Davita Roxboro Dialysis

“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: 38766 Based on policy review, observations, and staff interviews, the facility staff failed to clean and disinfect non-disposable equipment between patient use for 2 of 2 observations (stations #35 and #28). The findings include: Review on 10/28/2025 of the facility’s policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES,” revised 04/2023, revealed, “PURPOSE: to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment... DISINFECTION 12. 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...” 1. Observation on 10/28/2025 at 1050 revealed that RN #3 obtained a Hoyer Lift from a holding area to station #35. RN #3 and PCT #1 assisted a patient from a wheelchair into the treatment chair via the Hoyer Lift. The observation revealed that RN #3 returned the Hoyer Lift to the holding area near oxygen concentrators. The observation failed to show the staff cleaning and disinfecting the equipment before returning to the holding area. An interview on 10/28/2025 at 1130 with RN #3, Clinical Coordinator, revealed that the holding area where the Hoyer Lift and oxygen concentrators were stored was considered a clean area. The interview revealed that dirty equipment was not to be kept in the same area as clean equipment. RN #3 stated that the equipment was considered dirty after each use and had to be sanitized before returning to the clean area. 2. Observation on 10/28/2025 at 1120 revealed that RN #3 obtained a Hoyer Lift from a holding area to station #28. RN #3 and PCT #4 assisted a patient from a wheelchair into the treatment chair via the Hoyer Lift. The observation revealed that RN #3 returned the Hoyer Lift to the holding area near oxygen concentrators. The observation failed to show the staff cleaning and disinfecting the equipment before returning to the holding area. An interview on 10/28/2025 at 1130 with RN #3, Clinical Coordinator, revealed that the holding area where the Hoyer Lift and oxygen concentrators were stored was considered a clean area. The interview revealed that dirty equipment was not to be kept in the same area as clean equipment. RN #3 stated that the equipment was considered dirty after each use and had to be sanitized before returning to the clean area.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 38766 Based on a review of facility policy, Daily Water Treatment Logs, and staff interviews, the facility staff failed to complete the daily water treatment logs accurately for 2 of 26 Daily Water Treatment Logs reviewed. Findings included: Review on 10/29/2025 of the facility policy titled “DAILY WATER TREATMENT SYSTEM MONITORING,” revised October 2025, revealed “... Policy: ...6. All observations and test results will be within the limits specified on the Daily Water Treatment Log. If observations or test results are found outside the specified limits, follow the instructions given on the daily treatment log for the parameter(s) in question. In addition to following the log instructions, the teammate completing the log will notify the Facility Administrator/designee and Biomed teammate assigned to the facility...” Review on 10/29/2025 of the CWP Daily Waterlog Explanation revealed, “Monitoring Process or Component: CWP Percent Rejection, Acceptable Limit(s): >/= Monitor Location: CWP Display Panel. Enter the Percent Rejection value displayed on the RO monitor. If the observed quality value is outside the acceptable limits or if the RO monitor is not operational, immediately contact the Biomedical Team for direction and assistance...” Review on 10/29/2025 of the “CWP Daily Waterlog” for 08/01/2025 through 09/30/2025 revealed that the RO Percent Rejection was reported to be 73% on 09/01/2025 and 35% on 09/02/2025. The review revealed no documentation that the Biomedical Team was notified. Review of the monthly quality meeting minutes revealed no documentation of percent rejection outside of the specified limits or errors in documentation. An interview on 10/29/2025 at 1320 with the Biomedical Technician revealed that he performed the monthly CWP Daily Waterlog audits and failed to notice that the percent rejection was outside of the normal limits on those days. He also mentioned that the staff did not inform him of these results. The interview confirmed that the staff did not adhere to the facility’s 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: 38766 Based on review of policy and procedures, medical records, and staff interviews, the facility staff failed to ensure that standing blood pressures, pre- and post-hemodialysis treatments, were taken on ambulatory patients for 4 out of 11 patients’ treatment sheets reviewed (Patient #5 and #2). Findings included: Review on 009/10/2025 of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, revised April 2024, revealed, “... Policy: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. ...ii. Measurement of Blood Pressure (BP) 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document in the patient electronic record or flow sheet...” 1. Medical record review on 10/30//2025 of Patient #5 revealed a 75-year-old male patient admitted for hemodialysis on 05/29/2025. The review revealed the patient was ambulatory with no assistance needed. Review of the treatment sheets dated 10/07/2025 through 10/18/2025 revealed no pretreatment or posttreatment standing blood pressure on 10/07/2025, 10/09/2025, 10/14/2025, 10/16/2025, and 10/18/2025. The review revealed that no standing BP was done in 5 of 6 treatment records reviewed. An interview on 10/30/2025 at 1350 with the Clinical Coordinator revealed that pre- and post-standing blood pressure was required for all ambulatory patients unless ordered by the provider to omit standing blood pressure for a history of orthostatic pressure. The interview revealed that the expectation was for the staff to always follow the facility’s policies. 2. Medical record review on 10/29//2025 of Patient #2 revealed a 73-year-old male patient admitted for hemodialysis on 10/20/2020. The review revealed the patient was ambulatory with no assistance needed. Review of the treatment sheets dated 09/02/2025 through 10/02/2025 revealed no pretreatment or posttreatment standing blood pressure on 09/02/2025, 09/20/2025, and 10/02/2025. The review revealed no standing BP was done in 3 of 4 treatment records reviewed. An interview on 10/30/2025 at 1350 with the Clinical Coordinator revealed that a pre- and post-standing blood pressure was required for all ambulatory patients, unless a patient had an order to omit standing blood pressure by the provider due to a history of orthostatic pressure. The interview revealed that the staff were expected to follow the facility’s policies.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 38766 Based on facility policy and procedure review, observations, and staff interviews, the facility staff failed to verify the accuracy of a patient’s post-treatment weight in two (2) of the two (2) patients observed. Findings included: Review on 009/10/2025 of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, revised April 2024, revealed, “... Policy: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: ...ii. Measurement of Blood Pressure (BP).” 1. Observation on 10/29/2025 at 0925 revealed PCT #5 entered station #14 to terminate a patient’s treatment. The observation revealed that the patient ambulated to the scale and obtained the post-treatment weight without staff supervision for accuracy. The observation revealed that PCT #5 remained in the station to document. The patient returned to the station and handed the printed receipt indicating the post-treatment weight to PCT #5 An interview on 10/29/2025 at 0927 with PCT #5 revealed that the staff should take the patient to the scale to obtain their weight. The PCT added that the process was to ensure the accuracy of the patient’s weight. The interview confirmed that the facility’s policy was not adhered to. An interview on 10/30/2025 at 1350 with the Clinical Coordinator revealed that staff were expected to physically observe the patient taking their weight before and after treatments. If a patient obtained their weight without staff supervision, the staff should ask the patient to reweigh to ensure the accuracy of the weight. 2. Observation on 10/29/2025 at 0926 revealed RN #3 entered station #30 to perform a post-treatment assessment for a patient. The observation revealed that the patient ambulated to the scale and obtained the post-treatment weight without staff supervision for accuracy. The observation revealed that RN #3 remained in the station to document. The patient returned to the station and gave RN #3 the printed receipt showing their post-treatment weight. An interview on 10/29/2025 at 0930 with RN #3 revealed that the staff should watch the patients taking their weights. RN #3 added that “we can start doing that.” The interview confirmed that the facility’s policy was not adhered to. An interview on 10/30/2025 at 1350 with the Clinical Coordinator revealed that staff were expected to physically observe the patient taking their weight before and after treatments. If a patient obtained their weight without staff supervision, the staff should ask the patient to reweigh to ensure the accuracy of the weight.”

“POC-TRANSPLANT STATUS PLAN OR WHY NOT CFR(s): 494.90(a)(7)(ii) When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient’s plan of care must include documentation of the- (A) Plan for transplantation, if the patient accepts the transplantation referral; (B) Patient’s decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or (C) Reason(s) for the patient’s nonreferral as a transplantation candidate as documented in accordance with §494.80(a)(10). This Standard is not met as evidenced by: 38766 Based on a review of policy and procedures, medical records, and staff interviews, the facility failed to ensure that a monthly blood sample was submitted to the transplant center for a patient on the active transplant list for one of the active patients reviewed (Patient #1). The findings included: Review on 10/30/2025 of the current facility policy, “Monthly Laboratory Specimens for Patients Awaiting Transplant,” revised in March 2025, revealed “Purpose: To provide guidance for obtaining laboratory specimens for patients awaiting transplant. Policy: 1. The dialysis facility will coordinate laboratory draws with the transplant center. 2. The dialysis facility will follow transplant center requirements for obtaining, processing, and submitting monthly specimens for patients awaiting transplantation, as applicable...” A review of the medical record for patient #9 indicated a 61-year-old female was admitted for hemodialysis treatments three times per week on 03/14/2022. The record revealed a letter dated 11/18/2022, from the Named Transplant Center, confirming that the patient was active on the transplant waitlist. However, a letter from the Named Transplant Center dated 10/10/2024 indicated that the Center had not received a serum sample from the clinic for the patient since 07/17/2024, resulting in a 3-month gap. Additional review revealed that the most recent blood sample was sent to the transplant center on 07/15/2025, resulting in a 3-month gap. The review confirmed that the facility failed to submit the patient’s monthly blood samples to the transplant center as required by the policy. An interview on 10/30/2025 at 1550 with the Manager of Clinical Services revealed that the facility’s Administrative Assistant (AA) was responsible for sending lab samples to the transplant centers on behalf of patients listed on the active transplant list. An interview on 10/30/2025 at 1600 with the Administrative Assistant confirmed that she would be responsible for sending lab samples to the transplant centers. The interview revealed that the AA admitted not sending a sample for Patient #9 since July 2025. The AA added that “it was an error on my part due to being on vacation and other responsibilities.” The interview confirmed that the policy was not adhered to. NC00231748”