032571 North Scottsdale Dialysis (Fmc)

“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 a review of policy and procedure, observation, and staff interview, the Department determined that the facilty failed to ensure: Staff maintained a clean and sanitary environment which has the potential risk of harm to patients due to cross contamination from an unsanitary environment and potential exposure to contaminated sharps and supplies. Findings include: Observation on 04/03/2024 revealed generalized debris and supplies on the treatment floor around all 20 dialysis stations and within the isolation room as follows: Station 2, where the chair and wheels connect there is a bulid up of dirt. Station 7, redish brown stains around the wheels. Station 9, behind the machine and patient chair, there is several redish brown stains and white stains on the wall. Station 12, the acid wand had white crust like substance around it and it was also leaking fluid onto the machine. Station 13, Oxygen condenser had white crust like substance down the front.. Station 16, a redish brown substance was on the bottom of chair, which was removed with a bleach rag during the survey. Station 17, blood saturated gauze on the floor near the trash can, at a “clean” station. Station 21/22- floor covered in white crust like substance. Isolation Room- visable debris on floor, hemodialysis (HD) machine screen with 3 water test strips stuck to the screen, 1 live moth on HD machine screen, death bugs and debris in the lighting covers, red/brown stains on chair side table. Mulitple red trash cans have white, red or brown stains on the lids. Chair #8 has multiple red, brown and white stains on the bottom that are seen from the back of the chair. Chair also had leaves on the seat of the chair. Employee #2 confirmed on 04/03/2024 that the facility was not maintained in a sanitary manner are required by 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 policy and procedure, observation, and staff interview, the Department determined that the facilty failed to ensure: Staff appropriately cleansed the patient’s (Patients #10 and #11) vascular access prior to cannulation with fistula needles. Failure to practice appropriate safe aseptic technique when cleansing and disinfecting a patient’s vascular access increases the risk of vascular access and bloodstream infection if bacteria are not sufficiently reduced at the cannulation sites before needle insertion. Repeat Deficiency, Event # D8K011, April 5, 2023 Findings include: 1. The policy titled “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” 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....” Patient # 10 On April 3, 2024, observation revealed Employee #13 cleansing and disinfecting the patient at station # 3’s vascular access in preparation for cannulation. Employee #13 used one alcohol prep pad to cleanse the arterial cannulation site for a 31-second contact time. Employee #13 repeated the same process for the venous site with a contact time of 23 seconds. Patient #11 On April 4, 2023, observation revealed Employee #12 cleansing and disinfecting patient #11’s vascular access in preparation for cannulation. Employee #12 used one alcohol prep pad to cleanse the arterial cannulation site and the venous site for 8 seconds, then listened to the access and proceeded to cannulate the arterial and venous sites without cleansing the site again prior to cannulation. Employee #1 confirmed on April 4, 2024, that Employees #12 and # 13 did not follow policies and procedures for cannulation of the patient’s vascular access.”

“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: 49430 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff did not store clean and dirty supplies in the same area after use which has the potential for cross contamination and increased infection. Findings include: Area with sinage reading “clean oxyegen concentrator storage area” with open dialyzyers, open blood line set up, 3 used face sheilds being stored with packaged dialyizers, Facility policy titled “Storage of Supplies and Supply Expiration Dates for Inpatient Services” requires “...Storage areas will be kept clean and in order...”. Facility policy titled “Dialysis Precautions” requires “...Clean areas should be clearly designated for...storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored...”. Employee #2 confirmed on 04/03/2024, that the items were a mix of clean and dirty supplies and the storage of such itmes together was not in compliance with 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: 48842 Based on document review, observation, and interview, it was determined that the facility failed to ensure (13) of (24) dialysis station chairs did not have torn vinyl and open seams with exposed foam and fabric. Failure to maintain intact vinyl on dialysis chairs poses a risk of infection though cross contamination as exposed foam and fabric on the chair may harbor potentially infectious material that cannot be cleaned and disinfected. Findings include: A policy regarding maintenance and repair and infection control related to integrity and maintenance of dialysis chair upholstery was requested. Employee #3 confirmed on 04/03/2024 that the facility did not have a policy to provide. Observation on 04/03/2024 revealed (13) of (24) dialysis chairs in use on the treatment floor had torn upholstery in various locations on the chairs including arm rests, foot rests, head rests, seats and sides of the chairs. The tears in the chairs ranged from 1/4 inch to 2 inches long with exposed underlying fabric backing on the vinyl. Employee #2 confirmed on 04/03/2024 that the observed chairs were in disrepair with torn vinyl that prevented appropriate disinfection between patients.”

“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: 49430 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff labeled multi-dose medication vials when opened. Failure to label medication vials when opened and/or with a legible 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. The facility policy titled “Medication Preparation and Administration” requires: “...Labeling Vials...When preparing medication if the vial is not used immediately in its entirety, the nurse or PCT (if allowed by state regulations), must place the date and time the vial was opened on the medication label along with their initials...Label any open multi-dose vial that is not used immediately and store vial accordingly...Any open multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date....” Observations on 04/03/2024 revealed, A metal combination lock box in POD 5 was open, not locked and contained an open unlabeled bottle of heparin. Employee #1confirmed on 04/03/2024 that the medication was not properly 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: 49430 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, “Storage of Supplies” revealed: “...Storage areas must be kept clean and in order at all times...Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not contaminated or damaged....” 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...Expiration dates of sterile supplies contained in emergency boxes or code carts should be noted and logged as per facility protocol....” 1. and 2. Facility policy, “FMS Clinical Services Medication Preparation and Administration” revealed: “Label any multi-dose vial that is not used immediately and store vial accordingly...Expired medications are to be discarded via Fresenius Medical Services off-site return program or in accordance with local and/or state law...Any open multi dose vials must be discarded 28 days after opening (Epogen is 21 days;)....” Observation on 04/03/2024 revealed the following expired supplies: 6- BBL CulturSwab Plus, expired 02/29/2024 8- WingEater SAfety AV Fistula Needle Set, expired 03/21/2022 36- Lure Lock Cap Set, expired 10/01/2023 4- Envirox Critical Care disinfectant..., expired 09/2022 1- Embrace Pro test strips, expired 10/01/2022 2- Embrace Pro control solution, expired 07/21/2022 2- Germstar instant hand sanitizer, expired 08/2022 1- Heparin Sodium Injuection 30 ml, expired 09/01/2023 3- Calcium Chloride Injection 100mg/ml, expired 01/01/2024 Employee #2 confirmed the expiration dates of supplies and medications and that policy was not followed in the removal and disposal of these items.”

“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 facility observation and employee interview, it was determined that the facility failed to maintain the facility free from a condition or situation that may cause an individual to suffer physical injury. This deficient practice could result in a facility patient and/or employee to suffer injury or illness due to facility conditions. Findings include: Four (4) fire safety ceiling sprinkler in facility, including staff areas and patient care areas, are missing their escutcheons. Five (5) ceiling tiles that each contained discoloration in patterns of dried water stains. Observation on tour revealed an actively leaking dialyzer, from the rear of the machine. The active leak originated at the machine, and terminated three stations from the patient facing left side. The termination of the leak culminated into a puddle, which was located at the front of the emergency exit on the north side of the patient care area. The concerns include mold formation, electrical shock, and a slippery walking surface. Employee # 1 and Employee #2 confirmed during an interview on April 3, 2024, that the facility fire safety ceiling sprinklers needed their escutcheon to be replaced. Employee # 1 and Employee #2 confirmed during an interview on April 3, 2024, that the facility, and that the ceiling tiles were water damaged, and that some tiles had already been replaced in a storage area. Employee #8 was present during the tour and acknowledged the active leak from the rear of the dialyzer into the patient care area.”

“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: 45999 Based on a review of facility policy, medical records, and staff interviews, it was determined that the facility failed to require that 1. Clinical staff to notify the nurse and the nurse provide a documented intervention for 5 out of 6 patients reviewed when the patient’s blood pressure (BP) and/or heart rate (HR) was out of range per the facility policy. 2. Clinical staff failed to ensure staff performed safety checks every 30 minutes per facility guidelines for (3) of (6) patients (Patients #1, #5, and #11) which poses the potential risk of cardiovascular compromise and hospitalization and the risk that the necessary interventions are not taking which could also lead to hospitalization Findings include: 1.The facility policy titled “Patient Assessment and Monitoring” requires: “...During Treatment...Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 [sic] or more often as needed but not to exceed 45 minutes or per state regulations....” Patient #1 Patient #1’s treatment sheet dated October 13, 2023, revealed blood pressure/safety checks were not done every 30 minutes as follows: 16:19 to 16:53 17:55 to 18:55 Patient #1’s treatment sheet dated October 16, 2023, revealed blood pressure/safety checks were not done every 30 minutes as follows: 16:00 to 16:52 16:52 to 17:31 17:31 to 18:09 18:35 to 19:10 19:10 to 19:45 Patient #5 Patient #5’s treatment sheet dated November 24, 2023, revealed blood pressure/safety checks were not done every 30 minutes as follows. 08:59 to 10:03 Patient #5’s treatment sheet dated March 18, 2024, revealed blood pressure/safety checks were not done every 30 minutes as follows. 08:02 to 08:42 09:24 to 10:33 Patient #5’s treatment sheet dated March 21, 2024, revealed blood pressure/safety checks were not done every 30 minutes as follows. 14:44 to 15:17 Patient #5 treatment sheet dated March 28, 2024, revealed blood pressure/safety checks were not done every 30 minutes as follows. 13:26 to 14:26 Patient #11 Patient #11’s treatment sheet dated March 29, 2024, revealed blood pressure/safety checks were not done every 30 minutes as follows. 09:26 to 11:20 Employee #1, confirmed during an interview conducted on April 4, 2024, that staff did not perform and document blood pressure and safety checks every 30 minutes as required by regulation and facility policy. 2. Findings include: Facility policy titled, “...Patient Assessment and Monitoring....” published December 2022, revealed: “...Monitoring During Treatment...Report to the nurse: Systolic blood pressure greater than 180 mm/Hg, Diastolic blood pressure greater than 100 mm/Hg, Blood Pressure less than or equal to 100 mm/Hg systolic...Heart rates that have dropped below 60 or risen above 100 ...Report to the nurse any significant findings....” “...Treatment Sheets....” revealed: Patients #1, #4, #5, #10 and # all had multiple treatment sheets with BP and HR out of facility parameters that were not found to have any documentation of Patient Care Technician (PCT) reported to nurse or that the nurse assessed and/or treated out of range BP and/or HR. Employee #1 confirmed, on April 4, 2024, that this practice was not following facility policy.”