032550 North Phoenix Dialysis (Fmc)

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff performed hand hygiene between patient stations and prior to donning gloves to provide patient care which has the potential risk of increased infection to patients through contact transmission and cross contamination. 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...Before and after direct contact with patients...After contact with inanimate objects near the patient...After contact with other objects within the patient station or treatment space....” Observation on 02/07/2024 revealed Employee #17 gather clean fistula clamps in bare hands and walk to Station #2 where s/he hung a clamp on the dialyzing patient’s IV pole, then walk to Station #3 and hung another fistula clamp on the dialyzing patient’s IV pole, then walk to Station #7 and hand a third clamp on anther dialyzing patient’s IV pole. The patient’s machine at Station #8 alarmed during these observations. Employee #17 donned gloves without performing hand hygiene between three dialysis stations and answering a machine alarm at a fourth dialysis station. Observation on 02/07/2024 revealed Employee #20 wear the same pair of gloves into three dialysis stations before removing the gloves and performing hand hygiene. Observation on 02/07/2024 revealed Employee #11 ending the patient’s treatment at Station #15. Employee #11 donned gloves, removed and replaced his/her eye protection while adjusting the machine settings, and continued to terminate the patient’s treatment and draw post treatment labs without removing his/her gloves, hand sanitizing, and donning clean gloves after contaminating them. Employees #1 and 2 confirmed on 02/7/2024 that staff did not follow facility policy for hand hygiene.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure nurses cleaned and disinfected their stethoscope between and after use on multiple patients which poses a potential risk of increased infection for patients through contact transmission and cross contamination of pathogenic organisms that may be harbored on the dirty stethoscope. Findings include: The facility policy titled “Cleaning and Disinfecting the Dialysis Station” requires: “...The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between used...Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease...Dialysis station...General Cleaning...After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station....” Observation on 02/07/2024 revealed Employee #20 use a stethoscope to assess the patient at Station #16. Employee #20 placed the used stethoscope around his/her neck afterwards without cleaning and disinfecting the stethoscope. Employee #20 used the dirty stethoscope to assess the patient ending treatment at Station #17 placed the dirty stethoscope around his/her neck, then returned to the nurse’s station to document in the patients’ medical records. Observation on 02/07/2024 revealed Employee #20 using a stethoscope to assess a patient beginning treatment at Station #17. Employee #20 placed the dirty stethoscope around his/her neck, used gloved hands to pump hand sanitizer from a bottle in a dispenser on the side of the patient’s machine, and then rub his/her gloved hands together several times, then wipe the hand sanitizer on the stethoscope and hang it around his/her neck. The EPA.gov website revealed: “...Using hand sanitizer kills pathogens on skin...hand sanitizers are regulated by the Food and Drug Administration (FDA)...Surface disinfectant products are subject to more rigorous EPA testing requirements and must clear a higher bar for effectiveness than surface sanitizing products. Many products are registered with EPA as both sanitizers and disinfectants because they’ve been tested using both methods. EPA-registered sanitizers and disinfectants may also contain cleaning agents....” Employee #2 confirmed on 02/07/2024 that the nurse did not disinfect his/her stethoscope between use on multiple patients at different stations as required by policy with bleach solution or EPA registered disinfectant.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff thoroughly cleaned and disinfected the dialysis station after use which has the potential risk of spread of infection between patients. Findings include: The facility policy titled “Cleaning and Disinfecting the Dialysis Station” requires: “...General Cleaning...The dialysis station could become contaminated with blood and other body fluids during treatment...Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment....” Observation on 02/07/2024 revealed Employee #17 cleaning and disinfecting the vacated dialysis Station #2. Employee #17 failed to disinfect all surfaces of the machine with bleach solution and missed the YubiKey scanner device and wiring on the side of the dialysis machine. Observation on 02/07/2024 revealed Employee #11 cleaning and disinfecting the vacated dialysis Station #15. Employee #11 failed to disinfect all surfaces of the machine with bleach solution and missed the YubiKey scanner device and wiring, as well as missed the four IV pole hangers. Employee #1 and 2 confirmed on 02/07/2024 that staff did not clean and disinfect all surfaces of the dialysis machine as required by 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: 37489 Based on observation, manufacturer’s recommendations, and interview, it was determined that the facility failed to ensure staff labeled a multi-dose medication vials when opened. Failure to label medication vials when opened with an expiration date prevents staff from knowing when to discard the vial which increases the risk a patient will receive a medication that is no longer stable, and that may be contaminated due to reduction of preservative efficacy as well as an increased exposure to pathogens from accessing a vial multiple times. Findings include: The facility policy titled “Medication Preparation and Administration” requires: “...Labeling vials...When preparing medications if the vial is not used immediately in its entirety, the nurse...must place the date and time the vial was opened on the medication label along with their initials. Note: To ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened....” Observation on 02/07/2024 revealed an open vial of Tubersol that was not labeled and dated in the medication refrigerator. Employees #1 and 2 confirmed on 02/07/2024 that the open multi-dose Tubersol vial was not dated and labeled as required by 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: 37489 Based on document review, observation, and staff interview, it was determined that the facility failed to ensure: 1. staff secured patient medications when not in use; and 2. staff discarded expired emergency medications and supplies in the crash cart. Failure to discard expired medications and secure medications when not in use has the potential risk patient will receive unstable, ineffective, contaminated, and/or tampered with medications and supplies. Findings include: 1. and 2. The facility policy titled “Medication Preparation and Administration” requires: “...Monitoring Expired Medications...Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law...Securement...All medications will be kept in a locked cabinet except when in use....” 1. Observation on 02/07/2024 revealed an unlocked medication cabinet that contained multiple boxes of unopened and opened, in use multidose vials of Heparin and Lidocaine for injection. Employee #2 confirmed on 02/07/2024 that staff did not lock and secure the aforementioned medications as required by policy. 2. Observation on 02/06/2024 revealed the following expired medications in the emergency medications/crash cart in the home therapies treatment area. Sodium Bicarbonate 50 ml vial expired 02/01/2024 Sodium Chloride 250 ml bag expired January 2024 (2) Sodium Chloride 10 ml prefilled syringes expired 12/31/2023 (2) SysLoc MINI AV Fistula Needle Sets expired 01/24/2024 Employee #5 confirmed on 02/06/2024 that expired medications and supplies were not removed from the emergency medication box in the crash cart as required.”

“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: 37489 Based on document review and interview, it was determined that the facility failed to ensure biomedical technical staff accurately documented in dialysis equipment maintenance records and performed annual preventive maintenance as required in the manufacturer’s directions for use (DFU) which has the potential for patient injury or harm if dialysis machines are not maintained and normal operation is not verified. Findings include: The document titled “2008T HEMODIALYSIS SYSTEM PREVENTATIVE MAINTENANCE PROCEDURES” requires: “...Preventive Maintenance for the 2008T Hemodialysis System...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...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...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 and corresponding maintenance, as well as preventive maintenance not performed in the required interval according to the manufacturer’s DFU. The following dialysis machine records contained inaccurate documentation of hours in operation and that preventive maintenance was not performed within the manufacturer’s DFU after 4000 hours of operation. Dialysis machine 2T0S-111918 11/22/2023: clock hours 53,516 Diasafe 11/29/2023: clock hours 47,540 Annual PM 01/07/2024: clock hours 53,933 Diasafe Dialysis machine 2T0S-111987 11/22/2023: clock hours 55,131 Diasafe 12/13/2023: clock hours 5,070 Annual PM 01/07/2024: clock hours 55,654 Diasafe Dialysis machine 3T0S-120598 03/05/2023: clock hours 44,279 Diasafe 05/08/2023: clock hours 47,732 Diasafe 07/19/2023: clock hours 13,867 Annual PM 08/21/2023: clock hours 47,098 Diasafe Dialysis machine 3T0S-120675 03/05/2023: clock hours 42,364 Diasafe 05/08/2023: clock hours 45,288 Diasafe 07/19/2023: clock hours 29,761 Annual PM 08/21/2023: clock hours 21,434 Diasafe Dialysis machine 3T0S-120723 03/05/2023: clock hours 43,890 Diasafe 05/08/2023: clock hours 44,347 Diasafe 07/19/2023: clock hours 23,467 Annual PM 08/21/2023: clock hours 27,434 Diasafe 09/13/2023: clock hours 23,758 Diasafe 11/22/2023: clock hours 239,873 Diasafe 01/04/2024: clock hours 24,620 Annual PM Dialysis machine 3T0S-120746 03/05/2023: clock hours 43,054 Diasafe 05/08/2023: clock hours 46,842 Diasafe 07/19/2023: clock hours 22,243 Electrical leakage 07/19/2023: clock hours 24,443 Annual PM 08/21/2023: clock hours 47,089 Diasafe Dialysis machine 3T0S-120756 08/21/2023: clock hours 45,921 Diasafe 08/21/2023: clock hours 45,089 Electrical Leakage Test 08/21/2023: clock hours 43,076 Annual PM Dialysis machine 3T0S-121099 03/05/2023: clock hours 42,185 Diasafe 04/13/2023: clock hours 40,406 Electrical leakage test 04/13/2023: clock hours 20,406 Annual PM 05/08/2023: clock hours 47,642 Diasafe 08/21/2023: clock hours 21,723 Diasafe Dialysis machine 3T0S-121186 05/08/2023: clock hours 43,675 Diasafe 06/23/2023: clock hours 46,323 Electrical leakage test, Annual PM 09/13/2023: clock hours 4,605 Diasafe 11/22/2023: clock hours 48,036 Diasafe 12/13/2023: clock hours 55,408 Annual PM 12/13/2023: clock hours 5,070 Electrical leakage test Employee #24 and 26 confirmed on 02/07/2024 that equipment records were not accurate and machines were not serviced according to the manufacturer’s DFU. Employees #24 and 26 confirmed that equipment logs used to track, monitor, and perform preventive maintenance for dialysis machines contained numerous inaccurate entries for machine clock hours which is used to determine preventive maintenance timeframes based on the manufacturer’s DFU.”