Fmc New Castle

“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: 44230 Based on observation, record review, and interview, the facility failed to ensure proper disinfection of the dialysis station preventing the spread of bloodborne pathogens in 1 of 2 Cleaning and Disinfection of the Dialysis Stations observations. (Station #7) Findings Include: 1. A policy titled, “General Cleanliness and Infection Control Guidelines” indicated but was not limited to, “All non-disposable containers, baskets, pails, etc., that are to be reused and have a reasonable likelihood of becoming contaminated, must be inspected, and disinfected on a regularly scheduled basis”. 2. During an observation on 10/25/2024 at 10:35 AM, PCT 4 disinfected the dialysis station chair and hemodialysis machine using bleach except for the prime container. PCT 4 removed the prime container, emptied it in the dirty sink, then replaced it back on the dialysis machine without disinfecting it. PCT 4 proceeded to string the hemodialysis machine with new lines for the next patient. 3. During an interview on 10/25/2024 at 10:55 AM, PCT 4 indicated that the prime bucket should be emptied before starting disinfection of the dialysis station. PCT 4 further indicated that the prime bucket is to be disinfected along with the entire station, chair, machine, blood pressure cuffs, wall box) prior to prepping the station for the next patient.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 44230 Based on record review and interview the agency failed to ensure Hepatitis B status was obtained prior to admission to the facility in 1 of 2 new admissions reviewed. (Patient #4) Findings Include: 1. A policy titled, “Patient Hepatitis B Testing Requirements” indicated but was not limited to, “The CDC recommends the following tests: 1) Hepatitis B surface antigen (HBsAg) 2) Hepatitis B surface antibody (anti-HBs) 3) Hepatitis B core antibody “total” (anti-HBc) ... HBV status should be know prior to admission for all new patients. To be admitted to a facility, FKC requires a new patient have at a minimum a, Hepatitis B surface antigen (HBsAg) result within 30 days prior to the admission date. If Hepatitis B surface antibody (anti-HBs), and Hepatitis B core “total” (anti-HBc “total”) are not available prior to admission, obtain a physician order to immediately draw blood specimens and submit for testing. Anti-HBs and anti-HBc “total” results must be available within 7 days of admission”. 2. A document titled, “Plan of Care” indicated an admission date of 07/31/2024 for Patient #4, a new admit. 3. An untitled document for Patient #4 indicated the following Hepatitis B lab results: Antigen—non-reactive and Antibody--<3.5 on 07/23/2024. The facility failed to obtain a Hepatitis B core antibody “total” (anti-HBc) prior to admission the facility. 4. During an interview on 10/30/2024 the CM indicated that policy indicates that an antigen and antibody are required to be obtained prior to admission, not the core antibody “total” (anti-HBc). The CM further indicated having problems with laboratories/hospitals not drawing the core when requested.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 44230 Based on record review and interview the facility failed to ensure the second Tuberculosis skin test was completed upon hire for 1 of 3 employees reviewed. (PCT 1) Findings Include: 1. A policy titled, “Employee Tuberculosis Testing” indicated but was not limited to, “TB testing using the two-step tuberculin skin test (TST) method is required upon hire”. 2. A document titled “Employee Tuberculosis Skin Test Administration Record” for PCT 1 indicated the initial test dose was administered on 04/08/2020 with a negative result confirmed on 04/10/2020. The facility failed to obtain the second TST. 3. A personnel document provided by the facility indicated that PCT 1 was hired on 04/07/2020. 4. During an interview on 10/28/2024 at 2:39 PM, the Clinic Manager indicated that all new employees should receive a two-step tuberculosis screening and is unsure why PCT 1 did not.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 44230 Based on record review and interview the agency failed to ensure the patient hematologic status were addressed to meet anemia needs in 1 of 5 anemia patients reviewed. (Patient #1) Findings Include: 1. A document titled, “Mircera Algorithm InCenter 4.0 Quick Reference Guide” indicated but was not limited to, “Spectra Hemoglobin to be drawn weekly ... Post-hospitalization: Draw first treatment back to facility and then follow weekly Hgb lab draw schedule”. 2. A policy titled, “Corportate MAB Recommended Anemia Algorithm Mircera IVP Administration (In Center Only) Version 4.0” indicated but was not limited to, “Post hospitalization patient: Draw Spectra Hgb [Hemoglobin] first treatment back to facility and then follow weekly Hgb lab draw schedule ... Hospitalization of any period of time or misses a Mircera dose for more than 7 days ... If a patient is hospitalized for any period of time or has an absence of more than 7 days ... Discontinue Mircera dose ... Following return from hospitalization or absence complete the Absence and Hospitalization Assessment ... Draw and obtain Spectra Hgb result ... Select the dose using the Maintenance Dose Chart and administer the dose following the Lab Draw/Dose Administration Schedule”. 3. A document titled, “Lab Results/medication Administration Summary” indicated the following Hemoglobin labs: 09/16/2024 Hemoglobin of 13.1, 09/23/2024 Hemoglobin of 11.2, 09/30/2024 Hemoglobin of 10.1, 10/18/2024 Hemoglobin of 9.0, 10/21/2024 Hemoglobin of 9.1. 4. A document titled “Patient Transfer” indicated a physician order for Mircera (medication used to treat anemia) 75 milligrams Intravenous Push (IVP) during dialysis every 4 weeks. Start date was 10/04/2024. 5. During an interview on 10/30/2024 at 10:21 AM, the CM indicated that Patient #1 had been hospitalized from 10/04/2024-10/16/2024. A Hemoglobin was drawn on 10/18/2024 upon returning from the hospital. A 10/4/2024 order for Mircera 75 micrograms had not been administered to date. The CM was indicated waiting to obtain hospitalization records to see if any Erythropoietin Stimulating Agent (ESA) had been administered during his/her hospital stay. The CM acknowledged that 14 days has since passed since discharge and Patient #1’s hemoglobin continues to rapidly fall with no intervention to date. The CM further explained having a very difficult time obtaining records from hospitals when requested, however she was able to pull up the Electronic Medical Record (EMR) for the hospital for Patient #1 to review with surveyor. No documentation was found in the discharge summary indicating Patient #1 received an ESA during his/her hospitalization. The Clinic Manager confirmed that the last dose of Mircera was administered on August 16th, 2024, in the facility. The Clinic Manager indicated that there had been a significant decline in Patient #1 ’ s Hemoglobin over the past month as well as his/her overal health status. The CM indicated that since discharge from the hospital on 10/16/2024, Mircera has not been administered.”

“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: 44230 Based on record review and interview the agency failed to ensure that the physician prescribed Blood Flow Rates (BFR) and Dialysate Flow Rates (DFR) were followed in 4 of 5 clinical records reviewed. (Patient #1, #2, #3, #4) Findings Include: 1. A policy titled, “Patient Assessment and Monitoring” indicated but was not limited to, “Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered”. 2. A 10/18/2024 document titled, “Treatment Sheet for Facility” for Patient #1 indicated a physician ordered BFR of 400. The treatment sheet evidenced a BFR of 350 without documentation of why the BFR order was not followed. The facility failed to follow the physician order. 3. A 10/18/2024 document titled, “Treatment Sheet for Facility” for Patient #2 indicated a physician ordered BFR of 400. The treatment sheet evidenced a BFR of 300 without documentation of why the BFR order was not followed. The facility failed to follow the physician order. 4. A 10/18/2024 document titled, “Treatment Sheet for Facility” for Patient #2 indicated a physician ordered BFR of 400. The treatment sheet evidenced a BFR of 275-350 without documentation of why the BFR order was not followed. The facility failed to follow the physician order. 5. A 10/16/2024 document titled, “Treatment Sheet for Facility” for Patient #3 indicated a physician ordered BFR of 400. The treatment sheet evidenced a BFR of 350 without documentation of why the BFR orders were not followed. The facility failed to follow the physician order. 6. A 10/11/2024 document titled, “Treatment Sheet for Facility” for Patient #4 indicated a physician ordered DFR of 800. The treatment sheet evidenced a DFR of 500, without documentation of why the DFR orders were not followed. The facility failed to follow the physician order. 7. A 10/14/2024 document titled, “Treatment Sheet for Facility” for Patient #4 indicated a physician ordered DFR of 800. The treatment sheet evidenced a DFR of 500, without documentation of why the DFR orders were not followed. The facility failed to follow the physician order. 8. A 10/18/2024 document titled, “Treatment Sheet for Facility” for Patient #4 indicated a physician ordered BFR of 400 and DFR of 800. The treatment sheet evidenced a BFR 350 and DFR of 500, without documentation of why the BFR and DFR orders were not followed. The facility failed to follow the physician order. 9. A 10/21/2024 document titled, “Treatment Sheet for Facility” for Patient #4 indicated a physician ordered DFR of 800. The treatment sheet evidenced a DFR of 500, without documentation of why the DFR orders were not followed. The facility failed to follow the physician order. 10. During an interview on 10/30/2024 at 10:21 AM the Clinic Manager indicated that staff should be following the prescribed BFR and DFR. If unable to obtain prescribed rate, staff should document the reason why in the clinical record. For Patient #1, the clinic manager indicated she was aware of the physician rounding on 10/18/2024 and may have advised staff to change the BFR but was unable to provide documentation that this happened. 11. During an interview on 10/30/2024 at 11:14 AM, the clinical manager indicated that for Patient #2, staff should be following the physician order for BFR. If unable to obtain, the expectation is to document the reason why and notify the nurse. 12. During an interview on 10/30/2024 at 12:28 PM, the clinical manager indicated that for Patient #3, the staff should be following the physician order for BFR and DFR. If unable to obtain, the expectation is to document the reason why and notify the nurse. 13. During an interview on 10/30/2024 at 12:04 PM, the clinical manager indicated that for Patient #4, the staff should be following the physician order for BFR and DFR. If unable to obtain, the expectation is to document the reason why and notify the nurse. 14. During an interview on 10/30/2024 at 12:53 PM, PCT 1 indicated the staff should be following the physician order for BFR and DFR. PCT 1 indicated if the BFR or DFR cannot be met, they document the rate and reason and notify the nurse. 15. During an interview on 10/30/2024 at 12:40 PM, RN 2 indicated the staff should be following the physician order for BFR and DFR. RN 2 indicated the physician ’ s order should be entered and doubled checked on the machine before treatment begins.”

“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: 44230 Based on record review and interview, the facility failed to follow policy by removing expired supplies from the treatment floor in 1 of 1 facility reviewed, failed to properly label medications set up in advance in 1 of 1 facility reviewed and failed to complete an initial nursing assessment on a new patient prior to starting treatment in 1 of 2 new admissions reviewed. (Patient #5) Findings Include: 1. A policy 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, contaminated or damaged ... Supplies must be rotated First-in First-out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date”. 2. A policy titled, “Medication Preparation and Administration” indicated but was not limited to, “All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of the patient, date, time and initials of the person who prepared the medication ... Oral medications not being administered immediately must also be labeled as indicated above”. 3. A policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” indicated but was not limited to, “A registered nurse must perform an assessment of patient NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs”. 4. During an observation of the isolation room on 10/23/2024 at 11:16 AM, a yellow container stored in a cabinet int the isolation room housed multiple supplies. Two mint green laboratory tubes expired on 12/31/2023 and one lavender tube expired on 05/31/2024. Two ChloraPrep Single Swab sticks (disinfectant used to clean dialysis catheter exit site), both had expired June of 2024 and July of 2024. 5. During an observation on 10/23/2024 at 10:24 AM, two boxes of surgical tape with an expiration date of 07/13/2024 were found in a cabinet on the treatment floor. 6. During an observation on 10/23/2024 at 10:24 AM, one box of Povidone-iodine swabsticks (antiseptic used to cleanse or disinfect skin) with an expiration date of 03/2021 were found in the cabinet on the treatment floor. 7. During an observation on 10/23/2024 at 10:55 AM, three medications cups, each containing one oral pill each were found in the cabinet at the medication preparation area. Medication cup #1 was labeled 10/23/2024 Patient #6 Sensipar (medication used to lower calcium levels) 30 milligrams. Medication cup #2 was labeled 10/23/2024 Patient #7 Sensipar 30 milligrams. Medication cup #3 was labeled 10/23/2024 Patient #8 Calcitriol 0.25 micrograms. The medication labels affixed to the individual medicaiton cups failed to include the time the medications were set-up and the initials of the staff that prepared them. 8. During interview on 10/30/2024 at 12:04 PM, the FA indicated the admission date for Patient #5 was 10/21/2024, The initial nursing assessment was documented at 8:09 AM. The first, initial treatment data indicated that Patient #5 started treatment at 7:38 AM. The facility failed to ensure a nursing assessment was completed prior to starting treatment for a new patient admit. 9. During an interview on 10/23/2024 at 11:05 AM, RN 2 indicated that she had set-up the oral medications located in the medication cabinet for the day and indicated the expectation is include the time the medications were prepared along with her initials. 10. During an interview on 10/23/2024 at 11:35 AM, RN 1 indicated that all staff members are responsible for ensuring supplies have not expired. If found to be expired, those supplies should be discarded and not used. 11. During an interview on 10/25/2024 at 10:45 AM, RN 2 indicated that the Betadine and plastic tape found during the flash tour on 10/23/2024 was indeed expired and should have been discarded. She indicated that it was a team effort to check for expired supplies, it was not designated to just one or two individuals. 12. During an interview on 10/30/2024 at 12:02 PM, the Clinic Manager indicated the expectation is for the RN to complete an assessment of each patient prior to starting the first treatment. 13. During an interview on 10/25/2024 at 9:49 AM, RN 1 indicated if a patient has an allergy to paper tape, the surgical tape may be substituted however this happens rarely. RN 1 indicated it is the FA ’ s responsibility to maintain up to date stock. RN 1 also indicated the iodine swabs were used for a previous patient with an allergy to Chlorahexidine (disinfectant for skin). RN 1 indicated she would dispose of the expired supplies promptly.”

“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: 44354 Based on observation and interview, the agency failed to ensure supplies were stored appropriately for 1 of 1 in stand alone dialysis centers. Findings include: 1. An agency policy titled, “Storage of Supplies” received from the Facility Administrator on 01-04-2024 at 11 AM contained but was not limited to, “ Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged. All clean supplies must be stored off the floor ....” 47343 2. During the flash tour of the agency’s treatment area on 01-02-2024, the clean sink next to station 6 evidenced a blue bucket under the sink. The clean sink at the Patient Care Technician (PCT) station evidenced a glass vase with a yellow ribbon, 4 screws, 2 washers, drain plug, an orkin commercial box cover, magic eraser, and a container of extra soap. 3. During the flash tour of the agency’s supply room on 01-02-2024, 5 chemosafe boxes were stored on the floor next to the door to the treatment room. A brown box filled with 10 ml (milliliter) syringes of Normal Saline was on the floor next to the shelves. An ice melter box, Ginger Ale bottle box, Apple bottle box, and 2 light blue and 2 dark blue boxes with a Medegen Medical products box were on the floor next to the back door and water softener. 4. During an interview with Biomed on 01-02-2023 at 3:30 PM, they indicated the boxes with sterile syringes and blood culture tubes on the floor by the shelf and the Citracal jugs by the salt on the floor were not to be on the floor and moved them to the shelf. On 01-04-2024 at 7:30 AM, the boxes of sterile syringes and blood cultures were evidenced on the floor next to the shelf. The agency failed to ensure boxes with supplies were not stored on the floor. 5. During an interview with the Area Team Lead on 01-04-2023 at 2:18 PM, they indicated there was not to be anything under the sinks.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 44354 Based on observation, record review and interview the facility failed to ensure all sink drainage pipes were functioning properly for 1 of 1 stand alone dialysis centers. Findings include: 1. A document titled “Biomedical Technician III” received from the Area Team Lead on 01-04-2024 at 7:50 AM contained but was not limited to “PRINCIPAL DUTIES AND RESPONSIBILITIES: Performs and oversees effective, timely management troubleshooting, repair activities ... of the physical plant ....” 2. During the flash tour on 01-02-2024 at 12:42 PM observed a sink next to the entrance of the storage area marked “dirty sink”. The cabinet underneath the sink contained a bucket under the drain pipe and a pink and purple crystal like sediment and rust colored dust on the cabinet floor. 3. During an interview on 01-02-2024 at 3:30 PM with the facility Biomedical Technician, they reported being aware of the leaking pipe and said the debris under the sink was a result of staff emptying water testing chemicals down the dirty sink causing the drain pipe to erode. When queried if a work order was made for repairs, they reported “ no “ but they were looking for quotes and would clean up the sink now and remove the bucket. When queried how long this has been leaking, they reported a few months. 4. During an observation on 01-04-2024 at 7:25 AM observed the sink with the leak to have no sediment, water, or bucket under the pipe in the cabinet. 47343 5. During a flash tour of the agency on 01-02-2024, the clean sink at the Patient Care Technician (PCT) station evidenced a green, blue stain with powder in the center of the cabinet under sink. The agency failed to ensure the cabinets under the sinks were clean and the pipes were not leaking.”