| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 012507 | (X3) Date Survey Completed 08/15/2025 |
| Name of Provider or Supplier Fresenius Kidney Care Mobile | Street Address, City, State 2620 Old Shell Road, Mobile, AL | |
| For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency. | ||
| (X4) ID Prefix Tag | Summary Statement of Deficiencies
(Each deficiency should be preceded by full regulatory or LSC identifying information) |
| E0000 | A Recertification survey was conducted by Healthcare Management Solutions, LLC on behalf of the Alabama Department of Public Health, Bureau of Health Provider Standards. An unannounced on-site Emergency Preparedness survey (ASPEN #4T3W11) conducted at the above-named End Stage Renal Disease (ESRD) facility from 08/13/25 to 08/15/25 resulted in a finding of no deficiency respective to the Emergency Preparedness Program Condition for Coverage under 42 CFR494.62. Total Facility Census: 105 In-Center Hemodialysis:105 Home Hemodialysis (HHD): 0 Peritoneal Dialysis (PD): 0 Nocturnal: 0 Pediatrics: 0 Sample Size:10 Network 8 was contacted after entrance. |
| V0000 | A Recertification Survey was conducted by Healthcare Management Solutions, LLC on behalf of the Alabama Department of Public Health, Bureau of Health Provider Standards. An unannounced on-site Recertification (CORE) survey (ASPEN #4T3W11) conducted at the above-named End Stage Renal Disease (ESRD) facility from 08/13/25-08/15/25 resulted in a finding of substantial compliance respective to applicable Conditions for Coverage (CfC) under 42 CFR 494, Subpart A through D with the following standard-level deficiencies listed below. Total Facility Census: 105 In-Center Hemodialysis: 105 Home Hemodialysis (HHD): 0 Peritoneal Dialysis (PD): 0 Nocturnal: 0 Pediatrics: 0 Sample Size: 10 Network 8 was contacted after entrance. |
| V0113 | 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: Based on observation, interview, and policy review, the facility failed to ensure proper hand hygiene was performed during central venous catheter access for one of one patient (Patient (P)7) observed with a central venous catheter. Failure to perform proper hand hygiene has the potential to place all patients and visitors at risk for cross contamination, resulting in increased infections to all 105 patients receiving dialysis at the facility. Findings include: During an observation on 08/14/25 at 10:45 AM, Registered Nurse (RN)7 was observed accessing P13's central venous catheter for dialysis treatment. RN9 repeatedly used the hand sanitizer that was mounted on the patient's dialysis machine at the next patient's station instead of using the hand sanitizer mounted on P13's dialysis machine. During an interview on 08/14/25 at 11:00 AM, RN7 confirmed the above findings. During an interview on 08/14/25 at 11:15 AM, the Clinic Manager 2 confirmed that the staff should use the hand sanitizer mounted on the machine of the patient they are providing care to. Review of the facility's policy titled "Hand Hygiene" dated 11/06/23 indicated, "Clean the dialysis machine-mounted dispenser and bracket between patients with a 1:100 bleach ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ..." |
| V0116 | IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient's station should be used only for that patient and should not be returned to a common clean area or used on other patients. This STANDARD is not met as evidenced by: Based on observation, interview, and policy review, the facility failed to ensure the hemostats and clamps used in patient care were disinfected appropriately. This increased the risk of cross contamination for 105 of 105 patients receiving care at the facility. Findings include: During a tour of the treatment floor on 08/13/25 at 8:55 AM, the blue clamps (hemostats) used in patient care were observed to be drained, next to the bleach container. There was one clamp seen on the top of the pile that was observed to be in the closed position versus the open position to ensure adequate disinfection and drainage of the interior surface of the clamp. During an interview on 08/13/25 at 8:55 AM, the Certified Clinical Hemodialysis Technician (CCHT) 17 confirmed the clamp on top was in the closed position and should have been in the open position during draining after disinfection. During an interview on 08/13/25 at 9:30 AM, the Clinic Manager 2 confirmed the clamps were to be in the opened position when draining. He/she confirmed the staff did not follow the policy. Review of the facility's policy titled, "Cleaning and Disinfecting Plastic Hemostat Clamps and Vascular Clamp" dated 07/01/24 revealed, ". . . Air dry in the opened position . . ." |
| V0544 | 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: Based on record review, interview, and policy review, the facility failed to follow the individualized dialysis plan (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) by following the physician prescription as determined by the medical provider for two of 10 sampled in-center dialysis patients (Patient (P)2 and P10). Failure to follow the medical providers' dialysis prescription had the potential to negatively impact on the effectiveness of the prescribed dialysis treatments for all 105 patients receiving in-center dialysis treatments at this facility. Findings include: Review of P2's electronic medical record (EMR) revealed a prescribed Blood Flow Rate (BFR) of 425 milliliters per minute (ml/min). Review of three of six "Post Treatment" flowsheets from 07/24/25 through 08/12/25 in the EMR indicated the following: a. On 07/26/25 from 8:08 AM until 12:08 PM, the BFR was documented at 400 ml/min. b. On 08/09/25 from 8:00 AM until 11:47 AM the BFR was documented at 400 ml/min. c. On 08/12/25 from 7:45 AM until 11:32 AM the BFR was documented at 400 ml/min. There was no documentation for the change to the prescribed BFR in the EMR. Review of P10's EMR revealed a prescribed Dialysis Flow Rate (DFR) of 800 ml/min. Review of one of six "Post Treatment" flow sheets from 07/31/25 through 08/12/25 in the EMR indicated the following. a. On 08/09/25 from 12:45 PM until 3:37 PM the DFR was documented at 500 ml/min. There was no documentation for the change to the prescribed BFR in the EMR. During an interview on 08/13/25 at 1:15 AM, Clinic Manager 2 confirmed the above findings and that staff did not follow the physician's order for dialysis treatment. Review of the facility's policy titled, "Patient Assessment and Monitoring" dated 05/01/23 revealed, "Check dialysate flow rate setting is correct, and the correct prescribed flow is being delivered ..." |