032521 Dialysis Center of Glendale (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 Arizona state rules were followed regarding policy and procedures for medication receiving, storing, inventorying, tracking, dispensing, returning, and/or discarding. This deficient practice poses the potential risk to patient safety which includes but is not limited to tampering, contamination, substitution, diversion of medication, and/or inability to track cases of adverse events involving medication not prescribed to an individual. Findings include: 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 “...For patients who choose to have their medications shipped to their dialysis clinic, the clinic muse:...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 ...All pharmacy medication packages received at the facility will be tracked using the Clinic FRx Delivery Log ....The staff person delivering the medications (as allowed by state) must: document on the Clinic FRx Delivery Log that the package was delivered to the correct patient ...” Observation on 12/16/2025 revealed 12 medications stored in the facility ’ s FRx medication storage cabinet. Review of the facility document titled “Clinic FRx Delivery Log” on 12/07/2025 revealed 12 medications had been received by the clinic between 11/14/2025 and 12/16/2025. Of the 12 medications found in the FRx medication storage cabinet, 10 were accounted for on the Clinic FRx Delivery Log. Two (2) of the medications found in the FRx medication storage cabinet were not associated with any of the medication shipments, tracking numbers, or medications that appear on the Clinic FRx Delivery Log. The origin of the medications, when the medications arrived at the facility, and how long the medications had been at the facility was unknown. Two (2) of the medications that were marked “Received” on the Clinic FRx Delivery Log were not found in the FRx medication storage cabinet, and could not be located within the facility. Employee #3 confirmed on 12/17/2025 that the medications were not tracked on the Clinic FRx Delivery Log as required by facility policy.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. 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 clean and dirty supplies were not stored together. This deficient practice poses the potential risk of infection through contract transmission and cross contamination. Findings include: The facility policy titled “Storage of Supplies” requires “...Supplies ...Definition ...Any product used to treat, care or allow testing of a patient, and any product used in the operation and testing of a medical device ...Store supplies away from other general use products ...” The facility policy titled “General Cleanliness and Infection Control Guidelines” requires “...All areas must be kept clean and organized ...” Observations on 12/16/2025 revealed the following: A supply drawer in the medication preparation area. In the drawer were multiple 3 mL syringes, multiple needles of various sizes, a box of bandaids, a box of alcohol prep pads, a glucometer, a box of staples, JiMMY protein bars, a calculator, a pair of scissors, and multiple Sharpie markers. A clear plastic bin on the technician station containing multiple sterile gauze pads, a box of bandaids, multiple sterile cotton swabs, a container of chlorine test strips, a pair of scissors, and an Expo marker. A clear plastic Biohazard bag containing multiple prepared put on packs containing fistula needles, alcohol pads, gauze and tape. Also stored in the bag was an employee ’ s personal cell phone. Employees #1, 2, and 3 confirmed on 12/16/2025 that the drawer, plastic bin, and plastic bag were a mix of clean and dirty supplies, and that the supplies in these locations were not stored 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 medications were stored in a secure manner. This deficient practice poses the potential risk of patients receiving contaminated or compromised medications. Findings include: The facility policy titled “Medication Preparation and Administration” requires “...All medications will be kept in a locked cabinet ...” Observations on 12/16/2025 revealed the following: At 09:07 a medication cabinet containing various oral and intravenous medications was found unlocked and unattended. At 10:41 a medication lock box containing multiple vials of heparin was found open and unattended at the technician station. At 11:53 a medication lock box containing multiple vials of heparin was found open and unattended at the technician station. At 11:59 a registered nurse (RN) was observed at the medication preparation area preparing oral medications. The RN left the medication preparation area and did not lock the medication cabinet. Employees #13 and 21 confirmed on 12/16/2025 that the medication cabinets and lock boxes were not locked according to facility policy.”

“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: 52993 Based on document review and interview, it was determined that the facility failed to ensure biomedical technical staff accurately documented in the dialysis equipment maintenance records and performed annual preventive maintenance as required in the manufacturer’s directions for use (DFU). This deficient practice poses the potential risk of patient injury or harm if dialysis machines are not maintained and normal operation is not verified. Findings include: The document titled “2008T Machine Operator’s Manual” referenced preventive maintenance in the “2008T Hemodialysis System Preventive Maintenance Procedures” document as follows. The document titled “2008T HEMODIALYSIS SYSTEM PREVENTIVE MAINTENANCE PROCEDURES” requires: “...Preventive Maintenance for the 2008T Hemodialysis System...Failure to install, operate and maintain this equipment according to the manufacturer’s instructions may cause injury or death to the patient or the operator ...Scheduled maintenance is performed based on timed intervals or number of hours a machine is operated, whichever comes first. The time and hours intervals are as follows: ...Machines without...with Extended Life Pump Components...Six (6) months...Annually or after 4000 hours of operation...Included in the Preventive Maintenance procedures are tests to verify normal machine operation....” The “FKC EQUIPMENT RECORD” for preventive maintenance and work orders for the last 12 months for dialysis machines was reviewed and found to have discrepancies in record keeping for tracking machine hours. The following dialysis machine records contained inaccurate documentation of hours in operation and that preventive maintenance was not performed within the manufacturer’s DFU. Dialysis machine 2T0S111620 5/19/2025: clock hours 39,256 5/21/2025: clock hours 39785 Dialysis machine 4T0S-126399 1/23/2025: clock hours 53,343 1/23/2025: clock hours 52,243 3/23/2025: clock hours 52,959 5/18/2025: clock hours 52,344 Dialysis machine 4T0S-126537 04/07/2025: clock hours 54,056 05/18/2025: clock hours 53,867 Dialysis machine 4T0S-126587 03/23/2025: clock hours 51,069 05/18/2025: clock hours 51,066 Dialysis machine 4T0S-126958 04/08/2025: clock hours 54,194 05/18/2025: clock hours 53,466 Dialysis machine 4T0S-126971 03/23/2025: clock hours 51,311 05/18/2025: clock hours 51,025 07/06/2025: clock hours 52,830 08/05/2025: clock hours 52,310 Dialysis machine 4T0S-126982 07/06/2025: clock hours 53,953 08/08/2025: clock hours 53,420 Dialysis machine 4T0S-126993 05/18/2025: clock hours 52,455 05/23/2025: clock hours 51,965 05/26/2025: clock hours 52,677 Dialysis machine 4T0S-126994 05/15/2025: clock hours 49,987 05/18/2025: clock hours 49,034 Dialysis machine 4T0S-127012 02/06/2025: clock hours 51,640 03/23/2025: clock hours 51,492 05/18/2025: clock hours 51,234 07/06/2025: clock hours 53,706 08/08/2025: clock hours 51,492 08/12/2025: clock hours 51,492 09/07/2025: clock hours 51,492 Dialysis machine 4T0S-127013 03/23/2025: clock hours 52,542 05/18/2025: clock hours 52,899 07/06/2025: clock hours 54,108 08/14/2025: clock hours 53,946 Dialysis machine 4T0S-127014 03/23/2025: clock hours 52,872 05/21/2025: clock hours 52,322 05/18/2025: clock hours 52,456 05/20/2025: clock hours 52,344 11/05/2025: clock hours 56,028 11/09/2025: clock hours 55,982 Dialysis machine 4T0S-127016 03/06/2025: clock hours 51,874 03/06/2025: clock hours 51,897 03/23/2025: clock hours 52,039 05/18/2025: clock hours 51,675 Dialysis machine 4T0S-127032 03/18/2025: clock hours 52,254 03/23/2025: clock hours 52,235 05/18/2025: clock hours 51,876 09/07/2025: clock hours 54,966 09/07/2025: clock hours 55,102 09/10/2025: clock hours 55,102 11/09/2025: clock hours 54,676 Dialysis machine 4T0S-127039 03/23/2025: clock hours 53,323 05/18/2025: clock hours 52,656 06/10/2025: clock hours 55,876 07/06/2025: clock hours 54,866 Dialysis machine 4T0S-127040 03/23/2025: clock hours 51,963 05/18/2025: clock hours 51,567 Dialysis machine 4T0S-127058 07/06/2025: clock hours 54,393 09/07/2025: clock hours 55,318 09/12/2025: clock hours 54998 Dialysis machine 4T0S-127090 05/18/2025: clock hours 49,786 06/20/2025: clock hours 47,781 07/06/2025: clock hours 46,387 09/07/2025: clock hours 47,403 Employee #24 confirmed on 12/17/2025 that clock hours used to determine timeframes for performing dialysis machine preventive maintenance were not logged accurately in the facility equipment record, making it difficult to determine if the DFU for machine maintenance was followed.”

“PE-COMFORTABLE TEMPERATURE CFR(s): 494.60(c)(2) The dialysis facility must: (i) Maintain a comfortable temperature within the facility; and (ii) Make reasonable accommodations for the patients who are not comfortable at this temperature. This Standard is not met as evidenced by: 52534 Based on document review, observation and interview, it was determined that the facility failed to maintain a comfortable temperature in the dialysis treatment area. This deficient practice poses the 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 Occupancies 1.5.2 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 12/16/2025 revealed the treatment floor temperature was controlled by two thermostats. One was mounted by the lab area, and one mounted by Station 15. Both thermostats were set to 70°F. Observations on 12/16/2025 of the thermostat by the lab area revealed the following readings: At 09:31 70°F At 09:52 70°F At 10:42 70°F At 11:42 68 °F Observations on 12/16/2025 of the thermostat by Station 15 revealed the following readings: At 09:25 70°F At 09:53 70°F At 10:43 70°F At 11:43 70°F The following temperature readings were taken with a Triplett Mini Infrared Thermometer at various places on the treatment floor on 12/17/2025: The Northeast corner of the treatment floor was 69°F The center of the East wall of the treatment floor was 71°F The Southeast corner of the treatment floor was 70°F The center of the South wall of the treatment floor was 70°F The center of the West wall of the treatment floor was 66.5°F The Northwest corner of the treatment floor was 65.5°F The lab area of the treatment floor was 71°F Employee #11 stated on 12/16/2025 that the temperature of the dialysis treatment area was cold and is uncomfortable for staff and patients. Patient #15 stated on 12/16/2025 that a jacket, blanket, and head covering is needed to be warm enough during treatment. Employee #3 confirmed on 12/17/2025 that the thermostats in the treatment area are set to 70°F.”

“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: 52993 Based on document review and interview, it was determined that the facility failed to ensure staff followed hemodialysis (HD) treatment orders for prescribed BFR (blood flow rate) for (3) of (5) patients (Patients #3, 4, and 5). This deficient practice has the potential for increased risk of adverse events related to electrolyte imbalance, inadequate dialysis and fluid removal, and other factors if the nephrologists’ orders are not followed. Findings include: Facility policy, “Patient Assessment and Monitoring,” requires: “...Machine Parameters ...Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow ....” Patient #3 Patient #3 ’ s HD treatment order revealed a prescribed blood flow rate (BFR) of 400. Treatment sheets revealed BFRs were not delivered as prescribed as follows: 12/02/2025: BFR initiated at 300 at 12:10 The medical records did not contain documentation of the rationale for why the prescribed BFR was not delivered as ordered. Patient #4 Patient #4 ’ s HD treatment order revealed a prescribed blood flow rate (BFR) of 450. Treatment sheets revealed BFRs were not delivered as prescribed as follows: 12/04/2025: BFR initiated at 300 at 10:39 12/11//2025: BFR changed from 400 to 350 at 11:42 The medical records did not contain documentation of the rationale for why the prescribed BFR was not delivered as ordered. Patient #5 Patient #5 ’ s HD treatment order revealed a prescribed blood flow rate (BFR) of 400. Treatment sheets revealed BFRs were not delivered as prescribed as follows: 12/05/2025: BFR changed from 400 to 350 at 15:01, BFR changed from 300 to 275 at 16:07 12/12/2025: BFR changed from 400 to 350 at 18:23 The medical records did not contain documentation of the rationale for why the prescribed BFR was not delivered as ordered. Employee #3 confirmed on 12/17/2025, that Patients #3, 4 and 5’s treatments were not delivered at the prescribed BFR and the records contained no documentation of why the prescription was not followed.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 52993 Based on document review and interview, it was determined that the facility failed to ensure staff notified the nurse and provided a documented nursing assessment for (4) of (5) patients (Patients #1, 3, 4 and 5) when the patient’s blood pressure (BP) and/or heart rate (HR) was out of range. This deficient practice poses the potential risk of cardiovascular compromise and hospitalization if there is not adequate oversight and care provided by the registered nurse and dialysis staff. Findings include: Facility policy, “Patient Assessment and Monitoring,” requires: “...Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed ...Blood Pressure ...Verify: ...Systolic blood pressures greater than 180 mm/Hg and diastolic blood pressures greater than 100 mm/Hg ...Systolic blood pressures less than or equal to 100 mm/hg systolic during treatment ...Pulse ...Verify manually if automated readings display below 60 or greater than 100 beats per minute ...Assess patient for symptoms ...shortness of breath, chest pain or cough, cramping, loss of appetite or vomiting or diarrhea ....Report to the nurse ....” Patient #1 Patient # 1 had a “Special Attention ...2025 Incenter Hemodialysis Standing Orders” requiring: “...Okay to run patient with SBP>/=180 and asymptomatic per MD. Notify Md if SBP>/= 220 ....” The treatment sheet dated 12/01/2025 revealed the following: Pre-dialysis BP 223/98 15:56 BP 223/88 at 16:08 BP 230/115 at 16:23 BP 208/95 at 16:28 BP 211/90 at 16:46 No documentation was provided regarding a notification of the elevated BP to the nurse, a nursing assessment of the patient’s symptoms, or notification to the nephrologist. The treatment sheet dated 11/23/2025 revealed the following: Pre-dialysis BP 165/117 at 16:43 BP 223/98 at 16:52 BP 227/97 at 16:52 No documentation was provided regarding a notification of the elevated BP to the nurse, a nursing assessment of the patient’s symptoms, or notification to the nephrologist. Patient #3 Patient #3 had a “Special Attention ...2025 Incenter Hemodialysis Standing Orders” requiring: “...OKay to run patient if HR at 40s as long as asymptomatic ...MD okay to resume HD as long as asymptomatic if DBP at high 40s to 50s ....” The treatment sheet dated 12/13/2025 revealed the following: Pre-dialysis “BPSIT” 193/71, “BPSTAND” 188/67, HR 54 at 11:47 BP 192/72 at 12:00 - The patient care technician noted “rn aware of elevated bp” No documentation was provided regarding a notification of the elevated BP to the nurse or nursing assessment of the patient’s symptoms. The treatment sheet dated 12/04/2025 revealed the following: Pre-dialysis HR 54 at 11:35 The patient ’ s HR range from 48-52 throughout treatment. No documentation was provided regarding a nursing assessment of the patient’s symptoms. The treatment sheet dated 12/02/2025 revealed the following: BP 186/71 at 12:10 No documentation was provided regarding a notification of the elevated BP to the nurse or nursing assessment of the patient’s symptoms. Patient #4 The treatment sheet dated 12/13/2025 revealed the following: Pre-dialysis “BPSIT” 195/99, “BPSTAND” 193/100 at 10:31 BP 190/101 at 10:42 BP 186/91 at 10:58 BP 184/97 at 11:44 BP 184/94 at 12:00 BP 187/87 at 12:22 BP 189/91 at 13:02 BP 172/105 at 13:41 No documentation was provided regarding a notification of the elevated BP to the nurse or nursing assessment of the patient’s symptoms. The treatment sheet dated 12/09/2025 revealed the following: Pre-dialysis BP 166/100 at 10:37 BP 189/92 at 10:51 BP 190/91 at 14:55 No documentation was provided regarding a notification of the elevated BP to the nurse or nursing assessment of the patient’s symptoms. The treatment sheet dated 12/04/2025 revealed the following: BP 183/91 at 14:03 BP 194/95 at 14:28 No documentation was provided regarding a notification of the elevated BP to the nurse or nursing assessment of the patient’s symptoms. The treatment sheet dated 12/02/2025 revealed the following: BP 184/93 at 10:44 BP 181/91 at 13:26 BP 188/90 at 13:42 BP 181/89 at 13:53 No documentation was provided regarding a notification of the elevated BP to the nurse or nursing assessment of the patient’s symptoms. Patient #5 The treatment sheet dated 12/10/2025 revealed the following: BP 185/95 at 16:27 BP 198/89 at 18:01 No documentation was provided regarding a notification of the elevated BP to the nurse or nursing assessment of the patient’s symptoms. The treatment sheet dated 12/15/2025 revealed the following: BP 219/104 at 16:03 BP 198/96 at 16:29 No documentation was provided regarding a notification of the elevated BP to the nurse or nursing assessment of the patient’s symptoms. Employee 3 confirmed on 12/17/2025, that Patients #1, 3, 4 and 5 did not have the required documentation of notifications or nursing assessments following out of range vital signs readings.”