Davita Durham Regional Dialysis

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 38766 Based on policy and procedure reviews, emergency drill reviews, and staff interviews, the facility administration failed to ensure fire drills were conducted quarterly per facility policy. Findings included: A review of the “Facility Emergency Management Plan ((ICHD, Home)” revised April 2024 revealed “...Fire Safety Preparedness 1. FA, or designee, is responsible to: ...b. Conduct and review quarterly fire safety and evacuation training and drills for compliance, identify additional trading and education needs...” A review of emergency fire drills on 07/25/2024 revealed that the most recent fire drill documentation was from 01/31/2023 (18 months ago). An interview on 07/25/2024 at 0930 with the Manager of Clinical Services (MCS) revealed that they could not locate documentation regarding fire drills. The interview revealed the MCS had conducted a clinic audit in April and June 2024, and she could not find the fire drill log and had notified the FA of the need to perform quarterly fire drills at the clinic. The interview revealed that the Medical Director was informed that fire drills had not been conducted. The interview confirmed the findings.”

“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: 38766 Based on observations, and interviews, the facility staff failed to prevent the spread of infectious disease by not ensuring facility-owned equipment was disinfected, between patient use, for 1 of 2 observations. Findings included: A review on 07/24/2024 of the facility’s policy titled, “Infection Control For Dialysis Facilities” revised 04/2024 revealed “...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 infections materials (i.e. used or brought into the station and prior to returning to the clean/designated area or removal from the treatment area...” Observation on 07/24/2024 from 1045 to 1145 in the patient treatment area revealed Patient #8 treatment was discontinued, and homeostasis was achieved. The observation revealed a Hoyer Lift, used to transfer patients, was brought to Station 19 by PCT #1 who assisted with lifting the patient from the dialysis chair to a wheelchair. The observation revealed the PCT immediately returned the Hoyer Lift to the same area. The observation failed to reveal the cleaning and disinfection of the equipment before or after its use. An interview on 07/24/2024 at 1135 with PCT #1 confirmed that the PCT did not clean or disinfect the Hoyer Lift before or after its use. PCT #1 stated “ I was unaware that the lift needed to be cleaned after each patient use. An interview on 07/24/2024 at 1140 with PCT/CCHT #2 confirmed that the lift should have been wiped after each patient use before being returned to the clean area, and clarified that the failure to clean the lift was the result of an error by PCT #1.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 38766 Based on facility policy review, observations, and staff interviews, the facility staff failed to prevent cross-contamination by failing to ensure personal protective equipment (PPE) was not worn outside of the treatment area for 1 of two observations (RN #3). Findings included: A review on 07/24/2024 of the facility’s policy titled, “Infection Control For Dialysis Facilities” revised 04/2024 revealed “... PPE (i.e., gown, gloves, eye protection, face shield) 5. ...PPE is to be: a. Removed before leaving the treatment area...” Observation on 07/24/2024 at 1125, in the patient treatment area, revealed RN #3 left the treatment area, wearing a gown used during the provision of care to the water room, returned to the treatment area, and resumed patient care. The observation revealed RN #3 failed to remove PPE (the gown) before entering the designated clean area per policy. An interview on 07/24/2024 at 1135 with RN #3 revealed “I should not have gone to the water room with the gown on. I should have taken the gown off before leaving the treatment area”. An interview on 07/24/2024 at 1620 with the Clinical Coordinator emphasized the expectation for staff to adhere to all infection control protocols, including the proper removal of PPE before entering certain areas, as outlined in the 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 policy review, observations, and staff interviews, the facility staff failed to obtain a post-treatment weight for 1 of 2 patients’ treatment termination observed (Patient #5). Findings included: A review on 05/10/2024 of the facility’s policy and procedure, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” revised 04/2024 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: ...iv. Patient weight...” An observation on 07/23/2024 at 1110 revealed Patient #5’s dialysis treatment was complete. The patient walked unassisted from the dialysis station to the weight scale. Once at the scale, the patient obtained and printed a slip detailing the post-treatment weight. The observation revealed the patient returned to the station, handed the slip to RN #3, and exited the treatment area. The observation revealed the RN failed to verify the patient’s post-treatment weight. An interview on 07/23/2024 at 1510 with RN #3 revealed the nurse acknowledged that walking the patient to the scale to ensure the accuracy of the weight was necessary. An interview on 07/24/2024 at 1620 with the Clinical Coordinator reinforced the expectation for the staff to have monitored the patients while taking their weights to ensure accuracy. The interview confirmed that the policy was not followed.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 38766 Based on policy review, medical record review, and staff interview the facility staff failed to follow the adequacy plan of care by failing to dialyze patients at the prescribed treatment duration time and/or obtain a signed against medical advice (AMA) form for 4 of 8 (Patient #5, #2, #6, and #1) sampled in-center hemodialysis records. Findings included: A review on 07/23/2024 of the policy and procedure “Prescribed Treatment Time Not Met” revised 04/2024 revealed, “... Policy: A. Completion 0f The Early Termination of Treatment Against Medical Advice Form 1. The RN will verify that a patient signs the Early Termination of Treatment Against Medical Advice Form any time the patient requests to terminate their treatment earlier than the prescribed run time... B. Prescribed treatment Time Not Met ...5. Additionally, if the patient’s dialysis treatment is terminated 30 minutes or more minutes prior to the ordered treatment length, the reason must be documented in the patient electronic health record at the time the treatment was terminated while reconciling the treatment times. 1. Medical record review on 07/25/2024 of Patient #5, a 54-year-old male was admitted to the facility for ICHD treatments on 11/16/2021. The review of the Physician’s dialysis orders revealed the patient’s frequency for ICHD was three times per week for four hours (240 minutes). The review of the treatment sheet dated 07/02/2024 revealed that the patient received dialysis for 185 minutes (55 minutes less than the prescribed 240 minutes). The review of the treatment sheet dated 07/04/2024 revealed that the patient received dialysis for 196 minutes (44 minutes less than the prescribed 240 minutes). The review of the treatment sheet dated 07/08/2024 revealed that the patient received dialysis for 201 minutes (69 minutes less than the prescribed 240 minutes). The review of the treatment sheet dated 07/11/2024 revealed that the patient received dialysis for 195 minutes (45 minutes less than the prescribed 240 minutes). The review revealed no documentation of the rationale for the patient not running the full prescribed treatment time on 07/02/2024, 07/04/2024, 07/08/2024, and 07/11/2024. The review revealed no completed AMA form for early termination of the treatment on 07/02/2024, 07/04/2024, 07/08/2024, and 07/11/2024. An interview on 07/25/2024 at 1410 with the Manager of Clinical Services revealed that no AMA form could be located for the patient. “We have to re-educate the staff on AMA for early termination of treatment. The interview revealed once a patient requested to terminate their treatment, the patient should be presented with the AMA form for the patient’s signature. The interview confirmed that the policy was not followed. 2. Medical record review on 07/23/2024 of Patient #2, a 35-year-old male was admitted to the facility for ICHD treatments on 03/17/2020. The review of the Physician’s dialysis orders revealed the patient’s frequency for ICHD was three times per week for three and a half hours (210 minutes). The review of the treatment sheet dated 07/01/2024 revealed that the patient received dialysis for 69 minutes (141 minutes less than the prescribed 210 minutes). The review revealed no documentation of the rationale for the patient not running the full prescribed treatment time on 07/01/2024. The review revealed no completed AMA form for early termination of the treatment on 07/01/2024. An interview on 07/25/2024 at 1410 with the Manager of Clinical Services revealed that no AMA form could be located for the patient. “We have to re-educate the staff on AMA for early termination of treatment. The interview revealed once a patient requested to terminate their treatment, the patient should be presented with the AMA form for the patient’s signature. The interview confirmed that the policy was not followed. 3. Medical record review on 07/25/2024 of Patient #6, a 78-year-old female was admitted to the facility for ICHD treatments on 02/14/2022. The review of the Physician’s dialysis orders revealed the patient’s frequency for ICHD was three times per week for three and a half hours (210 minutes). The review of the treatment sheet dated 07/04/2024 revealed that the patient received dialysis for 112 minutes (98 minutes less than the prescribed 210 minutes). The review revealed no documentation of the rationale for the patient not running the full prescribed treatment time on 07/04/2024. The review revealed no completed AMA form for early termination of the treatment on 07/04/2024. An interview on 07/25/2024 at 1410 with the Manager of Clinical Services revealed that no AMA form could be located for the patient. “We have to re-educate the staff on AMA for early termination of treatment. The interview revealed once a patient requested to terminate their treatment, the patient should be presented with the AMA form for the patient’s signature. The interview confirmed that the policy was not followed. 4. Medical record review on 07/24/2024 of Patient #1, a 78-year-old female was admitted to the facility for ICHD treatments on 05/07/2024. The review of the Physician’s dialysis orders revealed the patient’s frequency for ICHD was three times per week for three and a half hours (210 minutes). The review of the treatment sheet dated 07/09/2024 revealed that the patient received dialysis for 182 minutes (28 minutes less than the prescribed 210 minutes). The review revealed no documentation of the rationale for the patient not running the full prescribed treatment time on 07/09/2024. The review revealed no completed AMA form for early termination of the treatment on 07/09/2024. An interview on 07/25/2024 at 1410 with the Manager of Clinical Services revealed that no AMA form could be located for the patient. “We have to re-educate the staff on AMA for early termination of treatment. The interview revealed once a patient requested to terminate their treatment, the patient should be presented with the AMA form for the patient’s signature. The interview confirmed 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, observation, and staff interview, the facility staff failed to properly label medication syringes in eight (8) of ten (10) observed pre-drawn syringes. Findings included: A review on 07/23/2024 of the facility’s policy titled, “Medication Policy” revised 10/2023 revealed, “...19. Medications administered via infusion are to be prepared, and administration started within four (4) hours... 20. ...If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with ...time prepared, ...and initials of teammate preparing the medication...” Observation on 07/23/2024 between 1040 and 1230 of the treatment areas revealed a medication preparation area near the nursing station. Observation revealed a total of 2 syringes of Venofer (medication used to treat iron deficiency anemia) and 8 (eight) syringes of Heparin (medication used to decrease the clotting ability of the blood) were stored in a locked drawer. The observation revealed the labels on 8 of the ten syringes did not contain the preparation time or the initials of the nurse who prepared them. The observation revealed the nurse did not label the syringes according to policy. An interview on 07/23/2024 at 1230 with RN #3 revealed the pre-drawn syringes were suitable for 4 hours from the preparation time. The interview revealed RN #3 usually timed and initialed the syringes but did not have time to do them this morning. The interview confirmed that the nurse should have labeled the syringes with the time and her initials. An interview on 07/24/2024 at 1620 with the Clinical Coordinator further reinforced the expectation for staff to adhere to all policies and procedures. The Clinical Coordinator reported that the facility policy regarding medication labeling was not followed.”