Fresenius Kidney Care Red Oak

“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: 50873 Based on observation, staff interview, and facility policy review, 3 (Patient Care Technician [PCT] #3, PCT #4, and Registered Nurse [RN] #1) of 4 staff observed performing patient care during infection control observations failed to perform hand hygiene per facility policy. The findings include: A facility policy titled, “Hand Hygiene,” with a publication date of 11/06/2023, revealed that hands would be “Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water.” The policy revealed that hands should be decontaminated in this manner for the following situations: “-Before and after direct contact with patients; -Entering and leaving the treatment area; -Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications; -Immediately after removing gloves; -After contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled; -After contact with inanimate objects near the patient; -When moving from a contaminated body site to a clean body site of the same patient; -After contact with the dialysis wall box, concentrate, drain, or water lines; and -After contact with other objects within the patient station or treatment space.” During an observation on 03/24/2025 at 3:30 PM, RN #1 performed treatment discontinuation for a patient with an arteriovenous fistula (AVF) at patient treatment station #8. RN #1 disconnected the canulation needles from the bloodlines, had the patient stand up to take a standing blood pressure reading, and had the patient sit back down. RN #1 then removed the cannulation needles. RN #1 failed to perform hand hygiene and change gloves prior to removing the cannulation needles. During an interview on 03/24/2025 at 4:04 PM, RN #1 confirmed that the expectation was to perform hand hygiene and change gloves after reinfusing a patient’s blood and removing the bloodlines, and prior to removing the needles. The RN confirmed that she did not perform hand hygiene and change gloves at the appropriate times when she discontinued treatment for the patient in station #8. RN #1 stated she forgot to do so. During an observation on 03/24/2025 at 3:39 PM, PCT #3 wore the same gloves while she touched the dialysis machine at treatment station #7, went to treatment station #6 and touched the dialysis machine, went to treatment station #10 and touched the patient, then went to treatment station #8 to talk to an RN. PCT #3 then removed the gloves and performed hand hygiene. PCT #3 failed to change her gloves and perform hand hygiene when leaving the patient treatment areas, before and after touching a patient, and after contact with objects present within the patient treatment area. During an interview on 03/24/2025 at 4:31 PM, PCT #3 confirmed the expectation was for staff to change gloves and perform hand hygiene when entering and leaving a patient station and that she was trained regarding that expectation. PCT #3 acknowledged that she might have gone between treatment stations as observed, but was unable to remember. PCT #3 stated that she always tried to change her gloves and perform hand hygiene per policy but sometimes forgot. During an observation on 03/24/2025 at 4:10 PM, PCT #4 performed treatment discontinuation for a patient with an AVF at patient treatment station #1. PCT #4 disconnected the cannulation needles from the bloodlines, helped the patient with a blood pressure cuff, then removed the cannulation needles. PCT #4 failed to perform hand hygiene and change gloves prior to removing the cannulation needles. During an interview on 03/24/2025 at 4:39 PM, PCT #4 confirmed the expectation was to change gloves and perform hand hygiene after reinfusing a patient’s blood and prior to removing the needles during treatment discontinuation for a patient with an AVF. PCT #4 confirmed she did not do that when performing the care activity at station #1. PCT #4 stated she did not know why she did not perform hand hygiene when required. During an interview on 03/24/2025 at 5:27 PM, the Clinic Manager (CM) confirmed she expected staff to perform hand hygiene and change gloves when moving between patient treatment stations, prior to removing cannulation needles, prior to cannulation of a patient’s access, and per policy. During an interview on 03/27/2025 at 9:00 AM, the Medical Director confirmed she expected staff to perform hand hygiene and change gloves per facility policy.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 50873 Based on observation, staff interview, and facility policy review, 1 (Patient Care Technician [PCT] #4) of 4 staff observed during infection control observations failed to disinfect, dispose of, or dedicate reusable supplies after leaving a dialysis treatment station. The findings include: A facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” with a publication date of 09/05/2023, indicated, “After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA [Environmental Protection Agency] registered disinfectant before being removed from the dialysis station.” During an observation on 03/24/2025 at 11:54 AM, PCT #4 entered treatment station #1 to initiate dialysis treatment for a patient with an arteriovenous fistula (AVF). PCT #4 palpated the patient’s access and then opened cannulation needle packages. PCT #4 removed their gloves and threw away the packages. At 11:58 AM, PCT #4 returned to treatment station #1 with a stethoscope, auscultated the patient’s access, then returned the stethoscope to a drawer in a clean station next to the nurses’ station. PCT #4 failed to disinfect the stethoscope when removing it from the patient treatment station. During an interview on 03/24/2025 at 3:50 PM, PCT #4 confirmed the expectation was for reusable items to be disinfected upon removal from a patient treatment station. PCT #4 confirmed that they did not disinfect the stethoscope when removing it from the treatment station. During an interview on 03/24/2025 at 2:45 PM, the Clinic Manager confirmed the expectation was for reusable supplies to be disinfected prior to removal from a patient treatment station. During an interview on 03/27/2025 at 9:00 AM, the Medical Director confirmed the expectation was for reusable supplies to be disinfected prior to exiting a treatment station.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 50873 Based on observation, staff interview, and facility policy review, staff failed to dispose 3 out of 12 sharps bins containing potentially hazardous medical waste per protocol. The findings include: A facility policy titled, “General Cleanliness and Infection Control Guidelines,” with a published date of 11/04/2024, indicated, “All containers for storage or disposal of needles/sharps shall be replaced on a regularly scheduled basis or when no more than 2/3 to ¾ full.” During patient care observations on 03/24/2025 at 12:51 PM, Patient Care Technician (PCT) #3 performed initiation of dialysis and site care for a patient with a central venous catheter at station #5. While the PCT was performing these tasks, Registered Nurse (RN) #1 assessed the patient. The sharps bin at station #5 was observed to be so full that PCT #3 had difficulty putting used syringes into the bin. During an interview on 03/24/2025 at 1:00 PM, RN #1 confirmed that the sharps bin at station #5 was overfull and stated that the facility expectation was that sharps bins be removed when they were ¾ full. During a tour of the dialysis treatment floor on 03/24/2025 at 5:27 PM with the Clinic Manager (CM), the sharps bins for each treatment station were observed. The bins at stations #5, #9, and #10 were more than ¾ full. The CM confirmed that the bins were overfull and should have been changed. The CM confirmed the expectation was sharps bins be changed when they were ¾ full. On 03/27/2025 at 9:00 AM, the Medical Director confirmed her expectation was that sharps bins be emptied when ¾ full.”

“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: 50873 Based on observation, staff interview, and facility policy review, the facility failed to disinfect patient treatment stations per policy for 2 out of 2 observations of patient treatment station disinfection. The findings include: A facility policy titled, “Cleaning and Disinfecting the Dialysis Station,” with a publication date of 09/05/2023, indicated staff should “disinfect the dialysis station after each dialysis treatment” to include “Use a cloth wetted with 1:100 bleach solution or EPA [Environmental Protection Agency] -approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, IV [intravenous] pole, B/P [blood pressure] cuff, hand sanitizer dispenser and holder, chaise wall behind chair).” During an observation on 03/24/2025 at 12:37 PM, Patient Care Technician (PCT) #3 was observed disinfecting dialysis station #5 after the completion of patient treatment. PCT #3 failed to clean the shelf behind the patient chair. During an observation on 03/24/2025 at 3:19 PM, PCT #3 was observed disinfecting dialysis station #2 after the completion of a patient treatment. PCT #3 failed to clean the shelf behind the patient chair. During an interview on 03/24/2025 at 4:31 PM, PCT #3 stated staff cleaned the shelves behind the treatment stations, but she was not told that they had to do it every time when disinfecting the treatment station. PCT #3 confirmed that they did not clean the shelves when disinfecting stations #2 and #5. During an interview on 03/24/2025 at 4:04 PM, Registered Nurse (RN) #1 confirmed the expectation was for staff to clean the shelves behind a treatment station when disinfecting the station. During an interview on 03/24/2025 at 5:27 PM, the Clinic Manager confirmed the expectation was that the shelves behind a dialysis station be cleaned during station disinfection. During an interview on 03/27/2025 at 9:00 AM, the Medical Director confirmed it was expected that the shelves behind a dialysis station be cleaned during station disinfection.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 50873 Based on record review, staff interview, and facility policy review, the facility failed to monitor fluid status per policy for 5 (Patients #1, #2, #3, #4, and #5) of 5 patients sampled for medical record review. The fiindings include: A facility policy titled, “Patient Assessment and Monitoring,” with a publication date of 05/01/2023, indicated that staff should “Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes.” Further review revealed to “Report to the nurse: Systolic blood pressures greater than 180 mm/Hg [millimeters of mercury], Diastolic blood pressure greater than 100 mm/Hg, Blood pressure less than or equal to 100 mm/Hg systolic” and indicated to “Report to the nurse any complaints by the patient during treatment.” A “Treatment Sheet” for Patient #1, dated 03/21/2025, failed to reveal evidence of patient monitoring occurring between 1:30 PM and 2:30 PM (one hour). A “Treatment Sheet” for Patient #2, dated 03/19/2025, failed to reveal evidence of patient monitoring occurring between 11:27 AM and 12:35 PM (one hour and 12 minutes). A “Treatment Sheet” for Patient #2, dated 03/19/2025, indicated that Patient Care Technician (PCT) #4 obtained the patient’s blood pressure at 11:27 AM, notating that it was 199/97 mm/Hg. The record did not indicate that a registered nurse (RN) was notified of the out-of-range vital sign. The record then reflected that, at 12:35 PM, PCT #6 obtained a blood pressure reading of 185/84 mm/Hg and noted that the patient was experiencing cramping. The record did not indicate an RN was notified of the out-of-range vital sign or that the patient was experiencing adverse symptoms. A “Treatment Sheet” for Patient #3, dated 03/12/2025, failed to reveal evidence of patient monitoring occurring between 7:10 AM and 8:05 AM (55 minutes). A “Treatment Sheet” for Patient #3, dated 03/19/2025, failed to reveal evidence of patient monitoring occurring between 4:41 AM and 5:32 AM (51 minutes). A “Treatment Sheet” for Patient #3, dated 03/21/2025, failed to reveal evidence of patient monitoring occurring between 4:45 AM and 5:35 AM (50 minutes) or between 7:02 AM and 7:58 AM (56 minutes). A “Treatment Sheet” for Patient #4, dated 03/10/2025, failed to reveal evidence of patient monitoring occurring between 8:03 AM and 9:01 AM (58 minutes). A “Treatment Sheet” for Patient #5, dated 03/10/2025, failed to reveal evidence of patient monitoring occurring between 11:32 AM and 12:33 PM (one hour and 11 minutes). Further review revealed that, at 1:31 PM, PCT #5 obtained a blood pressure reading of 99/36 mm/Hg; at 2:00 PM, PCT #3 obtained a blood pressure reading of 90/31 mm/Hg; and at 2:30 PM, PCT #5 obtained a blood pressure reading of 93/42 mm/Hg. The document did not indicate an RN was notified of the out-of-range blood pressure readings. A “Treatment Sheet” for Patient #5, dated 03/14/2025, revealed that, at 12:01 PM, PCT #6 obtained a blood pressure reading of 92/61 mm/Hg and, at 1:34 PM, PCT #6 obtained a blood pressure reading of 84/53 mm/Hg. The document did not indicate an RN was notified of the out-of-range blood pressure readings. A “Treatment Sheet” for Patient #5, dated 03/17/2025, revealed that, at 12:01 PM, PCT #5 obtained a blood pressure reading of 99/51 mm/Hg. The document did not indicate an RN was notified of the out-of-range blood pressure reading. A “Treatment Sheet” for Patient #5, dated 03/19/2025, failed to reveal evidence of patient monitoring occurring between 11:30 AM and 12:26 PM (54 minutes). A “Treatment Sheet” for Patient #5, dated 03/21/2025, failed to reveal evidence of patient monitoring occurring between 11:05 AM and 12:07 PM (one hour and two minutes). The document revealed that, at 2:00 PM, PCT #5 obtained a blood pressure reading of 93/61 mm/Hg. The document did not indicate an RN was notified of the out-of-range blood pressure reading. During an interview on 03/26/2025 at 3:54 PM, PCT #3 stated that PCTs should notify an RN of blood pressure readings between 180-190 systolic, over 110 or greater diastolic, or less than 90 systolic over 50 diastolic. PCT #3 stated that the PCT should document any notification to the RN. PCT #3 stated the PCTs knew the patients and would not always call the nurse if the PCT knew that a reading was normal for the patient. PCT #3 stated that monitoring should occur every 30 minutes and include documentation of a patient’s blood pressure and heart rate, if any fluids were given, and if there were any problems noted. During an interview on 03/26/2025 at 3:14 PM, RN #1 stated it was expected for PCTs to report to the RNs any systolic blood pressure above 180-200 or below 100, depending on the patient, diastolic blood pressures greater than 100 or less than 50, and any patient symptoms such as cramping, pain, bleeding, or anything out of the ordinary for the patient. RN #1 confirmed that PCTs were supposed to chart RN notifications. RN #1 stated that patient monitoring and documentation of vital signs should occur at a minimum of every 30 minutes. During an interview on 03/25/2025 at 9:30 AM, the Clinic Manager (CM) stated the expectation for monitoring of patients was at least every 30 minutes with documentation of vital signs and access checks. The CM stated the PCTs should notify an RN of any vital signs that were in red on the machine or if a patient had recent hospitalization(s), became non-responsive, or experienced any falls, bleeding, changes in mental status, sick symptoms, or symptoms while on treatment, to include lightheadedness, cramping, or dizziness. The CM was unsure of parameters, and the policy was pulled as a reference during record review. During an interview on 03/27/2025 at 9:00 AM, the Medical Director confirmed that PCT notification to the RNs should be carried out per facility policy. The Medical Director stated that patient monitoring should occur every 30 minutes at a minimum and include documentation of a patient’s vital signs.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 50873 Based on observation, interview, and facility policy review, the facility failed to provide vascular access monitoring per facility policy for 1 out of 2 observations of initiation of dialysis with an arteriovenous fistula (AVF). The findings include: Facility policy titled, “Access Assessment and Cannulation,” with a publication date of 05/06/2024, indicated that staff should perform the following to assess the patient’s vascular access: “Prior to treatment, ask patient to wash access area with soap and water, per hand hygiene procedure. If the patient is unable to wash their own access, the staff or care partner should wear gloves to wash the patient’s access with soap and water.” Further review revealed, “LISTEN: Bruit high pitch/whistle, Bruit not present throughout access” and “Note and report any unusual findings to the nurse in charge or home therapies staff before proceeding with needle insertion.” During an observation on 03/24/2025 at 1:30 PM, Patient Care Technician (PCT) #4 and PCT #5 brought a patient to station #6. While PCT #3 set up the dialysis machine, PCT #5 performed hand hygiene, donned gloves, cleaned the access with an alcohol pad, and then cannulated the first access site, securing it with tape. PCT #5 cleaned the access with an alcohol pad and then cannulated the second access site, securing it with tape. PCT #5 failed to have the patient wash their access or to wash it for the patient and auscultate the access. During an interview on 03/24/2025 at 1:37 PM, PCT #5 stated the patient’s access was not washed due to the patient being unable to stand at the sink. PCT #5 confirmed staff did not wash the access site for the patient. PCT #5 stated that to evaluate the access prior to cannulation they should feel the access and auscultate the access site. PCT #5 confirmed she did not auscultate the patient’s access and that she was trained to auscultate every time. PCT #5 stated, “Sometimes it’s one of those things you get in a hurry and you forget.” During an interview on 03/24/2025 at 2:45 PM, the Clinic Manager confirmed it was her expectation for staff to auscultate and palpate a patient’s access prior to cannulation. During an interview on 03/27/2025 at 9:00 AM, the Medical Director confirmed that washing a patient’s access with soap and water and auscultating the access were to be done prior to cannulation.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 50873 Based on staff interview and facility policy and document review, the facility Quality and Performance Improvement (QAPI) program failed to analyze benchmark data and identify a trend of not meeting Centers for Medicare and Medicaid Services (CMS) benchmarks. The findings include: A facility policy titled, “Quality Assessment and Performance Improvement Program,” with a publication date of 11/04/2024, indicated, “The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate, and improve the quality and safety of patient care and services by identifying opportunities and resolving identified problems through the use of continuous quality improvement (CQI) methodology to achieve measurable improvement of health outcomes, optimize the number of patient who achieve individual patient targets and prevent and reduce medical errors.” Review of “QAPI Program Notes” from November 2024, December 2024, January 2025, and February 2025 indicated that the facility’s numbers for the percentage of influenza vaccine administered was 69%, 68%, 67%, and 65%, respectively. The facility failed to meet the national benchmark of 78% of patients having received the flu vaccine in each month. Review of “Dialysis Facility Report for Fiscal Year 2025” indicated the percentage of patients vaccinated for influenza was 78% nationally. During an interview on 03/27/2025 at 11:11 AM, the Clinic Manager (CM) confirmed that the facility failed to identify that they were not meeting the benchmark for influenza vaccines, that no trends were identified, and no action plan was created. The CM stated, “They [the patients] have the right to refuse,” but all patients were offered the flu vaccine. During an interview on 03/27/2025 at 2:12 PM, the CM stated the QAPI meeting notes in November (2024) and December (2024) only had comments related to the hepatitis B vaccine. The CM stated that the January (2025) and February (2025) notes identified the influenza vaccine numbers were stable but did not identify that the facility was not meeting CMS benchmarks. The CM stated that the education provided to patients about the influenza vaccine included providing the patients with the vaccine information sheet and a reminder on a bulletin board in the clinic. The CM confirmed that there were no other patient education measures taken by the facility to encourage the patients to get the flu vaccine.”