Davita Lake Road Dialysis

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 47148 Based on interview, review of personnel files and review of documentation, it was determined the facility failed to ensure all staff received required training on the facility’s EMP and emergency procedures. Findings: The review of documentation included an audit worksheet document of the facility staff training records which was completed by the FA on 12/04/2024. The worksheet revealed numerous gaps in the required personnel documentation. Examples included, but were not limited to: - 2 of 23 staff (Staff #s 7 and 23) had documentation of annual “EP Training” on 12/03/2024 after the surveyors were on site for the recertification survey. - 1 of 23 staff (Staff #23) had documentation of “Emergency Procedures” on 12/03/2024 after the surveyors were on site for the recertification survey. During review of the facility policy titled, “Facility Emergency Management Plan” dated, “April 2024” stipulated, “The FA, or designee, is responsible to provide training of EMP ... i. Annually ... Policy Facility Emergency Management Plan ... Facility specific emergency response procedures ... III ... Upon Hire ... v. Document training in teammate file.” During an interview with the FA on 12/05/2024 at 1210, the above findings were confirmed.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 47148 Based on interview and review of documentation, it was determined that the facility had failed to ensure that staff members that were not immune to Hepatitis B were offered Hepatitis B vaccination. Findings: The review of documentation included an audit worksheet document of the facility staff presonnel records which was completed by the FA on 12/04/2024. Review of the worksheet document revealed a column titled, “Hepatitis B Vaccine or Decline” and the following: - 1 of 23 staff (Staff #4) with a DOH of 01/01/2023 had documentation that the employee received a vaccine or declined on “12/3/2024” after the surveyors arrived on site. - 1 of 23 staff (Staff #17) with a DOH of 09/23/2024 lacked documentation that the employee had received or declined the Hepatitis B vaccine. Review of the facility policy titled, “Teammate Hepatitis B Monitoring and Follow-up Guidance” dated “April 2024” stipulated, “New teammates who are not able to provide documentation of Hepatitis B surface antibodies of 10 mIU/ml or greater from any time in the past, regardless of documentation indicating completion of the Hepatitis B vaccine series, will be screened for Hepatitis B surface antigen (HBsAg) and Hepatitis B surface antibody (anti-HBs) within 10 days and offered the vaccination as indicated by their results.” During an interview with the FA on 12/05/2024 at 1210, the above findings were confirmed.”

“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: 31224 Based on observation, interviews, and review of documentation it was determined that the facility failed to ensure that medications were prepared and stored correctly. Findings: Observation of the treatment floor and medication preparation areas on 12/03/2024 starting at 0950 revealed: - 12 pre-filled syringes of heparin with incomplete labels that did not indicate when the medication was drawn or which staff member filled the syringe. - 2 pre-filled syringes of lidocaine with incomplete labels that did not indicate when the medication was drawn or which staff member filled the syringe. Review of facility policy titled, “Medication Policy,” dated 10/2023, stipulated, “If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the...time prepared...and initials of teammate preparing the medication.” During an interview on 12/03/204 at 1500, the MCS confirmed the above findings.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 31224 47148 Based on observation, interview and review of documentation, it was determined the facility failed to maintain a safe and functional treatment environment. Findings: Observations of the facility on 12/03/2024 starting at 0950 included: On the treatment floor: - 1 syringe of NS expired on 01/31/2024. - 1 container of pH test strips expired on 11/30/2024. - 2 hemodialysis fistula needle sets expired on 09/30/2024. - 22 adhesive tape remover pads expired in 08/2024. - 1 opened box of 100 adhesive tape remover pads expired in 08/2024. - White precipitate on the floor, cabinets, countertops, back of patient chairs and in the wall boxes - Tape residue on the counter in the medication prep area - Wall areas throughout the facility had unfilled holes and chipped paint with exposed sheet rock. - All blood pressure cuffs on the treatment floor contained fuzzy material in the velcro - A missing drawer face in Pod #1 - An unidentified capsule on the floor in the medication prep area - Bleach bottles stored under one of the clean sinks In the isolation room: - 1 lab tube (3.0 mL) expired on 11/30/2019. - 1 lab tube (3.5 mL) expired on 07/31/2022 - 1 lab tube (5.0 mL) epired on 01/31/2023. - A broken cabinet door above the sink - Wall areas with chipped and scuffed paint exposed sheet rock In storage room: - 1 box of button hole needle sets expired on 11/20/2024. - 4 boxes of 100 adhesive tape remover pads expired in 03/2024. - 11 boxes of 100 adhesive tape remover pads expired in 08/2024. Review of facility policy, “Infection Control for Dialysis Facilities,” dated 04/2023, stipulated “expiration date and package integrity will be verified prior to use.” The policy did not address rotating stock or discarding expired items. During interview on 12/03/2024 at 1500. the MCS confirmed the above findings.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 31224 47148 Based on interview, review of patient medical records and review of documentation, it was determined that the facility failed to ensure: 1. VS checks and patient visualizations were completed regularly and on time for 8 of 8 patients (Patient #s 1-7, and 9) 2. Patients with VS outside of established parameters were not reported to the RN for 2 of 8 patients (Patient #s 5, 6) 3. Patients received their hemodialysis treatments as prescribed for 7 of 8 patients (Patient #s 1, 2, 3, 5-7 and 9). Findings: 1. Review of patients’ treatment flowsheets, “Treatment Details Reports,” revealed VS checks and patient visualizations were missed and/or abnormal values were not addressed. Examples included, but were not limited to: Patient #1 - Patient visualization and vital sign checks were late and/or missed for 10 of 13 treatments. * On 10/28/2024, VS and patient checks were documented by the RN at 0832. The next VS and patient check was documented by the RN at 0941, 69 minutes later. * On 11/22/2024, Patient #1 was placed on 15 minute VS and checks at 0807. Vital signs were automatically taken every 15 minutes, however the VS and patient were checked at 0807, 0832, 0937, 0938, 0939, and 0957, that indicated 25-65 minutes would lapse between checks. * Similar findings were noted on 10/30/2024, 11/13/2024, 11/18/2024, 11/20/2024, 11/25/2024, 11/27/2024, 11/29/2024, and 12/2/2024. Similar findings were noted for Patient #’s 2, 3, 4 and 9. Patient #5 - Patient visualization and vital sign checks were late and/or missed for 6 of 13 treatments. * On 10/30/2024, VS were automatically taken at 30 minute intervals, however the PCT conducted the patient and VS check at 0507 and then at 0553, 46 minutes later. * On 11/18/2024, the PCT conducted VS and patient checks at 0535. The next checks were documented at 0639, 64 minutes later. As treatment continued, the PCT also conducted VS and patient checks at 0742, with the next checks documented at 0826, 44 minutes later. * Similar findings were noted on 11/01/2024, 11/06/2024, 11/08/2024, and 11/20/2024. - Patient #5 had documented abnormal DBP readings during 1 of 13 treatments. There was no documentation to show VS were retaken or the RN was notified. * On 11/13/2024 at 0800 the DBP was documented as 39. At 0832, the DBP was documented as 51. The PCT did not document efforts to recheck these readings or notify the RN. Patient #5 ended treatment at 0832 and was sent home. Patient #6 - Patient visualization and vital sign checks were late and/or missed for 4 of 13 treatments. - Patient #6 had documented abnormal BP readings. During 4 of 13 treatments, there was no documentation to show the RN was notified or was notified in a timely manner. * On 10/16/2024, the PCT started treatment at 1443. Patient #6’s SBP was 212/92. It appeared the patient was placed on Q15min VS checks and while the VS were taken, the PCT did not check the patient or VS again until 1520, 37 minutes later. The PCT noted the elevated BP, but did not document notifying the RN. Another VS and patient check was not conducted until 1608, 48 minutes later. This was conducted by the RN and PRN medications were administered. * On 11/26/2024, the PCT started treatment at 1116. Patient #6’s BP was 177/103. The BP readings remained high throughout treatment with SBPs ranging from 145-191 and DBPs ranging from 68-110. There was no documentation to show the RN was notified. * Similar findings were noted on 10/18/2024 and 11/26/2024. Similar findings were noted for Patient #7. 2. Review of patient’s treatment flowsheets, “Treatment Details Reports,” revealed physician orders were not followed. Examples included, but were not limited to: Patient #1 - Physician orders included BFR was 400 mL/min. * On 10/28/2024 at 0550, the RN verified the prescription was 400 mL/min. At 0606, the RN documented “bfr @ 400.” However, the BFR was set to 350 mL/min, where it remained for the duration of the treatment. * On 11/20/2024, the RN and PCT verified the prescription was 400 mL/min at 0432 and 0632, respectively. At 0604, the RN documented, “BFR 350.” The BFR was set to 350 mL/min at 0604, where it remained for the duration of the treatment. - Physician orders included the treatment time was 240 minutes. * On 11/29/2024, treatment was ended at 0922 and the patient only completed 197 minutes per “Patient Choice.” A completed AMA form was not found. Similar findings were noted for Patient #’s 2, 3 and 9. Patient #5 - Physician orders included Max UFR was 13.0 mL/kg/hr. - The Max UFR exceeded 13.0 mL/kg/hr for 8 of 13 treatments and ranged from 13.3 to 21.3 mL/kg/hr. * On 11/06/2024, the actual UFR was 19.0 with no documentation to show why the physician order was not followed. * On 11/15/2024, the actual UFR was 21.3 with no documentation to show why the physician order was not followed. * Similar findings were noted on 10/25/2024, 11/13/2024, 11/18/2024, 11/20/2024, 11/22/2024, and 11/27/2024. Patient #6 - Physician orders included the treatment time was 210 minutes. * On 10/21/2024, treatment was ended at 1826 and the patient only completed 155 minutes per “Patient Choice.” A completed AMA form was not found. * On 11/13/2024, treatment was ended at 1327 and the patient only completed 176 minutes per “Patient Choice.” A completed AMA form was not found. *Similar findings were noted on 10/18/2024. - Physician orders for heparin infusion included the instruction to stop the infusion 60 minutes before the end of treatment for treatments reviewed from 10/16/2024 to 10/25/2024. The documentation indicated the infusion pump was not stopped and continued to run through the end of treatment for 5 of 5 treatments occurring during this time (10/16/2024, 10/28/2024, 10/21/2024, 10/23, 2024, and 10/25/2024). Similar findings were noted for Patient #7. Review of the facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” dated 04/2024, stipulated: * “Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment ... Prescription components include but are not necessarily limited to... UFR and Max UFR ...” * “Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: * “Vital signs and treatment monitoring ... are completed at least every 30 minutes.” * “At a minimum, obtain and document the following ... Blood pressure ... Heart or pulse rate ... Blood and dialysate flows, arterial and venous pressures ... Fluid removal and/or replacement ... Vascular access visible and line connections intact ... Patient subjective statement(s) i.e., patient report on overall health, any complaints.” * Abnormal findings “should be reported to the licensed nurse and documented in the patient’s medical record.” Abnormal findings included SBP “greater than 180 mm/Hg or less than 90 mm/Hg” and DBP “greater than or equal to 100 mm/Hg or less than 50 mm/Hg.” Review of the facility policy, “Prescribed Treatment Time Not Met,” dated 04/2024, stipulated: * “The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice from any time the patient requests to terminate their treatment earlier than the prescribed run time.” * “If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs.” During interview on 12/05/2024 at 1200, the MCS and CC confirmed the above findings.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 31224 Based on interview and review of documentation, it was determined that the facility failed to offer the pneumococcal vaccine to patients in a timely manner for 4 of 94 patients (Patient #s 10-13). Findings: Review of the “Vaccinations and Surveillance Report,” printed on 12/03/2024 revealed: * Patient #10 admitted to the facility in 05/2024 and had a history of receiving PCV13 on 09/15/2015 and PPSV23 11/02/2017, both prior the age of 65 years. There was no documentation to show Patient #10 was offered or received PCV20 since 2023. * Patient #11 admitted to the facility in 08/2024, but there was no documentation to show Patient #11 was offered or received PCV20 since admission. * Patient #12 admitted to the facility in 10/2024 and had a history of receiving PCV13 on 03/27/2017. There was no documentation to show Patient #12 was offered or received PCV20 since admission. * Patient #13 admitted to the facility in 10/2024, but there was no documentation to show Patient #13 was offered or received PCV20 since admission. Review of the facility policy titled, “Pneumococcal Vaccination for Adult Patients,” dated 10/2023, stipulated: * Patients with no previous history of pneumococcal vaccination should be given PCV20. * Patients with a history of receiving PCV13 at any age should be given “PCV20 at least one year after PCV13.” * Patients with a history of receiving PCV13 and PPSV23, with PPSV23 administered prior to the age of 65 years, should receive “PCV20 at least 5 years after the most recent pneumococcal dose.” During interview on 12/05/2024 at 1220 and in an email dated 12/06/2024, the MCS confirmed the above findings.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 47148 Based on interview, review of personnel files and the review documentation, it was determined the facility failed to ensure that 10 of 23 staff members (Staff #s 2, 3, 5, 6, 8, 13, 14, 16, 17 and 23) had an up-to-date personnel file and had the qualification and demonstrated competencies required to meet the comprehensive care needs of the patients. Findings: The review of documentation included an audit worksheet document of the facility staff training records which was completed by the FA on 12/04/2024. The worksheet included 16 categories for training and competency that staff were required to have completed and documented in their personnel file. Review of the worksheet revealed a list of 23 facility staff members. The worksheet revealed numerous gaps in the required personnel documentation. Examples included, but were not limited to: - 5 of 23 staff (Staff #s 3, 5, 8, 13 and 17) lacked current documentation of annual verification of skills and competencies - 10 of 23 staff (Staff #s 2, 3, 5, 6, 8, 13, 14, 16, 17 and 23) lacked current documentation of “H2O Dialysate Training” and “Machine Training.” During review of the facility policy titled, “Auditing of Clinical Practice Requirements for Water and Dialysate Concentrate” dated, “April 2024” stipulated, “The ESRD Conditions for Coverage require the operators of the water/dialysate system equipment to be trained ... Initial training will be completed after new hire and annually thereafter ... Periodic audits of the teammate ’ s compliance with procedures should be performed. These audits should be completed at least annually or more frequently if needed.” During an interview with the FA on 12/05/2024 at 1210, the above findings were confirmed. During email communications with the MCS on 12/06/2024, the MCS reported they were only able to locate a facility policy for annual water training. They stated they unable to locate a policy to address general annual staff training requirments.”