Fmc - Neomedica - Munster

“Policies/Procedures for Medical Documentation CFR(s): §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This Standard is not met as evidenced by: 51199 Based on observtion, record review, and interview, the dialysis facility failed to evidence their emergency prepardness plan included a system of medical documentation that secures and maintains availability of patient records. Findings include: A revised policy, dated 07/03/2023, titled “Guidelines For Emergency Preparedness” indicated that patient emergency information and contact lists should be created and locked in the emergency supply boxes or cart. During an observation on 04/15/2025, beginning at 11:40AM, a review of the dialysis facility emergency preparedness “kit” failed to evidence a current list of patients’ demographics, dialysis prescription, and emergency contacts. During an interview on 04/15/2025, begining at 11:40AM, the Administrative Assistant [AA] indicated that patient information was located in an emergency binder, was not kept in or near the emergency preparedness kit, and was updated quarterly. The AA was unable to locate the binder. During an interview on 04/15/2025, beginning at 11:41AM, RN 1 indicated that she was unsure where patient information for the emergency preparedness kit should be located or how often it should or was updated.”

“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: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure bleach water solution, minimize transmission of infectious agents, was covered with a lid when not in use, to reduce loss of efficacy, in 1 of 2 observations on the dialysis treatment floor. Findings include: 1. A revised policy, dated 02/03/2025, titled “Mixing Bleach” indicated that Bleach solutions must be made daily, labeled, and covered by a lid to prevent contamination. 2. During an observation period on 04/16/2025, from 2:40 PM-3:45 PM, a container of 1:100 bleach solution was left uncovered, with the lid on the counter beside the container, during the duration of the observation period 2:40 PM- 3:45 PM. 4. During an interview on 04/17/2025, beginning at 4:30 PM, RN3 indicated that bleach solutions on the treatment floor should be covered with a lid when not in use.”

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to have available an isolation room or a waiver of the requirement for an isolation for the treatment of HB’s Ag positive patients. Findings Include: 1. The Provider was initially built and certified prior to October 14, 2008. During a record review of the dialysis facility waivers and agreements, the Provider failed to evidence a CMS waiver of the requirement for an isolation room or area. 2. During an interview on 04/17/2025, beginning at 9:30AM, the Corporate Senior Regulatory Manager indicated that while the dialysis facility has agreements from other facilities to accommodate isolation needs, the dialysis facility does not have a CMS waiver for the requirement of an isolation room or area.”

“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: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure RN2 demonstrated aseptic techniques when dispensing and administering intravenous medications from vials in 1 of 2 observations of parenteral medication preparation and administration. Findings include: 1. A revised policy, dated 02/06/2025, titled, “Medication preparation and administration” indicated aseptic technique was to be used to prepare medications. The policy indicated medication vials were to be disinfected with an alcohol pad before each entry by a needle. 2. During an observation on 04/16/2025, beginning at 3:16PM, RN2 performed hand hygiene, removed protective top from medication vial, and failed to wipe the vial stopper with alcohol or any other disinfectant prior to withdrawing medication. 3. During an interview on 04/17/2025, beginning at 4:30PM, RN3 indicated that all medication vials should be disinfected with alcohol prior to withdrawing medication with a syringe.”

“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: 51199 Based on record review and interview, the dialysis facility failed to ensure PCT3 , PCT4, PCT5, and PCT6 administered the correct hemodialysis [HD] (a process to clean the blood of a patient whose kidneys do not work normally) prescription in 5 of 8 in center hemodialysis clinical record reviews. Findings include: 1. A revised policy, dated 02/06/2023 and titled “Pre-Treatment Safety Checks Procedure” indicated the clinician, initiating treatment, must verify the prescribed setup matches the patient. 2. A Treatment Flowsheet, dated 03/25/2025, for Patient #1 indicated the prescribed blood flow rate [BFR] was 400. PCT 4 charted a BFR of 450 at 7:08 AM, 7:38 AM, 8:07 AM, 8:32 AM, 9:02 AM, 9:40 AM, 10:06 AM, 10:36 AM, and 11:01 AM. 3. A Treatment Flowsheet, dated 04/01/2025, for Patient #2 indicated the prescribed BFR is 425. PCT 3 charted a BFR of 435 at 7:30 AM, 8:01 AM, 8:31 AM, 9:06 AM, 9:34 AM, and 10:08 AM. 4. A Treatment Flowsheet, dated 03/24/2025, for Patient #7 indicated the prescribed BFR is 415. PCT 5 charted a BFR of 450 at 3:01 AM, 3:35 PM, 4:04 PM, 4:33 PM, 5:01 PM, 5:31 PM, 6:06 PM, 6:35 PM, 7:03 PM, 7:32 PM, and 7:44 PM. 5. A Treatment Flowsheet, dated 04/16/2025, for Patient #19 indicated the prescribed BFR is 400. PCT 4 charted a BFR of 425 at 11:20 AM, 11:33 AM, 12:01 PM, 12:37 PM, 1:02 PM, 1:31 PM, 2:01 PM, 2:36 PM, 3:00 PM, and 3:30 PM. 6. A Treatment Flowsheet, dated 03/25/2025, for Patient #6 indicated the prescribed dialysis flow rate [DFR] is 800. PCT 6 charted a DFR of 500 at 9:32 AM, 10:08 AM, 10:32 AM, 11:01 AM, 11:33 AM, and 12:05 AM. 7. During an interview on 4/16/2025, beginning at 2:48 PM, RN 2 indicated that the RN may change the BFR higher to see how well a patient will tolerate it. 8. During an interview on 04/17/2025, beginning at 11:15 AM, The Medical Director indicated that RN’s do not have autonomy, nor is there a protocol, to increase a BFR without an order. 9. During an interview on 04/17/2025, beginning at 4:30 PM, RN3 indicated that occasionally, BFR’s may need to be decreased due to increased arterial pressure, but there would never be any reason that the BFR would be run higher than prescribed without a new order from MD.”

“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: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure appropriate vascular access care when PCT2 cleaned the arteriovenous fistula [AVF] (entry into the blood vessel for hemodialysis [HD])(a process to clean the blood of a patient whose kidneys do not work normally), then repalpated area prior to cannulation (needle insertion) in 2 of 2 AVF cannulations observed. Findings include: 1. A revised policy, dated 04/19/2024, titled “Assessment and Cannulation of AVF/AVG for Inpatient Setting” indicates that the needle insertion site should be disinfected, allowed to dry, and to not touch cannulations sites after skin disinfection. 2. During an observation on 04/15/2025, beginning at 11:05 AM, at Station #5, PCT2 disinfected the cannulation site of Patient 13, allowed it to dry, and then palpated the cannulation site and inserted the needle. 3. During an observation on 04/15/2025, beginning at 11:46 AM, at Station #6, PCT2 disinfected the cannulation site of Patient 14, allowed it to dry, and then palpated the cannulation site and inserted the needle. 4. During an interview on 04/17/2025, beginning at 4:30 PM, RN3 indicated that after disinfecting the cannulation site, needle insertion site should not be touched, and if repalpation is needed, then area should be cleansed again prior to needle insertion.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to maintain accurate records in 1 of 2 record reviews of in-center hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) who have central venous catheters [CVC] (catheter into a large vein). Findings include: 1. A Hospital Discharge Summary, dated 03/11/2025, for Patient #4, indicated that Patient #4 had been admitted for a HD catheter infection and had placement of a new CVC on 03/05/2025. 2. During a clinical record review on 04/17/2025, for Patient #4 the following documents indicated that Patient #4’s current dialysis access was a CVC catheter with an insertion date of 08/13/2019: A. A Treatment Run Sheet, dated 04/14/2025. B. A Treatment Run Sheet, dated 04/11/2025 C. A Treatment Run Sheet, dated 04/09/2025 D. A Treatment Run Sheet, dated 04/07/2025 E. A Treatment Run Sheet, dated 04/04/2025 F. A Treatment Run Sheet, dated 04/02/2025 G. A Treatment Run Sheet, dated 03/31/2025 H. A Treatment Run Sheet, dated 03/28/2025 I. A Treatment Run Sheet, dated 03/26/2025 J. A Treatment Run Sheet, dated 03/24/2025 K. A Basic Provider Note, dated 04/14/2025 L. A Comprehensive Provider Note, dated 04/02/2025 3. During an interview on 04/17/2025, the Clinical Manger indicated that staff was aware that the CVC dated 08/13/2019 had been removed and a new CVC had been placed.”