Davita Georgetown Dialysis

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 43999 Based on observation, interviews and documentation reviewed, the facility is not in compliance with applicable State regulatory licensing requirements. The Charge Nurse(CN) provided direct patient care duties contrary to Texas ESRD Rules and Regulations. Findings : During an interview with staff #7 on 9/11/24, it was shared, there is only one RN/CN (Registered Nurse/Charge Nurse) assigned with eight or more patients and this nurse provides direct patient care as well as charge nurse duties. Review of the staff/patient daily assignments for August 2024 revealed the Registered Nurse (RN) who is also the CN (charge nurse) and CC (Clinical Coordinator) was assigned all nursing responsibilities for all patients that included initiation and termination of patient that have a central venous catheter (CVC) as well as administration of all patient ordered medications, assessments, and other CN duties. Review of the staff schedule for July -August 2024 revealed only one RN scheduled each day and no CN identified. In an interview with staff #1 (Facility Administrator) on 9/11/24, it was acknowledged the RN/CN does provide direct patient care and there is not another nurse scheduled when the daily patient census reaches eight on dialysis. It was stated, the FA who is also an ESRD nurse is scheduled at the facility and can act as CN when available, but is not available everyday.”

“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: 43999 Based on observation and interview, the facility failed to provide general infection control measures to minimize the transmission of infectious agents during patient care activities to prevent potential infections. Findings: Facility procedures, “ Title: Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps procedure partly states, NOTES: - Use Dialysis Precautions and aseptic technique throughout procedure. - Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason. 2. Set up clean field with all appropriate supplies on a clean, moisture proof barrier. During observation in treatment area on 9/11/24 , staff # 7 placed dirty supplies on clean field with clean supplies during initiation of treatment of pt with a CVC (central venous catheter). This technique allowed for cross contamination. Staff #7 did not perform 15 second hub scrub of the CVC reversing the lines to improve bloodflow rate for the treatment. The above infection control concerns were confirmed by the Facility Administrator on 09/11/24.”

“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: 43999 Based on observation and staff interviews the facility failed to ensure staff followed their procedures in the assessment and care changes in patients blood pressure during treatment. This practice has the potential to cause patient harm. Findings: Facility procedure titled : “ CWOW-PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT partly stated: 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient ’ s medical record. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Blood pressure: Pre dialysis: · Systolic greater than 180 mm/Hg or less than 90 mm/Hg · Diastolic greater than or equal to 100 mm/Hg Review of patient # 1 treatment sheets revealed direct care staff did not report out-of-parameter blood pressures findings to the Charge Nurse/RN for assessment and further evaluation and instruction. Patient # 1 Date: 7/22/24 1103 AM: BP (blood pressure) - 227/150 LPN (staff # 11) did not notify RN, rechecked B/P manually 1106 AM BP- 157/107 LPN (staff # 11) did not notify RN, no intervention taken 1132 AM: BP- 149/112 LPN (staff # 11) did not notify RN,, no intervention taken Date: 7/26/24 1030 AM: BP -207/102 PCT(staff # 12) did not notify RN,no intervention taken 1106 AM: BP- 206/100 PCT (staff #12) did not notify RN, no intervention taken 1130 AM: BP- 188/74 PCT(staff #12) did not notify RN, no intervention taken Date: 7/29/24 0933 AM BP- 185/101 PCT(staff # 13) did not notify RN, no intervention taken 1103 AM: BP- 170/100 PCT (staff # 12) did not notify RN, no intervention taken The above findings were confirmed in an interview with the FA 9/11/24 , the staff did not follow facility blood pressure parameters for documentation and reporting changes in the patient condition to the charge nurse/RN.”

“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: 43999 Based on record review and interview, the facility medical director failed to ensure that all policies and proceduresa relative to patient care and treatment are followed. The facility failed to ensure that direct patient care staff (PCT) reported significant changes in patient health status while receiving hemodialysis to the Registered Nurse (RN); and/or the RN failed to reassess the patient when significant changes occurred during treatment, notifying the physician when appropriate. Findings included: Facility “Policy 1-03-08 TITLE: CWOW-PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT , revision date April 2021 partly stated, Record review of the facility TDH (Texas Department of Health) self report documents dated 12/4/23 for incident on 11/22/23 revealed in part the following information: PRE-TREATMENT DATA COLLECTION/ASSESSMENT 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 5. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient ’ s condition. 6. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis... 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient ’ s medical record. ABNORMAL FINDINGS: Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time... Heart or Pulse Rate Pre/Intra/Post: - Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heart beat. “Summary: On 11/22/23 patient arrived with a Blood Pressure of 190/128 with a pulse of 98. Patient’s pre-weight was 76.2 kg. Patient’s blood pressure remained elevated throughout treatment, and patient ended treatment 1 hour early. Patient standing pulse at end of treatment was 150, with a blood pressure of 143/87. Patient post-weight was 74kg. Physician was made aware at end of treatment of patient’s pulse with no new orders given. Patient treatment ended at 15:36 with patient leaving to the lobby at approximately 15:45. Patient currently had transportation to and from the facility. When transportation arrived, driver asked the RN if he knew where the patient was located, as the patient was not currently in the lobby. RN looked for patient in lobby, and patient bathroom, and quickly glanced around the parking lot, and could not locate the patient. Driver left the facility, as he had another patient to take home and stated that he had to stick with his schedule. At end of day, at approximately 17:44, the RN was walking to his car to leave, which was parked on the northside of the building. RN looked over in the field next to the facility, and saw an individual lying on the ground. RN ran to the individual, identified the person as the patient, found the patient to be pulseless and cold. RN dialed 911 from his cell phone and began compressions. EMS arrived and loaded patient, along with the Fire Department and Police Department. Patient was pronounced deceased. TDH Report Narrative: Patient was a 65 year old male that started with the facility on 7 /26/23, and was admitted from the Estelle Unit after having been incarcerated. Patient dialyzed with a CVC (central venous catheter) to the right chest. Patient routinely would walk through the field at the back of the facility in order to go to the nearby gas station to get snacks, post treatment. Patient had several recent hospitalizations: Pt was recently placed in a SNF (skilled nursing facility), patient appeared to have status changes, missed previous treatment and left 3.5kg over TW. Patient had pain in treatment, also. RN did not assess patient during treatment and MD was not notified of patients change in status. -9/15/23-9/17 /23 - diagnosed with Atrial fibrillation -10/12/23-10/19/23 - Hypertension, SOB, and decrease 02 saturation -11/7 /23-11/16/23 - Syncopal episode ending in hospitalization Review of patient flowsheets, showed need for facility improvement regarding reportable parameter documentation, and documentation of AMAs. Facility employees were educated on 11/27 and 11/28 on policy 1-03-08 Pre-Intra-Post Data Collection and Assessment with emphasis on reportable parameter documentation, nurse assessment documentation, and nursing documentation of follow-up during dialysis. AMA (treatment ending early) was also reviewed with clarification that AMAs are completed any time a patient ends treatment early, and if a patient refuses to sign it will be reviewed with the patient and then signed by both the RN and a co-signer of patient refusal. If a patient AMAs greater than 30 minutes the physician must be notified in order to determine if there are any further orders. Flowsheet audits will be completed daily x 2 weeks in order to determine compliance with the above policy with goal of overall compliance greater than 90%. Flowsheet audits will then be completed weekly x 2 weeks, and then monthly thereafter. Results of flowsheets audits will be reviewed with staff; and all audits will be reviewed in FHR monthly. “ Above findings confirmed during phone interview of the incident report with the FA via phone on 12/11/23 at 1330pm.”