Davita Conroe 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 review of documentation and interview, the facility staff did not comply Texas ESRD Rules and Regulations. The Charge nurse was assigned direct patient care and the patient was not seen by the physician once every two weeks. Findings: During review of patient/staff assignments for patient care on 4/15/25 and 4/16/25 it was found there were two nurses assigned to provide patient care with no designated CN (charge nurse). In an interview with the nurse (staff # 1) on 4/15/25 during observation of the treatment floor it was shared all the nurses provide direct patient care. The two RN’s provide patient care to all patients that have a CVC (Central Venous Catheter) administer medications, perform patient assessments, supervise patient care and other CN (charge nurse) responsibilities. The two RNs share direct patient care and there is no other RN scheduled as the CN who is not assigned direct patient care. Additional review of the facility’s January - March 2025 staff schedule and patient/staff assignments revealed two RNs are scheduled with no additional CN scheduled. Review of patient provider progress notes for the months of January 2025 through March 2025, revealed the following: - Patient # 3 - One provider note in March 2025. - Patient # 8 - No provider note in February or March 2025. - Patient # 13 - One provider note in January and February 2025, no provider note in March 2025. - Patient # 14 - No provider note in January 2025, and one provider note in March 2025. - Patient # 15 - One provider note in January, February and March 2025. - Patient # 16 - One provider note in January and March 2025, no provider note in February 2025. - Patient # 17 - One provider note in January 2025, no provider note in February and March 2025. In an interview on 04/15/25, Staff #1 & #2 the above findings were confirmed.”

“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: 43999 Based on observation and review the facility staff failed to follow standard infection control precautions while performing direct patient care. Findings: Review of Procedure: 1-04-02B, titled CENTRAL VENOUS CATHETER (CVC) WITH CLEARGUARD HD ANTIMICROBIAL END CAPS PROCEDURE, stated in part: “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 ...” During the facility tour on 4/15/25, observations revealed: -At 12:02 p.m., Staff #9 only performed a 2 to 3 second scrub of the CVC hubs while disconnecting the blood lines for patient #2. Review of Procedure: 1-21-02, titled OPERATION OF PORTABLE MYRON L CONDUCTIVITY METER (D-1), stated in part: “The exterior of D1 meter should be cleaned with 1:100 bleach solution after collecting a sample from another dialysis delivery system to prevention [sic] cross contamination ... ...The outside of the D-1 meter must be disinfected after use prior to returning the meter to the storage location.” During the facility tour on 4/15/25, observations revealed: -Staff #10 demonstrated the use of the shared Myron L meter - staff takes the meter to the hemodialysis machine (HD) to perform the test - then takes the Myron L meter back to the clean area without disinfecting it. Review of Procedure: 1-05-01, titled INFECTION CONTROL FOR DIALYSIS FACILITIES, stated in part: “HAND HYGIENE 1. All teammates ...will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves ... d. after patient and dialysis delivery system contact ... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse.” During the facility tour on 4/15/25, observations revealed: - 4 of 4 staff members (#9, 10, 11, and 12) failed to perform hand hygiene before donning gloves. - Staff #10 failed to perform hand hygiene after removing gloves and before documenting on the computer. - At 12:00 p.m., Staff #9, RN, failed to remove their gloves used while performing patient care then went to a clean area to retrieve a catheter removal kit. - At 12:02 p.m., while performing catheter care, Staff #9 removed their gloves and failed to perform hand hygiene before donning a new pair of gloves. Staff #1 witnessed the above and told staff #9 to perform hand hygiene before donning a new pair of gloves. In an interview with Staff #1 on 4/16/25, the above findings were confirmed.”

“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: 43999 Based on observation and interview, the facility staff failed to maintain the floors in the patient treatment area to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. Findings : During observation of the facility treatment area on 4/15/25, the floor laminate had areas that were worn and cracked, preventing effective cleaning of the areas. In an interview 4/16/25 with staff #17, the above findings were confirmed. Staff #17 shared the work orders had been submitted, approved and closed with no evidence the floor laminate in the treatment area was repaired.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 43999 Based on facility documentation, observation and staff interviews, the facility Interdisciplinary team failed to adjust the patients’ plan of care to achieve specific goals for 2 of 2 patients (#2 and #4). Findings: A review of facility policies revealed: Review of Incenter Hemodialysis Policies & Procedures DaVita Inc., Policy 1-03-08, titled “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT”, which states in part: “INTRADIALYTIC DATA COLLECTION/ASSESSMENT 10. If the dialysis prescription is not being met (including dialysis flow rate or change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately .... 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 Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. ...” Observations revealed: During the facility tour on the morning of 4/15/25, observations revealed a Blood Flow Rate (BFR) set at 280 mL/min on the Hemodialysis (HD) machine for patient #2. The treatment overview sheet revealed a prescribed BFR of 350 mL/min. Staff #1 confirmed these findings and stated they had been having issues with patient #2’s central venous catheter (CVC) access, and staff typically had to decrease the BFR. Staff #1 also confirmed there was no documentation showing the physician was aware of any ongoing issues with patient #2’s CVC or had ordered any interventions to improve the BFR. Review of treatment sheets for patient #2 revealed the following: 04/15/25: 09:02 - BFR 300 by staff #12, no RN assessment/notification. 09:32 - BFR 280 mL/min by staff #12, no RN assessment/notification. 04/10/25: 08:30 - “BFR set to 300 due to poor outflow on CVC” by staff #9. 09:32 “BFR set to 210 due to AP bottoming out” by staff #9. A review of the “Comprehensive Assessment Report” from 01/28/25 for patient #2 revealed a prescribed BFR of 350 and an average BFR below 350 mL/min on 13 of 13 dates: 01/28/25 - 214 01/25/25 - 211 01/23/25 - 274 01/20/25 - 242 01/18/25 - 304 01/16/25 - 267 01/14/25 - 245 01/11/25 - 291 01/09/25 - 333 01/07/25 - 284 01/04/25 - 250 01/02/25 - 332 12/31/24 - 284 During the facility tour on 04/15/25, at 12:02 pm, patient #4 was observed to have a heart rate (HR) of 57 and a blood pressure of 155/48. Staff #1 stated these vital signs (v/s) were “normal” for this patient but could not provide documentation that the physician was aware and had changed patient #4’s v/s parameters. Staff #1 could not confirm that other staff would know these were “normal” v/s for patient #4. Review of treatment sheets for patient #4 revealed the following: 04/08/25: 10:14 - BP 126/42, HR 55 by staff #1 10:34 - BP 140/36, HR 52 by staff #12 11:04 - BP 106/29, HR 54 by staff #12 11:05 - BP 107/38, HR 54 by staff #12 11:34 - BP 110/21, HR 53 by staff #10 12:04 - BP 133/35, HR 52 by staff #9 12.34 - BP 140/41, HR 48 by staff #9 13:04 - BP 128/36, HR 52 by staff #9 13:16 - BP 119/22, HR 52 by staff #9 04/15/25: 10:15 - BP 177/47, HR 58 by staff #1 10:31 - BP 159/42, HR 57 by staff #11 11:01 - BP 179/42, HR 56 by staff #12 11:03 - BP 161/44, HR 56 by staff #12 11:31 - BP 172/43, HR 55 by staff #12 12:02 - BP 155/48, HR 57 by staff #12 12.31 - BP 151/124, HR 59 by staff #12 13:01 - BP 156/43, HR 54 by staff #12 13:16 - BP 165/42, HR 53 by staff #9 A review of the “Comprehensive Assessment Report” from 04/08/25 for patient #4 revealed: - A SBP > 180 on 3 out of 8 treatment dates: 04/05/25 - 190/51 04/01/25 - 188/47 03/18/25 - 187/40 - Under the heading “Fluid/BP”, for “Blood Pressure Screening”, and in response to “Is pre-dialysis blood pressure elevated?”, staff #1 documented “No”. - A review of the “Fluid and BP Management Report” from 04/15/25 for patient #4 revealed a SBP > 180 on 2 out of 3 treatment dates: 04/15/25 - 184/55 04/05/25 - 190/51 On 4/16/25 staff #1 & 2 acknowledged the above.”

“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 reviews and interviews, the medical director did not ensure all policies and procedures relative to patient care are adhered to by facility staff. Findings: Facility Procedure titled, “12-13-10F - TITLE: OPERATION OF PORTABLE MYRON L CONDUCTIVITY METER (D-1)” states in part, “11. When finished with the D-1 meter, RINSE thoroughly with dialysis quality water.” On 4/16/25, staff (#10 & 11) were observed using the Myron L meter to check conductivity of the machine and did not rinse with RO (reverse osmosis) water between machine testing per procedure. The staff member acknowledged they did not follow the procedure when using the Myron-L meter. Facility Procedure titled “1-03-08F- TITLE: TREATMENT INITIATION UTILIZING FRESENIUS 2008 SERIES DIALYSIS DELIVERY SYSTEMS WITH ALL SINGLE USE DIALYZER TYPES AND STREAMLINE OR COMBISET OR NIPRO BLOOD LINES” states in part, “7. Establish access per procedure and administer heparin loading dose per procedure, as applicable. Wait a minimum of three (3) to five(5) minutes following administration of heparin loading dose prior to actual initiation of treatment.” During observation 4/16/25 on the treatment floor, Staff #9 & 14 did not wait 3-5 minutes following administration of heparin to initiation of treatment. Both staff confirmed they soul wait 3-5 minutes after heparinization to initiate treatment. Review of Incenter Hemodialysis Policies & Procedures titled, “Policy 1-03-08, titled “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT”, which states in part: “INTRADIALYTIC DATA COLLECTION/ASSESSMENT ...11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately .... 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 Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific 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 .... Blood pressure (BP): Pre-dialysis: o Systolic greater than 180 mm Hg or less than 90 mm Hg o Diastolic greater than or equal to 100 mm Hg Blood Pressure-Intradialytic: o Difference of 20 mm Hg increase or decrease from patient’s last intradialytic treatment BP reading .... Heart or Pulse Rate Pre/Intra/Post: o Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heart beat ....” Review of treatment sheets for patient #2 revealed the following: 04/10/25: 08:32 BP 146/111 by staff #10, no RN assessment/notification of diastolic blood pressure (DBP) greater than (>) 100. 09:02 BP 150/108 by staff #10, no RN assessment/notification of DBP >100. 09:34 BP 147/102 by staff #14, no RN assessment/notification of DBP >100. 10:02 BP 147/111 by staff #14, no RN assessment/notification of DBP >100. 10:32 BP 130/106 by staff #10, no RN assessment/notification of DBP >100. 11:02 - V/S documented by staff #10 within defined limits (WDL). 11:32 BP 140/109 by staff #10, no RN assessment/notification of DBP >100. 04/15/25: 08:30 - BP 177/114 by staff #9, no RN assessment/notification of DBP >100 09:02 - BP 166/115 by staff #12, no RN assessment/notification of DBP >100. 09:32 - BP 166/121 by staff #12, no RN assessment/notification of DBP >100. 10:02 - BP 156/117 by staff #12, no RN assessment/notification of DBP >100. 10:32 - BP 153/112 by staff #12, no RN assessment/notification of DBP >100. 11:02 - BP 163/106 by staff #12, no RN assessment/notification of DBP >100. 11:32 - BP 135/102 by staff #12, no RN assessment/notification of DBP >100 or decrease of 28 mm Hg from patient’s previous systolic (S) BP measurement. 12:00 - BP 137/101 by staff #12, no RN assessment/notification of DBP >100. During the same facility tour on 04/15/25, at 12:02 pm, patient #4 was observed to have a heart rate (HR) of 57 and a BP of 155/48. Staff #1 stated these vital signs (v/s) were “normal” for this patient but could not provide documentation that the physician was aware and had changed patient #4’s v/s parameters. Staff #1 could not confirm that other staff would know these were “normal” v/s for patient #4. Review of treatment sheets for patient #4 revealed the following: 04/08/25: 10:14 - BP 126/42, HR 55 by staff #1 10:34 - BP 140/36, HR 52 by staff #12 11:04 - BP 106/29, HR 54 by staff #12 11:05 - BP 107/38, HR 54 by staff #12 11:34 - BP 110/21, HR 53 by staff #10 12:04 - BP 133/35, HR 52 by staff #9 12.34 - BP 140/41, HR 48 by staff #9 13:04 - BP 128/36, HR 52 by staff #9 13:16 - BP 119/22, HR 52 by staff #9 04/15/25: 10:15 - BP 177/47, HR 58 by staff #1 10:31 - BP 159/42, HR 57 by staff #11 11:01 - BP 179/42, HR 56 by staff #12 11:03 - BP 161/44, HR 56 by staff #12 11:31 - BP 172/43, HR 55 by staff #12 12:02 - BP 155/48, HR 57 by staff #12 12.31 - BP 151/124, HR 59 by staff #12 13:01 - BP 156/43, HR 54 by staff #12 13:16 - BP 165/42, HR 53 by staff #9 Staff #1 confirmed the above findings in an interview 4/16/25.”