Fmc Charlotte

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 32003 Based on policy review, observation, medical record review, personnel file review and staff interview, the facility staff failed to ensure a nurse was present when a PCT drew up heparin dwells for 1 of 1 patient (#12). The findings include: Review on May 1, 2025 of the facility’s policy, “North Carolina State Specific: Heparin Administration by Patient Care Technicians” published February 2025 revealed, “Purpose [space] The purpose of this document is to implement North Carolina Board of Nursing’s (“Board”) position on heparin administration by patient care technician. Responsibility ...Background ...Policy [space] 1. PCT’s may assist the licensed nurse (RN or LPN) with the administration of heparin, provided there is an established written protocol ...Validation Process [space] To validate heparin dose: 1. The Licensed Nurse will watch the PCT draw up heparin into the syringe based on the information on the medication label. ...” Observation on April 30, 2025 at 9:38 AM revealed, PCT #1 drew up 2.3 milliliters and 2.4 milliliter of heparin dwells for Patient #12 without Nurse #1 being present. Telephone interview on April 30, 2025 at 11:51 AM with Nurse Educator revealed, a nurse must be present to validate the amount of heparin drawn up the PCT. Open medical record review on May 1, 2025 revealed, Patient #12 was admitted to the in-center facility and there was an order for 2.3 milliliters and 2.4 milliliters of heparin dwells for a CVC. Personnel file review on May 1, 2025 revealed, PCT #1 was hired at the dialysis facility and annual competencies were valid until April 2026.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 32003 Based on policy review, observations, staff interview, and personnel file and worksheet review, the facility staff failed to discard a soiled facemask and don a new facemask for 2 of 2 observations for 1 of 3 nurses employed at the facility (Nurse #1). Review on May 1, 2025 of the facility’s policy, “Personal Protective Equipment” published, November 6, 2023 revealed, “Purpose ...Responsibility ...Background ...Definitions ...Policy ...Personal Protective equipment including a full-face shield or mask and protective eyewear ...PPE is used to protect employees who are occupationally exposed to blood or OPIM when performing procedures during which spurting or spattering or blood might occur ...Facemasks [space] Facemasks are single-use only and must be discarded after the task for which they were needed to complete. ...” 1. Observation on April 29, 2025 from 12:15 PM through 2:30 (135-minutes) revealed, Nurse #1 wore a facemask that was soiled and tattered while performing chairside pre and post patient assessments and medication administrations. Interview on April 29, 2025 at 4:00 PM with the Clinical Manager revealed, the manager spoke with Nurse #1 on multiple occasions about wearing a facemask that was soiled and tattered while performing patient care. Review on May 1, 2025 of the personnel file for Nurse #1 revealed on July 22, 2024, the nurse successfully completed annual infection control training. Review on May 1, 2025 of the personnel worksheet revealed three nurses were employed at the dialysis facility. 2. Observation on April 29, 2025 from 9:15 AM through 10:30 AM (75-minutes) revealed, Nurse #1 wore a facemask that was soiled and tattered as the nurse performed chairside pre and post patient assessments and medication administrations. Interview on April 29, 2025 at 4:00 PM with the Clinical Manager revealed, the manager spoke with Nurse #1 on multiple occasions about wearing a facemask that was soiled and tattered while performing patient care. Review on May 1, 2025 of the personnel file for Nurse #1 revealed on July 22, 2024, the nurse successfully completed annual infection control training. Review on May 1, 2025 of the personnel worksheet revealed three nurses were employed at the dialysis facility.”

“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: 32003 Based on policy review, observations, and staff interview, the facility staff failed to clean and disinfect oxygen concentrators that remained at the chairside between patient treatments for 12 of 28 stations in use (#1, #2, #4, #6, #7, #9, #13, #17, #19, #20, #21 and #25). The findings include: Review on May 1, 2025 of the facility’s policy, “Cleaning and Disinfecting the Dialysis Station” published September 5, 2023 revealed, “Purpose ...Responsibility ...Background ...Definition [space] Dialysis Station [space] ...Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine ...Chair/bed ...Individual television and remoted ...General Cleaning ...The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station ...must be disinfected with 1:100 bleach ...” 1. Observation on April 29, 2025 from 12:15 PM through 2:30 (135-minutes) revealed, oxygen concentrators were located at dialysis stations #1, #6, #17, #19, #21 and #25 during patient treatments and they were not cleaned and disinfected between patient treatments. Interview on April 29, 2023 at about 11:30 AM with the Clinical Manager revealed currently, the facility utilized 28 of 42 certified dialysis stations. Interview on May 1, 2025 at 2:10 PM with the Clinical Manager revealed, infection control audits were conducted monthly and were ongoing. Staff education occurred via a huddle notebook but the notebook was not up-to-date and the education could not be validated. 2. Observation on April 30, 2025 from 9:15 AM through 10:30 AM (75-minutes) revealed, oxygen concentrators were located at dialysis stations #2, #4, #6, #7, #9, #13, #20, and #25. Observation revealed the concentrators were not cleaned and disinfected between patient treatments. Interview on April 29, 2023 at about 11:30 AM with the Clinical Manager revealed currently, the facility utilized 28 of 42 certified dialysis stations. Interview on May 1, 2025 at 2:10 PM with the Clinical Manager revealed, infection control audits were conducted monthly and were ongoing. Staff education occurred via a huddle notebook but the notebook was not up-to-date and theducation could not be validated.”

“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: 32003 Based on policy review, observations, medical record reviews and staff interview, the facility staff failed to ensure the BFR was administered as prescribed for 2 of 3 of patients (#10, #11 and #19). The findings include: Review on April 9, 2025 of the facility’s policy, “Patient Assessment and Monitoring” published May 1, 2023 revealed, “Purpose ...Responsibility ...Definitions ...Delegation ...Data Collection ...Pre-Treatment ...During Treatment ...Step 1 ...Step 3 [space] Machine Parameters and Extracorporeal Circuit [space] Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. ...” 1. Observation on April 30, 2025 at 10:05 AM revealed, dialysis treatment for Patient #10 was in progress with a BFR of 500 milliliters per minute Open medical record review on May 1, 2025 revealed Patient #10 was admitted to the in-center facility and on April 23, 2025, the physician ordered a BFR of 500 milliliters per minutes. Treatment sheet review from April 21, 2025 through May 30, 2025 (6-consective treatments) revealed, on April 21, 2025 - the BFR was not at the prescribed rate for 241 of 272-minutes; on April 28, 2025 - the BFR was not at the prescribed rate for 94 of 256-minutes and on April 30, 2025 - the BFR was not at the prescribed rate for 277 of 277-minutes. Review revealed staff did not document a reason for not administering the prescribed BFR. Interview on May 1, 2025 at 2:10 PM with the Clinical Manager revealed, treatment sheet audits occurred monthly for randomly selected patients and staff. Additionally, the audits demonstrated inconsistent documentation with the 30-monitoring which seems to occur at breaktimes. 2. Observation on April 29, 2025 at 12:53 PM revealed, dialysis treatment for Patient #19 was in progress with a BFR of 400 milliliters per minute. Open medical record review on May 1, 2025 revealed #19 was admitted to the in-center facility and on April 7, 2025, the physician ordered a BFR of 400 milliliters per minute. Treatment sheet review from April 21, 2025 through May 30, 2025 (6-consective treatments) revealed, April 11, 2025 - the BFR was not at the prescribed rate for 87 of 180-minutes and on April 25, 2025 - the BFR was not at the prescribed rate for 175 of 175-minutes. Review revealed staff did not document a reason for not administering the prescribed BFR. Interview on May 1, 2025 at 2:10 PM with the Clinical Manager revealed, treatment sheet audits occurred monthly for randomly selected patients and staff. Additionally, the audits demonstrated inconsistent documentation with the 30-monitoring which seems to occur at breaktimes. 3. Observation on April 30, 2025 at 10:30 AM revealed, dialysis treatment for Patient #11 was in progress with a BFR of 400 milliliters per minute. Open medical record review on May 1, 2025 revealed Patient #11 was admitted to the in-center facility and on April 16, 2025, the physician ordered a BFR of 400 milliliters per minute. Treatment sheet review from April 21, 2025 through May 30, 2025 (6-consective treatments) revealed, on April 25, 2025 - the BFR was not at the prescribed rate for 106 of 220-minutes and staff did not document a reason for not administering the prescribed BFR. Interview on May 1, 2025 at 2:10 PM with the Clinical Manager revealed, treatment sheet audits occurred monthly for randomly selected patients and staff. Additionally, the audits demonstrated inconsistent documentation with the 30-monitoring which seems to occur at breaktimes.”

“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: 32003 Based on policy review, observation, medical record review, personnel file review and staff interview, the facility staff failed to administer an intravenously medication using an IV pump for 1 of 1 patient (Patient #2). The findings include: Review on May 1, 2025 of the facility’s policy, “Medication Preparation and Administration” published February 2023 revealed, “Purpose ...Responsibility ...Medication Orders ...Qualifications ...Controlled Substances & Sample Medications ...Needles ...Labeling Reconstituted Medication Solutions and Syringes ...Labeling Vials ...Medication Label Handling ...Pre-drawing Medications ...Principles for Medication Preparation ...Monitoring Expired Medications ...Preparing and Administered Medications During Hemodialysis Treatment [space] ...IV infusion pumps are required when medications are administered intravenously. ...” Observation on April 29, 2025 at 12:15 PM revealed Nurse #1 administered 250 milligrams of Calcium gluconate in 250 milliliters intravenously off the IV pump. Interview on April 29, 2025 at 12:15 PM with Nurse #1 revealed, Patient #2 had a recent surgery and Calcium gluconate should be administered toward the end of treatment. Open medical record on May 1, 2025 revealed, Patient #2 was admitted to the in-center facility and there was an order for Calcium gluconate. Personnel file review on May 1, 2025 revealed, Nurse #1 was hired at the in-center facility and the competencies for medication administration and IV check-off were valid until March 2026.”