Davita North Burlington Dialysis

“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: 38766 Based on policy and procedures review, observations, and staff interviews, the facility staff failed to prevent cross-contamination by failing to separate clean and dirty equipment during a tour of the treatment area in one (1) of two (2) observations. The findings included: A review on 12/09/2025 of the facility policy titled, “Infection Control For Dialysis Facilities”, effective 04/2023, revealed “...Facility Hygiene: 16. 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...” Observation on 12/09/2025 between 1215 and 1325 during a tour of the treatment area revealed a cubby area located in front of the nursing station. The observation indicated that the area contained multiple black evacuation boxes and patient wheelchairs. The wheelchairs and the black evacuation boxes were positioned in such a way that they were touching each other. An interview on 12/09/2025 at 1315 with the FA during the observation revealed that the area was considered clean, and the evacuation boxes were clean and contained clean supplies for patient care in the event of clinic evaluation. The interview revealed that patients’ wheelchairs were considered dirty pieces of equipment and should not be with the evacuation boxes. The interview revealed that it was the expectation that the staff follows policy and procedures to prevent cross-contamination of equipment. The interview showed that the infection control policy was not adhered to.”

“ENVIRONMENT-ACCESS TO PORTS/METERS CFR(s): 494.40(a) 8 Environment: access to ports/meters The layout of the water purification system should provide easy access to all components of the system, including all meters, gauges, and sampling ports used for monitoring system performance. This Standard is not met as evidenced by: 38766 Based on policy review, Calibration Log review, and staff interviews, the facility staff failed to ensure the Myron L Ultrameter 4P meter was calibrated daily, nor maintain a calibration log for one of one functional conductivity meters. Findings included: Review on 12/09/2025 of the facility policy “Calibration Check and Calibration of Myron L Ultrameter 4P Bicarbonate Batch Testing” revised 10/2024 revealed “...Note: Calibration is verified and/or calibrated by trained teammate prior to each use... This meter is used to measure the conductivity of bicarbonate batch testing...” A review on 12/09/2025 of the “Conductivity Calibration Log” for 09/01/2025 and 10/30/2025 revealed the facility had one Myron L Ultrameter 4P meter. The review revealed no documentation of daily calibration for the Myron L Ultrameter 4P meter for September or October 2025. The review indicated that the facility staff failed to conduct or document daily calibration checks for the meter. An interview on 12/09/2025 at 1445 with the Biomedical Technician revealed that the conductivity meters should have been calibrated and documented daily by the staff. The interview confirmed that the staff used the 4P meter each day to measure the conductivity of the bicarbonate mixture. The interview revealed that staff members were required to calibrate the meter and record this in the log every day. Additionally, the Biomedical Technician was responsible for performing monthly calibration, conducting a monthly audit of the daily calibration log, and presenting the audit results to the interdisciplinary team during their monthly meetings. The interview concluded that this represented a system failure. An interview on 12/10/2025 at 1550 with PCT/CCHT #1 revealed that the staff used the 4P meter daily to test the conductivity of the bicarbonate mixture. The PCT indicated that she had not been instructed to document the daily calibration of the meter on a separate log.”

“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: 38766 Based on policy review, observations, and staff interviews, the facility staff failed to maintain oxygen (O2) cylinders per facility policy for three (3) of twelve (12) O2 cylinders observed. Findings included: A review on 12/09/2025 of the “Safety Data Sheet” revised on 09/09/2022 revealed “1. Identification: Product Identifier: Oxygen... 7. Handling and Storage: Precautions for safe handling... Secure cylinders in an upright position at all times...” An observation on 12/09/2025 between 1215 and 1325 during a tour of the treatment floor revealed that 12 oxygen cylinders were stored in the wheelchair storage area near the patient’s scale area. The observation showed that three of the 12 oxygen cylinders were on the floor unsecured. An interview on 12/09/2025 at 1315 with the Facility Administrator (FA) revealed that the oxygen cylinders were not supposed to be left unsecured on the floor. The interview confirmed that the policy was not followed. An interview on 12/09/2025 at 1445 with the Biomedical Technician revealed that the Technician was responsible for ensuring that the oxygen cylinders were stored according to the Safety Data Sheet. The Technician added that the cylinders were to be kept in a rack or secured with a chain.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 38766 Based on policy review, record review, and staff interviews, the facility staff failed to ensure that a patient without documented photosensitivity to light did not wear sunglasses during dialysis per policy for one (1) of one (1) patient observed wearing sunglasses (Patient #6, Station #7). Findings included: A review on 12/09/2025 of the facility’s policy, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” revised in 04/2024 revealed, “...Intradialytic Data Collection/Assessment... c. The vascular access site, bloodline connections, and the patient’s face should be visible throughout the dialysis treatment...” Observation on 12/09/2025 from 1215 through 1325 revealed Patient #6 dialyzing in Station #7, wearing dark sunglasses. The observation revealed that the patient did not remove the sunglasses and that the staff did not request their removal during the observation period. The observation revealed that the facility staff failed to ensure the patient did not wear sunglasses during treatment. A medical record review on 12/10/2025 revealed that Patient #6 was admitted for ICHD on 08/26/2025. The record review did not indicate any documentation of photosensitivity to light. The review of Patient #6’s order summary report failed to show a provider order for the use of the dark sunglasses during the treatment. An interview with the FA on 12/10/2025 at 0920 confirmed that the patient did not have an order from the provider for dark glasses during treatment, and the patient should not have had the dark glasses on during his treatment. The interview revealed that the policy was not followed.”

“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: 38766 Based on policy review, observations, medical records review, and staff interviews, the facility staff failed to ensure patients on an ESA (Erythropoesis Stimulating Agents [stimulates the bone marrow to make red blood cells]), were informed of the risks and benefits of receiving an ESA in seven of eight in-patient records review, and failed to ensure that the staff wore proper footwear while on the treatment floor for one of 5 staff observed on the treatment area. The findings included: A. 1. Review on 12/10/2025 of Patient #3’s medical record revealed the patient was admitted to the facility on 11/21/2014 for ICHD. Review revealed the patient’s current medication prescriptions included Mircera (ESA), 30 mcg IVP, every two weeks. The review revealed no documentation to show that the patient had been informed of the risks and benefits of the ESA. Interview on 12/11/2025 at 0920 with the Clinical Coordinator reported that the prescribing provider was to educate the patient on the risks and benefits of the Mircera. The patient, the provider, and the RN witnessing the education were to sign the patient education acknowledgment form before the first dose was administered. The Clinical Coordinator added that the RN administering the first dose was to ensure that the patient had signed the acknowledgment form. The interview confirmed the facility was unable to locate the acknowledgment form for the Patient. The Clinical Coordinator revealed that “it is clear that there has been a gap in the policy.” 2. Review on 12/10/2025 of Patient #2’s medical record revealed the patient was admitted to the facility on 03/14/2022 for ICHD. Review revealed the patient’s current medication prescriptions included Mircera (ESA), 100 mcg IVP, every two weeks. The review revealed no documentation to show that the patient had been informed of the risks and benefits of the ESA. Interview on 12/11/2025 at 0920 with the Clinical Coordinator reported that the prescribing provider was to educate the patient on the risks and benefits of the Mircera. The patient, the provider, and the RN witnessing the education were to sign the patient education acknowledgment form before the first dose was administered. The Clinical Coordinator added that the RN administering the first dose was to ensure that the patient had signed the acknowledgment form. The interview confirmed the facility was unable to locate the acknowledgment form for the Patient. The Clinical Coordinator revealed that “it is clear that there has been a gap in the policy.” 3. Review on 12/10/2025 of Patient #1’s medical record revealed the patient was admitted to the facility on 10/28/2025 for ICHD. Review revealed the patient’s current medication prescriptions included Mircera (ESA), 30 mcg IVP, every two weeks. The review revealed no documentation to show that the patient had been informed of the risks and benefits of the ESA. Interview on 12/11/2025 at 0920 with the Clinical Coordinator reported that the prescribing provider was to educate the patient on the risks and benefits of the Mircera. The patient, the provider, and the RN witnessing the education were to sign the patient education acknowledgment form before the first dose was administered. The Clinical Coordinator added that the RN administering the first dose was to ensure that the patient had signed the acknowledgment form. The interview confirmed the facility was unable to locate the acknowledgment form for the Patient. The Clinical Coordinator revealed that “it is clear that there has been a gap in the policy.” 4. Review on 12/10/2025 of Patient #6’s medical record revealed the patient was admitted to the facility on 08/26/2025 for ICHD. Review revealed the patient’s current medication prescriptions included Mircera (ESA), 60 mcg IVP, every two weeks. The review revealed no documentation to show that the patient had been informed of the risks and benefits of the ESA. Interview on 12/11/2025 at 0920 with the Clinical Coordinator reported that the prescribing provider was to educate the patient on the risks and benefits of the Mircera. The patient, the provider, and the RN witnessing the education were to sign the patient education acknowledgment form before the first dose was administered. The Clinical Coordinator added that the RN administering the first dose was to ensure that the patient had signed the acknowledgment form. The interview confirmed the facility was unable to locate the acknowledgment form for the Patient. The Clinical Coordinator revealed that “it is clear that there has been a gap in the policy.” 5. Review on 12/10/2025 of Patient #8’s medical record revealed the patient was admitted to the facility on 06/05/2025 for ICHD. Review revealed the patient’s current medication prescriptions included Mircera (ESA), 50 mcg IVP, every two weeks. The review revealed no documentation to show that the patient had been informed of the risks and benefits of the ESA. Interview on 12/11/2025 at 0920 with the Clinical Coordinator reported that the prescribing provider was to educate the patient on the risks and benefits of the Mircera. The patient, the provider, and the RN witnessing the education were to sign the patient education acknowledgment form before the first dose was administered. The Clinical Coordinator added that the RN administering the first dose was to ensure that the patient had signed the acknowledgment form. The interview confirmed the facility was unable to locate the acknowledgment form for the Patient. The Clinical Coordinator revealed that “it is clear that there has been a gap in the policy.” 6. Review on 12/11/2025 of Patient #5’s medical record revealed the patient was admitted to the facility on 08/06/2021 for ICHD. Review revealed the patient’s current medication prescriptions included Mircera (ESA), 150 mcg IVP, every two weeks. The review revealed no documentation to show that the patient had been informed of the risks and benefits of the ESA. Interview on 12/11/2025 at 0920 with the Clinical Coordinator reported that the prescribing provider was to educate the patient on the risks and benefits of the Mircera. The patient, the provider, and the RN witnessing the education were to sign the patient education acknowledgment form before the first dose was administered. The Clinical Coordinator added that the RN administering the first dose was to ensure that the patient had signed the acknowledgment form. The interview confirmed the facility was unable to locate the acknowledgment form for the Patient. The Clinical Coordinator revealed that “it is clear that there has been a gap in the policy.” 7. Review on 12/11/2025 of Patient #4’s medical record revealed the patient was admitted to the facility on 12/27/2024 for ICHD. Review revealed the patient’s current medication prescriptions included Mircera (ESA), 90 mcg IVP, every two weeks. The review revealed no documentation to show that the patient had been informed of the risks and benefits of the ESA. Interview on 12/11/2025 at 0920 with the Clinical Coordinator reported that the prescribing provider was to educate the patient on the risks and benefits of the Mircera. The patient, the provider, and the RN witnessing the education were to sign the patient education acknowledgment form before the first dose was administered. The Clinical Coordinator added that the RN administering the first dose was to ensure that the patient had signed the acknowledgment form. The interview confirmed the facility was unable to locate the acknowledgment form for the Patient. The Clinical Coordinator revealed that “it is clear that there has been a gap in the policy.” b. Review on 12/09/2025 of the facility policy titled “Personal Appearance Policy” revised 06/13/2025 revealed, “...Standard of Dress for Teammate Who Will Be In or Around the Treatment Area... Teammates who work in a facility, including facility administrators and support teammates, must wear lip-resistant, closed-toe shoes...” Observation on 12/09/2025 from 1215 through 1325 revealed one RN and four PCTs providing patient care. The observation revealed that a male PCT, PCT #2, was wearing a pair of back Crocs sliders with holes on the top. An interview on 10/09/2025 at 1655 with the Manager of Clinical Services revealed that the staff were expected to wear closed-toe shoes. The interview revealed that closed-toe shoes were shoes with the toes and the back closed. The Manager of Clinical Services revealed that crocs with holes on the top of the shoes were not considered closed-toe shoes and should not be worn by teammates on the treatment floor. Interview on 10/10/2025 at 1550 with PCT #1 revealed that she was the preceptor training PCT #2. The interview indicated that as a preceptor, she was responsible for ensuring new staff wore appropriate uniforms, including closed-toe shoes. The interview revealed that PCT #1 was busy when she noticed that the new staff did not have closed-toe shoes on and forgot to mention it to PCT #2 or management. The interview confirmed that the policy was not adhered to.”