Davita Rochester Hills Dialysis

“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: 50585 Based on observation, interview and record review, the facility failed to ensure clinical equipment was disinfected following patient use for 1 of 3 patients observed resulting in the increased likelihood of spreading infections to all patients. Findings include: On 5/12/2025 at 1145, Technician Staff J was observed using a thermometer on a patient’s forehead to take the temperature of a patient at dialysis station number 10. After obtaining the temperature, Staff J returned the thermometer to the counter of a supply cart (common area) without disinfecting the thermometer. Staff J returned to station 10 and was queried whether the thermometer had to be disinfected and Staff J revealed “yes,” both “before and after” using the thermometer. According to the facility’s policy “Infection Control for Dialysis Facilities,” dated April 2023, “Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility failed to ensure clean medical adhesive tape was stored separately from dirty areas prior to patient application for 2 of 7 patients observeded resulting in the increased likelihood of infection transmission and cross-contamination of infectious agents. Findings include: On 5/12/2025 at 1053, Technician Staff K was initiating dialysis for a patient at station 18. Seven strips of medical adhesive tape (clean) were observed to be attached on the chair tray (dirty). There was no barrier between the medical adhesive tape strips and the surface of the chair tray. Staff K proceeded to place the seven strips of medical adhesive tape to the patient’s skin and gauze pad. Technician Staff K was queried whether the medical adhesive tape was stored appropriately on the chair tray, and they did not know. On 5/12/2025 at 1130, Technician Staff J was observed at station 10. Six strips of medical adhesive tape were observed attached to the top of a single barrier strip of medical adhesive tape on the chair tray. The ends of all six strips of the medical adhesive tape were observed to be extended beyond the tape barrier and the ends of the tape (clean) were attached to the chair tray (dirty). Staff J proceeded to apply the six strips of medical adhesive tape to the patient’s skin and gauze pad. Staff J was immediately queried and confirmed the ends of the tape were attached to the dirty tray prior to placing the tape on both the patient’s skin and gauze pad. On 5/14/2024 at 1145, Facility Administrator Staff A was queried if medical adhesive tape was allowed to be placed directly on the chair tray surface without a barrier and they said “no.” According to the facility’s policy “Infection Control for Dialysis Faculties,”Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.””

“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: 50585 Based on observation and interview, the facility failed to ensure the condition of the upholstery of patient dialysis treatment chairs for 4 (#3, #6, #13, #14) of 20 chairs observed resulting in the inability to effectively clean and disinfect the worn chairs thereby increasing the likelihood of transmitting infection to all patients utilizing the compromised chairs. Findings include: On 5/12/2025 from 1000 to 1200, during a tour of the facility’s treatment area, tears in the outer covering of four dialysis treatment chairs were observed. Chairs at stations 13 and 14 each had a patch of foam exiting the upholstery in the arm of the dialysis treatment chair. Chairs at stations 3 and 6 each had torn upholstery on the right lower side of the dialysis treatment chairs. On 5/12/2025 at 1215, Facility Administrator Staff A confirmed the findings, was queried and acknowledged that the chairs with the torn fabric could not be adequately cleaned and disinfected.”

“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: 15195 Based on observation, interview, and record review, the facility failed to ensure that proper aseptic technique was used while drawing up intravenous (IV) medications and labeling IV medications, resulting in the potential for transmission of infectious agents to all patients undergoing dialysis. Findings include: On 5/12/25 at approximately 1040, two opened vials of IV Heparin 30 milliliter (ml) bottles were observed without dates or initials on top of the cart at the nurses’ station. On 5/12/25 at approximately 1045, staff nurse E was queried about the vials and verified that an expiration date and staff initials should have been noted on the opened Heparin vials to determine the expiration date of an opened vial. Review of the facility policy/procedure titled “Medication Policy, #1-06-01, dated October 2023” documented, “Medications containing a preservative must be discarded 28 days after opening or accessed... Each vial is labeled with the initials of the person opening the vial and the expiration date...” 50585 On 5/12/2025 at 1000, during a tour of the medication preparation area, a syringe of Parsabiv containing 2 milliliters (mL) of fluid was observed labeled and stored on the top shelf of the medication refrigerator and the label did not have the date or time the syringe was prepared. Nurse Staff E confirmed the findings at the time of discovery. On 5/12/2025 at 1005, four parenteral heparin syringes with a medication label containing 2 mL’s of fluid were observed on the chair tray at station 3 and the four syringes did not have the date or time the syringes were prepared. Facility Administrator Staff A confirmed the findings at the time of discovery. On 5/13/2025 at 0905, Clinical Coordinator Staff D was observed drawing up a dose of parenteral iron into a syringe. Staff D proceeded to remove the plastic cap from the vial top of the parenteral iron and injected the syringe needle without disinfecting the vial top. When queried whether an alcohol pad was needed prior to drawing up the medication, Staff D revealed “no,” not if the “flip top” was present. On 5/14/2025 at 1230, Facility Administrator Staff A was queried and confirmed the vial top should have been disinfected after the plastic cap was removed and prior to withdrawing the contents into a syringe. According to the facility’s policy “Medications” dated October 2023, “If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication.” The policy also revealed “An aseptic environment and aseptic technique is used when preparing medications.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 15195 Based on observation, interview, and record review, the medical director failed to ensure that staff followed policies/procedures for visitors wearing gowns and orders related to dialysis flow rates for 1 (#2) of 7 patients reviewed, resulting in the potential for less than optimal outcomes. Findings include: On 5/12/25 at approximately 1145, a male was seated right next to and across from a patient dialyzing at station 16. On 5/12/25 at 1150, staff nurse E was queried about visitors in the dialysis unit and she verified that the visitor should have had a protective gown on. Review of the facility policy titled “Infection Control For Dialysis Facilities, #1-05-01, dated April 2023” documented, “Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physician (NPP) and visitors when in the treatment area.” Interview with the covering medical director (Staff C), on 5/12/25 at approximately 1500, verified that the expectation was that staff follow policies/procedures and physician orders. 50585 On 5/13/2025 at 0900, P-2’s dialysis treatment sheets were reviewed. On 4/22/2025, P-2’s prescription for dialysis included a Dialysis Flow Rate (DFR) of 800 milliliters (mL) / minute. P-2’s documented DFR on 4/22/2025 from 1147 to 1356 was 500 mL/minute. On 5/5/2025, P-2’s prescription for dialysis included a DFR of 800 mL/minute. P-2’s documented DFR on 5/5/2025 from 1217 to 1454, was 500 mL/minute. On 5/13/2025 at 1230, Clinical Coordinator Staff D was queried if the DFR was modified, where would staff document the reason for the rate change, they revealed that a note would be documented in the treatment sheet’s “post assessment” or under “vital signs” sections. Staff D reviewed the two treatment sheets for P-2 and acknowledged there was no documentation regarding reason for the the DFR rate change. According to the facility’s policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” dated April 2024, “If the dialysis prescription is not being met (including dialysis flow rate or change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.” The policy also revealed that “All findings, interventions and patient response will be documented in the patient ’ s medical record.””