Fresenius Kidney Care Tomball

“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: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to encourage patients to remove gloves and wash or sanitize hands after holding vascular access site post hemodialysis treatment: 2 of 5 staff observed: Registered Nurse (C): Random Patient #s 8, 10 and Patient Care Technician (E): Random Patient #9 Findings: Review of the facility’s current policy and procedure: Hand Hygiene: published 03/17/2023, reference number 47664, version 7 directs the staff as follows: “Hands Will Be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water “ Entering and leaving the treatment area ... “ Immediately after removing gloves ... “ After contact with inanimate objects near the patient “ After contact with other objects within the patient station or treatment space Hand Hygiene Patients: Patients should perform hand hygiene if able, prior to and after each dialysis treatment ... To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed.” Registered Nurse (C) Random Patient #8 Observation on 01/07/2025 at 9:43 a.m., revealed Random Patient #8 holding her vascular access with a gloved hand at station #9. After the bleeding ceased, Registered Nurse (C) taped the patient’s vascular access site. The patient walked to the weigh scale, was weighed by Registered Nurse (C) and left the treatment area without being encouraged to clean or sanitize her hands after holding her vascular access. Random Patient #10 Observation on 01/07/2025 at 10:09 a.m., revealed Random Patient #10 holding his vascular access with a gloved hand at station #5. After the bleeding ceased, Registered Nurse (C) taped the patient’s vascular access site. The patient picked up his items, walked to the weigh scale, was weighed by Registered Nurse (C) and left the treatment area without being encouraged to clean or sanitize hands after holding his vascular access. The Surveyor immediately notified Registered Nurse (C) of the break in infection control when Random Patient #10 left the treatment area without washing or sanitizing his hands. She also notified her of the same break in infection control with Random Patient #8. Registered Nurse (D) stated “Okay, thank you.” Patient Care Technician (E) Random Patient #9 Observation on 01/07/2025 at 10:04 a.m., revealed Random Patient #9 holding his vascular access with a gloved hand at station #12. After the bleeding ceased, Patient Care Technician (E) taped the patient’s vascular access site. The patient picked up his items, walked to the weigh scale, was weighed by Patient Care Technician (E) and left the treatment area without being encouraged to clean or sanitize his hands after holding his vascular access. On 01/07/2025 at 10:32 a.m., the Surveyor notified Patient Care Technician (E) of the break in infection control when Random Patient #9 left the treatment area without washing or sanitizing his hands. Patient Care Technician (E) stated “He should have sanitized his hands.””

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s licensed nurses and direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 4 of 15 sampled and random patients: Patient #s 7, 8, 2, 13 Findings: Review of the facility’s current Policy and Procedure on Nursing Supervision and Delegation; Policy #45265, published 11/06/2023 directs staff as follows: Policy The registered nurse must evaluate each patient preferably within an hour or according to state requirements to: ... “ Review accuracy and completeness of treatment and patient data “ Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. Patient #7 Dialysate Flow Rate: On 01/07/2025 at 8:24 a.m. Patient #7 was observed on the treatment floor of the facility at station #2 machine #3. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 700 mL/min. The patient was utilizing an Optiflux 180 non reuse dialyzer via a left central venous catheter. Review of the physician’s order dated 01/02/2024 revealed the prescribed dialysate flow rate of Manual 700 mL/min. Treatment sheet review: Review of the patient’s treatment sheet dated 12/24/2024 revealed documentation which indicated the patient was prescribed a dialysate flow rate of Manual 700 mL/min on the treatment sheet but received hemodialysis treatment at a dialysate flow rate of 800 mL/min from 11:42 a.m. - 15:19 p.m. There was no justification documented for the dialysate flow rate of 800 mL/min. Blood Flow Rate: Review of the physician’s order dated 01/02/2025 revealed the prescribed blood flow rate of 350 mL/min. Treatment sheet review: Review of the patient’s treatment sheet dated 12/28/2024 revealed documentation which indicated the patient was prescribed a blood flow rate of 350 mL/min on the treatment sheet but received hemodialysis treatment at a blood flow rate of 400 mL/min from 6:58 a.m. - 10:32 a.m. There was no justification documented for the blood flow rates of 400 mL/min. Review of the patient’s treatment sheet dated 12/30/2024 revealed documentation which indicated the patient was prescribed a blood flow rate on the treatment sheet of 350 mL/min but received hemodialysis treatment at a blood flow rate of 400 mL/min from 7:18 a.m. - 11:22 a.m. There was no justification documented for the blood flow rates of 400 mL/min. Random Patient #8 Blood Flow Rate: On 01/07/2025 at 9:43 a.m. Random Patient #8 was observed on the treatment floor of the facility at station #9 holding her vascular access after the completion of the hemodialysis treatment. Treatment sheet review: Review of the patient’s treatment sheet dated 12/23/2024 revealed documentation which indicated the patient was prescribed a blood flow rate of 350 mL/min on the treatment sheet but received hemodialysis treatment at a blood flow rate of 325 mL/min from 11:24 a.m. - 15:04 p.m. There was no justification documented for the blood flow rate of 325 mL/min. Patient #2 Dialysate Flow Rate: On 01/08/2025 at 8:25 a.m. Patient #2 was observed on the treatment floor of the facility at station #11 machine #8. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 500 mL/min. The patient was utilizing an Optiflux 180 non reuse dialyzer via a left central venous catheter. Treatment sheet review: Review of the patient’s treatment sheet dated 09/27/2023 revealed documentation which indicated the patient was prescribed a dialysate flow rate of Manual 500 mL/min on the treatment sheet but received hemodialysis treatment at a dialysate flow rate of 700 mL/min from 11:24 a.m. - 15:04 p.m. There was no justification documented for the dialysate flow rate of 700 mL/min. Patient #13 Blood Flow Rate: Review of the patient’s clinical record on 01/08/2025 revealed the patient was admitted to facility on 11/04/2020 with diagnosis of end-stage renal disease, heart failure, diabetes, on three times a week hemodialysis. The patient also had diagnoses of hypotension, erythematous condition, peripheral vascular disease, lymphedema, anemia. Treatment sheet review: Review of the patient’s treatment sheet dated 07/30/2024 revealed documentation which indicated the patient was prescribed a blood flow rate of 400 mL/min on the treatment sheet but received hemodialysis treatment at a blood flow rate of 350 mL/min from 8:32 a.m. - 10:35 a.m. There was no justification documented for the blood flow rate of 350 mL/min. Record review and interview on 01/08/2025 at 12:50 p.m. with the facility’s Charge Nurse (B) confirmed patient above did not receive their hemodialysis treatments as prescribed for the dates in question.”

“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: 48020 Based on observation, record review and interview: the facility’s registered nurses failed to conduct assessments when patients experienced a change in condition before or during hemodialysis treatment per the facility’s policy in 6 of 15 sampled, random and closed patients: Patient #s 1, 8, 2, 4, 13, 15 Findings: Review of the facility’s current Policy and Procedure on Patient Assessment and Monitoring; Policy # 45284, published 05/01/2023 directs staff as follows: Data Collection Direct patient care staff may collect data such as weight, BP, pulse, respirations, temperature, general observations, access, and complaints reported by the patient. 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. o 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. Patient #1 On 01/07/2025 at 8:17 a.m. Patient #1 was observed on the treatment floor of the facility at station #7 machine #4. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 700 mL/min. The patient was utilizing an Optiflux 160 non reuse dialyzer via a left upper arm vascular access. Review of the patient’s clinical record on 01/07/2025 revealed the following: Treatment sheet review: Review of treatment sheet dated 10/25/2022 revealed the following documentation: 06:25 a.m.: registered nurse documented the pretreatment assessment which revealed “Respiratory: Patient complains of: Short of breath When did the respiratory symptoms start ?: Patient does not know How long have the symptoms lasted ?: On-going Breath Sounds: Decreased breath sounds or no breath sounds, Rales/Crackling Breath Sound Location: RLL, RUL Fluid Assessment Symptoms: Shortness of Breath Lungs: Decreased breath sounds Ankle - Severity: 1+: 2 mm or less, disappears rapidly Lungs - Sound Location: Bilateral Edema Ankle - Location: Bilateral Notes: goal 2.5L as tolerated, challenging EDW due to crackles/diminished lung sounds/sob, 2L oxygen initiated via nasal canula due to 92% sp02, +1 bilateral ankle edema, ufr<13, denied chest discomfort, dialysis orders reviewed and verified by r.n.” 13:49 p.m.: registered nurse documented the post treatment assessment which revealed “Notes: patient left >1kg below edw and stable no sob or chest discomfort EDW adjusted post vitals stable headache and nausea improved by post rinseback.” The registered nurse did not document a reassessment of edema and lung sounds found during the pretreatment assessment. Review of treatment sheet dated 10/22/2022 revealed the registered nurse did not document a reassessment of edema and lung sounds found during the pretreatment assessment. Random Patient #8 On 01/07/2025 at 9:43 a.m. Random Patient #8 was observed on the treatment floor of the facility at station #9 holding her vascular access after the completion of the hemodialysis treatment. Review of the patient’s clinical record on 01/07/2025 revealed the following: Treatment sheet review: Review of treatment sheet dated 01/07/2024 revealed the following documentation: 06:21 a.m.: registered nurse documented the pretreatment assessment which revealed “Symptoms Ankle - Severity: 1+: 2 mm or less, disappears rapidly Edema Ankle - Location: Bilateral” 10:51 a.m.: registered nurse documented the post treatment assessment which revealed “Notes: pt left <1kg above edw and stable fluid restrictions enforced denied sob or chest discomfort no htn post treatment patient advised to take bp meds as prescribed md notified for adjustment and review.” The registered nurse did not document a reassessment of edema found during the pretreatment assessment. Review of treatment sheets dated 12/30/2024, 01/02/2025 and 01/04/2025 revealed the registered nurse did not document a reassessment of edema found during the pretreatment assessment. Patient #2 On 01/08/2025 at 8:25 a.m. Patient #2 was observed on the treatment floor of the facility at station #11 machine #8. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 500 mL/min. The patient was utilizing an Optiflux 180 non reuse dialyzer via a left central venous catheter. Review of the patient’s clinical record on 01/07/2025 revealed the following: Treatment sheet review: Review of treatment sheet dated 09/27/2023 revealed the following documentation: 11:45 a.m.: registered nurse documented the pretreatment assessment which revealed “Symptoms Ankle - Severity: 1+: 2 mm or less, disappears rapidly Edema Ankle - Location: Bilateral Notes: pt AOx4, pt UFR <13, uf goal set at 2.9L as pt tolerates with 1 hr added for seq, dialysis machine orders reviewed & verified, c/o nausea and constipation, +1 bilat ankle edema noted, lungs CTA, L AVF +b/t, no s/s of infection, VS stable” 15:37 p.m.: registered nurse documented the post treatment assessment which revealed “Notes: during tx, pt given Benadryl for itching and promethazine for N/V as req by pt. med effective as pt verbalized relief. Pt refused to stay 45 min extra for seq. pt agreed to come in 9/28/23 for extra tx 3 hour SEQ.” The registered nurse did not document a reassessment of edema found during the pretreatment assessment. Review of treatment sheet dated 09/25/2023 revealed the registered nurse did not document a reassessment of edema found during the pretreatment assessment. Patient #4 On 01/08/2025 at 8:30 a.m. Patient #4 was observed on the treatment floor of the facility at station #14 machine #15. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 800 mL/min. The patient was utilizing an Optiflux 180 non reuse dialyzer via a left upper vascular access. Review of the patient’s clinical record on 01/07/2025 revealed the following: Treatment sheet review: Review of treatment sheet dated 03/04/2024 revealed the following documentation: 5:51 a.m.: registered nurse documented the pretreatment assessment which revealed “Symptoms Lungs: Decreased breath sounds Ankle - Severity: 1+: 2 mm or less, disappears rapidly Lungs - Sound Location: Bilateral Edema Ankle - Location: Bilateral Notes: “Pt. with high IDWG, reinforced fluid restrictions. Will uf 4kg as tolerated. Denies any pain, cp, sob. Will monitor closely.” 13:42 p.m.: registered nurse documented the post treatment assessment which revealed “Notes: pt left <1kg below edw and stable fluid restrictions enforced denied sob or chest discomfort post vitals stable hemostasis achieved peer policy.” The registered nurse did not document a reassessment edema and lungs sounds found during the pretreatment assessment. Patient #13 Review of the patient’s clinical record on 01/08/2025 revealed the patient was admitted to facility on 11/04/2020 with diagnosis of end-stage renal disease, heart failure, diabetes, on three times a week hemodialysis. The patient also had diagnoses of hypotension, erythematous condition, peripheral vascular disease, lymphedema, anemia. Review of treatment sheet dated 07/30/2024 revealed the following documentation: 07:00 a.m.: registered nurse documented the pretreatment assessment which revealed “Symptoms Lungs: Decreased breath sounds Ankle - Severity: 1+: 2 mm or less, disappears rapidly Lower Leg - Severity: 1+: 2 mm or less, disappears rapidly Lungs - Sound Location: Bilateral” Edema Lower Leg - Location: Bilateral Edema Ankle - Location: Bilateral 11:32 a.m.: registered nurse documented the post treatment assessment which revealed “Notes: pt A&Ox4, tx complete, tolerated tx well, no distress noted, no c/o from pt. left at 1.7kg over EDW, fluid restrictions enforced, vss, homeostasis achieved p to d/c.” The registered nurse did not document a reassessment edema and lungs sounds found during the pretreatment assessment. Review of treatment sheet dated 07/27/2024 revealed the registered nurse did not document a reassessment edema and lungs sounds found during the pretreatment assessment. Patient #15 Review of the patient’s clinical record on 12/05/2024 revealed the patient was admitted to the facility on 03/26/2019 with diagnoses of end stage renal disease, history of hypertension and diabetes currently on insulin, on in-center hemodialysis three times weekly. Review of the patient’s clinical record on 01/08/2025 revealed the following: Review of treatment sheet dated 12/26/2024 revealed the following documentation: 11:45 a.m.: registered nurse documented the pretreatment assessment which revealed “Symptoms Lungs: Decreased breath sounds Lungs - Sound Location: Bilateral” 09:25 a.m.: registered nurse documented the post treatment assessment which revealed “Notes: treatment completed, blood returned without difficulty, v/s are stable post treatment, no post treatment complications noted, encouraged pt to follow renal diet recommendations.” The registered nurse did not document a reassessment lungs sounds found during the pretreatment assessment. Review of treatment sheet dated 12/28/2024 revealed the following documentation: 06:15 a.m.: registered nurse documented the pretreatment assessment which revealed “Symptoms Lungs: Decreased breath sounds Lower Leg - Severity: 1+: 2 mm or less, disappears rapidly Ankle - Severity: 1+: 2 mm or less, disappears rapidly Edema Ankle - Location: Bilateral Lungs - Sound Location: Bilateral Edema Lower Leg - Location: Bilateral” 11:57 a.m.: registered nurse documented the post treatment assessment which revealed “Notes: treatment completed, blood returned without difficulty, v/s are stable post treatment, no post treatment complications noted, encouraged pt to follow renal diet recommendations. Late entry due to patient care.” The registered nurse did not document a reassessment of edema and lungs sounds found during the pretreatment assessment. Record review and interview with Charge Nurse (B) on 01/08/2025 at 9:26 a.m. confirmed the registered nurses did not complete the reassessments of edema and lung sounds post treatment for the patients above.”