Davita Phoenix Dialysis Center

“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: 49430 Based on observation and interview, it was determined that the facility failed to ensure the facility provide and monitor a sanitary environment to minimize the transmission of infectious agents, which has the potential risk of harm to patients due to potential exposure to contaminated sharps, supplies, biohazard materials and food products. Findings include: Observation on 04/15/2024 revealed generalized debris and supplies on the treatment floor around 9 dialysis stations as follows. Station 1- Dialysis machine strung with new, clean dialyzer but the blood tubing connection cap was missing and no blood tubing was connected to the dialyzer. The new, clean dialyzer blood tubing connection was left open air in excess of 10 minutes. Station 2- What appeared to be popcorn under and around the floor by chair after chair had been cleaned/disinfected after the prior patient had vacated the chair and the new, clean setup had been placed on the clean dialysis machine. Station 3- Excess Bicarb buildup on the wall box and a red spot, which appeared to be blood, on the floor in between the chair and machine. Station 4- Excess Bicarb buildup on the wall box. Station 5- Excess Bicarb on the wall box and the chair at station #5 to have tape hanging down from the bottom of the tray table after being cleaned. Observation on April 16, 2024 (next day) the chair at station #5 to have the same tape hanging down from the bottom of the tray table after watching staff clean the chair. Station 6- Staff touching the machine at station #6 with only one glove on. During same time of observation there was staff touching machine at station 16 with only one glove on. Station 8- Red-brown spot on machine after being cleaned by staff. Station 9- Machine that had been cleaned by staff and upon close up inspection remained a red spot in the bottom of the machine next to a jugged bath. Observation on April 15, 2024, revealed employee #14 only cleaning the bell of their stethoscope not the whole stethoscope. Employee #13 confirmed that the stations were not cleaned and disinfected per facility policy.”

“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 procedure, observation, and staff interview, the Department determined that the facility failed to ensure that the AV fistula or graft cannulation procedure was performed by employee #14, according to the facility procedure for one of one patient observed, which has the potential risk of development of a bloodstream infection and hospitalization. Findings include: The policy titled “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” dated 10/2022, requires: “...Check for patient sensitivity to preferred skin antiseptic/skin disinfectant listed in the table below (povidone-iodine, hypochlorite ExSept Plus). Use Isopropyl Alcohol 70% as the single skin antiseptic ONLY when the patient has documented allergies to other skin antiseptics...Isopropyl Alcohol 70%...At least 4 prep pads per site...Effective Contact Time...60 seconds....” Observation on April 15, 2024, at station #7, revealed Employee # 14 cleansing and disinfecting patient # 3 ‘s vascular access in preparation of cannulation. Employee #14 used one alcohol prep pad to cleanse the arterial cannulation site for a 25-second contact time. Employee #4 repeated the same process for the venous site with a contact time of 28 seconds. Observation on April 15, 2024, at station #4, revealed Employee #14 cleansing and disinfecting patient #’2s vascular access in preparation of cannulation. Employee #14 used one alcohol prep pad to cleanse the arterial cannulation site for a 32-second contact time. Employee #14 repeated the same process for the venous site with a contact time of 27 seconds. Observation on April 15, 2024, at station #1, revealed Employee # 14 cleansing and disinfecting patient # 1’s vascular access in preparation of cannulation. Employee #14 used one alcohol prep pad to cleanse the arterial cannulation site for a 20-second contact time. Employee #14 repeated the same process for the venous site with a contact time of 25 seconds. Employee #13 confirmed on April 2024, that Employee #14 should have used at least (4) alcohol prep pads per cannulation site for skin asepsis prior to cannulation when alcohol is used as the single skin antiseptic for patients # 1 and # 2 and # 3, with a contact cleaning time of 60 seconds per site.”

“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: 49430 Based on document review, observation, and interview, it was determined that the facility failed to ensure direct care staff did not have artificial nails while providing patient care. Failure to follow established standard and infection control precautions poses an increased risk of infections for immunocompromised patients through contact transmission and cross contamination. Findings include: 1. The facility policy titled “Infection Control for Dialysis Facilities” requires: “...It is a requirement for all DaVita teammates whose primary location is working in a facility to have only natural nails and fingernail length should not extend more than 1/4 inch. Traditional nail polish that is not chipped may be worn....” The facility document titled “Infection Control Quick Reference Guide” requires: “...Fingernails...Artificial fingernails, nail extenders or nail enhancements ‘including but not limited to nail jewelry, sculptor, acrylic or resin overlays or bonding, gels, tips, wraps, hybrid gels’ are not permitted....” The CDC “Morbidity and Mortality Weekly Report, October 25, 2002 / Vol. 51 / No. RR-16, Guideline for Hand Hygiene in Health-Care Settings Recommendations” revealed: “...HCWs who wear artificial nails are more likely to harbor gram-negative pathogens on their fingertips than are those who have natural nails, both before and after handwashing...Personnel wearing artificial nails also have been epidemiologically implicated in several other outbreaks of infection caused by gram-negative bacilli and yeast...These recommendations are designed to improve hand hygiene practices of HCWs and to reduce transmission of pathogenic microorganisms to patients and personnel in healthcare settings...Do not wear artificial fingernails or extenders when having direct contact with patients at high risk....” Observation on 04/15/2024 revealed Employee #14 providing patient care services in the treatment area for patients on dialysis while wearing artificial nails. Employee #13 confirmed in an interview on 04/17/2024 that the team member wore artificial nails while providing patient care despite the facility policy prohibiting wearing artificial nails while providing direct patient care.”

“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: 49430 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff cleaned, disinfected, and discarded and/or disinfected supplies used at the dialysis station which has the potential risk of infection to patients through cross contamination and contact transmission. Findings include: The policy titled “Infection Control for Dialysis Facilities” requires: “...Disinfection...Prior to routine disinfection, remove all visible blood...a 1:10 (one to ten) bleach solution must be utilized...Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces...using a wiping motion with friction. Sufficient disinfectant should be applied so that surfaces are visibly wet...Non-disposable items are to be disinfected after each patient use....” Observation on 04/15/2024, revealed Employee #10 cleaning and disinfecting Station #10. Employee #10 did not disinfect the entire machine surface, the entire chair surfaces, and partially cleaned the TV but did not clean the TV arm. Employee #1 confirmed on 04/15/2024, that staff did not clean and disinfect the dialysis stations as required by facility policy. Observation of care area on 04/15/2024 revealed employee #15 did not replace the emergency supply bag located in dialysis station #13 after disinfecting the dialysis. The bag remained opened during the disinfection process, and was not replaced nor disinfected when disinfecting the dialysis station. Observation of employee #15 on 4/15/2024 noted that the employee used a stethoscope for an assessment of a patient prior to treatment being initiated. It was noted that the only portion of the stethoscope that was disinfected was the diaphragm, and the tubing nor ear pieces were cleaned. Observation of employee #16 on 4/15/2024 disinfecting station #18 noted used sharps in the area immediately under the station chair. Employee noted that they had completed disinfecting the station prior to the beginning of interviewing them. During an interview with them at station #18, they confirmed that had completed the disinfecting the station, and confirmed that a used sharp was still located on the floor. The employee then discarded the used sharp from the floor in the appropriate receptible.”

“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: 50568 Based on review of facility policies and procedures, observations and staff interviews, it was determined that the facility failed to require staff dispose of expired supplies and medications, which has the potential risk of infection by using outdated items that may have lost their intended effectiveness for patients receiving hemodialysis treatments; Findings include: Facility policy, “Expiration Dates of Sterile Supplies” revealed: “...Sterile items will be checked before use to ensure that they have not expired...Appropriately dispose of sterile items that have reached the expiration date...” Observation on 04/15/2024 revealed the following expired supplies were found in the patient care area: 85 (eighty-five) BD Eclipse Needles 21G x 1, expired 3/31/2023 4 (four) BD PrecisionGlide Needle 22Gx1 expire 6/30/2023 2 (two) Minncare residual test strips expired 2/15/2024 1 (one) Nipro safe touch safety fistula needle expired 3/31/2023 8 (eight) Vacuette test tube 6 ml navy top expired 4/10/24 68 (sixty-eight) BP Precision Glide Needle and Syringe Leuk-lock 21Gx1 expired 3/31/2024 1 (one) Watercheck; Chlorine or peroxide strips expired 3/2022 2 (two) Manually drawn heparin, in syringe with needle, labeled with patient information, dated 4/12/2024 96 (ninety-six) Nitroglycerin tablets, expired 09/2022 Employee #13 confirmed the expiration dates of supplies and that policy was not followed in the removal and disposal of these items.”

“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: 50568 Based on document review, observation, and interview, it was determined that the facility failed to ensure medications in the treatment area were locked and secured to prevent unauthorized access. 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 facility policy titled “Medication Policy” requires: “...Non-refrigerated medications are to be stored in cabinets(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations....” Observation on 04/15/2024 revealed one unlocked free standing mobile medication lockbox at the handwash station located in the southeast corner of the patient care area. No staff were present in the area and the medications were not in use for patients present. The drawer contained 5 multiple use vials of heparin, with 2 of the 5 vials being uncapped and previously punctured. Observation on 04/15/2024 revealed one locked free standing mobile medication lockbox at the handwash station located in the middle southeast corner of the patient care area. No staff were present in the area and the medications were not in use for patients present. The drawer contained 6, 3 cc syringes. Upon inspection 5 of the 6 syringes were labeled heparin with a patient’s label affixed to the syringe. Upon inspection 1 of the 6 syringes was filled with an unknown substance and contained no labelling nor initials of staff who filled the syringe. Observation on 04/15/2024 revealed one locked free standing mobile medication lockbox at the handwash station located in the front east area of the patient care area. No staff were present in the area and the medications were not in use for patients present. The drawer contained 5 vials of heparin and 1, 3 cc syringe that had been manually filled. Of the 5 vials of heparin, 1 appeared to be unopened and 4 vials appeared to be previously punctured. Upon inspection, the 1, 3 cc syringe was filled with an unknown substance and contained no labelling nor initials of staff who filled the syringe. Employee #15 and Employee #8 confirmed on 4/15/2024 that the medications were not locked when not in use as required by facility policy. The employees also confirmed that the presented syringes were not labeled and could not verify the medication in syringes”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 49430 Based on observation, review of facility documentation, policy and procedures, and interviews with staff, the Department determined the facility failed to ensure the hourly infusion of heparin was followed as the doctor ordered with a stop time of sixty minutes prior to end of treatment. This deficient practice poses a health risk to patients including the potential risk of insufficient anticoagulation, blood loss, and hospitalization. -Findings Include: A review of a policy “ANTICOAGULATION” (Policy: 1-06-02; Revision Date: October 2023) revealed, “ ...heparin is the primary anticoagulant used to prevent clotting ...to anticoagulated the patient ...hourly dose of heparin is administered ..at start of treatment and ended 60 minutes prior to the end of the hemodialysis treatment...”. The following findings were discovered during review of patient treatment sheets: Patient #10 April 12, 2024 The patient’s treatment was terminated at 9:32 and the documented time heparin stop time was 9:37. April 08, 2024 The patient’s treatment was terminated at 9:38 and the documented time heparin stop time was 9:41. April 3, 2024 The patient’s was terminated at 9:28 and the documented time heparin stop time was 9:29. April 1, 2024 The patient’s treatment was terminated at 9:30 and the documented time heparin stop time was 9:33. Patient #9 April 12, 2024 The patient’s treatment was terminated at 10:28 and the documented time heparin stop time was 9:32. April 8, 2024 The patient’s treatment was terminated at 9:11 and the documented time heparin stop time was 9:37. April 5, 2024 The patient’s treatment was terminated at 10:12 and the documented time heparin stop time was 9:21. April 3, 2024 The patient’s s treatment was terminated at 10:21 and the documented time heparin stop time was 10:29. April 1, 2024 The patient’s treatment was terminated at 10:11 and the documented time heparin stop time was 10:14. Employee #13 verified in an interview on April 17, 2024, that the hourly heparin was not stopped 60 minutes prior to the end of treatment for patient #9 and patient #10 on the dates listed within the findings as required by facility policy.”

“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: 49430 Based on a review of facility policy, medical records, and staff interviews, it was determined that the facility failed to require clinical staff to notify the nurse and the nurse provide a documented intervention for 4 out of 4 patients reviewed when the patient’s blood pressure (BP) and/or heart rate (HR) was out of range, and/or vital signs were not preformed within a 30 minute interval per the facility policy, and/or the dialysis machine was not programmed to the prescribed dialysis order for the patient, which poses the potential risk of cardiovascular compromise and hospitalization. Findings include: Facility policy titled “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” requires “...Vital signs and treatment monitoring...completed at least every thirty (30) minutes...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record...Post-treatment: If patient is above or below 1 kg from the target weight...Pre-dialysis: Systolic greater the 180 mm Hg or less than 90 mm Hg...Diastolic greater than or equal to 100 mm Hg...Intradialytic: Difference of 20 mm Hg increase or decrease from patient’s last intradialytic treatment BP reading...Post Treatment: Standing systolic BP greater than 140 mm Hg or less than 90 mm Hg...Standing diastolic BP greater than 90 mm Hg or less than 50 mm HG...Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute...”. Medical record review of 4 patient’s treatment sheets revealed all (4/4) patients had multiple occurrences of incorrect machine settings, blood pressures, heart rates, and/or vital signs greater than 30-minute intervals without documentation of the licensed nurse being notified or the licensed nurse assessing the occurrence. Patient #10 April 10, 2024 During the prescribed treatment, vital signs were conducted greater than the allowed 30 minute interval time. The initial temperature of the dialysis machine was not set to the prescribed temperature as indicated in the patient’s prescribed dialysis order. April 8, 2024 During the prescribed treatment a diastolic heart rate of less than 60 was recorded without notification to the licensed nurse on duty. The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. April 5, 2024 During the prescribed treatment, a diastolic blood pressure greater than 100 and a diastolic blood pressure less than 50 was recorded 3 times without notification to the licensed nurse on duty. The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. April 3, 2024 During the prescribed treatment the blood flow rate (400) was not set to the prescribed rate as indicated in the patient’s prescribed dialysis order (450). No documentation was noted for the change in the set rate. The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. April 1, 2024 During the prescribed treatment, vital signs were conducted greater than the allowed 30 minute interval time. The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. Patient #8 April 12, 2024 The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. April 10, 2024 The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. April 8, 2024 The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. During the prescribed treatment, a diastolic blood pressure greater than 100 recorded 5 times without notification to the licensed nurse on duty. April 5, 2024 The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. During the prescribed treatment, a diastolic blood pressure greater than 100 was recorded 4 times without notification to the licensed nurse on duty. April 3, 2024 The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. During the prescribed treatment, a diastolic blood pressure greater than 100 was recorded 6 times without notification to the licensed nurse on duty. April 1, 2024 The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. During the prescribed treatment, a diastolic blood pressure greater than was recorded 2 times without notification to the licensed nurse on duty. Patient #9 April 12, 2024 During the prescribed treatment, a diastolic blood pressure greater than 100 was recorded 3 times without notification to the licensed nurse on duty. April 8, 2024 The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. April 5, 2024 During the prescribed treatment, a systolic blood pressure greater than 140 and a systolic blood pressure less than 100 was recorded without notification to the licensed nurse on duty. The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. April 3, 2024 During the prescribed treatment, a heart rate of less than 60 was recorded without notification to the licensed nurse on duty. A systolic blood pressure less than 100 was recorded without notification to the licensed nurse on duty. April 1, 2024 During the prescribed treatment, a heart rate of less than 60 was recorded 5 times without notification to the licensed nurse on duty. Patient #11 April 12, 2024 During the prescribed treatment, a heart rate of less than 60 was recorded 8 times without notification to the licensed nurse on duty. Documentation present did not reflect if the heart rate of less than 60 was accurately presented to the designated Nurse Practitioner (NP). Vital signs were conducted greater than the allowed 30 minute interval time. April 10, 2024 During the prescribed treatment, a heart rate of less than 60 was recorded 6 times without notification to the licensed nurse on duty. The initial temperature of the dialysis machine was not set to the temperature as indicated in the patient’s prescribed dialysis order. April 8, 2024 During the prescribed treatment, a heart rate of less than 60 was recorded without notification to the licensed nurse on duty. A post treatment systolic blood pressure less than 140 was recorded without notification to the designated provider. April 5, 2024 During the prescribed treatment, a heart rate of less than 60 was recorded 8 times without notification to the licensed nurse on duty. A note documented at 9:10 treatment by the nurse on duty noted “hr > 50 <60 no complaints ...” despite a heart rate of 48 documented at 6:34, 7:01, and 7:31. April 3, 2024 During the prescribed treatment, a heart rate of less than 60 was recorded 6 times without notification to the licensed nurse on duty. A diastolic blood pressure less than 50 was documented without notification to the licensed nurse on duty. The dialysate flow rate (510) was not set to the prescribed rate as indicated in the patient’s prescribed dialysis order (500) at 3 different times during the treatment timeframe. April 1, 2024 During the prescribed treatment, a heart rate of less than 60 was recorded 9 times without notification to the licensed nurse on duty. Employee #13 confirmed in an interview on 4/17/2024 that this practice did not follow facility policy.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 49430 Based on document review, observation, and staff interview, it was determined that the facility failed to ensure staff stored patient medical records in a secure manner. Failure to store patient medical records per facility policy poses the potential risk of unauthorized use. Findings include: The facility policy titled “Medical Records Custodian and Maintenance” requires: “...A purged medical record will be created for each patient and maintained in the same order as the active record. The information that is removed from the permanent medical record is placed in the patient’s purged record. The purged records are kept in a secure medical records storage site in the facility....” Observation on 04/15/2024 revealed multiple patients’ medical records on a rolling filing cart in an unlocked storage room in the conference room. The storage room door was open and the rolling filing cart with the patient files was visible and accessible by all team members and the storage room has a direct, unsecured path directly to/from the treatment floor. Employee #13 confirmed on 04/16/2024 that the medical records were not secured.”