Liberty Dialysis Hawaii - Hilo Dialysis

“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: 47783 Based on observations, interview and record review, the facility failed to ensure staff members wore appropriate Personal Protective Equipment (PPE) when performing procedures where there is a potential for exposure. As a result of this deficient practice, the staff members were placed at risk for potential exposure to chemicals and possible bloodborne pathogens that could affect all the patients in the facility. Findings include: On 01/31/24 at 11:30 AM, observed Patient Care Technician (PCT)3 disinfecting the dialysis chair in station 10 with bleach wipes after the patient vacated the station. PCT3 was not wearing a gown. On 01/31/24 at 03:45 PM, observed PCT4 disinfecting station 5 after the patient vacated the station. PCT4 wiped the machine and dialysis chair with bleach wipes and was not wearing a gown. Review of the facility policy titled, “Exposure Categories and Determination” with a publish date of 11/06/23 revealed that gloves, full face shield or mask and goggles and gown are required for staff to use when “Cleaning the machine and patient area.” On 02/02/24 at 10:03 AM, interview was conducted with the Clinical Manager (CM) in her office. CM confirmed that the staff are supposed to wear full PPEs (gown, gloves and face shield) when disinfecting the dialysis machine and chair to prevent possible exposure to chemicals and bloodborne pathogens.”

“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: 47783 Based on observations, staff interview and record review, the facility failed to ensure that items taken into the dialysis station were either disposed of, dedicated for use on a single patient or disinfected before being returned to a common area. As a result of this deficient practice, the patients were placed at risk for the potential exposure to communicable diseases. Findings include: On 01/30/24 at 01:28 PM, observed Registered Nurse (RN) 3 use a scanning thermometer (touchless digital thermometer that needs to be brought within an inch of the forehead) to check the patient’s temperature in station 30. After obtaining a temperature, RN3 placed the thermometer back on the table where staff prepare supplies used for dialysis treatments without disinfecting it first. On 01/31/24 at 04:33 PM, observed RN3 assisting Patient Care Technician (PCT) 4 with incoming patient at station 14. RN3 used the thermometer to check the patient’s temperature. After RN3 obtained a temperature reading, then placed the thermometer back on the table close to the clean supplies area. The thermometer was not wiped/disinfected after use. On 02/02/24 at 10:03 AM, interview was conducted with the Clinical Manager (CM) in her office. CM confirmed that staff are supposed to disinfect the thermometer and anything else that is brought into the patient’s station unless it is dedicated for use only for that patient or discarded after use. Review of the facility’s policy titled “Cleaning and Disinfecting of the Dialysis Station” stated, “. . . After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected . . .””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 47783 Based on observation and staff interviews, the facility failed to ensure the clean areas were kept free from the transmission of potentially infectious diseases. A staff member was observed wearing Personal Protective Equipment (PPE) in a designated clean area. Findings include: On 02/01/24 at 10:30 AM, observed Registered Nurse (RN)4 sitting behind the desk at the nurse’s station wearing a gown. RN4 was on the computer and observed five cups in a tray on the desk. Asked RN4 what the five cups contained. RN4 said three of the cups contained water and the other two contained medications. Asked RN4 if the staff were allowed to wear PPE in the nurse’s station. RN4 replied, “I was told we can wear our gowns in the nurse’s station.” On 02/02/24 at 10:03 AM, interview was conducted with the Clinical Manager (CM) in her office. CM confirmed that the staff are not supposed to wear gowns in the nurse’s station since it is considered a clean area and medications are kept there in the locked drawers.”

“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: 22063 Based on observations, interviews, and review of the facility’s policy and procedures, the facility did not assure the disinfection of contaminated surfaces. This deficient practice has the potential to expose patients to transmission of bloodborne pathogens and other infections from one patient to another. Findings include: On 01/30/24 at 12:40 PM observed a Patient Care Technician (PCT)1 disinfecting a patient’s chair at station 18. The PCT wiped the top of both chairside trays and the outer sides of the chair. On 01/30/24 at 01:30 PM observed PCT2 disinfect a patient’s chair at station 3. The PCT was observed to fold down the chairside trays to wipe all sides of the tray (including the inner facing area) and the portion of the chair that was covered when the tray is up. Interviewed PCT1 to inquire whether the chairside trays can be folded down to ensure disinfecting all sides of the tray and the side of the chair that is obstructed while the tray is up. PCT1 stated the chairside trays can be folded down and he/she usually folds the tray down and wipes the inner portion of the tray and the side of the chair. On 02/02/24 at 10:40 AM interview with the Charge Nurse and Clinic Manager confirmed, PCTs should put the chairside tray down to wipe the inside surface of the tray and chair. A review of the facility’s policy and procedure titled, Cleaning and Disinfecting the Dialysis Station. The procedure for disinfecting the dialysis station after each dialysis treatment included: “Use a cloth wetted with 1:100 bleach solution or EPA-approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, IV pole, B/P cuff, hand sanitizer dispenser and holder, chaise wall behind chair).”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 47783 Based on observations, interviews and record review, the facility failed to ensure staff provided care for a patient with a Central Venous Catheter (CVC) to prevent catheter-related infections. As a result of this deficient practice, all patients with a CVC are placed at risk for developing preventable vascular access infections. Findings include: On 01/30/24 at 02:30 PM, observed Registered Nurse (RN) 2 terminate hemodialysis treatment for Patient (P) 26 in station 1. P6 had a CVC for her vascular access. RN2 disconnected the bloodlines from the CVC while P26 had her mask under her chin and was not covering her mouth and nose. RN2 scrubbed the CVC hub (ends of the catheter) and flushed the line. Asked RN1, who was making her rounds on another patient, if P26’s mask is supposed to cover both her mouth and nose. RN1 said, “Yes.” and told RN2 to make sure P26’s mask was on properly. On 02/02/24 at 10:03 AM, interview was conducted with the Clinical Manager (CM) in her office. CM confirmed that the patients with CVCs are supposed to wear a mask covering both their mouth and nose whenever staff are initiating or terminating treatment, during dressing change, or whenever the staff are working on their CVC. Review of facility’s policy titled, “Initiation and Termination of Treatment Using a Central Venous Catheter (CVC)” stated, “. . . A mask must be worn that covers the nose and mouth by the staff, patient and care partner for all procedures that require accessing the catheter. . .””

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 39754 Based on observation, staff interview and review of policy, the facility failed to discard an expired container of RP E-Z Chek Ozone Test Strips and an expired container of Minncare HD 1% Indicator Test Strips. As a result of this deficiency, there was a risk of increased disinfection residual in the dialysis water system. Findings include: During observation of the water room on 01/30/24 at 10:15 AM, a container of RP E-Z Chek Ozone Test Strips was noted to have an expiration date of 11/30/23. Also, another container of Minncare HD 1% Indicator Test Strips was noted to have an expiration date of 03/16/23. During staff interview on 01/30/24 at 10:30 AM, Biomed Tech acknowledged that the containers previously mentioned were expired and should have been discarded. Review of policy on RPC EZ Check Ozone (in Water) Test Strip Use Procedure read the following: Equipment and Materials, the following supplies will be needed for this procedure; RPC EZ Check Ozone in Water Test Strip, Clear plastic sample collection cup or container, Timing Device, Personal protective equipment: safety glasses, gloves, gown. Procedure, follow the steps below to test for ozone in the range of 0.0 ppm to 0.4 ppm using a RPZ EZ Check Ozone in Water Test Strip ... Documentation, for information on documenting test results refer to the procedure in which the test strips are being used.”

“DIALYZER PRIMING/RINSING THE GERMICIDE CFR(s): 494.50(b)(1) 12.4 Priming the dialyzer and rinsing the germicide If the manufacturer’s instructions so require, a germicide presence test shall be performed before the germicide is rinsed from the dialyzer. The dialyzer shall be rinsed and primed according to a written procedure that has been documented to produce a reduction in the concentration of germicide to an acceptable level and result in a physiological solution in the blood and dialysate compartments. The dialyzer manufacturer ’ s instructions should be considered in developing these procedures. This Standard is not met as evidenced by: 47783 Based on observations, interview and record review, the facility failed to ensure staff were following procedures to prime dialyzers according to their policy as required by the dialyzer manufacturer. Findings include: On 01/30/24 at 10:44 AM, observed Patient Care Technician (PCT) 5 set up hemodialysis machine at station 15. PCT5 set the blood pump speed of the machine to 200 ml/min (milliliters per minute) when priming the dialyzer. At 12:40 AM in station 32, observed PCT6 setting up hemodialysis machine and had the blood pump speed set at 200 ml/min while priming the dialyzer. On 02/01/24 at 10:50 AM, observed PCT3 set up station the hemodialysis machine in station 33. PCT3 was priming the dialyzer with the blood pump speed was set at 200 ml/min. On 02/02/24 at 10:03 AM, interview was conducted with the Clinical Manager (CM) in her office. CM confirmed that the staff are supposed to be priming the dialyzers at 150 ml/min blood pump speed as required by the dialyzer manufacturer. Review of the facility’s policy titled “Priming an Optiflux Single Use E-Beam Dialyzer” stated, “. . . All Optiflux Single Use dialyzers . . . Must be primed at a blood flow rate of 150 ml/min to maximize air removal . . . The slow pump speed and the pinch and release on the line allow air to be replaced with the saline more evenly, reducing the chance of air remaining in the pump segment . . . allows the fibers to be wetted more evenly.””

“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: 39754 Based on observation, staff interview and review of policy, the facility failed to discard five packets of IV Administration Sets. As a result of this deficiency, the facility put the patients at risk for adverse outcomes when being exposed to expired equipment. Findings include: During observation of the Emergency Cart on 01/30/24 at 02:05 PM, five packets of IV Administration Sets were noted to have an expiration date of 08/20/23. Staff interview on 01/30/23 at 02:10 PM, Clinical Coordinator acknowledged that the five packets of IV Administration Sets previously mentioned should have been discarded. Review of policy on Emergency Medications, Equipment and Supplies read the following: Purpose; the purpose of this policy is to provide guidelines for staff when determining and maintaining emergency equipment and supplies. Responsibility; clinic manager or designee (as defined by job description, license, certification, State and Federal Regulation) ... Policy, the following minimum emergency supplies and equipment must be on the premises at all times, clean, functional, accessible and immediately available: Automated External Defibrillator (AED), Oxygen, tubing, and masks/cannulas, Emergency medications, Suction machine, disposable catheter, and canisters, Disposable Ambu Bag with face mask, IV solutions and administration sets, Cardiac back board, Oral airway, CPR pocket mask. Only staff properly in-serviced and trained on the use of all emergency equipment can use emergency equipment. Documentation of this training must be placed in the employee file. Emergency Cart; The medications and supplies outlined in this policy must be maintained at the facility for emergency use. The emergency cart must be: Locked when not in use, checked monthly or after use for contents, expiration dates, cleanliness and proper functioning of all equipment. Equipped with a dedicated oxygen tank. Staff must check the pressure gauge on the oxygen cylinder weekly. Replace the tank when the pressure gauge reaches 500 psi. The emergency cart should be located where it is readily accessible during medical emergency situations and shall NOT be blocked by wheelchairs, equipment, or other facility supplies. An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must me reordered and replaced prior to the actual expiration date ...”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 22063 Based on observations, record reviews, and interviews, the facility did not assure 2 of 24 patients (Patients 1 and 15) physician prescribed dialysis orders were followed. This deficient practice places patients at risk for not achieving or sustaining adequacy of dialysis. Findings include: 1) Patient (P)1 was admitted to the facility on 08/01/20. On 01/30/24 at 12:20 PM, P1 was interviewed. P1 reported coming to treatment once a week and eats whatever he wants. P1 clarified that he decided himself that he would do treatment once a week and does not adhere to diet restrictions because he controls the amount he eats and exercises. P1 further reported that he does restrict his fluids. P1 further explained treatment three times a week makes him feel weak. Inquired about his lab results, P1 responded he is prescribed insulin, however, his blood sugar levels are from 100 to 170. P1 stated he has been prescribed new medication to take, two pills with meals to clean out his system, however, medication makes him go to the bathroom so he quit taking it. Observed dialyzer was 180NRe, dialysis flow rate was 800, and blood flow rate was 350. Treatment was scheduled for 3-1/2 hours. Record review was done on 02/01/24 at 08:56 AM. P1’s dialysis order by the physician included a frequency of three times a week for 3-1/2 hours, 180NRe dialyzer, blood flow rate (BFR) of 350, and dialysate flow rate (DFR) of 800. Review of P1’s treatment records from 01/04/24 to 01/29/24 noted eight missed treatments and two incidences of patient’s request to terminate treatment before the prescribed treatment duration time. P1 was identified as “unstable”. Review of treatment records found discrepancy in the prescribed BFR of 350 and the average treatment BFR. The treatment record dated 01/09/24 noted in the post-dialysis vitals and evaluation section, an average BFR of 330. The treatment data noted a BFR of 300 at 12:14 PM and 12:34 PM. P1 was noted to discontinue his treatment after 1:48 hours. There was no documentation for delineation of the physician’s treatment order was found. Review of treatment record dated 01/16/24 noted in the post-dialysis vitals and evaluation section, BFR average was 300. The treatment time was 2:31. The treatment data noted the BFR was 300 at 11:33 AM, 12:06 PM, 12:33 PM, and 01:01 PM. There was no documentation of the reason for not implementing the physician’s order. Also noted no change in the physician’s prescribed order. On 02/02/24 at 10:15 AM an interview and concurrent review of P1’s treatment record was done with the Charge Nurse (CN). The BFR discrepancy for 01/09/24 and 01/16/24 were reviewed with CN. CN confirmed the BFR of 350 was not achieved and reported there were no notes in the treatment record to explain why the prescribed BFR was not attained. 2) P17 was admitted to the facility on 12/05/23. Review of the Electronic Health Records (EHR) was done on 02/01/23. P17’s dialysis orders per the attending nephrologist were a treatment time of 3-1/2 hours for three times a week frequency, Optiflux 180NRe dialyzer, BFR of 300 ml/min (milliliters per minute), and DFR of 1.5 times the BFR. Review of hemodialysis treatment records from 01/02/24 to 01/27/24 was done. Noted that the BFR for the treatment on 01/23/24 was set at 350 ml/min throughout the whole treatment. No documentation was found on the treatment sheet or progress notes in the EHR why the BFR was set at a higher rate than what was ordered. On 02/02/24 at 10:15 AM during an interview and concurrent record review with the CN, no other notes were found in the EHR why the BFR order was not followed for the 01/23/24 treatment. CN stated that the staff should be looking at the dialysis orders and make sure they are followed.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 38870 Based on record review and interview, the facility failed to provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/ hematocrit level and obtain orders for erythropoiesis stimulating agents (ESAs) for one patient (P)15. The deficient practices resulted in the patient having anemia (low hemoglobin levels). Findings include: Electronic medical record (EMR) for P24 reviewed on 02/02/2024 at 08:25 AM. 51-year-old male admitted on 11/02/2023. Primary diagnosis End stage renal disease (ESRD). Anemia/Hematology: Hemoglobin (HGB): 9.1 01/30/2024; 01/23/2024 HGB: 9.0; 01/16/2024 HGB 8.6; 01/09/2024 HGB 9.5; 01/04/2024 HGB 10.2; 12/26/2023 HGB 9.9 normal range is 14.0-18.0. Anemia Medication Administration: Iron Sucrose (Venofer) 01/30/2024: 50 milligrams, (mg); 01/27/2024: 100 mg; 01/25/2024: 100 mg; 01/23/2024: 100 mg; 01/23/2024: 100 mg. Noted P15 was not on ASE. HD adequacy is ok. Chairside adequacy is ok. Provider notes: Service Date; 01/09/2024 MD1 “I met face to face with the patient today. Overview: The patient presented with ESRD on dialysis. Primary cause of renal failure: Type 2 diabetes mellitus with diabetic chronic kidney disease. IDT notes: Admit date: 11/02/2023. Last plan of care meeting: 11/22/2023. Stable interval meeting 90 days. Next plan of care meeting on 02/20/2024. Plan of care Problem: Anemia Management. Lab test Ferritin, 272 Transferrin Sat (Calc) 29 HGB 9.1 on 01/23/2024. HGB 9.0 01/23/2024. HGB 8.6 01/16/2024. Drug: Iron Sucrose (Venofer), test Dose 50 mg intravenous push (IVP) once on 01/13/2024; 50 mg IVP one time per week on 01/30/2024. Goal: HGB 10-11 g/dl; due date: 01/31/2024. Interview with Registered Nurse (RN)4 on 02/02/2024 at 10:00 AM at the nurse’s station on Sun eight. When asked if he knew the reason why P15 didn’t come in to his scheduled dialysis appointment the previous day RN4 reviewed the EMR and confirmed that P24 didn’t come in yesterday for his scheduled treatment. RN4 then reviewed a notebook in the desk drawer and read a note, “P24 not coming for treatment and refused to reschedule. He had a doctor’s appointment”. When asked how the patient’s anemia is being managed? RN4 replied that P24 is on Iron, 50 mg. every two weeks and directed surveyor to the RN40 in charge of the anemia management who would have additional information. Interview with RN40 on 02/02/2024 at approximately 10:15 AM in her office and confirmed she does the anemia management for the patients and has recently returned from leave. Surveyor asked what is the best practice for anemia management and why hasn’t P24 been prescribed an ESA? RN 40 explained P15’s HGB goal is 10 to 11. He has been receiving only Venofer (iron) and will start Mircera (an ESA) tomorrow when he comes in for his Dialysis treatment. Plan of care dated 11/17/2023 reviewed on 02/02/2024 at 10:30 AM. Problem 1: Anemia Management. Goal: HGB 10 - 11 grams (gm) per deciliter (dl). Interventions: Evaluate vascular access plan if patient has a CVC Monitor HGB, Ferritin and T-Sat. Corporate MAB Recommended Anemia algorithm Mircera IVP Administration (In Center Only) Version reviewed at 10:40 AM. “Mircera is generally administered every two weeks or less frequently, and dosing is tied to the patient’s hemoglobin result. Mircera will be administered to all patients on the same dialysis day of the week, which is based on the facility weekly lab draw schedule. If Patient is new to Dialysis- starting dose chart: When TSAT is 20% or greater and Ferritin is 100 ng/mL or greater, or Patient has received a 1-gram iron sequence: If Hgb is less than 10.0: Administer Mircera per Starting Dose Chart.”

“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: 38870 Based on record review and interview, the facility’s medical director failed to ensure all policies and procedures relative to patient care and safety were followed by the nursing staff working in the facility. The licensed nurse (LN) failed to review the medical record or contact the family member for vaccination status for one patient (P)10 prior to administering a vaccine. The deficient practice resulted in P10 received the wrong dose of Covid 19 vaccine. Findings include: Intake information (From the aspen complaint tracking system ACTS 8873) reviewed on 01/30/2024 at 02:00 PM. Complainant reported concerns regarding care of her father at the facility, specifically that her father received an extra dose of a vaccine in spite of the facility being provided with a copy of his shot card. Telephone call to complainant to obtain additional information on 01/31/2024 at 02:45 PM, message left on Voicemail. No return call to surveyor. Medical Record reviewed on 02/01/2024 at 02:30 PM. P10 Expired: Cardiac arrest at Acute care facility. Patient admission services checklist indicated patient is able to sign his own consents. Medical history included acute renal failure (ARF): Ischemic nephropathy. Cardiomyopathy: Anemia of Chronic kidney disease and iron depletion. Reviewed the Fresenius Kidney care (FKC) Patient COVID-19 Vaccine Administration Record. Completed with Manufacturer, lot # Dosage and route (expiration date left blank. Left Deltoid, Person Administered and date 04/14/0221. Reviewed the Fresenius Kidney Care (FKC) Patient COVID-19 Vaccination Consent form. Patient’s name is list on the form, The Moderna vaccine is checked. Page 2 is dated Facility name and Signature of ill-legible signature with witness initial’s dated 04/14/2021. Interview with the Clinic Manager (CM) on 02/01/2024 at 03:33 PM to discuss the incident with the patient who received the extra vaccine dose. CM explained that there was a staff meeting with all of the staff. We were going to begin providing the COVID 19 vaccine in the clinic. We were very structured about the planning. Our charge nurse coordinated the effort to start vaccinating the patients when they came for their treatment. We had the meeting and identified the patients on the schedule, highlighted their names in pink who would get the vaccine. Once we got the orders from the physician (MD) and all of the consent forms completed, the patients who were on the schedule would get the vaccine when they came in to the center for their treatment. When P 10 came on his scheduled day, he had a “C” next to his name which meant “Catheter”, but the nurse thought it meant he would get the shot. The Nurse had P10 read and sign the consent form. After he received the dose of the COVID 19 vaccine, it was discovered that P10 had already received two doses of the vaccine and now received an extra “third” dose. The MD was notified of the incident and P10’s daughter (FM1). FM1 was very upset saying she had the power of attorney (POA) and should have been informed about her father getting the vaccine before he received it and that she should have signed the consent form. After he died later (for unrelated reasons), FM1 thought the vaccine dose may have caused it. Received and reviewed the Pneumococcal vaccine for adults (requested and received from the CM) on 02/01/2024 at 04:00 PM. Page 2, Vaccination Status: Source of Data “Review vaccination status of all new patients to the facility. Review the following sources for vaccination status: Medical records; discharge summaries...Speak with patient and/or family.””