Fmc - Indianapolis-North

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure emergency medications and supplies were checked for expiration dates and failed to complete their monthly itemized log per the facility policy for 1 In-Center and 1 Home Progam Emergency Carts observed. Findings include: 1. A review of a Fresenius Kidney Care policy dated 05/01/2023, titled “Emergency Medication, Equipment, and Supplies” indicated but was not limited to, “Emergency Cart ... The emergency cart must be: ... Checked monthly or after use for contents, expiration dates ... An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date ... “ 2. During the flash tour observation on 01/07/2025 at 10:50 AM, the in-center Emergency Cart contents were reviewed. The emergency Cart contained 2 vials of Diphenhydramine (a medication used in an emergency for an allergic reaction) 50 milligrams (mg) /1 milliliter (ml), 1 ml vial expired 12/2024, 8 vials of 23.4% Sodium Chloride 120 milliequivalents (mEq) /30 ml, 30 ml vials expired 12/2024. 3. A review of an agency document titled “ Emergency Code Cart, Medications and Machine Hand Crank Checklist” dated January 2024 through December 2024, indicated the Emergency cart audit had been completed by the Clinical Manager in December 2024. The audit indicated the Diphenhydramine 50 mg vials and the 23.4% Sodium Chloride 120 mEq /30 ml, 30 ml vials expired 12/2024. During an interview on 01/07/2025 at 10:55 AM, the Clinical Manager confirmed the 2 vials of Diphenhydramine 50mg/ml, and 8 vials of 23.4% Sodium Chloride 120 mEq/30 ml, 30 ml vials expired 12/2024. The Clinical Manager further indicated they had been aware of the expired medications and had told the nurses to remove them from the Emergency Code Cart. The Clinical Manager stated, “ I know. I should have taken them out. I am responsible.” 47343 4. The contents of the Emergency Cart, on the home dialysis side, where reviewed on 01/07/2024 at 3:44 PM. The Emergency Cart contained a Yankauer (an oral suctioning tool) and the tubing expired on 12/01/2024, two Sodium Chloride bags expired on 12/2024, a 20 gauge Autoguard winged needle expired 09/30/2024, and a 22 gauge Autoguard winged needle expired 08/31/2024. During an interview with RN 4 and RN 5 on 01/07/2025, they indicated they checked the code cart on 01/03/2025. They evidenced they checked the code cart monthly by verifying expiration dates and ensuring it contained all necessary supplies. RN 4 indicated the expired items found in the code cart should have been replaced.”

“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: 47343 Based on observation, record review, and interview the facility failed to demonstrate appropriate hand hygiene in 1 of 1 home dialysis program observations. (Employee: RN 5 ) Findings include: 1. A review of a Fresenius Kidney Care policy dated 11/06/2023, titled “Hand Hygiene,” indicated but was not limited to, “Purpose: The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross-contamination. Responsibility: All staff, patients ... Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content ... When ... Before and after direct contact with patients. Entering and leaving the treatment area ... Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications ... Hand Hygiene: Patients: Patients should perform hand hygiene if able, prior to and after each dialysis treatment ... “ 2. On 01/08/2025 at 9:02 AM, RN 5 was observed performing a routine checkup with Patient #17. RN 5 took the patient ’ s blood pressure, cleaned the blood pressure cuff, and donned gloves without performing hand hygiene. RN 5 stuck the patient ’ s right arm with a needle to draw labs and placed a gauze on the site after withdrawing the needle. RN 5 had Patient #17 hold the gauze over the needle site and did not offer gloves for the patient to wear to hold the site. After RN 5 placed a band-aid on the site, hand hygiene was not offered to the patient. The table was cleaned with bleach by RN 5, they doffed their gloves and reached into the cabinet to retrieve a clamp. Hand hygiene was not performed after doffing gloves. During an interview with RN 5 on 01/08/2025 at 10:15 AM, they indicated hand hygiene should be performed when gloves were removed. They indicated patients were to sanitize their hands after holding their access site.”

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure the proper storage of supplies in 3 of 3 observations. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 05/05/2021, 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. On 01/07/2025 at 8:45 AM, during the Flash Tour the following observations were made: An observation of a lab bag with a green top vacutainer and needle on top of the dialysis machine at Station #6. An observation of a swab, and blue connection wires on the wall unit shelf behind Station #7. An observation of a spray bottled label vinegar on the wall unit shelf behind Station #24. An observation of a box of Kleenex, and a spray bottled label alcohol on the wall unit shelf behind station #18. During an interview on 01/07/2025 at 1:20 PM, when queried about the supplies and items being on the dialysis machines and wall unit shelves, PCT 1 indicated the spray bottles should be back in the supply room and nothing is to be on the wall unit shelves or dialysis machines. 3. On 01/08/2025 at 10:40 AM, the following treatment floor observations were made: An observation of a tan arm cushion on the wall unit shelf behind Station #14. An observation of a pile of blue gloves and blue connection wires on the wall unit shelf behind Station #24. An observation of a pile of blue gloves and blue connection wires on the wall unit shelf behind Station #4. During an interview on 01/08/2025 at 3:20 PM, when queried about items on the wall unit shelves, the Clinical Manager confirmed the blue connection wires were extra connections for the dialysis machines that were on the wall unit shelves. The Clinical Manager further confirmed nothing was to be on the dialysis machines or wall unit surround shelf. 47343 4. On 01/07/2025 at 10:20 AM, the following treatment floor observations were made: An observation of a spray bottle with fluid liquid on the wall unit shelf behind Station #11. An observation of the equipment for initiation of dialysis including a Normal Saline bag, tubing, needles, and drapes was on top of the dialysis machine at Station #16. A blue connection wire was observed on the wall unit shelf behind Station #4. A blood pressure cuff was observed on top of the dialysis machine at Station #5. A bag with lab tubes and a vacutainer were observed on top of the dialysis machine at Station #6. 5. On 01/08/2025 at 10:36 AM, the following treatment floor observations were made: An observation of a glove, Normal Saline bag, tubing, and initiation supplies including needles and normal saline syringes were on the wall unit shelf behind Station#9 and Station #10. An observation of a glove box and a blue wedge were on the wall unit shelf in between Station #21 and Station #22. An observation of two glove boxes were on the wall unit shelf in between Stations #19 and #22. An observation of a tan arm cushion on the wall unit shelf behind Station #12. An observation of a Sodium Bicarbonate bag and a schedule were on the wall unit shelf in between Stations #5 and #6. 6. On 01/09/2025 at 11:40 AM, the following treatment floor observations were made: An observation of a glove box and a single glove were on the wall unit shelf in between Stations #9 and #10. 7. During an interview with RN 2 on 01/08/2025 at 3:35 PM, when queried regarding what things were allowed to be on top of the dialysis machine, they indicated they were “not really sure” and they at times place the caps and scissor clamps on the dialysis machine as well. 8. On 01/8/2025 at 12:15 PM, RN 2 was observed administering Zofran (a medication used to help with nausea) to Patient #11. RN 2 brought the syringe containing 2 Milliliters (ml) of Zofran and a 10 ml syringe of normal saline to Station #22 and placed the syringes on the top of the dialysis machine. During an interview on 01/08/2025 at 3:15 PM with the Administrator and the Director of Nursing (DON), the Administrator evidenced nothing was supposed to be on the top of the dialysis machines. During an interview with RN 2 on 01/08/2025 at 3:35 PM, when queried regarding what things were allowed to be on top of the dialysis machine, they indicated they were “not really sure” and they at times place the caps and scissor clamps on the dialysis machine as well.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to ensure the building was maintained to ensure the safety of patient and staff in 1 of 1 stand one dialysis treatment centers. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 04/05/2021, titled “Storage of Supplies” indicated but was not limited to, “ All clean or sterile supplies ... must be stored off the floor ...”. 2. A review of a Fresenius Kidney Care policy dated 07/06/2021, titled “Equipment Installation-Operation-Maintenance-Repair-And Disposal” indicated but was not limited to, “ ... Any equipment or device that is not fully functioning ... must be repaired or replaced as soon a reasonably possible ... Identified issues may include fluid leaks: nonfunctional, broken, or misadjusted parts and components; or aesthetic damages ... “ 3. On 01/07/2025 at 10:00 AM, during a flash tour the following water room observations were made: An observation of the water room plastic wrappers, piles of dirt, and debris under the grey pallet in the corner by the granulated concentrate. An observation of a white crystal substance surrounding the V-57 pump control, pipes, and halfway up the back wall of the 3K tank. During an interview on 01/08/2024 at 11:29 AM, PCT 1 confirmed there should not be trash and debris under the grey pallets. PCT 1 further indicated the pipes occasionally leak and the acid forms the crystals around the area from the tanks of the 3K. PCT 1 indicated they had to soak the floor and pipes with Reverse Osmosis (RO) water to get it to come off. 4. On 01/8/2025 at 2:12 PM, observed rusted door frame and the concrete floor was cracked and had a gravel appearance, at the back door of the stairway entrance to the supply room. During an interview on 01/08/2025 at 2:28 PM, the Area Technical Operations Manager (ATOM), indicated the concrete was cracked and door frame was rusted due to it is age and was worn out. 47343 5. On 01/07/2025 at 10:20 AM, an observation of the treatment room evidenced a white, crumpled piece of white trash on the floor in front of Station #11, a needle with a cover on it under the back right wheel of the chair at Station #12, and a white cloth in front of Station #13. 6. On 01/08/2025 at 10:36 AM, an observation of the treatment room evidenced a white, thin piece of trash and an alcohol swab wrapper in front of Station #13 ’ s dialysis machine. 7. On 01/08/2025 at 3:30 PM, an observation of the treatment room evidenced a glove, clear wrapper, and an alcohol pad next to the trash can in front of Station #12. An alcohol swab, white cap, and white piece of paper were next to the dialysis chair at Station #14. Station #4 had a wrapper from a Normal Saline syringe next to the chair. 8. During an interview with RN 2 on 01/08/2025 at 3:30 PM, they indicated the treatment area was to be kept clean and trash was to be picked up and thrown away.”

“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: 44232 Based on record review, and interview, the facility failed to ensure direct patient care staff monitored the patients during their dialysis treatment per the facility policy in 5 of 12 active records (Patients: #2, 6, 13, 20) and 1of 3 inactive records reviewed. (Patient: #10) 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 ... Report to the nurse: Systolic blood pressure greater than 180 mm/Hg. Diastolic blood pressure greater than 100 mm/Hg ... “ 2. A review of the medical record for Patient #2 contained treatment sheets from 12/10/2024 through 01/04/2025 evidenced the following: Treatment sheet dated 12/10/2024, a blood pressure, and pulse check at 11:07 AM by RN 1. PCT 7 completed the next blood pressure, and pulse check at 1:34 PM. Treatment sheet dated 12/12/2024, Intradialytic blood pressure readings: 222/121 at 10:53 AM, 196/114 at 11:30 AM, 216/114 at 12:04 PM, and 209/123 at 12:35 PM, documented by PCT 1 not reported to RN. RN 1 completed an assessment, blood pressure, and pulse check at 1:09 PM. Treatment sheet dated 12/21/2024, a blood pressure, and pulse check at 10:43 AM by RN 1. RN 1 completed a nursing evaluation, blood pressure, and pulse check at 11:22 AM. RN 1 completed a machine safety check at 11:40 AM. PCT 2 completed the next blood pressure, and pulse check at 12:06 PM. Treatment sheet dated 12/23/2024, Intradialytic blood pressure readings: 187/102 at 11:34 AM, 211/106 at 1:36 PM, and 182/103 at 2:03 PM, documented by PCT 10 not reported to RN. RN 6 completed an assessment, blood pressure, and pulse check at 1:02 PM. Treatment sheet dated 12/26/2024, Intradialytic blood pressure readings: 195/119 at 10:48 AM, 198/111 at 11:06 AM, 221/118 at 11:43 AM, 209/122 at 12:04 PM, 214/121 at 12:36 PM, 202/109 at 1:05 PM, and 200/116 at 1:30 PM, documented by PCT 9 not reported to RN. RN 2 completed an assessment, blood pressure, and pulse check at 3:08 PM. Treatment sheet dated 01/02/2025, a blood pressure, and pulse check at 10:34 AM by RN 6. PCT 10 completed the next blood pressure, and pulse check at 12:36 PM. During an interview on 01/09/2025 at 11:50 AM, when queried regarding the process of frequency and issues with blood pressures during safety checks and patient assessments, RN 1 and PCT 1 indicated the RN is to be notified if a systolic blood pressure is over 180 or a diastolic blood pressure is above 100. RN 1 and PCT 1 further indicated patient assessment, blood pressure, pulse, and machine checks are to be completed every 30-45 minutes. 3. A review of the medical record for Patient #13 contained treatment sheets from 12/11/2024 through 01/06/2025 evidenced the following: Treatment sheet dated 12/11/2024, a blood pressure, and pulse check at 5:36 PM by RN 7. RN 7 completed the next blood pressure, and pulse check at 6:36 PM. Treatment sheet dated 12/18/2024, a blood pressure, and pulse check at 3:10 PM by PCT 4. RN 7 completed the next blood pressure, and pulse check at 4:09 PM. Treatment sheet dated 12/24/2024, a blood pressure, and pulse check at 4:32 PM by PCT 12. RN 7 completed the next blood pressure, and pulse check at 5:33 PM. Treatment sheet dated 12/31/2024, a blood pressure, and pulse check at 5:32 PM by PCT 12. RN 7 completed the next blood pressure, and pulse check at 6:38 PM. 4. A review of the medical record for Patient #20 contained treatment sheets from 12/10/2024 through 01/07/2025 evidenced the following: Treatment sheet dated 12/21/2024, a blood pressure, and pulse check at 8:05 AM by RN 1. PCT 3 completed the next blood pressure, and pulse check at 9:05 AM. Treatment sheet dated 12/23/2024, a blood pressure, and pulse check at 8:40 AM by PCT 4. PCT 4 completed the next blood pressure, and pulse check at 9:42 AM. Treatment sheet dated 12/26/2024, a blood pressure, and pulse check at 6:34 AM by PCT 1. PCT 1 completed the next blood pressure, and pulse check at 7:34 AM. The next blood pressure, and pulse check was completed at 10:02 during discontinuation of dialysis treatment by PCT 1. During an interview on 01/09/2025 at 11:50 AM, when queried regarding the treatment safety checks during dialysis treatment, PCT 4 indicated machine and patient safety checks were to be completed every 30-45 minutes. PCT 4 when queried what they report to the RN, further indicated changes in the patient’s condition, blood pressures with systolic over 185, a diastolic over 100, or pulse over 100, were to be reported to the RN. 51279 5. A review of Patient #6’s medical record contained treatment sheets from 12/11/2024 through 1/6/2024, which evidence the following: The treatment sheet dated 12/20/2024, indicate RN 1 measured a blood pressure and pulse at 7:36 AM. At 8:31 AM, PCT 9 measured a blood pressure and pulse. The treatment sheet dated 12/22/2024, indicate RN 3 took a blood pressure and pulse at 5:38 AM. At 6:34 AM, RN 1 measured a blood pressure and pulse. The treatment sheet dated 12/24/2024, indicate RN 8 measured a blood pressure and pulse at 7:04 AM. At 8:06 AM, RN 8 measured a blood pressure and pulse. The treatment sheet dated 12/27/2024, indicate RN 8 measured a blood pressure and pulse at 7:06 AM. At 8:34 AM, PCT 9 measured a blood pressure and pulse. The treatment sheets dated 12/20/2024, 12/22/2024, 12/24/2024, and 12/27/2024 failed to evidence Patient #6’s blood pressure and pulse measurements every 30 minutes. 47343 6. A review of the medical record for Patient #14 contained treatment sheets from 12/11/2024 to 01/06/2025 evidenced the following: Treatment sheet dated 12/18/2024 evidenced safety checks were completed at 5:34 AM, 6:00 AM, 6:30 AM, 7:00 AM and 7:45 AM by PCT 3. The Blood Flow Rate (BFR) and Dialysis Flow Rate (DFR) were not verified at the 6:00 AM, 6:30 AM, and 7:00 AM safety checks. 7. A review of the inactive medical record for Patient #10 contained treatment sheets from 07/02/2024 to 07/23/2024 evidenced the following: Treatment sheet dated 07/02/2024 evidenced a blood pressure, pulse, BFR, DFR, and safety checks were completed at 10:04 AM by PCT 4. PCT 3 completed the next blood pressure, pulse, BFR, DFR, and safety check at 12:04 PM. Treatment sheet dated 07/06/2024 evidenced a blood pressure, pulse, BFR, DFR, and safety checks were completed at 9:32 AM by PCT 3. PCT 3 completed the next blood pressure, pulse, BFR, DFR, and safety check at 10:33 AM. PCT 11 completed the next BFR, DFR, and safety check at 12:13 PM. PCT 3 completed the next blood pressure and pulse check at 12:35 PM. Treatment sheet dated 07/09/2024 evidenced a blood pressure, pulse, BFR, DFR, and safety checks were completed at 10:38 AM by RN 7. PCT 4 completed the next blood pressure, pulse, BFR, DFR, and safety check at 11:38 AM. Treatment sheet dated 07/11/2024 evidenced a blood pressure, pulse, BFR, DFR, and safety checks were completed at 10:31 AM by RN 6. RN 1 completed the next blood pressure, pulse, BFR, DFR, and safety check at 12:04 PM. Treatment sheet dated 07/20/2024 evidenced the BFR, DFR, and safety checks were completed at 9:27 AM by PCT 3. The first blood pressure and pulse were taken in conjunction with verification of the BFR, DFR, and safety check at 11:32 AM by PCT 3. During an interview with PCT 1 on 01/09/2025 at 4:30 PM, they indicated safety checks were to be completed every 30 minutes to verify the patient ’ s blood pressure, conductivity, station, BFR, and the DFR.”