Davita Hopewell Dialysis Center

“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: 42042 Based on observations, interview and document review, it was determined the facility staff failed to maintain a sanitary environment by not covering the 1:100 bleach container. The finding include: On 02/05/24 at 2:22 pm, during walk-through inspection of the treatment floor, the surveyor observed an unsecure bleach container located adjacent to the “clean sink” area of the central station labeled, “1:100 Bleach Water”. The surveyor confirmed that the lid for the container covered only a portion of the top part of the container, and not fully closed and secured. In the afternoon of 02/06/24, the surveyor was provided by Staff Member #1 the facility policy titled, “Bleach Policy” (with last revision date of 10/23). The policy states, in part, “5. Bleach solution needs to be covered with a secure lid and the solution should not be placed in the splash zone. NOTE: Without a secure lid, the bleach solution is open to air causing the solution to degrade over time and become less effective”. On 02/07/24 at 12:40 pm, the surveyor met with Staff Member #1 for interview. The surveyor made the staff member aware of the aforementioned infection control findings observed on 02/05/24. Staff Member #1 verbalized understanding without additional response.”

“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: 40084 Based on one (1) infection control observation, interview and document review, it was determined the facility staff failed to maintain a sanitary environment by not cleaning and disinfecting non-disposable equipment brought into the dialysis station. The findings include: On 02/05/24 at 3:01 pm, the surveyor observed Staff Member #3 auscultating Patient #5 during treatment at Dialysis Station #9. Following use, the surveyor observed the staff member placing the used stethoscope around the staff member’s neck without cleaning and disinfecting. In the afternoon of 02/06/24, the surveyor was provided by Staff Member #1 the facility policy titled, “Infection Control for Dialysis Facilities” (with last revision date of 04/23). On page four (4), the policy reads, “14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses ...a. Stethoscopes will be disinfected with alcohol prep pad and/or 1:1009 (one to one hundred) bleach solution ...” [sic]. On 02/07/24 at 12:40 pm, the surveyor met with Staff Member #1 for interview. The surveyor made the staff member aware of the aforementioned infection control findings observed on 02/05/24. Staff Member #1 verbalized understanding without additional response.”

“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: 40084 Based on observations, interview and document review, it was determined the facility staff failed to maintain a sanitary environment by not appropriately cleaning and disinfecting the dialysis station following patient treatment for two (2) out of three (3) observations. The findings include: On 02/05/24 at 2:36 pm, the surveyor observed Staff Member #5 cleaning and disinfecting Dialysis Station #5 following patient treatment. Following the station cleaning, the surveyor confirmed that the staff member never used the disinfectant-soaked wipe to clean the Hansen connectors. On 02/05/24 at 2:44 pm, the surveyor observed Staff Member #4 cleaning and disinfecting Dialysis Station #2 following patient treatment. Following the station cleaning, the surveyor confirmed that the staff member never disinfected the wall box behind treatment chair. Additionally, following emptying of the prime waste receptacle, the surveyor observed that Staff Member #4 only cleaned the outer surfaces of the prime waste receptacle, and never the interior portion of the container. Under “Disinfection” section of page three (3) of the “Infection Control for Dialysis Facilities” policy, stated the following: “13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The wall box, drain and water supply lines are considered part of the dialysis delivery system. Pressurized washers, spray bottles, or sprayers for cleaning purposes ... ii. Priming containers are to be emptied prior to disinfection” [sic]. On 02/07/24 at 12:40 pm, the surveyor met with Staff Member #1 for interview. The surveyor made the staff member aware of the aforementioned infection control findings observed on 02/05/24. Staff Member #1 verbalized understanding without additional response.”

“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: 40084 Based on observation, interview and document review, it was determined that facility staff failed to ensure medications drawn up and ready for use included all of the necessary components of medication labeling for two (2) of two (2) intravenous (IV) medication syringes. The findings include: On 02/05/24 2:08 pm, the surveyor observed two (2) filled medication syringes resting on the chairside tray of Dialysis Station #4. The hemodialysis chair at the time was vacant without a patient. Upon closer examination, the surveyor identified labels on each syringe indicating they were for Patient #2 and contained “Heparin 3,000 Units”. The surveyor confirmed there was no indication on either syringe indicating the date and time in which the medication syringes were prepared or by whom. On 02/07/24 at 1:04 pm, the surveyor was provided by Staff Member #1 the facility policy titled, “Medication Policy” (with last revision date of 10/23). In reference to prepared medications, on page four (4) of document, the policy states, in part, “If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient’s name, name of medication, date, time prepared, dose and initials of teammate preparing the medication”. On 02/07/24 at 12:40 pm, the surveyor met with Staff Member #1 for interview. The surveyor made the staff member aware of the aforementioned infection control findings observed on 02/05/24. Staff Member #1 verbalized understanding without additional response.”

“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: 40084 Based on document review and interview, it was determined the facility staff failed to adhere to patient care policy and procedures related to the Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR) prescriptions for three (3) of four (4) patients reviewed. The finding include: During medical record review on 02/06/24 and 02/07/24, the surveyor reviewed the last two (2) weeks’ worth of treatment flowsheets for Patient # (6-9). The surveyor identified the following BFR and DFR discrepancies between the ordered prescription and actual treatment rates: Patient #7: Treatment Date: 01/22/24 Prescribed BFR: 400 mL/min Actual Treatment BFR: 200 mL/min between 3:36 pm until 4:59 pm Patient #8: Treatment Date: 01/22/24 Prescribed BFR: 550 mL/min Actual Treatment BFR: Between (0-500) mL/min throughout treatment Treatment Date: 01/31/24 Prescribed BFR: 550 mL/min Prescribed DFR: 800 mL/min Actual Treatment BFR: Between (0-500) mL/min throughout treatment Actual Treatment DFR: 500 mL/min throughout treatment Patient #9: Treatment Date: 01/22/24 Prescribed BFR: 450 mL/min Actual Treatment BFR: Between (250-400) mL/min throughout treatment Treatment Date: 01/26/24 Prescribed BFR: 450 mL/min Actual Treatment BFR: 400 mL/min between 5:31 pm until 6:50 pm. In the morning of 02/07/24, Staff Member #1 supplied the surveyor with the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (with last revision date of 10/23). Under “Patient Identity, Prescription, and Machine Settings” [sic] subsection of page two (2), the policy reads, in part, “Prescription components include but are not necessarily limited to: ...f. Blood flow rate ...g. Dialysate flow rate”. On page four (4) of same document, the policy continued to state, “If the dialysis prescription is not being met (including dialysis flow rate or change/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed” [sic]. On 02/07/24 at 12:17 pm, the surveyor met with Staff Member #1 for interview regarding the aforementioned variances in BFR and DFR. Staff Member #1 confirmed that any discrepancies regarding the DFR and/or BFR of the patient’s treatment with the ordered prescription should have an accompanying note in the medical record regarding a rationale for the change and physician contact. The surveyor informed the staff member that there was no note found in the medical record regarding the variance.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 42042 Based on document review and interview, it was determined the facility staff failed to ensure that plans of care (POC) were fully completed and signed by both the patient and all interdisciplinary staff for two (2) of three (3) care plans reviewed (Patient #8). The finding include: The surveyor reviewed the medical records of Patient # (6-9) on 02/06/24 and 02/07/24. On 02/07/24 at 10:55 am, the surveyor initiated the review of Patient #8’s medical record to include treatment flow sheets, consents, education, Plan of Care, and vaccination history. The surveyor identified a total of three (3) interdisciplinary team care plans that were conducted since the patient’s admission to facility on 09/17/21. The Plan of Care dated on 12/26/21, which corresponded to the ninety (90) day review contained the signatures of the patient, Registered Nurse, Dietitian, and Social Worker. There was, however, no signature by the provider. The Plan of Care dated on 01/26/24 corresponded to the annual review of Patient #8 who was determined to be in stable condition. The surveyor observed that the Care Plan contained signatures for the Registered Nurse, Dietitian, Social Worker, and Provider. There was, however, no signature by the patient or patient representative. Additionally, there was no documentation found regarding the reason for the patient and/or patient representative signature omission. There was no evidence on either care plan to support that the physician, patient, and/or patient representative, respectively, was present or made aware of the interdisciplinary team meeting. In the morning of 02/07/24, Staff Member #1 supplied the surveyor with the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” (with last revision date of 07/23). On page four (4) of document, the same policy stated, “14. The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative, and be signed by team members including the patient or the patient’s personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided”. On 02/06/24 at 12:17 pm, the surveyor met with Staff Member #1 regarding the lack of complete signatures by the patient and all pertinent IDT staff for the three (3) Plans of Care. Following review, Staff Member #1 confirmed the aforementioned signatures were not present, and stated they were unsure as to why the care plans lacked all the necessary signatures. The surveyor also informed the staff member that supporting documentation as to the missing patient and staff signatures could not be found throughout the medical record of Patient #8. The surveyor requested the staff member to make additional attempts in locating any insight surrounding the issue. As of 02/07/24 at 1:00 pm, the surveyor received no additional documentation or response from the staff member regarding the incomplete three (3) Plans of Care.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 40084 Based on observation, interview and document review, it was determined the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to take action to ensure sustained improvement over time. Specifically, the QAPI program failed to correct known issues identified during the previous recertification survey. The findings include: The Current Recertification Survey Based on observation, interview and document review, it was determined that facility staff failed to ensure medications drawn up and ready for use included all of the necessary components of medication labeling for two (2) of two (2) intravenous (IV) medication syringes. The Recertification Survey Ending March 1, 2021 Based on observation, document review and interview, it was determined that the facility failed to ensure medications drawn up and ready for use, yet not give at time drawn up were labeled with time and initials and clinical staff demonstrate compliance with aseptic technique when dispensing medications for one (1) of two (2) Staff Members (Staff Member # 4). The Current Recertification Survey Based on document review and interview, it was determined the facility staff failed to ensure that plans of care (POC) were fully completed and signed by both the patient and all interdisciplinary staff for two (2) of three (3) care plans reviewed (Patient #8). The Recertification Survey Ending March 1, 2021 Based on Clinical Record review and interview, it was determined that the facility failed to complete the plan of care by the interdisciplinary team (IDT) for one (1) of four (4) patients (Patient # 1).”

“GOV-PHYSICIAN ROSTER AVAILABLE CFR(s): 494.180(g)(2) (2) The dialysis facility must have available at the nursing/monitoring station, a roster with the names of physicians to be called for emergencies, when they can be called, and how they can be reached. This Standard is not met as evidenced by: 42042 Based on observation and interviews, it was determined the facility staff failed to maintain a readily available and complete list of physicians with emergency contact information within the nurse’s station to include Staff Member #9. The finding include: On 02/07/24 at 12:30 pm, the surveyor made additional observations of the treatment floor with specific goal in locating an available roster of physicians with contact information posted in or around the nurse’s station. The surveyor was unable to identify such information and met with the Charge Nurse, Staff Member #3, for interview on 02/07/24 at 12:34 pm. Staff Member #3 attempted to search the nurse’s station for any such roster and located a Rolodex rotary card file with various facility’s information. The surveyor inquired with Staff Member #3 whether information of the Medical Director and lead nephrologist for facility (Staff Member #9) was available. Following attempt, Staff Member #3 stated that the Rolodex file did not include contact information for Staff Member #9. Staff Member #3 stated that they had the direct contact number of Staff Member #9 “memorized”. On 02/07/24 at 12:57 pm, the surveyor disseminated to Staff Member #1 the findings during interview. The surveyor accompanied Staff Member #1 to the treatment floor for verification of the Rolodex and all other areas of the nurse’s station for Staff Member #9’s contact information. Staff Member #1 was unable to identify the aforementioned information. Staff Member #1 stated that Staff Member #9’s contact information was available within the Emergency Preparedness (EP) binder but acknowledged it was not available in the form of a roster list within the nurse’s station. The surveyor inquired whether an accompanying facility policy or procedure was available related to the posting of physician contact information. As of 02/07/24 at 1:00 pm, no such policy, procedure, or other document was received by the surveyor.”

“GOV-RESPONDS TO NW REQUEST/WORKS TOWARD GOALS CFR(s): 494.180(i) The governing body receives and acts upon recommendations from the ESRD network. The dialysis facility must cooperate with the ESRD network designated for its geographic area, in fulfilling the terms of the Network’s current statement of work. Each facility must participate in ESRD network activities and pursue network goals. This Standard is not met as evidenced by: 42042 Based on document review and interview, it was determined the facility staff failed to maintain ongoing participation with the local End-Stage-Renal-Disease (ESRD) network by not conducting a monthly review of the network dashboard. The finding include: On 02/05/24 at 1:12 pm, the surveyor contacted the Renal Engagement Specialist of the local Quality Insights Renal Network (Network #5) regarding acquisition of additional facility information to include involuntary discharges, goals, involvement of projects, concerns, etc. The surveyor received an email response from the Renal Engagement Specialist on 02/06/24 at 10:51 am indicating that the facility was overdue and non-compliant with monthly quality dashboard checks with last recorded log-in on 12/27/23. The surveyor received additional communication form the Renal Engagement Specialist on 02/06/24 at 1:13 pm who confirmed that ESRD clinics have a signed agreement requiring checking the End Stage Renal Disease (ESRD) Network Dashboard at least once monthly. In the morning of 02/07/24, the surveyor received additional information regarding the ESRD Network agreement terms with the facility by the Renal Engagement Specialist which read the following: “Per QIRN5’s Executive Director, someone from the clinic should be accessing the report monthly, I send an email to the Facility Administrator, Medical Director, and Social Worker the last week of each month notifying them that the report has been updated and that someone needs to access it so that it can be discussed in QAPI. The expectation is that action plans to reach Network goals are discussed and documented in their QAPI minutes. This expectation is stated in every email and presented during our Quarterly Virtual Council Meetings” [sic]. On 02/07/24 at 1:04 pm, following a request by the surveyor, Staff Member #1 provided the surveyor with the Mid-Atlantic Renal Coalition ESRD Network # 5 “Membership Agreement” with the facility. The agreement between the local ESRD Network and the facility was signed by both authorized representatives of both parties on 12/10/08, and clearly stated the following: “The undersigned, on behalf of Total Renal Care - Hopewell, hereby joins in membership with other Medicare-approved End-Stage Renal Disease (ESRD) providers in Network 5 in agreeing to participate in the activities of the Network as provided in 42 CFR Part 494.180(i) of the Department of Health and Human Services’ regulations.” “It is understood that: Participation in Network activities is a condition of approval to receive Medicare reimbursement for the provision of End-Stage Renal Disease services”. “The dialysis facility must cooperate with the ESRD Network designated for its geographic area, Network 5, in fulfilling the terms of the Network’s current Statement of Work. Each facility must participate in ESRD Network activities and pursue Network goals”. On 02/07/24 at approximately 1:00 pm, following review of the facility’s last six (6) months of Facility Health Records (FHR) meeting minutes and other quality data, the surveyor met with Staff Member #1 for interview. The surveyor interviewed the staff member regarding the last known contact with the local ESRD Network. Staff Member #1 could not provide a specific date to the surveyor but stated any and all recommendations and related requests by the network are discussed during the monthly FHR meetings. Staff Member #1 confirmed that any ESRD-related dashboard information discussed with the IDT staff would be included within that month’s FHR data. The surveyor reviewed the December 2023 quality data discussed during the FHR meeting performed on 01/26/24 and was unable to identify any information regarding checking the Network Dashboard report for the latest quality indicators. In the afternoon of 02/07/24, Staff Member #1 provided the surveyor with the report following Network #5’s on-site visit documented as performed on 10/25/23 without any more recent communication or other collaboration with the network since.”