Fmc - Shadeland Station

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(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:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[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. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 47343 Based on record review and interview, the facility failed to ensure they had a current list of all patient prescriptions and contact information for 2 of 2 Emergency Evacuation box reviewed on the incenter treatment floor. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 08/02/2017 titled “Emergency and Disaster Responsibility Guidelines” indicated but was not limited to, “ ... Maintain current listings of patients and staff including local contact, emergency contact and evacuation contact information ...” 2. A review of the Emergency Evacuation box on 03/10/2025 at 9:40 AM, on the incenter treatment floor in front of Stations #1-12, evidenced patient contact information dated 01/27/2025. The facility failed to ensure the patient information was up-to-date. 3. A review of the Emergency Evacuation box on 03/10/2025 at 9:46 AM, on the incenter treatment floor next to Stations #13 - 24, evidenced patient contact information dated 01/27/2025. The facility failed to ensure the patient information was up-to-date. 4. During an interview with the Clinical Manager (CM) on 03/10/2025 at 9:46 AM, they indicated the Administrative Assistant reviewed the Emergency Evacuation box monthly and was supposed to update the patient information monthly. 5. During an interview with the Administrative Assistant on 03/10/2025 at 10:15 AM, they indicated they checked the Emergency Evacuation box monthly to ensure everything was updated.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility 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. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 51279 Based on observation, record review, and interview, the facility failed to ensure all expired emergency medication and supplies were removed for 2 of 2 Emergency Evacuation box reviewed on the incenter treatment floor. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 02/03/2025 titled “Emergency Medications, Equipment and Supplies” indicated but was not limited to, “ ... An emergency evacuation box must ... Be checked monthly or after use for contents, expiration dates ...” 2. A review of a Fresenius Kidney Care document located in the emergency preparedness tote dated 2025 titled “Evacuation Box Checklist” indicated but was not limited to, “ ... Nitrile Gloves (L) 2 boxes in Jan and 1 box in Feb ...” The document failed to evidence the expiration date of 1 box of size large non-sterile exam gloves, and the presence and expiration date of 1 box of size medium non-sterile exam gloves, 1 box of small non-sterile exam gloves, and 2 AV Fistula 16 G x 1” needle sets. 3. During a flash tour of the facility on 03/10/2025 at 9:46 AM, the following observations were made: An observation of the emergency preparedness tote on the left side of the treatment room floor, with Stations #13 - 24, evidenced 1 box of size small non-sterile exam gloves with an expiration date of 08/2022, 1 box of size medium non-sterile exam gloves with an expiration date of 07/2022, 1 box of size large non-sterile exam gloves with an expiration date of 05/2022, 2 - AV Fistula (Arteriovenous Fistula, connection between an artery and vein used for dialysis) 15 G x 1” Needle Sets. 47343 4. During the flash tour of the facility on 03/10/2025 at 9:40 AM, the Emergency Evacuation box in the treatment room, on the side with Stations #1-12, evidenced a box of small gloves and a box of medium gloves with an expiration date of 03/2023 and a box of large gloves with an expiration date of 01/2023. A review of the “Evacuation Box Checklist” evidenced 1 box of gloves was accounted for in January and February. The checklist failed to include the expiration dates for the exam gloves. 5. During an interview with the Clinical Manager on 03/10/2025 at 9:46 AM, when queried regarding the Emergency Evacuation box, they indicated the Administrative Assistant was in charge of the Emergency Evacuation box and checked it monthly. They explained the Administrative Assistant only included how many gloves were in the tote and not the date of their expiration. The Clinical Manager confirmed the fistulas and the gloves were not removed when they expired. 6. During an interview with the Administrative Assistant on 03/10/2025 at 10:15 AM, they indicated they checked the Emergency Evacuation box monthly using the checklist to determine if any of the supplies need updating and remove the expired items and items about to expire.”

“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: 47343 Based on observation, record review, and interview, the facility failed to ensure the proper storage of supplies for 4 of 4 observations of the treatment room dialysis machines and wall boxes. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 11/04/2024, titled “General Cleanliness and Infection Control Guidelines,” indicated but was not limited to, “ ... The purpose of this policy is to provide guidance for the FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors ... Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station ... “ 2. During the flash tour on 03/10/2025 at 9:40 AM, the following treatment floor observations were made: An observation between Stations 7 and 8 evidenced a box of extra-large gloves on the wall box. An observation between Stations 3 and 4 evidenced a box of small gloves, tissue box, and at least three loose gloves on the wall box. An observation between Stations 23 and 24 evidenced a single glove on the wall box. An observation between Stations 15 and 16 evidenced a box of small gloves and an analog clock on the wall box. 3. An observation of the wall box in between Stations 11 and 12 evidenced a sign evidencing the following direction, “DO NOT PLACE ANY ITEMS ON BACK COUNTER”. 4. On 03/10/2025 at 11:24 AM, the following treatment floor observations were made: An observation of Station 8 evidenced a blue pad on top of the dialysis machine. An observation between Stations 6 and 7 evidenced an arm rest on the wall box. 5. On 03/10/2025 at 3:10 PM, the following treatment floor observations were made: An observation at Station 10 evidenced a patient’s large grocery bag behind the chair, on the wall box. An observation at Station 10 evidenced a blue pad on top of the dialysis machine. An observation at Station 12 evidenced a blue pad on top of the dialysis machine. 6. On 03/11/2025 at 10:20 AM, the following treatment floor observations were made: An observation between Stations 3 and 4 evidenced a tissue box on the wall box. An observation between Stations 5 and 6 evidenced a tissue box on the wall box. An observation at Station 9 evidenced a patient’s bag behind the chair on the wall box. An observation between Stations 9 and 10 evidenced a box of gloves on the wall box. During an interview with PCT 3 on 03/10/2025 at 3:55 PM, they indicated nothing was supposed to be on the wall boxes or the dialysis machines. During an interview on 03/11/2025 at 3:15 PM, PCT 7 indicated nothing should be placed on the wall box. 7. During an interview with the Area Technician Operations Manager, CM, and the Director of Operations on 03/12/2025 at 1:41 PM, they explained nothing was supposed to be on the wall boxes or dialysis machines.”

“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: 47343 Based on observations, record review, and interviews, the facility failed to ensure all expired medications and supplies were removed from 1 of 1 standalone dialysis facilities. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 02/06/2023 titled “Medication Preparation and Administration” indicated but was not limited to, “ ... Monitoring Expired Medications: Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded ...” 2. A review of a Fresenius Kidney Care policy dated 04/05/2021 titled “Storage of Supplies” indicated but was not limited to, “ ... Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired ...” 3. On 03/10/2025 11:39 AM, the following treatment floor observations were made: An observation of a drawer labeled “17 G (sic gauge) in the storage unit in front of Stations #1-12 evidenced six 15 G hemodialysis arteriovenous (AV) fistula needles (a needle inserted into a surgically connected vein and artery to remove waste and excess fluids when the kidneys no longer function appropriately) with an expiration date of 06/30/2024, one 14 G AV needle set with an expiration date of 07/2018, and six 17 G needle sets with clamps with an expiration date of 10/23/2024. During an interview with the CM on 03/10/2025 at 12:20 PM, they indicated the PCTs restocked the supplies daily and where to remove any expired items. 51279 4. A review of an undated facility document titled, “2024 Emergency Med Box,” indicated by was not limited to, the medication box check in July evidence 4 vials of Solu-Medrol with an expiration date of 10/2024. The document failed to evidence the medication box was checked since September of 2024. 5. During a flash tour of the facility on 03/10/2025 the following observations were made: An observation of the emergency medications on the ICHD treatment floor evidenced 4 - Solu Medrol 40 mg (milligram, measurement of mass in the metric system, one thousandths of a gram) vials with an expiration date of 10/2024. During an interview on 03/10/2025 at 10:09 AM, the CM indicated they were responsible for checking the emergency medication and should have completed the check prior to going on vacation.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 51279 Based on record review and interview, the facility failed to ensure direct patient care staff monitored the patients during their dialysis treatment in 6 of 6 active clinical records reviewed with patients receiving ICHD. (Patients #: 1, 10, 11, 12, 13, and 30) Findings Include: 1. A review of a Fresenius Kidney Care policy dated 05/01/2023, titled “Patient Assessment and Monitoring” indicated but was not limited to “The purpose of this policy is to provide guidance ... direct care staff on assessment and monitoring patients before, during and after treatment ... During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes ...” 2. A review of Patient #7’s active medical record contained treatment sheets from 02/18/2025 through 03/08/2025, which evidence the following: The treatment sheet dated 02/18/2025, indicate PCT 3 measured a blood pressure and pulse, and performed a safety check at 9:34 AM. At 10:35 AM, PCT 3 measured a blood pressure and pulse, and performed a safety check. The treatment sheet dated 03/01/2025, indicate PCT 1 measured a blood pressure and pulse and performed a safety check at 9:30 AM. At 10:30 AM, PCT 3 measured a blood pressure and pulse, and performed a safety check. The treatment sheet dated 03/08/2025, indicate PCT 3 measured a blood pressure and pulse, and performed a safety check at 8:13 AM. At 9:00 AM, PCT 8 measured a blood pressure and pulse, and performed a safety check. The treatment sheets dated 02/18/2025, 03/01/2025, and 03/08/2025 failed to evidence Patient #7’s blood pressure and pulse measurements and safety checks were performed every 30 minutes. 3. A review of Patient #10’s active medical record contained treatment sheets from 02/15/2025 through 03/08/2025, which evidence the following: The treatment sheet dated 03/04/2025, indicate PCT 9 measured a blood pressure and pulse, and performed a safety check at 5:53 AM. At 6:59 AM, PCT 9 measured a blood pressure and pulse, and performed a safety check. The treatment sheet dated 03/04/2025 failed to evidence Patient #10’s blood pressure and pulse measurements and safety checks were performed every 30 minutes. 4. A review of Patient #11’s active medical record contained treatment sheets from 02/18/2025 through 03/08/2025, which evidence the following: The treatment sheet dated 02/15/2025, indicate PCT 10 measured a blood pressure and pulse, and performed a safety check at 4:02 PM. At 4:30 PM, PCT 8 performed a safety check. At 4:49 PM, PCT 8 measured a blood pressure and pulse. The treatment sheet dated 02/22/2025, indicate PCT 8 measured a blood pressure and pulse, and performed a safety check at11:23 AM. At 12:12 PM, RN 6 measured a blood pressure and pulse, and performed a safety check. The treatment sheet dated 03/04/2025, indicate RN 1 measured a blood pressure and pulse, and performed a safety check at 11:39 AM. At 12:19 PM, PCT 9 performed a safety check. At 12:32 PM, PCT 9 measured a blood pressure and pulse, and performed a safety check. At 2:00 PM, PCT 9 measured a blood pressure and pulse, and performed a safety check. At 3:03 PM, PCT 2 measured a blood pressure and pulse, and performed a safety check. The treatment sheet dated 03/08/2025, indicate PCT 9 measured a blood pressure and pulse, and performed a safety check at 12:00 PM. At 12:30 PM, PCT 9 performed a safety check. At 1:02 PM, PCT 9 measured a blood pressure and pulse, and performed a safety check. The treatment sheets dated 02/12/2025, 02/22/2025, 03/04/2025, and 03/08/2025 failed to evidence Patient #11’s blood pressure and pulse measurements and safety checks were performed every 30 minutes. 5. A review of Patient #13’s active medical record contained treatment sheets from 02/13/2025 through 03/08/2025, which evidence the following: The treatment sheet dated 03/04/2025, indicate PCT 3 measured a blood pressure and pulse, and performed a safety check at 8:02 AM. At 9:02 AM, PCT 3 measured a blood pressure and pulse, and performed a safety check. The treatment sheet dated 03/04/2025 failed to evidence Patient #13’s blood pressure and pulse measurements and safety checks were performed every 30 minutes. During an interview on 03/10/2025 at 3:20 PM, RN 1 indicated patients are monitored before treatment starts, during treatment, and after treatment. When queried about the frequency of monitoring during treatment, RN 1 indicated patients should be monitored every 30 minutes during treatment. During an interview on 03/11/2025 at 3:15 PM, PCT 7 indicated patients should be monitored every 30 minutes. 47343 6. A review of Patient #12’s clinical record contained treatment sheets from 02/03/2025 through 03/03/2025 evidenced the following: The treatment sheet dated 03/03/2025 evidenced a blood pressure check was completed at 2:00 PM by PCT 4. PCT 5 completed a blood pressure check at 3:05 PM. The treatment sheet dated 02/28/2025 evidenced the Blood Flow Rate (BFR) and Dialysis Flow Rate (DFR) was completed at 2:01 PM by RN 7. The next BFR and DFR were completed at 2:52 PM by PCT 8. The BFR and DFR were completed at 4:07 PM by PCT 8 and was not checked for the remainder of the treatment, the treatment ended at 5:08 PM. The treatment sheet dated 02/24/2025 evidenced the blood pressure, BFR, DFR, and safety checks were completed at 3:36 PM by PCT 4, then checked by PCT 5 at 4:31 PM. The treatment sheet dated 02/12/2025 evidenced the treatment started at 1:11 PM and the first time the BFR and DFR were completed at 2:05 PM by PCT 3. The BFR and DFR were checked at 3:09 PM by RN 6 and again at 4:02 PM by PCT 3. The blood pressure was checked at 3:30 PM by RN 6 and was checked again at 4:32 PM by RN 6. The treatment sheet dated 02/03/2025 evidenced the blood pressure, BFR, DFR, and safety checks were completed at 1:32 PM by PCT 3. The next BFR, DFR, and safety checks were completed at 3:34 PM. The next blood pressure check was completed at 3:49 PM by PCT 3. 7. A review of Patient #30’s clinical record contained treatment sheets from 02/15/2025 through 03/08/2025 evidenced the following: The treatment sheet dated 03/06/2025 evidenced the BFR and DFR were completed at 9:31 AM by PCT 9 and again at 10:23 AM by PCT 2. The treatment sheet dated 03/04/2025 evidenced the blood pressure was checked at 6:00 AM by PCT 2 and again at 7:02 AM. The BFR and DFR were checked at 6:09 AM by PCT 2 and again at 6:58 AM by PCT 9. The blood pressure was checked at 8:03 AM by PCT 9 and again at 9:03 AM. The treatment sheet dated 02/27/2025 evidenced the BFR and DFR were checked at 6:04 AM and again at 7:00 AM by PCT 2. The blood pressure was completed at 9:00 AM and again at 10:03 AM by PCT 2. The treatment sheet dated 02/25/2025 evidenced the BFR and DFR were checked at 8:31 AM by RN 6 and again at 9:33 AM by PCT 7. The treatment sheet dated 02/20/2025 evidenced the BFR and DFR were checked at 9:31 AM by RN 6 and again at 10:30 AM by PCT 2. The treatment sheet dated 02/20/2025 evidenced the BFR and DFR were checked at 9:03 AM and again at 10:30 AM by PCT 3. 8. During an interview with PCT 1 on 03/10/2025 at 3:17 PM, they indicated they were to verify the dialysis machine was running as ordered by the dialysis prescription, run the patient’s blood pressure, and perform safety checks every 30 minutes. 9. During an interview with PCT 4 on 03/11/2025 at 10:49 AM, they indicated they were to perform safety checks, take a blood pressure, and verify the prescription on the dialysis machine every half hour. 10. During an interview with the CM on 03/12/2025 at 1:41 PM, they indicated the clinicians performed safety checks, blood pressures, and verified treatment orders every 30 to 45 minutes.”