Fresenius Kidney Care Regal Oaks

“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: 27438 Based on policy review, observation, and interviews, the facility staff failed to perform hand hygiene after removing gloves, after touching patient the dialysis machines and bloodlines, and before contact with the patient for 1 of 3 survey days. Findings included: Review of the facility’s policy, “Termination of Treatment Using an Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer,” revised February 7, 2022 revealed, “Prior to Termination ...Perform hand hygiene and don full PPE (gown, gloves, and goggles with mask, or mask with face shield). At any time during the termination process, if gloves are visibly contaminated, remove gloves, perform hand hygiene and don new gloves.” Observation on February 8, 2024 from 10:20 AM to 10:40 AM (20-minutes) revealed, CCHT #4 provided care at Station 12. The technician was observed moving two times between station 12 and touching the dirty dialysis machines and attached computer screen. The technician also failed to remove dirty gloves, sanitize hands, and don clean gloves before termination and removal of post-treatment needles for Patient #12. Additionally, the technician reached under his/her disposable gown with a dirty glove after the removal of one needle and held the needle site, using the lower portion of the gown over his/her gloved hand to press the computer screen to silence the machine at station 12 during the removal of the needles for Patient #12. Interview on February 8, 2024 at 10:40 AM, CCHT #4 confirmed the above findings. Interview on February 8, 2024 at 10:50 AM with RN #3 revealed, that after leaving the patient and using the computer of the dialysis machine, the staff should remove dirty gloves, provide hand hygiene, and don new gloves before removal of patient needles. RN #3 revealed that staff should not touch the computer screen with gloves wrapped in the disposable gown.”

“IC-SINGLE USE VIALS CFR(s): 494.30(a)(1)(i) Intravenous medication vials labeled for single use, including erythropoietin, should not be punctured more than once. This Standard is not met as evidenced by: 32003 Based on policy review, observation, and interview, the facility staff failed to ensure 1 of 1 single use vial was disposed of after first use for 1 of 3 observations in the medication preparation area. Findings included: Review on February 8, 2024 of the facility’s policy, “Medication Preparation and Administration” published February 6, 2023 revealed, “Purpose ...Qualifications ...Controlled Substances & Sample Medications ...Needles ...Labeling Vials ...Medication Label Handling ...Pre-drawing Medications ...Principles for Medication Preparation ...Monitoring Expired Medications ...Preparing and Administering Medications During Hemodialysis Treatment ...Administering the First Dose of any IV Medication New to the Patient ...Infection Control ...Discard single-dose vials after use. Never reuse for another patient. For single dose vials, never puncture the vial twice. ...” Observation on February 7, 2024 at 9:00 AM revealed, one single use vial of sterile water was opened, used, and stored back in the cabinet in the medication preparation area. Observation revealed the vial should have been disposed of after first use. Interview on February 7, 224 at 9:00 AM with the Clinical Nurse Manager and RN #8 revealed, the single use vial should have been disposed of after first use.”

“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: 27438 Based on policy review, observation, and interview, the facility staff failed to ensure the dialysis chair was vacated before disinfecting the dialysis machine between patient use for 1 of 3 treatment discontinuation observations. Findings included: Review of the facility’s policy, “Cleaning and Disinfecting the Dialysis Station” revised September 5, 2023 revealed, “Vacation the Machine: To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station and set up for the next patient.” Observation on February 7, 2024 at 9:40 AM, at Station 2 revealed, PCT #2 was observed disinfecting the dialysis treatment machine before Patient #3 vacated the dialysis station chair. Interview on February 7, 2024 at 11:30 AM with PCT #2 revealed, he/she failed to wait for Patient #3 to vacate the dialysis station before disinfection the dialysis station, stating, “I guess I was thinking of getting ready for the next patient,” Interview revealed the facility policy was to disinfect the station when it was completely vacant. Interview on February 7, 20/24 at 1:45 PM with the Clinical Manager confirmed the facility policy for disinfection of the stations.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 32003 Based on policy review, observations, and interviews, the facility staff failed to label multi-dose vials of heparin that were not used in their entirety at first use for 2 of 3 observations in the medication preparation area. Findings included: Review on February 8, 2024 of the facility’s policy, “Medication Preparation and Administration” published February 6, 2023 revealed, “Purpose ...Qualifications ...Controlled Substances & Sample Medications ...Needles ...Labeling Reconstituted Medications Solutions and Syringes ...Labeling Vials ...When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT ...must place the date and time the vial was opened on the medication label along with their initials. ...” 1. Observation on February 7, 2024 at 9:00 AM of the cabinets in the medication preparation area revealed, two 30-mL of heparin multi-dose vials were opened without a label of the date, time, and staff initials of the open date. Interview on February 7, 2024 at 9:00 AM with RN #8 revealed, the two opened multi-dose vials of heparin were not labeled. 27438 2. Observation on February 8, 2024 at 11:05 AM of the cabinets in the medication preparation area revealed, one 30-mL multi-dose vial of heparin was opened without a label of the date, time, and staff initials of the open date. Interview on February 8, 2024 at 11:05 AM with RN #3 revealed, the nursing staff that used medications in the medication area were required to date and initial all multi-dose medications when opened.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 27438 Based on policy review, manufacturer’s DFU review, observations, and interviews, the facility staff failed to follow the bloodline manufacturer’s DFU during dialysis treatments by not monitoring and maintaining the arterial drip chamber fluid levels at approximately 90% full during treatment for 2 of 3 survey days. Findings included: Review of the facility’s policy, “Patient Assessment and Monitoring,” revised May 1, 2023 revealed, “Observe to ensure that venous and arterial chambers are filled to fill level.” Review of the “Combo Set,” manufacturer’s DFU used at this facility revealed, “During Treatment ...Maintain fluid level in arterial chamber at approximately 90% full and venous chamber at approximately 70% full. Levels may rise or drop during the treatment due to changes in pressure of flow rate. Readjust levels as needed. Air leaks will also cause the chamber levels to fluctuate.” 1. Observation on February 7, 2024 from 9:10 AM to 9:40 AM (30-minutes) revealed, the arterial drip chamber fluid levels were less than 50% full in Stations #2, #3, #4, #8, #10, #13, #14, and #15. Interview on February 7, 2024 at 10:10 AM with PCT # 2 revealed, the arterial chamber level at Station #2 was below 50% and staff were responsible for observing the chamber levels during treatment and adjust the 90% level as needed. 2. Observation on February 8, 2024 from 9:05 AM to 11:45 AM (160-minutes) revealed, the arterial drip chamber fluid levels were less than 50% full in Stations #8, #9, #11, and #13. At 10:05 AM, CCHT #4 completed documentation at Station #11 and then left the station with the arterial drip chamber level remained less than 5% following machine verifications by CCHT #4. Interview on February 8, 2024 at 10:10 AM with CCHT #4 revealed, he/she had completed the chair side verifications at Station #11. Interview revealed, the technician failed to observe the arterial chamber levels at Station #11 was below 5% and stated, staff: 1.) should be aware of the arterial level, 2.) were responsible to observe the chamber levels during treatment, and 3.) should adjust the fill level as needed.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 32003 Based on policy review, medical record review, and interview, the facility staff failed to develop a new plan of care for 1 of 1 patient that changed modality from HPD to ICHD. (Patient #7). Findings included: Review on February 7, 2024 of the facility’s policy, “Comprehensive Interdisciplinary Assessment and Plan of Care” published July 3, 2023 revealed, “Purpose ...Responsibility ...Background ...General Policy for Patient Assessment and Plan of Care ...Components of the Patient Comprehensive Interdisciplinary Assessment ...CIA and POC for Patients New to Dialysis ...An initial comprehensive interdisciplinary assessment (CIA) and plan of care (POC) must be conducted on all patient new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. Patients changing modality are classified as new patient and must have comprehensive interdisciplinary assessments and plans of care completed with the same frequency as patients new to dialysis. ...” Open medical record review on February 7, 2024 revealed on September 5, 2023, Patient #7 was admitted to the in-center facility as a modality change from peritoneal dialysis. The plan of care was last updated November 10, 2023 and the goals and interventions were related to peritoneal dialysis. Review revealed, the facility staff failed to develop a new in-center POC for the patient. Interview on February 7, 2024 at about 10:00 AM with the Clinical Nurse Manager revealed, Patient #7 was admitted to the in-center facility as a modality change from home peritoneal dialysis to in-center dialysis. Interview revealed, the plan of care should have been changed to in-center. The delay was due to an idea that the patient may go back to home therapy, however, the Medical Director stated home therapy was no longer an option for the patient.”

“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: 32003 Based on policy review, observation, and interview, the facility staff failed to ensure the staff member that drew up the medication also administered the medication for 1 of 3 observations in the medication preparation area. Findings included: Review on February 8, 2024 of the facility’s policy, “Medication Preparation and Administration” published February 6, 2023 revealed, “Purpose ...Qualifications ...The person who prepares the medication must be the person who will administer the medication. ...” Observation on February 7, 2024 at 10:55 AM revealed RN #3 drew up heparin in a syringe for Patient #8. The RN then handed the medication-filled syringe to CCHT #6. CCHT #6 walked to Station #12 and provided the syringe to CCHT #7. CCHT #7 used the medication-filled syringe as a pre-treatment for the patient. Observation revealed the RN that drew up the medication did not administer the medication. Interview on February 8, 2024 at 9:00 AM with the Clinical Nurse Manager and a visiting Clinical Nurse Manager revealed, CCHT #7 was from Georgia, and in Georgia, CCHTs could not draw up heparin. Interview revealed, RN #3 should have verified the medication with CCHT #7.”