Dialysis Center of Lubbock

“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 regulations pertaining to licensure and any other relevant health and safety requirements. The facility is not in compliance with applicable State regulatory licensing requirements. Findings : During review of patient/staff assignments for patient care on 4/8/25 & 4/9/25 it was found there were two nurses assigned to provide patient care with no CN (charge nurse) scheduled . In an interview with the staff # 7 and staff # 12 on 4/8/25 during observation of the treatment floor, they shared there are two nurses scheduled daily that are RN team leads and are responsible for direct patient care. Direct patient care includes patient care to all patients that have a CVC (Central venous catheter), medication administration, patient assessments, and supervision of patient care technician and other CN (charge nurse) duties . When there is another nurse scheduled (RN or LVN) they provide direct patient care to their assigned patients and there is no designated charge nurse. The CC ( clinical coordinator ) is not scheduled as charge nurse. The CC schedule is not considered in the daily patient/staff assignments. Staff # 7 stated, “ The Monday, Wednesday, Friday shift have 18 of 48 patients with CVCs that only nurses can initiate and terminate treatments. The Tuesday, Thursday, Saturday shift have 15 of 48 patients with CVCs that only nurses can initiate and terminate treatments. “ Additional review of the facilities January 2025 through March 2025 staff schedule on 4/9/25 revealed two RN (team leads )were scheduled with no CN scheduled. In an interview on 4/8/25 with staff #1 and staff #2 the above findings were confirmed. Based on record review and interview, it was determined that the facility failed to meet the standard of Texas Administrative Code Title 25, Part 1 ,Chapter 117, Subchapter D §117.45 (i) Medical services (2) Medical staff (C) At a minimum, each patient receiving dialysis in the facility shall be seen by a physician on the medical staff once every two weeks during the patient’s treatment time. Findings: Review of physician documentation patient records for February and March 2025 revealed the following: - Patient # 5 only had one physician “Provider Rounding Note Comp HD” documented on 03/10/25. Weekly rounding notes were completed by a nurse practitioner. - Patient # 7 only had one physician “Provider Rounding Note Comp HD” documented on 03/08/25. Weekly rounding notes were completed by a nurse practitioner. - Patient # 8 had no physician “Provider Rounding Note Comp HD” documented in February or March 2025, No rounding notes were completed by a nurse practitioner. - Patient # 9 only had one physician “Provider Rounding Note Comp HD” documented on 02/14/25. No provider documentation in March 2025. - Patient # 10 only had one physician “Provider Rounding Note Comp HD” documented on 03/08/25. Weekly rounding notes were completed by a nurse practitioner. - Patient # 17 had no physician “Provider Rounding Note Comp HD” documented in February or March 2025.. Biweekly rounding notes were completed by a nurse practitioner. - Patient # 22 had no physician “Provider Rounding Note Comp HD” documented in February or March 2025. No rounding notes were completed by a nurse practitioner. In interview on 04/09/25, Staff #2 verified that currently some facility physicians do not consistently document seeing patients every 2 weeks as required by Texas regulations.”

“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 staff interview, the facility staff failed to ensure a clean and sanitary environment was monitored and maintained to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. Findings: In an article published by Spectrum Health in July, 2014 it was stated “The heavier corrugated cardboard shipping boxes might harbor vermin or insects and spread the pests to areas where the boxes are stored after delivery. Corrugated cardboard boxes are not appropriate as storage units in medical or clean supply rooms. These boxes are not appropriate because they are an excellent harbor for insects and pests.” Tour of the facility supply room on 04/08/25 revealed the following: 1- Clean supplies were stored with corrugated shipping boxes on the shelves in the storage room. 2- Clean supplies were observed in opened shipment boxes in the supply room. 3- Clean supplies were placed on shelves instead of in closed containers. This practice could lead to cross contamination. The above findings were confirmed during the tour on 04/08/25 with staff # 11.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 43999 Based on observation, interview and record review, the facility’s direct care staff failed to perform hand hygiene between between each patient or station. Findings: Facility policy and procedure: “ TITLE: INFECTION CONTROL FOR DIALYSIS FACILITIES- Policy 1-05-01 11/06/2023, revised April 2023, directs the staff as follows: HAND HYGIENE 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, e. after interacting with wall boxes (i.e., plugging/unplugging acid/bicarb lines form dialysis machine, changing acid types, when exchanging a dialysis machine) f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse” During a tour of the facility’s in-center treatment area on 04/09/25 at 10:00 am, 1 of 5 staff observed providing direct patient care that did not perform hand hygiene per facility policy. Staff #11 failed to perform hand hygiene after providing care to a patient, then picking up trash off the floor. Staff #11 did not remove gloves and wash hands and deglove prior to resuming care, touching screen on machine, cleaning, heparinizing, and capping patient catheter lines. At 10:30 am, Staff #11 was observed heparanizing a patient’s catheter lines after treatment was completed, and capping the catheter lines. He then removed his gloves, walked over to the wheel chair area, moved 3 wheelchairs to get to patient’s wheelchair, got patient’s wheelchair, assisted patient into wheelchair, and weighed the patient. Staff #11 did not wash his hands. Staff #11 failed to wash hands or sanitize immediately after removal of gloves. Staff # 1 confirmed the above findings that staff did not follow infection control practices during patient 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: 43999 Based on interview and review of documentation, it was determined that the facility failed to continuously monitor its performance and take action that resulted in performance improvement. Findings: Review of the QAPI (Quality Assurance and Performance Improvement) meeting notes on 4/9/25 for the months of January and February 2025 did not provide actions plans or followup to improve adherence to infection control practice identified during monthly infection control audits. In an interview with the Staff # 1 and Staff #2 on 4/9/25, it was acknowledged that the existing QAPI program was not updating action plans based on the data.”

“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 observation, interview and record review, facility’s medical director failed to enforce policies and procedures related to patient care provided during treatment. Findings : Review of Clinical Services, version 4 , reference 45284, dated 05/01/2023- titled “Patient Assessment and Monitoring partly stated: If the PCT/LPN note any changes or abnormal findings in the patient ’ s condition or vascular access are observed or reported by the patient, or the patient was hospitalized, the registered nurse must assess the patient. The RN will notify the patient ’ s physician/physician extender of any abnormal findings, if necessary, based on clinical judgment for additional instruction. The Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed.” Review of Clinical Services, version 6, reference 45265, dated 11/06/2023- titled- “Nursing Supervision and Delegation partly stated: The following criteria can be used as a guideline to identify when a PCT/LPN/LVN or RN shall refer a patient to the Team Leader/Charge Nurse for further assessment pre, during or post treatment. · Blood Pressure- A Systolic blood pressure greater than 180 mm/Hg and / or diastolic blood pressure greater than 100 mm/Hg at any time before, during or after the treatment. If B/BP less than or equal to 100 mm/hg systolic during treatment. A systolic blood pressure less than 100 mm/Hg post treatment when standing. A drop in systolic BP of 20 mmHg between sitting and standing.” Review of patient #16 treatment sheets revealed the following: 04/05/25: 1100 - B/BP (blood pressure) 186/140 by PCT #14 no RN assessment Review of patient #17 treatment sheets revealed the following: 04/03/25: 0603 - B/BP 197/101 by PCT #14. No RN assessment 0635 - B/BP 196/106 by PCT #14. No RN assessment 0701 - B/BP 166/109 by PCT #14. No RN assessment 04/05/25: 0701 - B/BP 183/102 by PCT #15. No RN assessment 0730 - B/BP 190/102 by PCT #16. No RN assessment 04/08/25: 0800 - B/BP 147/104 by PCT #6. No RN assessment 0801 - B/BP 147/104 by PCT #6. No RN assessment In an interview on 4/9/25 with Staff #1 the above findings were confirmed. During patient observations 4/9/25 at 10:00 am and 10:30 am, Patient #20 in chair #20 was observed with his access completely covered by a blanket. Connections and lines were not visible. Documentation reflected lines were visible every 30 minutes - at 9:30, 10:00 and 10:30. Surveyors were on the floor at 10:00 and patient’s access was not visible from 10:00 to 10:30 am. Patient #21, Chair #19 at 10:00 am, patient’s access was covered with a blanket. All documentation reflected “access was visible”. Access was not visible from 10:00 - 10:30 am. During an interview on 4/9/25, staff #15 and staff #17 (PCTs) stated when a patient is covered up and their access is not visible, they should tap the patient on the shoulder and uncover them enough to visualize their access. They both confirmed a patient’s access should be completely visible during treatment and actions taken documented with each incident.”

“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 regulations pertaining to licensure and any other relevant health and safety requirements. The facility is not in compliance with applicable State regulatory licensing requirements. Findings : During review of patient/staff assignments for patient care on 4/8/25 & 4/9/25 it was found there were two nurses assigned to provide patient care with no CN (charge nurse) scheduled . In an interview with the staff # 7 and staff # 12 on 4/8/25 during observation of the treatment floor, they shared there are two nurses scheduled daily that are RN team leads and are responsible for direct patient care. Direct patient care includes patient care to all patients that have a CVC (Central venous catheter), medication administration, patient assessments, and supervision of patient care technician and other CN (charge nurse) duties . When there is another nurse scheduled (RN or LVN) they provide direct patient care to their assigned patients and there is no designated charge nurse. The CC ( clinical coordinator ) is not scheduled as charge nurse. The CC schedule is not considered in the daily patient/staff assignments. Staff # 7 stated, “ The Monday, Wednesday, Friday shift have 18 of 48 patients with CVCs that only nurses can initiate and terminate treatments. The Tuesday,Thursday, Saturday shift have 15 of 48 patients with CVCs that only nurses can initiate and terminate treatments. “ Additional review of the facilities January 2025 through March 2025 staff schedule on 4/9/25 revealed two RN (team leads )were scheduled with no CN scheduled. In an interview on 4/8/25 with staff #1 and staff #2 the above findings were confirmed.”

“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, interview and record review, the facility failed to operate and furnish services in compliance with state laws that require patient shall be seen by a physician once every two weeks during the patient’s treatment time. Findings: Review of the Physician Documentation Summary 10/2/2023 thru 11/29/2023 revealed the following: Physician 1 did not have documentation bi weekly on 34 patients in October 2023 and 5 patients in November 2023. Physician 2 did not have documentation bi weekly on 3 patients in October 2023. Physician 3 did not have documentation bi weekly on 4 patients in October 2023 . Physician 4 did not have documentation biweekly on 19 patients in November 2023 Physician 5 performed physician visits via telephone on 3 patients in October 2023 and 6 patients in November 2023. Physician 6 performed physician visits via telehealth on 1 patient in October 2023. On 11/29/ 2023 the Surveyor notified the Director of Operations of the discrepancy with the Nephrologist documentation. The Regional Operational Director said she would speak with the facility’s Medical Director about the Nephrologist documentation.”

“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: 28421 Based on observation and interview, it was determined that the facility failed to provide and monitor a sanitary environment. Findings were: “OSHA/Bloodborne Pathogen Regulations Policy #138-030-060” stated in part “The facility provides sufficient housekeeping and maintenance personnel to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner.” Facility policy entitled “Cleaning and Disinfection” stated its purpose as “to provide guidelines to maintain a clean, safe and aesthetically pleasant environment for patients, staff and visitors. To prevent the spread of infectious disease in accordance with appropriate regulations.” The policy continued, “Noncritical equipment surfaces shall be cleaned with a low level disinfectant. High touch surfaces shall be cleaned and disinfected on a more frequent basis than minimally touched housekeeping surfaces.” Facility policy entitled “Cleaning and Disinfection” further stated “Cleaning Non-disposable Patient Care Supplies” said “Non-disposable items such as blood pressure cuffs, IV poles, TVs, TV remotes, portable phones etc., as well as clip boards or plastic hemostat clamps placed on the machine used or unused, should be disinfected with 1:100 bleach solution after each treatment * If using a clipboard it should be made of plastic to adequately disinfect between patients. Place used plastic pressure clamps and plastic hemostat clamps in a labeled opaque plastic container filled with a 1:100 bleach solution. * Make sure the items are completely submerged, unclamped, and in an open position when placed in the solution. * Allow items to soak in the solution at least 20 minutes.” Tour of the patient treatment area on 11/28/23 revealed a “dirty” sink next to patient station # 28. This sink had splatters on the counters, cabinets and dish drainer. The dish drainer that contained drying clamps that had been soaking in an 1/100 bleach solution, had unidentifiable brown splotches on it. Staff member # 10 stated that the clamps were soaked “for 2-3 hours” and then put into the dish drainer to dry. Tour of the facility treatment area on 11/29/23 revealed 7 of 28 machine keyboards had 1-3 missing buttons and some had tape to keep the buttons in place. In an interview with staff # 8 it was confirmed there are many machine keyboards needing replacement in use at the facility. In interviews with the Clinical Manager on 11/28/23, the above findings were acknowledged.”

“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: 28421 Based on review of documentation and interview it was determined that inadequate assessment and response to high fluid gains and hyper/hypo tension could result in cardiac mortality in patients . Findings were: Facility policy entitled “Guidelines for Nursing Assessment” stated “Patient assessment is a nursing responsibility and cannot be delegated to unlicensed direct patient care staff. Nurses assess the patient’s pretreatment if warranted by the patient’s condition. The assessment can be documented in the patient’s treatment sheet or in their progress notes. Significant changes in the patient condition that are reported by the patient or observed by the patient care staff should be brought to the immediate attention of the physician and documented in the patient medical record.” Facility policy entitled “Evaluating the Patient Pre-Dialysis” stated “The staff member who collects the information and evaluates the patient pre-treatment will document their findings on the hemodialysis treatment sheet. If any changes or abnormal findings in the patient’s condition or vascular access are observed or reported by the patient, or the patient was hospitalized, patient care technicians must report the changes in the patient condition to a licensed nurse who will further evaluate the patient.” Facility policy entitled “Evaluating the Patient Post-Dialysis” stated, “The staff member who collects the information and evaluates the patient post-treatment will document their findings on the hemodialysis treatment sheet. If any changes or abnormal findings in the patient’s condition or vascular access are observed or reported by the patient, or the patient was hospitalized, patient care technicians must report the changes in the patient condition to a licensed nurse who will further evaluate the patient.” The same policy further stated under “Guidelines for Nursing Assessment” stated “Significant changes in the patient condition that are reported by the patient or observed by the patient care staff should be brought to the immediate attention of the physician and documented in the patient medical record.” Facility Guidelines entitled: “Dialysis Evaluation Parameters Acknowledgement” stated in part: “The following items must be reported to your RN/CN: Blood Pressure: Systolic blood pressure (top number) greater than 180 or below 100 before, during and/or after the treatment. Diastolic blood pressure (bottom number) greater than 100 or less than 50 at any time before, during or after the treatment. Decrease in systolic more than 20 points from sitting to standing. Decrease in systolic more- then 20 points during treatment.” Patient # 12 was dialyzed on 11/24/23. At 12:30 her B/P was 172/99. At 1pm her B/P was 178/104. At 2:30 her B/P was 161/100. There were no documented RN or MD notification nor intervention. Patient # 12 was dialyzed on 11/20/23. At 1pm, her B/P was 165/101. At 3pm, her B/P was 171/100. There were no documented RN or MD notification nor intervention. Patient # 12 was dialyzed on 11/17/23. At 12:30pm, her B/P was 185/109. At 2pm, her B/P was 174/96. At 2:30pm, her B/P was 185/96. There was no documented RN or MD notification nor intervention. Patient # 5 was dialyzed on 11/27/23. MD order for 4-hour treatment time. Patient left after only 2.46 hours of treatment. Patient was hypotensive with B/P recorded as 80/54, 84/58, 94/55 and 105/50. Ultra Filtration was turned off in response but there was no MD notification or other intervention found. Patient # 5 was dialyzed on 11/24/23. Patient was again hypotensive during treatment. At 2:30, B/P was 87/38. At 3pm, B/P was 88/35. Patient only completed 3.3 hours of treatment. No AMA was found and there was no documented intervention for the hypotension or notification of the MD or Charge Nurse. Patient # 5 was dialyzed on 11/15/23. Patient only completed 3.15 hours of treatment. On 11/1/23, patient completed only 2.15 hours of treatment. No AMA form was found for 11/15/23. The above missing AMAs and notifications of MD/Charge Nurse were confirmed by the Clinical Manager on 11/29/23.”

“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 Medical Director failed to ensure that facility staff followed facility policies and procedures to test verification of final conductivity and pH of dialysate prior to treatment and failed to follow AMA policy. Findings included: A review of the facility’s Policy dated 4/11/2022 “Checking conductivity and final pH of dialysate: Test Verification Prior to Treatment Incenter setting: -2 staff members will verify the conductivity and pH parameters prior to treatment. All Modalities To verify conductivity and pH readings, both staff (or patient/care partner) watch the test being performed at the same time or if the test is not performed and results observed by both people at the same time, the second person (staff or care partner) must perform an additional test to verify the initial test results are within acceptable limits stated in this policy. -If a second person performs an additional test, results must be within acceptable limits stated in this policy and both must be documented on the treatment record.” A review of facility Policy: “ Early Termination or arriving late for treatment dated 11/7/22 Against Medical Advice forms are - Signed by the patient and witnessed by the supervising nurse upon completion of the above steps. - Signed with each early termination event and filed in the patient’s medical record. - Tracked, trended and reported to the QAI committee monthly.” During observation 11/28/23 on the treatment floor, the surveyor observed 4 of 6 staff (#7,8,12 & 13) who obtained sample for final dialysate,tested and did not request a second staff to check during the test. There was no second test performed for 4-6 treatments observed. In staff interviews with staff #8 & 12 it was stated they do not get a second staff to verify , that person should complete their own test and document. During review of treatment sheets, it was identified patient #5 signed AMA (against medical advice) 11/01,15,24 & 27/2023 with no nursing note , MD notification documented. There was no AMA form completed 11/15 & 11/24/2023 in the medical record. On 11/29/23 at 3:00 PM, the Clinic Manager, staff #3 confirmed the policy/procedures were not being followed.”