Fmc East Mobile

“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: 28297 Based on observation, interview, and policy review, the facility failed to ensure patients washed or sanitized hands after holding access sites (A vascular access is created so that blood can be drawn from the body and run through a dialysis machine, where excess fluid and toxins are removed from the blood.) for one of three survey days. The failure for patients to wash or sanitize hands after holding access site had the potential for cross contamination and could affect 77 in-center patients. Findings include: Observation on 06/05/25 at 10:40 AM revealed Patient (P) 7 at Station 14 applied pressure to the left lower access site until bleeding had stopped. When the patient was finished, he/she walked to the scale to retrieve weight without staff involvement. Patient 7 did not wash or sanitize hands before leaving the facility. During an interview on 06/05/25 at 11:10 AM P7 stated no one had ever educated him/her about washing or sanitizing hands after holding access site prior to leaving the facility. During an interview on 06/06/25 at 2:20 PM Certified Clinical Hemodialysis Technician (CCHT) 3 stated patients were required to wash or sanitize hands after holding access sites prior to leaving the facility to prevent cross contamination in the facility and that patients were educated upon admission. During an interview on 06/06/25 at 4:45 PM the Clinical Manager stated patients should wash or sanitize hands after holding access sites at the end of treatment to prevent cross contamination of blood borne pathogens. Review of the facility’s policy titled, “Hand Hygiene” revised 11/06/23 indicated the following: “Patients should perform hand hygiene if able, prior to and after each dialysis treatment ...Gloves must be provided to patients when performing procedures which risk exposure to blood or body fluids, such as when self-canulating or holding access sites post treatment to achieve hemostasis. To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed ...””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 28297 Based on observation, interview, and review of facility policy, the facility failed to ensure there was an appropriate means for patients to notify staff of an emergency that could occur in the patient lobby for one of three survey days. The failure to have an appropriate means to contact staff in an emergency had the potential for adverse events such as bleeding, falls or other potential accidents not to be addressed in a timely manner and could affect 77 in-center patients. In addition, the facility failed to ensure one of 11 oxygen cylinders was not secured for one of three survey days. The failure to ensure oxygen cylinders were secured had the potential for one to fall and malfunction and this could impact 77 in-center patients. Findings include: 1. Observation on 06/04/25 from 8:20 AM until 8:30 AM revealed the surveyor entered the building into the patient lobby area. The surveyor knocked on the treatment room door a total of three times with the third time continuous and banging. The Administrative Assistant answered the door. There was no doorbell and the window to the treatment area was completely obscured except for a small peep hole. The surveyor called both the Clinical Manager and Director of Operations number that was posted in the lobby, however there was no answer. The Administrative Assistant opened the treatment floor door, and the surveyor continued observation of the treatment floor revealed the nurse’s station was 30 feet (measured by the Clinic Manager) from the lobby door. There was a wall that goes from the floor to the ceiling from station 1 (closest to the lobby door) and extends all the way down the treatment floor that impedes the ability to hear if someone was knocking on the treatment room door from the lobby. During an interview on 06/04/25 at 8:32 AM the Administrative Assistant stated he/she normally was at the front desk, however he/she was working as a Patient Care Technician on this day. During an interview on 06/05/25 at 11:15 AM the Clinical Manager stated the facility had cameras throughout the facility, however staff have to pull it up on their emails to see the lobby area and that there was no other way to monitor patients in the lobby area. He/she stated the computer screen that has all the cameras was in the electrical room at the back of the facility. During an interview on 06/05/25 at 3:00 PM the Medical Director stated he/she did not realize there was no way to visualize patients in the lobby unless staff pull it up on their email. He/she stated there have been security issues in the past. During an interview with Registered Nurse (RN) 2 on 06/06/25 at 2:55 PM revealed in order for staff to visualize patients in the lobby, you have to close several tabs on the computer to open up the email that has the cameras to view the lobby. RN 2 stated they put a bell in the lobby on 06/05/25, however it was not working consistently. Review of an email provided by the Clinical Manager dated 05/30/25 The Area Technical Operations Director (ATOM) emailed a company for a “quote for moving the existing monitor for the security system from the electrical room to the nurses station. As soon as I have the quote ill (sic) let you know.” Review of the facility policy “Security Policy” revised 07/05/22 indicated the following: “ ...Install cameras to record activity in or around the facility. Alert individuals that cameras are I use with appropriate signage ...” Review of facility policy “Physical Security and Facility Access,” revised 09/05/23 indicated the following: “ ...If it is deemed necessary, security camera or communication intercoms will be placed in appropriate areas within the facility ...” 2. Observation on 06/04/25 at 11:00 AM revealed one of 11 oxygen cylinders stored in the supply storage area was not secured in a holding device. During an interview on 06/04/25 at 12:00 PM the Area Technical Operations Manager (ATOM) confirmed the oxygen cylinder was not secured. He/she stated it should be, and everyone was responsible for making sure they were secure to prevent them from falling over. During an interview on 06/06/25 at 2:20 PM Certified Clinical Hemodialysis Technician (CCHT) 3 stated he/she was not aware oxygen cylinders needed to be secured to prevent them from falling over. During an interview on 06/06/25 at 4:45 PM the Clinical Manager stated the oxygen cylinders should be secure to prevent them from falling over. Review of the facility policy “Emergency Administration of Oxygen,” revised 11/01/21 indicated the following: “ ...Oxygen cylinders must be secured in an area where that will not fall ...””

“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: 28297 Based on observation, interview, policy review and Manufacture Directions for Use, the facility failed to ensure solutions used to calibrate the “Myron L D6 TDS Meter” for one of three survey days, were within date. The failure to have solutions within date had the potential for inaccurate reading of the meter and this could affect 77 in-center patients. Findings include: Observation on 06/04/25 at 10:45 AM revealed (Total Dissolved Solvents (TDS) conductivity solutions manufacture expiration date was June 21, 2024. The Standard Buffer solution 4.0 PH manufacture expiration date was 04/26/25, Conductivity standard solution 14.0 manufacture expiration date was 03/29/25 and standard buffer solution 7.0 manufacture expiration date expired 04/04/25. All were opened and dated 04/09/25 by Certified Clinical Hemodialysis Technician (CCHT) 3. During an interview on 06/04/25 at 11:05 AM CCHT 3 confirmed he/she opened and dated all the solutions on 04/09/25 and failed to look at the manufacture date. CCHT 3 stated the potential risk was that the meter could read inaccurately if using expired solutions. During an interview on 06/04/25 at 12:00 PM the Area Technical Operations Manager (ATOM) stated it was not the Biomedical staff’s responsibility to check supplies for expiration dates. During an interview on 06/06/25 at 4:45 PM the Clinical Manager stated it was direct care staff to check for expiration dates on items and solutions used in the clinic to ensure they were not expired. Review of the facility policy Myron L D6 Meter Maintenance Procedure,” revised 09/01/22 indicated the following: “ ...At the beginning of the day, check conductivity, TDS (442), and PH solution expiration dates. Discard expired solutions or solutions found without a cap. Use unexpired solutions for meter verification ...” Review of the “Myron L Company Standard Solutions Instructions,” undated indicated the following: “ ... Warranty All Myron L Standard Solutions have a shelf life of one year if stored unopened and according to instructions (see expiration date on bottle label) ...””

“PA-RD-NUTRITIONAL STATUS CFR(s): 494.80(a)(6) The patient’s comprehensive assessment must include, but is not limited to, the following: (6) Evaluation of nutritional status by a dietitian This Standard is not met as evidenced by: 28297 Based on interviews, record review and review of facility policy, the facility failed to ensure one of six patients (P) 4 was started on a nutritional supplement in a timely manner. The failure to not start a nutritional supplement in a timely manner to aid in the improvement of albumin levels affected P4 and had the potential to affect all patients in the facility that require a nutritional supplement with low albumin levels. Findings include: Review of the medical record for P4 revealed the facility admitted the patient on 05/06/25 as a transfer from another facility. Review of P4 labs indicated on 05/05/25 the patient’s albumin was 2.9 grams/deciliter (g/dl). The goal for albumin in dialysis patients is >4.0 g/dl based on the Measure Assessment Tool (MAT) for dialysis patients. On 05/15/25 the albumin was 2.8 g/dl. On 05/22/25 Dietician 2 documented that he/she met with the patient. The Nutritional Notes dated 05/22/25 indicated the patient was on Oral Nutritional Supplement Program (ONSP). Reviews of six treatment flowsheets from 05/22/25 to 06/06/25 revealed P4 did not receive any nutritional supplement from the facility. During an interview on 06/06/25 at 12:26 PM Dietician 2 stated there had not been an order for a nutritional supplement at this facility since the patient was admitted (transferred). Dietician 2 stated they had seen the patient at chairside on 05/22/25 however there were other issues with the patient that day and they did not get to talk to the patient about what type of supplement the patient wanted and was going to get back with the patient at a later time. Dietician 2 said the nutritional note that said the patient was on a nutritional supplement was from the patient transfer facility and the patient last received a supplement on 05/02/25 at the previous facility. During an interview on 06/06/25 at 4:45 PM the Clinical Manager stated it was the Dietician responsibility to get the Nutritional Supplement ordered. Review of the facility policy titled “Oral Nutritional Supplements Program (ONSP),” revised 01/23/2023 indicated the following: “ ...Purpose: Administer oral nutritional supplements to FKC dialysis patients who meet the supplement criteria to: Improve nutritional status, ensure compliance with oral intake, Reduce the risk of morbidity and mortality ...Criteria starting and stopping Supplements: Albumin 3.5 g/dl or less or transfer patient with current oral nutrition supplement order at previous provide/clinic.””