Fmc Omak Dialysis Center

“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: 22198 Based on observation, interview, and policy review, the facility failed to ensure that for one of two observation days on blood pressure (BP) cuffs dedicated to a dialysis station were clean or disinfected prior to taking them out of one station and into another dialysis station. This has the potential for cross contamination and could affect all 55 in-center dialysis patients. Findings include: During an observation on 01/06/25 at 11:53 AM Patient Care Technician (PCT) 1 was observed initiating dialysis at dialysis Station #17, while taking patient (P) 2’s BP, PCT1 realized it was the wrong size causing an incorrect reading. Wearing the same gloves, PCT1 left dialysis Station #17 walked over to dialysis Station #16 that was empty, picked up the BP cuff and realized it was not the correct size and placed it back into the basket on the side of dialysis Station #16. Continuing looking for a BP cuff for P2 wearing the same gloves PCT1 walked in dialysis Station #12 that was evidently not cleaned (empty supply wraps and BP cuff attached to the dialysis machine were laying on the chair) picked up the BP cuff that was in the dialysis machine basket and took it into Station #17 and used it on P2 without cleaning the BP cuff. During an interview on 01/07/25 10:40 AM, PCT1 was asked about cleaning BP cuffs in the dialysis machine basket, and PCT1 stated, he/she thought the extra BP cuff stored on the dialysis machines only needed to be cleaned if they were used. Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, revealed, “The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day, and it is critical that these items be thoroughly cleaned and disinfected between uses. Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease. ... Definition Dialysis Station: Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment, patient training, and/or patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: o Dialysis machine cycler and attachments such as IV [intravenous] pole, BP cuff and ...The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station.””

“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: 22198 Based on observation, interviews and policy review, the facility failed to ensure staff maintained a separation between clean and dirty area/supplies for one of two dialysis treatment area observation days. This failure had the potential for contaminating clean patient supplies and could affect all 55 in-center dialysis patients. Findings include: During an observation on 01/07/25 at 11:15 AM Patient Care Technician (PCT) 1 and PCT3 were using a Hoyer lift to get patient (P) 9 from a wheelchair into the dialysis chair at dialysis Station #9, PCT1 removed the blanket and pillow from P9’s lap and set it on the clean supply counter that contained the prepared clean and sterile dialysis supplies for the day (dialyzers, needles, 2x2 gauze pads, etc. ...) At 11:40 AM, after dialysis treatment was started for P9, PCT1 turned around and removed P9’s pillow and blanket from the clean supply counter and gave it to P9. During an interview on 01/07/25 at 11:40 AM, PCT1 was asked if the countertop was a clean or dirty space. PCT1 confirmed the countertop was a clean space. PCT1 was asked in patient’s personal belonging were clean or dirty, PCT1 replied “dirty” PCT1 was asked if the patient’s personal belongings should be placed on a clean countertop, PCT1 stated “probably not”. Review of the facility’s policy titled, “General Cleanliness and Infection Control Guidelines,” dated 11/04/24, revealed, “The purpose of this policy is to provide guidance for FKC [Fresenius Kidney Care] staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors.” This policy did not clarify the separation of clean and dirty. The reference in the policy as follows: “Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station. Clean supplies may not be kept under dirty sinks.” During an interview on 01/08/25 at 7:45 AM the Clinical Manager/Facility Administrator was asked if the facility had a policy for the separation of clean and dirty? The Clinical Manager/Facility Administrator confirmed he/she could not find any other policy. The Clinical Manager/Facility Administrator confirmed that patient’s personal belonging should not be placed on the clean supply counters.”

“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: 22198 Based on observations, interviews and policy review, the facility failed to ensure that staff followed the procedures for cleaning and disinfecting the dialysis machine after patient use for two of two dialysis machine cleaning observations (Stations #2 and #6). This failure has the potential for cross contamination and could negatively affect all 55 in-center dialysis patients. Findings include: During an observation on 01/06/25 at 10:39 AM, during Patient Care Technician (PCT) 2 was observed cleaning and disinfecting dialysis Station #2, in the dialysis machine side basket there was a second blood pressure (BP) cuff, which was not cleaned with the dialysis station. During an interview on 01/06/25 at 10:39 AM, PCT2 was asked if all equipment in dialysis Station #2 should be cleaned as a part of the dialysis station and pointed out the additional BP cuff in the dialysis machine basket, and PCT2 stated yes, the additional BP cuff in the dialysis machine basket should be cleaned as a part of the dialysis machine cleaning. During an observation on 01/07/25 at 10:40 AM, PCT1 was observed cleaning and disinfecting dialysis Station #6, in the dialysis machine side basket there were two additional BP cuffs, which were not cleaned with the dialysis station. During an interview on 01/07/25 10:40 AM, PCT1 was asked if all equipment in dialysis Station #6 should be cleaned as a part of the dialysis station and pointed out the two additional BP cuffs in the dialysis machine basket, and PCT1 stated, he/she thought the extra BP cuff stored on the dialysis machines only needed to be cleaned if they were used. PCT1 left dialysis Station #6 without cleaning the two additional BP cuffs and returned to start setting up the dialysis machine for the next patient. During an interview on 01/07/24 at 11:50 AM the Clinical Manager/Facility Administrator confirmed that if there were additional BP cuffs on a dialysis machine, they should be cleaned between patients. Review of the facility’s policy titled “Cleaning and Disinfecting the Dialysis Station” dated 09/05/23 revealed, “The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day, and it is critical that these items be thoroughly cleaned and disinfected between uses. Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease. ... Definition Dialysis Station: Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment, patient training, and/or patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: o Dialysis machine cycler and attachments such as IV [intravenous] pole, BP cuff and ...””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 22198 Based on medical record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for one of five sampled in-center dialysis patients (P) (P3) in a total universe sample of nine. Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact on the effectiveness of the prescribed dialysis treatments for all 55 patients receiving in-center dialysis treatments at this facility. Findings include: A review of P3’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) of 500 milliliters per minute (ml/min). A review of two of six “Treatment Sheet” from 12/09/24 through 01/06/25, in the EMR indicated the following: a. On 12/09/23, the BFR was documented at 385 ml/min from 12:23 PM until 12:48 PM. b. On 01/06/25, the BFR was 300 ml/min from 11:18 AM until 12:04 PM. The BFR was documented at 440 ml/min from 12:04 PM for the remainder of the treatment at 3:21 PM. There was no documented rationale for the change to the prescribed BFR. During an interview on 01/08/25 at 8:00 AM the Clinical Manager/Facility Administrator confirmed the BFR for P3 was documented and not run as prescribed on 12/09/24 and 01/06/25, and the staff failed to document rationale for the change to the physician’s prescription. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Check machine settings and measurements: Check prescribed blood flow [BFR] is being achieved or reason is documented in medical record if unable to meet prescribed blood flow.””

“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: 22198 Based on observations, interviews and policy review, the facility failed to ensure that two of two staff (Registered Nurse (RN) 2 and Patient Care Technician (PCT) 3) confirmed that hemostasis had been achieved and the bandaged were changed prior to patients (P) (P1 and P8) left the facility. Failure to change the pressure dressing and confirm that hemostasis was achieved puts all arteriovenous fistula (AVF) and arteriovenous graft (AVG) patients at risk for bleeding post dialysis after leaving the facility. Findings include: During an observation on 01/06/25 at 10:32 AM RN2 after removing the clamps placed over the pressure dressing where the needles were removed on P1, RN2 applied another folded gauze pad and additional tape without assessing if hemostasis had been achieved or applying clean new dressing over the needled insertion sites. During an interview on 01/06/25 at 10:32 AM RN2 stated “I should have checked the insertion sites and changed the dressing, but the patient (P1) doesn’t like to wait.” During an observation on 01/06/25 at 11:25 AM PCT3 was observed during AVF discontinuation for P8 after 10 minutes of P8 holding pressure to achieve hemostasis, checked the lower insertion site, and blood squirted out onto PCT3’s gown sleeve, gloves and front of the gown. PCT3 reapplied a pressure dressing and left the floor to change bloody gown and gloves. PCT3 returned to the floor within five minutes, applied a second gauze and additional tape without checking to see if hemostasis had been achieved. PCT3 did not or applying clean new dressing over the needled insertion sites. During an interview on 01/06/25 at 11:25 AM PCT3 confirmed that he/she did not re-check the site for the P8 and had just added extra gauze and tape. PCT3 confirmed the needle insertion site should have been checked to ensure the bleeding had stopped and then re-dressed with clean dressing before P8 left. During an interview on 01/07/25 at 3:00 PM after reviewing the facility policy, the Clinical Manager/Facility Administrator confirmed the staff should be assessing hemostasis and apply a clean dressing after hemostasis was achieved. Review of the facility’s policy titled, “Post Treatment Fistula Needle Removal,” dated 07/01/24, revealed, “Once hemostasis is achieved: Remove the gauze. Apply antibiotic cream if ordered by a physician. Place Band-Aid, adhesive dressing or gauze dressing secured with clean tape. ... Confirm the presence of a thrill after hemostasis is achieved.””

“H-PT/CAREGIVER DEMO COMPREHEND TRAINING CFR(s): 494.100(b)(1) The dialysis facility must - (1) Document in the medical record that the patient, the caregiver, or both received and demonstrated adequate comprehension of the training; This Standard is not met as evidenced by: 22198 Based on reviews of medical records, email and policy and interview, the facility failed to ensure that Home Training was completed for one of two Home Peritoneal Dialysis (PD) patients (Patient (P)7). This failure put all five Home PD patients at risk of not having complete and accurate training to verify they are competent to perform PD at home safely and effectively. Findings include: Review of P7’s medical record revealed that the Home Training “Readiness Assessment” used to verify P7 had received training and was capable to performing the Home PD tasks safely was dated on 11/03/22. Review of the assessment indicated P7 and facility staff including the Medical Director signed off P7 as competent to perform home PD however for 11 of 34 tasks on the “Readiness Assessment.” were documented as “not yet completed” During an interview of 01/07/25 at 8:00 AM during a review of the incomplete Home PD training for P7, the Clinical Manager/Facility Administrator confirmed that P7 was signed off as ready to perform Home PD, but the training was not complete. During an interview on 01/07/25 at 4:00 PM, Clinical Manager/Facility Administrator confirmed there was no additional training documented to ensure P6 had completed the entire “Home Training Program.” Clinical Manager/Facility Administrator stated that PD Home Training Registered Nurse (RN) 1 had sent an email confirming this information. Review of the email sent by PD Home Training RN1 dated 01/07/25 at 1:13 PM revealed “There is no more available documentation to me to Support P7’s training being further completed than what I submitted.” During a review of the facility’s policy titled “Home Dialysis Patient Education and Training” dated 02/06/23 revealed, “At the completion of the training program: The patient and/or care partner(s) must successfully demonstrate competency in clinical and technical procedures and self-care management. The qualified home therapies nurse must validate the patient and/or care partner competency including evaluating comprehension and skills. These requirements must be met prior to the patient care partner(s) being deemed competent to perform home dialysis independently. ... Documentation: Training treatments will be documented in the medical record. Training of required material must be documented in the patient medical record and must include evidence of patient/care partner(s) demonstrated comprehension and competence in performing the home dialysis procedures.””