Fmc - Nephrology - Goshen

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 42617 Based on personnel file review, EP plan and training review, and interview, the dialysis facility failed to develop and maintain an EP training program for new staff for 2 of 2 personnel files reviewed of PCTs hired in 2024 (PCT 4, PCT 5), which had the potential to affect 47 active patients and all employees. Findings include: 1. The facility policy “Guidelines for Emergency Preparedness,” dated 9/02/2025, indicated staff would be trained “on emergency disaster preparedness such as fire drills, emergency disconnection and emergency evacuation.” 2. The facility’s Hazard Vulnerability Assessment, completed on 1/21/2025 by FA and Corporate Employee 1, indicated emergency events the facility was vulnerable to included but were not limited to “Ice Storm ... Earthquake ... Blizzard ... Water Interruption ... Hazardous Material Spill ... Terrorism Act ... Active Shooter ... Nuclear Plant Accident ... Civil Disturbance ... Pandemic ... Cyberterrorism/Ransomware ....” 3. Review of facility online EP training, identified by FA and CM on 11/25/2025 as EP training all staff received upon hire, failed to evidence education on facility EP policies and procedures for all emergency events the facility identified as a vulnerability. 4. PCT 4’s personnel file indicated a hire date of 7/22/2024. The file failed to evidence the technician received education on facility policies and procedures for all emergency events which the facility had identified as a vulnerability. 5. PCT 5’s personnel file indicated a hire date of 8/19/2024. The file failed to evidence the technician received education on facility policies and procedures for all emergency events which the facility had identified as a vulnerability. 6. During an interview on 11/25/2025 beginning at 3:07 PM, CM and FA reported EP training staff received on hire consisted of the online EP training video and a check-off where staff identified emergency equipment in the facility. CM and FA reported the staff did not receive any further EP training on-hire.”

“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 ensure bleach solution was stored in an opaque container for 1 of 2 days of ICHD observations, failed to ensure all dialysis clamps were cleaned according to facility policy and best practice for 1 of 1 observations of dialysis clamp cleaning, and failed to ensure all reusable equipment was cleaned in between patients for 1 of 2 days of ICHD observations, which had the potential to affect 47 active patients. Findings include: 1. The facility policy “Cleaning and Disinfecting the Dialysis Station,” dated 09/02/2025, indicated the plastic pressure and hemostat clamps should be disinfected in an “opaque pastic container filled with 1:100 bleach solution.” The clamps must be “ ... completely submerged, unclamped, and in an open position.” The policy also indicated bleach solution was to be stored in “opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air.” 2. The facility policy “General Cleanliness and Infection Control Guidelines,” dated 09/02/2025, indicated non-critical medical equipment must be disinfected with 1:100 bleach solution after each use. 3. During an observation on 11/24/2025 at 10:42 AM, one large container of 1:100 bleach solution was observed on a cart by Stations 12 and 13. The container was not opaque. During an interview on 11/24/2025 beginning at 4:42 PM, CM reported bleach solution should be stored in an opaque container. During an interview on 11/25/2025 beginning at 6:03 PM, Corporate Employee 1, a biomed technician, reported bleach solution was not to be stored in the non-opaque container. 44714 4. During an observation on 11/21/2025 at 03:58 PM, observed a stack of clamps on an absorbent pad on the counter of a dirty sink. The sink lacked a splash guard to protect the clamps from splashes from the sink. At the side of the dirty sink, used clamps were soaking in the bleach disinfecting solution. There were clamps sticking up out of the disinfecting solution. During an interview on 11/21/2025 beginning at 03:58 PM, PCT 1 indicated the clamps on the pad were clean and were air drying. When asked, PCT 1 indicated they were allowed to keep the clamps on the side of the dirty sink. When asked about the clamps soaking in the bleach solution, they indicated they swished the clamps around in the container so all the clamps would be covered under the bleach solution. During an interview on 11/25/2025 beginning at 10:02 AM, the CM indicated the clamps were at risk of contamination by splashes from the dirty sink. 5. During a floor observation on 11/24/25 beginning at 12:00 PM, observed 3 patients enter the treatment area and take their temperature with the same thermometer. No one disinfected the thermometer between patients. During an interview on 11/25/2025 beginning at 10:02 AM, the CM indicated the thermometer should be cleaned after every use.”

“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: 44714 Based on observation, policy review, and interview, the facility failed to ensure treatment staff performed hand hygiene according to facility policy and best practice for 1 of 2 observations of fistula cannulation (Patient #17), 2 of 3 observations of a nurse administering medications (Patient #7, #9), and 2 of 2 observations of PCTs drawing up Heparin (Patient #11, #12). Findings include: 1. The facility policy “Hand Hygiene,” dated 11/06/2023, identified hand hygiene procedures. The policy identified when hand hygiene was required as “Before and after direct contact with patients ... Before ... vascular access cannulation ... Immediately after removing gloves ...” and “ ... after contact with objects near the patient ....” 2. The facility policy “Access Assessment and Cannulation,” dated 05/05/2025, provided instructions for the assessment of the dialysis access. The instructions included look, listen, and feel of the access site. The step following the “feel” step, the policy stated, “Remove gloves and perform hand hygiene. Don new gloves.” According to the policy, the next steps included disinfecting the access site and then inserting the needles. 3. During a treatment floor observation on 11/21/2025 at 09:52 AM, PCT 6 assessed Patient #17’s access site by palpation (feel or touch). After palpation, PCT 6 applied antiseptic to the access site and inserted the needles, with no hand hygiene and glove change after palpation. During an interview on 11/24/2025 at 03:08 PM, PCT 6 explained the steps for cannulation. PCT 6 included hand hygiene and new gloves after palpation of the site. PCT 6 said they did not realize they failed to perform hand hygiene after palpation. During an interview on 11/25/2025 beginning at 10:02 AM, the CM indicated hand hygiene and glove change were required after palpation of the access site. 42617 4. During an observation on 11/24/2025 beginning at 11:02 AM, RN 3 took a medicine cup and handed it to Patient #9 in Station 23. The nurse then took a medicine cup to Patient #7 in Station 25. The nurse failed to change gloves and perform hand hygiene in between patients. During an interview on 11/24/2025 beginning at 4:25 PM, RN 3 reported she should perform hand hygiene prior to every “patient interaction.” 5. During an observation on 11/24/2025 beginning at 12:20 PM, PCT 3 was at a supply station drawing up Heparin (a blood thinner administered intravenously). PCT 3 then entered Station 24, donned gloves, and began providing care to Patient #12. The technician failed to perform hand hygiene upon entering the station and prior to donning gloves. During an interview on 11/24/2025 beginning at 3:37 PM, PCT 3 reported she should perform hand hygiene prior to providing care to patients and prior to donning gloves. 6. During an observation on 11/24/2025 beginning at 12:29 PM, PCT 6 was observed at a supply station drawing up Heparin. PCT 3 then entered Station 12, donned gloves, and began providing care to Patient #11. The technician failed to perform hand hygiene upon entering the station and prior to donning gloves. During an interview on 11/24/2025 beginning at 3:00 PM, PCT 6 reported she should perform hand hygiene prior to donning gloves.”

“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: 44714 Based on observation, record review, and interview, the facility failed to ensure treatment staff disinfected dialysis chairs according to policy for 1 of 2 dialysis station cleaning observations. Findings include: 1. The facility policy, “Cleaning and Disinfecting the Dialysis Station,” dated 09/02/2025, included the process for disinfection of the patient treatment area. Instructions for disinfecting the chair included opening the swing open side panels. The instructions included the direction to use wet cloths to “ ... Make the surfaces glisteningly wet and allow to air dry ....” 2. During a treatment floor observation on 11/21/2025 at 10:15 AM, PCT 3 cleaned patient station 14. PCT 3 opened the side panels and cleaned with disinfectant solution. PCT 3 immediately closed the side panels and failed to allow them to dry. 3. During an interview on 11/25/2025 beginning at 10:02 AM, CM indicated the proper disinfection process for the chair included making sure it was glistening wet and allowed to air dry. CM indicated the chair sides should remain open until dry. 42617 4. During an interview on 11/24/2025 beginning at 3:37 PM, PCT 3 reported after cleaning, the sides of the chair should be left open to dry.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all staff followed aseptic technique when drawing up and administering IV medications for 2 of 2 observations of IV medication preparation and administration (Patient #10, #11). Findings include: 1. The facility policy “Medication Preparation and Administration,” dated 7/07/2025, indicated staff should perform hand hygiene “prior to ... administering medications.” When drawing up medication from a multi-dose vial, staff should “cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol.” 2. During an observation on 11/24/2025 beginning at 11:36 AM, RN 3 donned gloves and entered Station 15 with oral and IV medications for Patient #10. RN 3 handed Patient a medicine cup with the oral medication then injected Venofer (an IV medication used to treat anemia). RN 3 failed to change gloves and perform hand hygiene in between patient contact and administering the IV medication. During an interview on 11/24/2025 beginning at 3:30 PM, RN 3 reported she should change gloves and perform hand hygiene prior to administering an IV medication. 3. During an observation on 11/24/2025 beginning at 12:29 PM, PCT 6 was drawing up Heparin (a blood thinner given intravenously) at a supply station for Patient #11. The technician failed to disinfect the diaphragm of a multi-dose Heparin vial prior to drawing up the medication. During an interview on 11/24/2025 beginning at 3:00 PM, PCT 6 reported the stopper of a multi-dose Heparin vial should be cleaned with alcohol prior to drawing up the medication.”

“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 facility failed to ensure all staff wore personal protective equipment (PPE) and disinfected the catheter hubs according to facility policy for 1 of 2 observations of CVC care (Patient #11) and 2 of 2 observations of disconnection from dialysis with a CVC (Patient #4, #5). Findings include: 1. The facility policy “Changing the Catheter Dressing Procedure,” dated 5/02/2025, indicated staff should wear “Full PPE” and a face mask during CVC care. 2. The facility policy “Termination of Treatment Using a Central Venous Catheters ...,” dated 11/04/2024, indicated staff wear a mask during termination procedures. The policy indicated when disinfecting the catheter hubs, staff should “Scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue ... (This step should take 10-15 seconds).” 3. During an observation on 11/24/2025 beginning at 11:50 AM, PCT 5 was performing CVC site care to Patient #11’s CVC. RN 3 entered the station and spoke with Patient during the procedure. The nurse failed to wear a mask nor eye protection during the procedure. During an interview on 11/24/2025 beginning at 3:30 PM, RN 3 reported she should wear a mask during CVC care procedures. The nurse reported she should wear eye protection when there was potential for exposure to bodily fluids. 4. During an observation on 11/24/2025 beginning at 4:26 PM, PCT 7 was disconnecting Patient #5 from dialysis using their CVC. PCT 6 entered the station and began removing Patient’s bloodlines. PCT 6 failed to wear a mask during the procedure. During an interview on 11/24/2025 beginning at 4:47 PM, PCT 6 reported she should wear a mask during CVC disconnection procedures. 44714 5. During an observation on the treatment floor on 11/21/2025 at 04:16 PM, observed PCT 5 terminate treatment with a CVC with Patient #4. PCT 5 scrubbed each CVC hub for 6 seconds. During an interview on 11/21/2025 at 04:38 PM, PCT 5 indicated they scrubbed each hub for 30 seconds. When asked PCT 5 indicated they counted the seconds by saying “one Mississippi, two Mississippi 3 Mississippi, [etc] ....” PCT 5 indicated they were not aware the scrubs were so short.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 44714 Based on observation, record review, and interview, the facility failed to ensure patients’ access sites always remained visible for 2 of 2 ICHD treatment floor observation days (Patient #2, #16, #19). Findings include: 1. The facility policy “Patient Assessment and Monitoring,” dated 05/01/2023, indicated the patient “ ... access site must remain uncovered throughout the treatment.” 2. During a treatment floor observation on 11/21/2025 at 09:48 AM, Patient #19’s access site was covered with a blanket. Patient #2’s access site was covered completely with a blanket. During an interview on 11/21/2025 at 9:48 AM, PCT 4 was asked to observe Patient #19’s access site. PCT 4 walked to the side of Patient #19’s chair and indicated the blanket obstructed the view of the access site. PCT 4 checked on Patient #2 and indicated their access site was completely covered and not visible. PCT 4 indicated one should be able to see the patients’ access sites from their work area, in the center of their treatment pod. During an interview on 11/25/2025 starting at 10:02 AM, CM indicated the patients’ access sites should be visible from the staff supply and working area. 42617 3. During an observation at Station 17 on 11/24/2025 at 10:39 AM, Patient #16’s access was covered with a blanket and not visible. Patient’s access remained covered and not visible until 11:44 AM, at which time Patient’s treatment ended. Staff failed to advise Patient to keep their access site visible throughout the dialysis treatment. During an interview on 11/24/2025 beginning at 3:25 PM, PCT 4 reported staff should check for patient access visibility “at least” every 30 minutes. During an interview on 11/24/2025 beginning at 3:30 PM, RN 3 reported staff should check for patient access visibility every 30 minutes. The nurse also stated she was “always scanning” the treatment floor to check for any issues. RN 3 stated if a patient’s access site was not visible, staff should uncover the site. During an interview on 11/24/2025 beginning at 3:37 PM, PCT 3 reported patients were to keep their access site visible at all times. The technician stated staff should be checking to ensure the access site was visible every 30 minutes.”

“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: 44714 Based on record review and interview, the facility failed to develop a QAPI program that recognized, measured, and analyzed all access site infections for 1 of 1 record reviewed which evidenced an access site infection (Patient #3). Findings include: 1. The facility policy “Quality Assessment and Performance Improvement Program,” dated 11/04/2024, indicated the policy was “... designed and implemented to objectively, systematically, and comprehensively monitor, evaluate, and improve the quality and safety of patient care ....” The policy indicated QAPI elements to be reviewed included “infection surveillance.” 42617 2. Patient #3’s clinical record evidenced on 5/28/2025, MD noted Patient had been recently hospitalized and was found to have corynebacterium (a bacteria) in his/her fistula site. Patient was started on an oral antibiotic. 3. Review of QAPI meeting notes for the months January 2025 through September 2025, failed to evidence discussion regarding Patient #3’s access site infection. 4. During an interview on 11/25/2025 beginning at 4:30 PM, CM and FA reported there was no documentation Patient #3’s access site infection was discussed during QAPI meetings.”

“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: 42617 Based on record review and interview, the MD failed to ensure all staff followed policies and procedures specific to obtaining and documenting vital signs and access checks during treatment, reporting abnormal vital signs during treatment to the nurse, and reporting post-treatment weights above the ordered Estimated Dry Weight (EDW) to the MD for 2 of 5 clinical records reviewed (Patient #3, 4). Findings include: 1. The facility policy “Patient Assessment and Monitoring,” dated 5/01/2023, indicated during treatment, staff were to obtain the patients’ blood pressure and heart rate as well as document “machine parameters and safety checks every 30 [minutes] ... not to exceed 45 minutes.” Staff were to report a heart rate less than 60 to the RN. 2. The facility policy “Nursing Supervision and Delegation,” dated 11/06/2023, indicated daily treatment records were to be reviewed for “whether patient is achieving dry weight and identifying reason for patient not achieving dry weight.” 3. Patient #3’s clinical record evidenced an ordered Estimated Dry Weight (EDW, a physician-ordered weight the patient is to achieve by the end of the dialysis treatment) of 73.0 kilograms (kg). Nine treatment flowsheets between 11/03/2025 - 11/21/2025 evidenced the following: a. On 11/03/2025, Patient had six recorded heart rates between 45-58. The record failed to evidence the PCTs notified the RN of the low HRs. b. On 11/05/2025, Patient had one heart rate of 58 during treatment. The record failed to evidence the PCTs notified the RN of the low HR. Patient’s post-treatment weight was 75.5 kg, which was 2.5 kg above Patient’s EDW. The record failed to evidence the RN noted the reason Patient was above their EDW nor notified MD of Patient’s post-treatment weight. c. On 11/07/2025, staff failed to document vital signs and access site checks were performed between 7:31 AM - 8:36 AM, which was 1 hour and 6 minutes between checks. d. On 11/12/2025, Patient had one heart rate of 55 during treatment. The record failed to evidence the PCTs notified the RN of the low HR. e. On 11/14/2025, Patient’s EDW was increased to 74.0 kg. On 11/17/2025, Patient had one heart rate of 58 during treatment. The record failed to evidence the PCTs notified the RN of the low HR. Patient’s post-treatment weight was 75.8 kg, which was 1.8 kg above Patient’s EDW. The record failed to evidence the RN noted the reason Patient was above their EDW nor notified MD of Patient’s post-treatment weight. f. On 11/19/2025, staff failed to document vital signs and access checks were performed between 6:33 AM - 7:35 AM and 9:31 AM - 10:29 AM, which was 62 minutes and 68 minutes between these checks, respectively. Patient’s post-treatment weight was 75.4 kg, which was 1.4 kg above Patient’s EDW. The record failed to evidence the RN noted the reason Patient was above their EDW nor notified MD of Patient’s post-treatment weight. g. On 11/21/2025, Patient had six heart rates between 47-59 during treatment. The record failed to evidence the PCTs notified the RN of the low HRs. During an interview on 11/24/2025 beginning at 3:25 PM, PCT 4 stated she should report a patient’s heart rate that was less than 60 to the nurse. PCT 4 stated this should be documented in the clinical record. During an interview on 11/24/2025 beginning at 3:30 PM, RN 3 stated she should report a patient’s post-treatment weight 1.0 kg or more above the EDW to the MD. During an interview on 11/25/2025 beginning at 2:36 PM, CM and FA reported staff should be performing and documenting vital signs and access checks every 30 minutes, but should not go past 45 minutes between checks, and PCTs should report a heart rate less than 60 to the RN. The administrative staff stated the RN should report a post-treatment weight 1.0 kg or above the patient’s EDW to MD.”