Fmc - Nephrology - Marshall County

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to implement its EP policies and procedures by failing to ensure all emergency drugs were on-site at all times, which had the potential to affect all 45 active patients. Findings include: 1. A facility policy #46865 “Emergency Medications, Equipment and Supplies,” dated 2/03/25, indicated the facility must maintain at least one dose of Naloxone (Narcan, a medication used to treat opioid overdose in emergency situations) on-site “to manage emergency situations.” The policy indicated “any requests by the Governing Body to modify the minimum required medications must be approved by the FKC Corporate Medical Office.” 2. An observation of the facility’s emergency cart on 4/16/25 beginning at 12:52 PM failed to evidence the emergency drug Narcan. 3. During an interview on 4/16/25 beginning at 3:05 PM, RN 2 reported the agency did not have Narcan on the premises. 4. During an interview on 4/16/25 beginning at 3:40 PM, Clinic Manager and Alternate Administrator reported the agency did not keep Narcan on the premises. The administrative staff reported the emergency drug had not been approved by Medical Director to keep on-site. During a follow-up interview on 4/17/25 beginning at 10:16 PM, Clinic Manager and Alternate Administrator reported the agency had not kept Narcan on-site since 2023 but had failed to follow its policy to obtain an approved exemption for maintaining this medication on-site.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to maintain a sanitary environment specific to the storage of bleach solutions and failed to ensure staff did not consume food while providing direct patient care for 1 of 2 ICHD treatment area observations on 4/16/25, which had the potential to affect all 45 active patients. Findings include: 1. A facility policy #47685 “General Cleanliness and Infection Control Guidelines,” dated 11/04/24, indicated staff were prohibited from eating in work areas “where there is reasonable likelihood of occupational exposure.” 2. A facility policy #47806 “Cleaning and Disinfecting the Dialysis Station,” dated 9/05/23, indicated bleach solution was to be stored in “covered opaque containers to prevent disintegration of the chemical (sodium hypochlorite when exposed to sunlight and air.” 3. During an observation at Station 14 on 4/16/25 at 10:45 AM, PCT 3 was observed providing care to Patient #14. The technician was observed chewing gum while providing direct patient care. During an interview on 4/16/25 beginning at 3:21 PM, PCT 3 reported food or drink was not allowed on the ICHD treatment floor. The technician was observed chewing gum during the interview, which occurred on the ICHD treatment floor. During an interview on 4/17/25 beginning at 10:16 AM, Clinic Manager and Alternate Administrator reported staff were not permitted to chew gum while on the ICHD treatment floor. 4. During an ICHD treatment floor observation on 4/16/25 from 10:34 AM - 1:05 PM, three containers with 1:100 concentration bleach solution were observed without a lid completely covering the solution on seven occasions. During an interview on 4/16/25 beginning at 2:36 PM, PCT 1 reported bleach solution was to be stored in a closed container. During an interview on 4/16/25 beginning at 2:48 PM, PCT 4 reported the lid to the bleach solution was to be covered with a lid. During an interview on 4/16/25 beginning at 4:35 PM, Clinic Manager and Alternate Administrator reported bleach solution was to be stored in an opaque container with the lid on.”

“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: 44714 Based on observation, record review, and interview, the facility failed to ensure clinical staff completed hand hygiene according to accepted standards of practice for 2 of the 3 observations on the treatment floor. Findings include: 1. A facility policy #47664 “Hand Hygiene,” dated 11/06/23, indicated hand hygiene should be performed “before and after direct contact with patients ...immediately after removing gloves ... after contact with other objects within the patient station or treatment space ....” When washing hands with soap and water, the procedure duration should be “40-60 seconds 2. During an observation on the treatment floor on 4/17/2025 at 11:36 AM, observed PCT 4 prepare to discontinue Patient #1’s dialysis treatment via a CVC. PCT 4 had gloves on, entered information into the computer, and moved to the patient’s side. PCT 4 then disconnected the blood lines. PCT 4 failed to remove gloves, sanitize hands, and don clean gloves after using the computer and before handling Patient #1’s CVC. 3. During an interview immediately after the observation, PCT 4 indicated gloves should be removed, hand sanitizer used, and new gloves donned prior to handling a CVC. During an interview on 4/15/2025 beginning at 4:15 PM, the Alternate Administrator indicated hand hygiene (hand wash or use of hand sanitizer) was required before donning gloves, after removing gloves. The Alternate Administrator also indicated the dialysis machine and computer were considered “dirty” and required hand hygiene and new gloves after use. 42617 4. During an ICHD treatment floor observation on 4/16/25 from 10:34 AM - 1:05 PM, observations of staff hand washing evidenced the following: a. At 10:39 AM, PCT 2 scrubbed her hands with soap and water for 16 seconds. b. At 10:45 AM, PCT 3 scrubbed her hands with soap and water for 15 seconds. c. At 10:55 AM, PCT 3 disinfected the machine at Station 14, removed her gloves and scrubbed her hands with soap and water for 10 seconds, then returned to the station. After completing disinfection of the station, PCT 3 removed her gloves and scrubbed her hands with soap and water for 5 seconds. During an interview on 4/16/25 beginning at 3:21 PM, PCT 3 reported hands should be scrubbed with soap and water for “30-60 seconds.” During an interview on 4/16/25 beginning at 4:21 PM, PCT 2 reported hands should be scrubbed with soap and water for “60 seconds.” The technician also hand hygiene with sanitizer should be performed prior to donning gloves. During an interview on 4/16/25 beginning at 4:35 PM, Clinic Manager, Alternate Administrator, and RN 1 reported they were unsure of the facility’s required duration for scrubbing hands with soap and water. RN 1 stated she thought it was “45-60 seconds,” but the administrative staff deferred to the agency’s policy for this requirement.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 44714 Based on observation, record review and interview, the agency failed to ensure the facility followed accepted standards for the replacement of full sharps containers for 1 of 1 facility surveyed. Findings include: 1. A review of the facility policy on cleanliness and infection control, dated 11/4/2024, indicated sharps containers should be replaced when 2/3 - 3/4 full. 2. During a floor observation on 4/15/2025 at 9:10 AM, observed a full sharps container in which the lid is closed, preventing its use. During an interview with PCT 5 at the time of the observation, PCT 5 indicated these are new sharps containers which close automatically when full. When asked, PCT 5 indicated the containers should be replaced when the lid is closed and all PCTs and nurses are responsible for replacing them. During an interview on 4/15/2025 at 11:45 AM, the Alternate Administrator indicated the sharps containers should be replaced when 3/4 full.”

“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: 42617 Based on observation, policy review, and interview, the facility failed to ensure all staff disinfected the dialysis station according to infection control policies and best practice in 2 of 2 observations of staff disinfecting a dialysis station (PCT 1, 3). Findings include: 1. A facility policy #47806 “Cleaning and Disinfecting the Dialysis Station,” dated 9/05/23, indicated “in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients ....” The dialysis station was defined as the “area including dialysis machine, chair/bed and other reusable equipment ....” Patients were to completely vacate the dialysis station “before the dialysis machine can be externally disinfected, allowed to dry and set up for the next treatment.” When cleaning the dialysis chair, staff should open the chair’s side panels, clean all surfaces of the chair, and “allow to air dry ....” 2. During an observation on 4/16/25 beginning at 10:55 AM, PCT 1 was observed cleaning Station 5 between patient use. When disinfecting the dialysis chair, PCT 1 opened the side panels, wiped them with a bleach wipe, then immediately closed the panels. The technician failed to allow the bleach solution to dry on all parts of the dialysis chair. During an interview on 4/16/25 beginning at 2:36 PM, PCT 1 reported after wiping the dialysis chair side panels with a bleach cloth, the side panels should be left open for “10 minutes.” 3. During an observation on 4/16/25 beginning at 12:12 PM, PCT 3 was observed cleaning Station 14 between patient use. PCT 3 disinfected the dialysis machine then brought clean supplies to the station and began to set up the machine, failing to disinfect the entire station prior to preparing it for a new patient. After preparing the machine, PCT 3 disinfected the dialysis chair’s side panels with a bleach wipe then immediately closed the panels. The technician failed to allow the bleach solution to dry on all parts of the dialysis chair. During an interview on 4/16/25 beginning at 3:21 PM, PCT 1 reported she was trained to prepare the dialysis machine for the next patient prior to cleaning the dialysis chair. The technician reported after wiping the dialysis chair side panels with a bleach cloth, the side panels should be kept open to dry. 4. During an interview on 4/16/25 beginning at 4:35 PM, Clinic Manager, Alternate Administrator, and RN 1 were asked how a dialysis machine should be prepared between patients. The administrative staff reported after the first patient vacated the station, the dialysis machine and chair should be disinfected with bleach, then the machine should be set up for the next patient. The administrative staff reported after being wiped with bleach cloth, the chair side panels should be kept open to dry.”

“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: 42617 Based on personnel file review, policy review, and interview, the dialysis facility failed to implement infection control policies and procedures specific to ensuring all staff had been screened for tuberculosis prior to direct patient contact for 3 of 3 personnel files reviewed (Employee A, B, C). Findings include: 1. A facility policy #47630 “Employee Tuberculosis [TB, a highly contagious respiratory infection] Testing,” dated 2/05/24, indicated a two-step tuberculin skin test (TST, a screening test for TB, which is done by injecting an inactive form of TB under the skin on 2 separate occasions and assessing the area for a reaction) would be performed on hire. If the first-step TB test had a negative result (no evidence of reaction), the second-step TB test was to be completed within 1-3 weeks. 2. The review of Employee A’s personnel file evidenced a hire date of 11/11/24. The employee’s duties included direct patient contact. The file failed to evidence the employee had completed a TST until 3/28/25, which was four months after hire. 3. The review of Employee B’s personnel file evidenced a hire date of 2/05/24. The employee’s duties included direct patient contact. The file failed to evidence the employee had completed a TST upon hire. 4. The review of Employee C’s personnel file evidenced a hire date of 12/11/23. The employee’s duties included direct patient contact. The file indicated Employee C completed a first-step TB test on 12/13/23 but failed to evidence a second step TB test was completed within 1-3 weeks. 5. During an interview on 4/17/25 beginning at 4:11 PM, Clinic Manager and Alternate Administrator reported all staff with direct patient contact were to be screened with a TST upon hire. The administrative staff reported the first-step TB test should be completed prior to direct patient contact. Clinic Manager estimated Employee A began having direct patient contact in late November or early December 2024. The administrative staff reported they could find no evidence of further TB evaluations for Employees A, B, and C.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all staff prepared intravenous (IV) medications in a clean area for 1 of 2 IV medication preparation observations (PCT 4). Findings include: 1. A facility policy #47488 “Medication Preparation and Administration,” dated 2/06/23, indicated aseptic technique (procedures used to minimize the risk of infection in a healthcare setting) was to be used when preparing IV medications. The medications were to be “prepared in a clean work area away from dialysis stations.” 2. During an observation on 4/16/25 beginning at 11:39 AM, PCT 4 was observed preparing IV Heparin (a blood thinner) at the ICHD nurse’s station. The technician failed to draw up and prepare the medication in a clean work area. 3. During an interview on 4/16/25 beginning at 2:48 PM, PCT 4 reported the facility did not have a medication preparation area on the ICHD treatment floor, and so medication was prepared at the nurse’s station. The technician reported she did not clean the area or place a clean barrier cloth on the counter surface prior to preparing IV medications. 4. During an interview on 4/16/25 beginning at 4:35 PM, Clinic Manager, Alternate Administrator, and RN 1 reported a clean barrier cloth should be placed at the nurse’s station prior to preparing IV medications.”

“PE-COMFORTABLE TEMPERATURE CFR(s): 494.60(c)(2) The dialysis facility must: (i) Maintain a comfortable temperature within the facility; and (ii) Make reasonable accommodations for the patients who are not comfortable at this temperature. This Standard is not met as evidenced by: 44714 Based on observation, record review, and interview, the facility failed to maintain a comfortable temperature on the treatment floor for patients undergoing dialysis treatment for 1 of 1 facility surveyed. Findings include: 1. During an observation on the treatment floor on 4/17/2025, beginning at 8:45 AM, noticed the area was cooler than previously. Checked the room thermostat near dialysis station #2, which read 67°. The thermostat was set to Cool, and the fan was set to auto. Noted 8 of the 9 patients had at least one blanket covering themselves. At 9:07 AM, noted Patient #7 wore multiple shirts and a hat which covered his face and head, except eyes, nose, and mouth. Patient #7 had a blanket and jacket on as well. Patient #17 wore a jacket and had no blanket. Patient #18 had a blanket covering themselves. At 9:28 AM, the thermostat read 66°. At 9:50 AM, the thermostat read 65°. Noticed a small room thermometer on the nurse’s desk. The temperature read 65°. At 10:06 AM, both the thermostat and room thermometer on nurse’s desk read 65°. At 11:35 AM, both the thermostat and room thermometer on nurse’s desk read 65°. 2. During an interview beginning at 9:07 AM, Patient #7 reported being cold. PCT 4 indicated Patient #7 was always cold. During an interview translated by PCT 4, beginning at 9:07 AM, Patient #17 indicated they were not cold, and it felt good in the room. During an interview beginning at 9:07 AM, Patient #18 nodded head yes when asked if they were cold today. Patient #18 then stated they were Okay. During an interview on 4/17/2025 beginning at 11:40 AM, discussed the temperature on the treatment floor with the Alternate Administrator. Accompanied the Alternate Administrator to the treatment floor to look at the thermostat and thermometer, both of which read 65°. The Alternate Administrator stated they thought it felt good as they liked cool temperatures. When asked about a policy regarding the temperature on the treatment floor, the Alternate Administrator indicated the Biomedical staff managed the building issues. The Alternate Administrator contacted the Area Technical Operations Manager and used the laptop camera to show him the thermostat. The Area Technical Operations Manager indicated the temperature on the thermostat was not 65°. When shown the thermometer at the nurse’s desk, he agreed the temperature was 65°. He and the Alternate Administrator identified things that made the treatment floor warmer: the dialysis machines running and the sun coming in the south windows. The Alternate Administrator indicated this facility was not managed by the corporate “Energy Management System,” in which the corporation determines the temperature ranges and adjusts the facility temperature to corporate standards. The Alternate Administrator indicated this facility was a tenant of the building and the landlord controlled the temperatures, not the corporation. The Alternate Administrator indicated they would adjust the thermostat if multiple patients requested an adjustment. When asked, the Alternate Administrator indicated they did not know what temperature range the corporation used at other facilities but would find out the answer. Prior to the exit interview the Alternate Administrator provided an email from the Area Technical Operations Manager, dated 4/17/2025 at 5:36 PM. The email had been forwarded to him by a corporate staff person, dated 4/17/2025 at 5:32 PM, with a subject line of “Regulation.” The text of the email included a standard on health care ventilation by the American Society of Heating, Refrigerating and Air Conditioning Engineers. The stated “ ... Dialysis Treatment areas must be maintained between 72-78 deg [degrees] F Fahrenheit.” The second page of the email contained the corporate Energy Management Systems Temperature Setting Standards. This document identified default temperature settings as quoted below: Setpoints Temp Occupied Cooling 71 Minimum Cooling 68 Unoccupied Heating 68 Maximum Heating 72 Unoccupied Heating 60 When asked if 65° followed the corporate standard of 68 - 71°, the Alternate Administrator gave a noncommittal response.”

“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: 42617 Based on observation, record review, and interview, the Medical Director failed to ensure all policies and procedures were followed by staff for 2 of 3 observations of arteriovenous (AV) fistula cannulation (PCT 2, 4) Findings include: 1. A facility policy #45178 “Access Assessment and Cannulation,” dated 5/06/24, indicated when disinfecting the access site with a 70% alcohol pad, staff should clean the site for 30 seconds and allow the disinfectant to dry prior to cannulation (insertion of dialysis needles). 2. During an observation at Station 10 on 4/16/25 beginning at 11:07 AM, PCT 2 was observed preparing Patient #11 for dialysis. The technician wiped the first access site with a 70% alcohol pad for 23 seconds. During an interview on 4/16/25 beginning at 4:21 PM, PCT 2 reported each fistula site was to be disinfected with 70% alcohol for “30 seconds.” 3. During an observation at Station 2 on 4/16/25 beginning at 11:48 AM, PCT 4 was observed preparing Patient #9 for dialysis. The technician wiped the second fistula access site with a 70% alcohol pad for 20 seconds, and failed to allow the alcohol to dry on both the first and second access site prior to cannulation. During an interview on 4/16/25 beginning at 2:48 PM, PCT 4 reported each fistula site was to be disinfected with 70% alcohol for “30 seconds” and allowed to dry for “at least 15 seconds” prior to cannulation. 4. During an interview on 4/16/25 beginning at 4:35 PM, Clinic Manager, Alternate Administrator, and RN 1 were unsure of the required duration to disinfect a fistula access site with 70% alcohol and defered to the facility’s policy. RN 1 stated the disinfectant should be dried prior to fistula cannulation.”