Fmc - Peru Dialysis

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to maintain a sanitary environment specific to the mixing and storage of bleach solution for 1 of 1 observation of bleach mixing and preparation, which had the potential to affect 40 active ICHD patients. Findings include: 1. The facility policy “Mixing Bleach”, dated 2/03/2025, indicated staff would prepare 1:100 concentration bleach by mixing 1 part bleach to 99 parts water. When mixing the bleach solution, staff should measure water and bleach to ensure proper concentration. 2. The facility policy “Cleaning and Disinfecting the Dialysis Station,” last updated 9/02/2025, indicated staff would store bleach solution in “covered opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air.” 3. During an observation on 9/12/2025 beginning at 3:20 AM, PCT 3 prepared a 1:100 concentration of bleach solution by following a recipe of 2,970 milliliters (mL) of water and 30 mL of bleach. When measuring 70 mL of water, PCT 3 used a large measuring cup with measurement markings beginning at 100 mL. After mixing the bleach solutions, PCT 3 transferred the solutions to three containers. One container with 1:10 bleach solution and one container with 1:100 bleach solution remained open with no lid until 4:00 AM, which was 40 minutes after the technician mixed and prepared the bleach solutions. During an interview on 9/12/2025 beginning at 7:55 AM, PCT 3 reported the measuring cup she used to measure 70 mL of water did not have a 70 mL line, so she would measure the water by going “right below” the 100 mL measuring mark. The technician stated staff were to store bleach solution in containers with the lid on.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all staff followed facility infection control policies and procedures for 4 of 4 PCTs observed performing care (PCT 1, PCT 2, PCT 3, PCT 4). Findings include: 1. The facility policy “Hand Hygiene”, last updated 11/06/2023, indicated staff should perform hand hygiene “before and after direct contact with patients ... before performing any invasive procedures such as vascular access cannulation ... immediately after removing gloves ... after contact with inanimate objects near the patients ... after contact with other objects within the patient station or treatment space ....” When staff washed their hands with soap and water, the duration of the procedure should be “40-60” seconds. 2. During an observation on the ICHD treatment floor on 9/12/2025 beginning at 5:17 AM, PCT 1 was treating Patient #8 in Station 1. The technician left Station 1, removed her gloves, and entered Station 8 to assist with machine setup procedures. The technician failed to perform hand hygiene after removing her gloves and prior to entering Station 8. During an interview on 9/12/2025 beginning at 8:39 AM, PCT 1 reported she would perform hand hygiene after removing gloves. 3. During an observation on the ICHD treatment floor on 9/12/2025 beginning at 5:37 AM, PCT 4 assisted Patient #23 into the treatment chair and moved their belongings. PCT 4 removed her gloves, left the station, and washed her hands for seven seconds. During an interview on 9/12/2025 beginning at 8:50 AM, PCT 4 reported she would perform hand hygiene after patient care. The technician stated she would wash her hands with soap and water for 60 seconds. 4. During an observation at Station 7 on 9/12/2025 beginning at 5:39 AM, PCT 3 donned gloves and began procedures to initiate Patient #9’s dialysis using a CVC. The technician failed to perform hand hygiene prior to donning gloves. During an interview on 9/12/2025 beginning at 7:55 AM, PCT 3 reported when initiating dialysis with a CVC, she would perform hand hygiene prior to donning gloves. 5. During an observation in PD Training Room 1 on 9/15/2025 beginning at 10:48 AM, PCT 4 drew Patient #6’s blood, removed her gloves, and washed her hands for 13 seconds. 6. During an observation at Station 6 on 9/15/2025 beginning at 1:56 PM, PCT 2 discontinued Patient #4’s dialysis using a CVC. The technician failed to perform hand hygiene prior to donning gloves on two occasions. During an interview on 9/15/2025 beginning at 2:45 PM, PCT 2 reported she would perform hand hygiene prior to donning gloves. 7. During an observation at Station 1 on 9/11/2025 beginning at 12:26 PM, PCT 1 discontinued Patient #7’s dialysis using a fistula. During the procedure, PCT 1 failed to perform hand hygiene prior to donning gloves on two occasions. 45607 During an interview on 09/15/2025 at 3:28 PM, PCT 1 indicated when discontinuing treatment for a patient with an arteriovenous fistula, a glove change should occur after disconnect before removing needles. PCT 1 also indicated she would perform hand hygiene after glove removal but not necessarily before putting on gloves.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff performed appropriate infection control measures specific to CVC care for 1 of 2 CVC exit site care observations (Patient #10) and 2 of 2 CVC discontinuation of dialysis with a CVC observations (Patient #4, 10). Findings include: 1. The “Changing the Catheter Dressing Procedure,” dated 5/02/2025, indicated when staff cleaned a CVC with Chloraprep (antiseptic solution comprised of 2% Chlorohexidine and 70% alcohol), they should “clean the exit site beginning in the center and continuing outward ... in a concentric circle ....” 2. During an observation at Station 4 on 9/12/2025 beginning at 5:59 AM, PCT 1 performed exit site care to Patient #4’s CVC. The technician scrubbed the site in a back-and forth motion, then placed the Chloraprep swab near the CVC insertion point and began to clean again, moving the swab from a “dirty” to “clean” area. While waiting for the Chloraprep to dry, Patient’s shirt moved and lay on the clean area near the insertion point. PCT 1 failed to re-clean the site prior to applying a new dressing. During an interview on 9/12/2025 beginning at 8:39 AM, PCT 1 reported she would clean a CVC site with Chloraprep by scrubbing around the site in a back-and-forth motion, flipping the Chloraprep swab to the other side, then scrubbing from near the insertion point to the outside in a circular motion. During an interview on 09/15/2025 at 3:28 PM, PCT 1 indicated she would have to reclean the CVC exit site if the patient’s clothes touched the site after it had been cleaned. 3. During an observation at Station 6 on 9/15/2025 beginning at 1:56 PM, PCT 2 discontinued Patient #4’s dialysis from their CVC. The technician failed to place a clean barrier pad under the CVC prior to disconnecting Patient from dialysis. During an interview on 9/15/2025 beginning at 2:45 PM, PCT 2 reported she would change the barrier pad prior to discontinuing a patient’s dialysis from their CVC. 4. During an observation at Station 4 on 9/15/2025 beginning at 9:57 AM, PCT 1 discontinued Patient #10’s dialysis from their CVC. The technician failed to place a clean barrier pad under the CVC prior to disconnecting Patient from dialysis. 45607 During an interview on 09/15/2025 at 3:28 PM, PCT 1 indicated she would not change the barrier pad prior to discontinuing a patient’s dialysis from their CVC unless it was visibly soiled.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 45607 Based on record review and interview, the dialysis facility failed to ensure the patient’s plan of care was updated to address goals not being met for 1 of 4 ICHD patient records reviewed (Patient #1). Findings include: 1.The facility policy “Comprehensive Interdisciplinary Assessment and Plan of Care”, last revised 07/03/2023, indicated “ ... If the patient specific expected outcome as determined by the attending physician, IDT and patient for the Plan of Care is not achieved within the identified timeframe ... the Interdisciplinary team must adjust the patient’s Plan of Care and document changes made to the POC ...” 2. Review of Patient #1’s clinical record included a plan of care dated 01/24/2025 which included a dialysis adequacy goal of spKt/V greater than or equal to 1.4 with a note indicating Patient signed off against medical advice every treatment; continue to encourage Patient to stay for prescribed treatment time. The plan of care included the interventions of change blood flow rate and refer to vascular access center or surgeon. The plan of care included an update by RN 1 on 04/30/2025 which indicated Patient #1 had not met their goal for Kt/V since December of 2024. The update also included the Patient signed off early every treatment stating they have lower back pain preventing them from staying the full treatment. Patient #1’s spKt/V for 06/16/2025 through 09/05/2025 were all under the goal of 1.4. The plan of care failed to include progress updates and changes in interventions for the plan of care adequacy goal. The plan of care included a goal for pain assessment of Patient will verbalize decreased pain levels with an intervention of continuing to monitor Patient. The plan of care failed to include any updates related to the pain assessment goal despite pain being cited as a reason for poor adequacy. The plan of care included a goal for dialysis access of no catheter with a note by RN 1 which indicated Patient refuses permanent access placement with interventions refer to vascular access center, educate Patient on benefits and risks of access types, and educate Patient on care of access. A provider note from 09/03/2025 indicated Patient #1 had vein mapping and needed to go back to have upper arm access. The plan of care failed to include updates regarding permanent access placement. 3. During an interview on 09/16/2025 at 1:15 PM, RN 2 indicated she updates the plan of care by putting in what they’ve done in the past month and what they’re planning to do. RN 2 indicated Patient now had a permanent access, and that should help with adequacy. RN 2 indicated staff couldn’t get Patient #1 to stay on treatment longer due to their back pain and indicated she didn’t think anything was being done by the facility to address the Patient’s back pain other than to offer Tylenol, an over-the-counter medication used to treat mild pain and fever, at treatment. RN 2 indicated she didn’t see that the plan of care had been updated to reflect the information she mentioned.”

“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: 45607 Based on observation, record review and interview, the medical director failed to ensure staff followed policies and procedures specific to performing standing blood pressures for 1 of 4 ICHD patient record reviews (Patient #1), and cleansing and assessing patients’ fistula sites prior to cannulation for 2 of 2 fistula access observations (Patient #8, 16). Findings include: 1. The facility policy “Determination of Blood Pressure”, last revised 02/07/2022, indicated “ ... Incenter patients ... Obtain blood pressure readings pre- and post-dialysis sitting and standing (if applicable) ...” 2. The facility policy “Access Assessment and Cannulation”, last revised 05/05/2025, indicated when staff were asessing an arteriovenous fistula or graft, staff should “... LISTEN ... Staff/patients/care partners who have been trained to auscultate vascular accesses should listen with a stethoscope to the entire length of the access for changes in the sound of the bruit - a normal low-pitched bruit should be present ... FEEL ....” After assessing the site, the policy indicated staff should clean the site with a 70% alcohol pad “in a concentric circle for 30 seconds” prior to cannulating (inserting dialysis needles into a fistula or graft). Staff were not to touch the cannulation sites after disinfection with alcohol. 3. Review of Patient #1’s clinical record included six treatment sheets dated 08/29/2025 to 09/10/2025. The treatment sheets failed to include pre-treatment or post-treatment standing blood pressures for Patient #1. The treatment sheets each indicated “Cannot Assess” where the standing blood pressures should have been recorded. Each treatment sheet indicated Patient #1 “Ambulates w/assistive device” in the RN assessment. The dialysis facility failed to ensure Patient #1’s pre-treatment and post-treatment standing blood pressures were performed. During an interview on 09/15/2025 at 2:48 PM, PCT 2 indicated standing blood pressures should be performed for ambulatory patients at the beginning and end of every treatment, and the systolic blood pressure should be greater than 100 before the patient walks out. PCT 2 also indicated Patient #1 refuses standing blood pressures, and she would chart that as patient refused standing blood pressure and the RN notified. During an interview on 09/15/2025 at 3:25 PM, PCT 1 indicated Patient #1 refuses standing blood pressures, and that should be documented as RN notified and then as a manual record in the treatment or in a multidisciplinary note. During an interview on 09/15/2025 at 2:53 PM, PCT 3 indicated Patient #1 refuses standing blood pressures, and she thinks she documents that in the multidisciplinary notes. During an interview on 09/16/2025 at 1:15 PM, RN 2 indicated standing blood pressures should be taken for ambulatory patients at the beginning of treatment when they walk in and at the end of treatment after taking a sitting blood pressure. RN 2 indicated Patient #1 refuses standing blood pressures citing back pain. RN 2 indicated the treatment sheets from 08/29/2025 through 09/10/2025 only said cannot assess as the reason for not having standing blood pressures. RN 2 indicated she guessed they needed to be charting that he refused. 42617 4. During an observation at Station 1 on 9/12/2025 beginning at 5:20 AM, PCT 1 failed to evaluate Patient #8’s fistula site by listening to the access with a stethoscope prior to cannulation. PCT 1 cleaned the first cannulation site for 19 seconds and the second cannulation site for 17 seconds with a 70% alcohol swab. 5. During an observation at Station 2 on 9/15/2025 beginning at 10:19 AM, PCT 1 failed to evaluate Patient #16’s fistula site by listening to the access with a stethoscope prior to cannulation. PCT 1 cleaned the first cannulation site for 20 seconds with a 70% alcohol pad, palpated the site, then cannulated. The technician cleaned the second cannulation site for 20 seconds with a 70% alcohol pad. 6. During an interview on 9/12/2025 beginning at 8:39 AM, PCT 1 reported she would clean a fistula or graft access site with alcohol for 30 seconds. 7. During an interview on 09/15/2025 at 3:28 PM, PCT 1 reported she did not routinely evaluate a fistula or graft by listening with a stethoscope, and she would only perform this assessment if she was unable to palpate the fistula or graft. 8. During an interview on 9/15/2025 beginning at 3:19 PM, Medical Director reported staff should obtain a standing blood pressure on patients at the end of treatment and should assess a fistula or graft site by auscultating the site at every ICHD treatment.”