032503 Phoenix Artificial Kidney Center (Fmc)

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 50568 Based on facility tour, review of policies and procedures, patient medical records, and staff interviews, it was determined that the facility failed to ensure that the building and equipment in which dialysis services are furnished be constructed and maintained for its’ designated use. The lack of maintaining a physical building poses a significant risk of impacting the health and safety of patients, staff, and the general public. The deficiency of maintaining safe is serious in nature, and may reflect both immediate and long term harm to patients, staff, and the general public. During an onsite survey of the water room conducted on August 6, 2024, two locations were found that pose a significant hazard to both staff and patient safety as it relates to water treatment portion of the medical facility. Location A, is the flooring located directly beneath Reserve Osmosis (RO) water system. The RO water system provides water that is used by dialysis patients during their treatments, and is a component of the patient blood being treated. The sealant under the RO System is warped and is cracked due to the presence of water. Upon further inspection, there is a sealant covering the underlying flooring which has separated due to presence of water between the two materials. Upon stepping on the sealant, additional water leaks from the crack where the sealant and flooring have separated. Location B, is the flooring located adjacent/under the water main and a booster pump. A pallet of bicarbonate bags was noted in the area, obstructing view of the area. During the survey, and upon request by surveyors, facility staff moved the pallet the of bicarbonate due to amount of significant water coming from underneath the epoxy sealant layer of the flooring in the area. Upon moving the pallet of bicarbonate, further review of the area noted both the presence of standing water, and significant warping of the sealant was noted. Upon stepping on the warping, additional water leaked from where the sealant and flooring had separated. As a result of these discoveries, CMS was contacted and approved an Immediate Jeopardy (IJ), with the relevant IJ Template was provided to Employee #20 on August 7, 2024. During an interview on August 7, 2024 Employee #20 confirmed the received an IJ template and was aware than an IJ had been called based on the above findings. (V401) fail to: ensure that the dialysis facility be maintained to provide dialysis patient, staff, and the public a safe, functional, and comfortable treatment, as evidenced by: the gaps between the layers of warped flooring present an area that would pose an infection control risk. (V402) failed to: ensure that 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 as evidenced by: The water treatment room had not been maintained regularly to ensure it free from defects that could ensure effective cleaning and would limit the potential for microbial growth. The findings of this problem within the facility’s Quality Assurance Improvement program (QAI) and Dialysis Facility Report (DFR) note an ongoing issue that has yet to be correctly by the facility in a manner that ensure patient safety. The cumulative effect of this systemic practice resulted in the failure of the ESRD facility to be in compliance with the Condition of Participation Pre-Building-Construction/Maintenance for Safety which requires administration to protect the health and safety of the patients and staff.”

“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: 45999 Based on observation, Centers for Disease Control and Prevention (CDC) guidelines, and staff interviews, the Department determined that the facility failed to ensure that facility equipment was free from debris and appropriately cleaned and disinfected. Failure to provide a clean and sanitary environment poses the potential risk of patient exposure to microorganisms and infectious cross-contamination among staff and patients. Findings include: A policy titled “Infection Control Overview” revealed “ ... The nature of dialysis, with frequent exposure to blood and body fluids, and proximity of patients and staff ...makes dialysis a high risk for spreading infectious diseases ...Housekeeping to ensure the environment is clean and sanitary ....” Centers for Disease Control and Prevention (CDC) document titled “Best Practices for Environmental Cleaning in Healthcare Facilities” [2019] revealed, “...environmental cleaning is a fundamental intervention for infection prevention and control....” Observation while on tour conducted on August 7, 2024, revealed the following: On the treatment floor, there were black dirt spots along all the edges of the cabinets, behind the machines and doorways. When prompted, these spots were easily wiped away with a bleach cloth, demonstrating that the floor was not being appropriately cleansed to ensure a clean and sanitary environment. During an interview conducted on August 7, 2024, Employee #1 confirmed that the area was not being regularly cleaned to ensure a clean and sanitary environment as per facility policy and CDC guidelines.”

“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: 45999 Based on a review of facility policy and procedure, observation, and staff interview, the Department determined that the facilty failed to ensure staff aseptically cleaned (4 of (4) patients’ vascular access prior to cannulation (Patients #15, #16, #17, and #18). Failure to adhere to infection control procedures prior to cannulation poses an increased risk of bloodstream and vascular access infection as bacteria at cannulation sites may not be reduced; and Findings include: The policy/procedure titled “Access Assessment and Cannulation”...Disinfect the cannulation site as follows using any of the disinfectants below...07% 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 August 7, 2024, revealed Employee #16, disinfecting patient #’15s vascular access in preparation for cannulation. Employee #16, used one alcohol pad to cleanse the arterial cannulation site for 30 seconds and the venous cannulation site for 28 seconds and proceeded to cannulate the arterial site and venous site without any further cleaning of the access. (station R) Observation on August 7, 2024, revealed Employee #17, disinfecting patient #16’s vascular access in preparation for cannulation. Employee #17, used one alcohol pad to cleanse the arterial cannulation site for 20 seconds and the venous cannulation site for 26 seconds and proceeded to cannulate the arterial site and venous site without any further cleaning of the access. Observation on August 7, 2024, revealed Employee #18, disinfecting patient #17’s vascular access in preparation for cannulation. Employee #18, used one alcohol pad to cleanse the arterial cannulation site for 10 seconds and no cleaning of the venous site and then proceeded to cannulate the arterial site and venous site without any further cleaning of the access. Observation on August 7, 2024, revealed Employee #19, disinfecting patient #18’s vascular access in preparation for cannulation. Employee #19, used one alcohol pad to cleanse the arterial cannulation site for 25 seconds and the venous cannulation site for 20 seconds and proceeded to cannulate the arterial site and venous site without any further cleaning of the access. Employee #20, verified during an interview conducted on August 7, 2024 that staff did not follow appropriate policy and procedures for cannulation of an AV fistula.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 49430 Based on document review and staff interview, the Department determined, b that the facility failed to ensure compliance with the Life Safety Code (LSC) of the National Fire Protection Association (NFPA) by not keeping a current, yearly City Fire Inspection which has the potential risk of harm to patients if identifiable fire sources are not removed/repaired, increasing the risk of a fire in the facility. Findings include: Policy regarding first inspection was requested from employee #20 on August 8, 2024. Employee #20 stated that they do not currently have a policy related to fire inspections requirements. Annual city fire inspections are required for Outpatient Treatment Centers per the Fire Code of the City of Peoria. The most recent fire inspection expired 05/25/2024. The facility administrator did provide documention showing an email request for a fire inspection sent to peoriaaz.gov on 05/22/2024, which was 3 days before the fire inspection expired. The second email request for a fire inspection was sent 07/09/2024, which was 74 days after the expiration date of the most recent fire inspection. During an interview conducted on August 7, 2024 an attempt was made to verify the findings with Employee #1, however Employee #1 refused to confirm or deny the findings.”

“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 staff 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...Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment...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....” The facility policy titled “Access Assessment and Cannulation” requires: “...Assessment of Vascular Access...LISTEN...Bruit high pitch/whistle...Document in treatment record...Staff...who have been trained to auscultate vascular accesses should listen to the entire length of the access for changes in the sound of the bruit...Clean stethoscope after assessing a patient....” Observation on 11/08/2023 revealed Employee #5 conduct pre and post assessment of heart and lung sounds with the same stethoscope between two patients at stations #J and K without cleaning and disinfecting his/her stethoscope. Observation on 11/08/2023 revealed Employee #9 auscultate heart and lung sounds on a patient at station #F and did not disinfect the entire stethoscope after use upon leaving the station. Employee #9 used a single isopropyl alcohol pad to clean the diaphragm only on the bell of the stethoscope but not the entire bell, nor the length of the stethoscope that was touched during use on the patient. Observation on 11/08/2023 revealed Employee #10 auscultate patients’ vascular access with the same stethoscope between two patients at stations #J and K without cleaning and disinfecting his/her stethoscope. Observation on 11/08/2023 revealed Employee #12 auscultate a patient’s vascular access at station #F, hang the stethoscope around his/her neck after use, and walk to and provide care for a patient at station #A without cleaning or disinfecting the stethoscope after use. Employee #1 confirmed on 11/08/2023 that staff did not clean and disinfect their stethoscopes after use at the dialysis station and between multiple patients as required by facility policy.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure medications were locked when not in use at the medication preparation station. Failure to secure medications when not in use may result in unauthorized access to medication not prescribed to an individual and the potential for tampering or other compromise to the integrity of medications administered. Findings include: The 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 11/07/2023 revealed two unlocked medication drawers at the medication preparation station. No staff were present in the area and the medications were not in use. One drawer contained open, in use multidose vials of Heparin and Lidocaine. The second drawer contained multiple oral and IV medications for patient administration. Employee #4 confirmed on 11/07/2023 that the medications were not locked when not in use as required by facility policy.”