Fresenius Medical Care Fondren

“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: 31974 Based on review of documentation and interview, it was determined that Charge Nurses were assigned patient care duties contrary to Texas ESRD Rules and Regulations. Based on review of documentation and staff interview, the facility failed to provide evidence of quarterly fire drills. Findings were: 20 patient treatment sheets X 2 weeks were reviewed. Also reviewed were 2 weeks of staff and patient assignments. It was documented that on 2 days, the assigned Charge Nurse provided patient care including catheter care and medication dispensation. In an interview with the Facility Administrator on 4/16/25, it was admitted that the Charge Nurse assumed patient care assignments, contrary to Texas ESRD Rules and Regulations. Findings: The facility provided policy titled “Fresenius Kidney Care Fire Drill” published 8/2/17 reflected in part, “ ...Fire Drills Quarterly, all FKC (Fresenius Kidney Care) facilities shall perform a fire drill for each shift of patients and staff including Home Therapies patient present in the facility and Nocturnal shifts ...” Review of the facility’s Emergency Preparedness and Facility Fire Drills for 2024 and 2025 revealed the last Emergency Preparedness/Disaster and Fire Drills were performed 1/8/25-1/9/25. Review reflected fire drills conducted in 2024 were conducted 4/16/24-4/17/24 and 8/15/24-8/16/24. During an interview 4/16/25 at 11:30 am, Staff #3 and Staff #8 stated they are responsible for facility fire drills. They confirmed the last drill conducted was 1/9/25. They confirmed drills conducted in 2024 were in April and August. They further stated a drill was conducted 12/6/24, but facility staff was unable to provide documentation of the drill conducted in December 2024.”

“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: 10802 Based on observation, interview and record review, facility’s direct care staff failed to remove contaminated gloves and wash/ sanitize hands after direct contact with contaminated items in 3 of 5 direct care staff observed : Registered Nurse ( D), Patient Care Technician (I) and Patient Care Technician (J) 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 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 (D) On 02/14/2024 at 7:58 a.m. Registered Nurse (D) was observed on the treatment unit between stations 2 and 3. The registered nurse was wearing a pair of gloves. The registered nurse wiped a clear solution that was on the floor with her gloved hands. After wiping the solution from the floor, Registered Nurse ( D) removed her contaminated gloves, walked to a clean box of gloves located near the sink and picked up a pair of clean gloves. The registered nurse did not wash/ sanitize her hands after removing the contaminated gloves used to clean the solution from the floor. The Surveyor immediately notified Registered Nurse (D) of her not washing / sanitizing her hands after removing her contaminated gloves. Registered Nurse (D) states “ You are right.” Patient Care Technician (I) On 02/14/2024 at 11:20 a.m. Patient Care Technician (I) was observed discontinuing hemodialysis treatment on Patient #3. Observed revealed Patient Care Technician (I) was observed wearing a pair of clean gloves. The patient care technician lowered the patient’s footrest with her gloved hands, readjusted the patient’s blood pressure cuff on the patient’s arm, then used her contaminated gloves to disconnect the patient’s external blood lines from the patient’s vascular access needle. The Surveyor immediately notified Patient Care Technician (I) of the break in infection control technique, of her using her contaminated gloved used to lower the patient’s footrest, then disconnecting the external blood lines from the patient’s vascular access needles. Patient Care Technician (I) states “ I got it.” Patient Care Technician (J) On 02/15/2024 at 7:18 a.m. Patient Care Technician (J) was observed on the hemodialysis unit at station #12, hemodialysis machine # 4. Observation revealed Patient Care Technician (J) wearing a pair of gloves reset the control panel on Patient #4’s hemodialysis machine and entered information in the computer attached to the hemodialysis machine. After resetting the panel on the patient’s hemodialysis machine and entering information in the computer attached to the machine, the patient care technician walked over to station #13 wearing the contaminated gloves, moved the hemodialysis machine located in station 13 over to the right, and repositioned the chair to the left using her contaminated gloved hands, previously used on Patient #4’s hemodialysis machine. The station was previously terminally cleaned, and external blood lines and dialyzer were placed in the chair in preparation to set up for an on coming patient. The Surveyor immediately notified the patient care technician of the break in infection control, of her using her contaminated gloved hands to reposition the clean hemodialysis machine and chair at station # 13. Patient Care Technician (J) proceeded to reclean the station and chair while the external blood lines and dialyzer remained in the chair. The patient care technician was observed setting up the blood lines and dialyzer that was in the contaminated chair in preparation for and on coming patient. The Surveyor immediately notified the patient care technician that she was utilizing the dialyzer and blood lines which were in the contaminated chair for the oncoming patient. Patient Care Technician (J) states” but they were in the packets,so they are clean” The Surveyor explained to Patient Care Technician (J) that she touched the outside of the contaminated packets to remove the dialyzer and external blood lines so they are now contaminated. On 02/15/ 2024 at 7:24 a.m. revealed Patient Care Technician (J) donned a pair of clean gloves and uncovered the vascular access of Patient #4. After uncovered the patient’s vascular access site and reposition the patient’s arm, Patient Care Technician (J), removed her contaminated gloves, walked over to the clean glove holder located in the hallway and picked up clean gloves from a box of clean gloves. The patient care technician did not wash/ sanitize her hands after removing her contaminated gloves . The Surveyor immediately notified Patient Care Technician of the break in infection control technique of her not washing or sanitizing her hands after removing contaminated gloves. Patient Care Technician (J) states “sorry”.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, facility’s direct care staff failed to ensure staff do not share personal protective equipment (gown and face shields) between staff while providing care and services to a patient who is Hepatitis (B) antigen positive in 2 of 5 direct care staff observed. Patient Care Technician (C) and Registered Nurse (K) Findings: During interview on 02/12/2024 at the entrance conference administrative staff revealed that there were three patients currently receiving care in the facility who were Hepatitis B antigen positive. On 02/14/2024 at 10:14 a.m. Patient #1 was observed in the isolation room of the facility. Interview with Patient Care Technician (C) revealed he said the patient is Hepatitis B antigen positive and he is assigned to care for the patient. Observation revealed Patient Care Technician ( C) was observed resetting the patient’s hemodialysis machine and external blood lines and entering data in the computer. Patient Care Technician (C) was wearing a face shield, a disposable gown and gloves which was stored in the patient’s isolation room. After removing the contaminated face shield and gown, the patient care technician hung it in the room and left the isolation room. On 02/14/2024 at 10:24 a.m. Registered Nurse (K) entered the isolation room and donned the face shield and gown previously used by Patient Care Technician (C ). The Surveyor immediately notified Registered Nurse (K) of break in infection control techniques of utilization of the contaminated personal protective equipment used by another staff member in the isolation room. Registered Nurse (K) states “ I didn’t have any in there. Now that you explain it like that, I see all the skin diseases.””

“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: 10802 Based on observation, record review and interview, the facility’s registered nurse failed to ensure patients received hemodialysis treatment based on physicians’ orders in of sampled patients in 2 of 9 sampled patients: Patient #s 1 and 2 Findings: On 02/14/2024 at 7:40 a.m. Patient #1 was observed on the treatment unit at station 21 ( isolation room), hemodialysis machine # 23. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 800 mls/ minute via a right thigh vascular access. The patient was utilizing 2 mEq potassium and 2 mEq calcium, bicarbonate 35 mEq and Sodium 137 mEq dialysate solution from a bottle attached to the hemodialysis machine. The Surveyor requested Patient Care Technician ( C) open the panel on the hemodialysis machine to validate the settings on the patient’s hemodialysis machine. Review of the hemodialysis machine setting revealed the machine was set to mix and deliver 2 mEq potassium, 2.5 mEq calcium, bicarbonate of 35 mEq and Sodium of 137 mEq dialysate solution. Review of the patient’s clinical record dated 1/29/2024 located on the computer attached to the hemodialysis machine revealed an order for 2 mEq potassium and 2 mEq calcium, bicarbonate 35 mEq and Sodium 137 mEq dialysate solution. The Surveyor immediately notified the Facility’s Manager that the patient’s hemodialysis machine was not set to deliver the patient’s prescription of 2 mEq potassium and 2 mEq calcium, bicarbonate 35 mEq and Sodium 137 mEq dialysate solution . The Facility’s Manager looked at the setting on the patient’s hemodialysis machine and validated that the hemodialysis machine was set to deliver dialysate solution of 2 mEq potassium, 2.5 mEq calcium, bicarbonate of 35 mEq and Sodium of 137 mEq instead of the prescribed dialysate solution of 2 mEq potassium, 2.0 mEq calcium bicarbonate of 35 mEq and Sodium of 137 mEq Patient #2 On 02/14/2024 at 7:57 a.m. Patient #2 was observed at station # 3 hemodialysis machine # 6 T. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 600 mls/ minute via left lower arm vascular access. The patient was utilizing Profile 2, bicarbonate of 33 mEq and Sodium of 137 mEq setting for hemodialysis treatment. The Surveyor requested Registered Nurse (D) open the control panel on the hemodialysis machine to validate the patient’s hemodialysis setting. Observation of the setting on the hemodialysis machine revealed the machine was set for profile 2, 2 mEq potassium, 2.0 mEq calcium bicarbonate of 33 mEq and Sodium of 137 mEq. Review of a special attention documentation revealed the following: “UF profile 2, sodium profile 142 exponential” The Surveyor immediately notified Registered Nurse (D) that the patient is on profile 2 but the setting was not for UF profile 2, sodium profile 142 exponential. Registered Nurse ( D) states “ I will change it.” Review of the patient’s clinical record dated 08/16/2023 - 08/14/2024 “ Special attention “ UF profile 2 Sodium profile 142, Exponential, every treatment.””

“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: 10802 Based on observation, interview and record review facility’s Registered Nurse failed to conduct pre- treatment assessment, intradialytic assessment and post treatment assessment on patients in 2 of 9 sampled patient’s; patient #s 6 and 4 Findings: Review of the facility’s current policy on Patient Assessment and Monitoring; policy # 45284, published 5/1/2023 directs staff as follows: “ “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. The RN will notify the patient patient’s physician/ physician extender of any abnormal findings, if necessary, based on clinical judgement for additional instruction. The Registered Nurse will assess / re-assess any findings addressed pre or during treatment as needed.” Patient #6 On 02/15/2024 at 7:40 a.m. Patient #6 was observed on the hemodialysis unit at station #5. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 800 mls/ minute via left lower arm vascular access. Observation of the patient’s hemodialysis machine revealed a blood pressure reading of 85/35. The patient care technician assigned to the patient readjusted the patient’s blood pressure cuff and reassessed the patient’s blood pressure. Repeated blood pressure 98/61. The Registered Nurse assigned to the patient was sitting at the desk and observed the Patient Care Technician’s evaluation of the patient. There was no registered nurse’s assessment done. Review of the patient’s treatment sheet dated 2/15/2024 revealed the following findings. 06:27 a.m.: Patient’s documented pre- treatment blood pressure 139/77 sitting and 132/85 standing. Pulse rate 90 beats per minute. 06:27 a.m. : Patient’s hemodialysis treatment initiated by the registered nurse assigned to the patient, documented blood pressure 133/88 pulse rate of 77 beats per minute. 07:07 a.m.: patient’s documented blood pressure 102/68, pulse rate 91 beats per minute. 07:30 a.m. patient’s documented blood pressure 98/61, pulse rate of 84 beats per minute . The patient care technician assigned to the patient documented : Patient alert; “Bps low uf off pt asymptomatic.” 07:51 a.m.: patient’s documented blood pressure 98/58, pulse rate 100 beats per minute. 07:52 a.m. the patient care technician assigned to the patient documented “ Access visible RN notified; Green Amp Light: UF off. Patient alert; bp still low ug off. “ 08:06 a.m.: patient’s documented blood pressure 100/56, pulse rate 100 beats per minute. 08:07 a.m.: patient’s documented blood pressure 100/56, pulse rate 100 beats per minute. The Patient Care Technician documented “ Access visible, green AMP light. Denies complaints. UF off.” 08:32 a.m.: patient’s documented blood pressure 124/82, pulse rate 99 beats per minute. 09:04 a.m.: patient’s documented blood pressure 122/77, pulse rate 99 beats per minute. The Patient care technician assigned to the patient documented : “ Pt alert BP improved.” 09:36 a.m.: patient’s documented blood pressure 144/83, pulse rate 99 beats per minute. 09:57 a.m.: patient’s documented blood pressure 121/85, pulse rate 101 beats per minute. 10:31 a.m.: patient’s documented blood pressure 136/75, pulse rate 91 beats per minute. Patient’s hemodialysis treatment ended. Review of the patient’s treatment sheet revealed no intradialytic assessment performed by the registered nurse. Treatment Sheet dated 1/25/2024. Review of Patient #6’s treatment sheet dated 1/25/2024 revealed documentation which indicated the Patient’s hemodialysis treatment was initiated by the patient care technician assigned to the patient 6:30 a.m. The patient care technician documented “ UF on; treatment initiated without problems. Access visible : RN notified; Patient alert; Green amp light; Denies complaints: pt educated on wt gain r.n. notified of v/s goal set @ 4.5 per r.n. assessment.” Documented blood pressure 177/94 07:00 a.m.: patient’s documented blood pressure 91/42, pulse 72. The patient care technician assigned to the patient documented “ Access visible. RN notified; green amp light; Denies complaints; UF off Patient alert; r.n. notified of b/p and assessed pt, uf off rechecking b/p.” 7:33 a.m.: Patient’s documented blood pressure 106/42, pulse 96 beats per minute. The patient care technician documented “ UF on access visible; RN notified; Green amp light; Denies complaints; Patient alert; r.n. notified of rechecked b/p goal lowered to 2.0 to support b/p per r.n. assessment.” 08:00 a.m.: patient’s documented blood pressure 126/66, pulse 80. The patient care technician documented “up goal to 3.9 pt b/p has improved.” 08:32 a.m.: patient’s documented blood pressure 111/53, pulse 98 beats per minute. 08:33 a.m.: The patient care technician assigned to the patient documented “ Access visible RN notified. green Amp light. Denies complaints. Patient alert; goal increase to 3.9. r.n. notified. “ 09:05 a.m.: patient’s documented blood pressure 140/78, pulse rate 94 beats per minute. 09:31 a.m.: patient’s documented blood pressure 114/63, pulse rate 72 beats per minute. 10:00 a.m.: patient’s documented blood pressure 134/83, pulse rate 72 beats per minute. The patient care technician assigned to the patient documented “ resting comfortably access visible green amp light; Denies complaints; goal lowered t 3.6 to support b/p. “ 10:35 a.m.: Patient’s hemodialysis treatment discontinued by the patient care technician. Review of the patient’s clinical record ( treatment sheet and nurses progress notes) revealed no pre- treatment or intradialytic assessment documented by the registered nurse assigned to the patient. Review of the registered nurse’s post treatment documentation at 10:51 a.m. revealed the following “No unusual findings noted No post treatment discomfort observed.” On 02/15/2024 at 2:40 p.m. during an interview with the Facility’s Manager, the Surveyor reviewed the patient’s treatment sheet with the facility’s Manager. The Facility’s Manager said on the date of the missing pre- treatment and intradialytic treatment documentation, the patient was assigned to a float nurse. Patient #4 Review of the Patient #4’s registered nurse pre- treatment assessment timed 7:00 a.m. revealed the patient was assessed with having ankle edema 1+:2 mm or less, which disappears rapidly. Review of Patient #4’s treatment sheet dated 2/3/2024 revealed the following findings: 06:35 a.m.: Patient’s documented pre- treatment blood pressure 105/81 sitting and 111/85 standing. Pulse rate 73 beats per minute. 06:51 a.m.: Patient’s hemodialysis treatment initiated by the registered nurse assigned to the patient, documented blood pressure 155/77, pulse rate of 82 beats per minute. 07:00 a.m.: Patient’s blood pressure 174/88 and, pulse rate of 88 beats per minute. 07:30 a.m.: Patient’s documented blood pressure 128/74 and pulse rate of 86 beats per minute. 08:04 a.m.: Patient’s documented blood pressure 154/74 and pulse rate of 69 beats per minute, documented blood flow rate 300 mls/ minute. The Patient Care Technician assigned to the patient documented “BP lowered due to machine problem.” 08:27 a.m.: Patient’s documented blood pressure 154/74 and pulse rate of 60 beats per minute. 09:00 a.m.: Patient’s documented blood pressure 180/78 and pulse rate of 67 beats per minute. Documented blood flow rate 400 beats per minute. 09:34 a.m.: Patient’s documented blood pressure 151/99 and pulse rate of 66 beats per minute. Documented blood flow rate 400 beats per minute. 09:34 a.m.: Patient’s documented blood pressure 151/122 and pulse rate of 66 beats per minute. Documented blood flow rate 300 beats per minute. 09:54 a.m.: Patient’s documented blood pressure 152/99 and pulse rate of 65 beats per minute. Documented blood flow rate 400 beats per minute. Patient’s hemodialysis treatment discontinued by the patient care technician. There was no documented intradialytic assessment by the registered nurse. Review of the registered nurse post treatment assessment revealed no documentation that the patient was assessed for edema of the ankle. The patient requested to have his hemodialysis treatment terminated 30 minutes earlier. The patient was discharged 3.4 kgs over estimated dry weight. Patient refused extra hemodialysis treatment. Patient’s documented post weight 106.70 kg.”