Fmc South Mobile

“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: 22676 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 58 of 58 patients receiving care at the facility. Findings include: During a tour of the treatment floor on 07/16/25 at 9:30 AM, the blue clamps (hemostats) used in patient care were observed to be draining on a blue cloth next to the bleach container. There were numerous clamps in the pile that were 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 07/16/25 at 9:30 AM, the Administrator confirmed the clamps were to be in the open position during draining after disinfection. 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 . . .””

“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: 22676 Based on observation, interview, facility policy review, and review of Centers for Disease Control (CDC) guidance, the facility failed to ensure that the wall boxes (dispensing outlets) at 25 of 25 dialysis stations (Station 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, and 25) were clean and free of a build-up of a dark yellow substance. This deficient practice had the potential to cause bacteria to grow in the wall boxes and could potentially affect 58 of 58 patients receiving in-center hemodialysis at the facility. Findings include: During an observation of all wall boxes on 07/16/25 at 9:15 AM, the wall boxes at Stations 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, and 25 were observed to have a dark yellow sediment build-up on the bottom of the wall boxes. During an interview on 07/16/25 at 9:15 AM, the Administrator confirmed the above findings. He/she stated the staff were supposed to clean the wall boxes daily. Review of the facility’s policy titled, “Cleaning and Disinfection of the Dialysis Station,” dated 09/05/23, indicated, “Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. All surfaces shall be surface disinfected with 1:100 bleach solution. Special attention should be given to removing build-up and/or cleaning splatter and spray of concentrate solution. If concentrate leaks are noted at the wall box, staff should notify biomedical services for repair.” Review of the “CDC Dialysis Safety,” located at www.cdc.gov and titled, “. . . Wall boxes and Drains,” dated October 25, 2019, indicated, “All box surfaces should be disinfected at least daily (e.g., at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (e.g., when visibly dirty). Cleaning and disinfection of the wall box should be performed after the patient has left the station, and not during patient care activities . . . More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer . . .””

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 22676 Based on observation, interview, and policy review, the facility failed to restrict access to the water purification and storage system to only authorized users on one of three survey days. Failure to restrict access to the water treatment area has the potential to negatively impact the safety and well-being of 58 of 58 in-center dialysis patients receiving treatments at this facility. Findings include: During the flash tour observation on 07/16/25 at 10:30 AM, it was revealed the gate designated as the entrance to the water purification system and storage system was secured by a key lock entry. The key was observed to be in the lock, and the water room was not secure. During an interview on 07/16/25 at 10:30 AM, Biomedical Technician 6 confirmed the key was in the lock. He/she stated that the staff usually kept the key in a drawer in the Nurses station. Review of facility’s policy titled, “Physical Security and Facility,” dated 09/05/23, revealed,”. . . Restricted access must be maintained to prevent unwanted tampering with the water treatment equipment . . .””

“MIXING SYSTEMS-CLEANING CFR(s): 494.40(a) 6.4.1 Mixing systems: cleaning Concentrate mixing equipment should be either: (1) completely emptied, cleaned, and disinfected according to the manufacturer’s instructions; or (2) cleaned and disinfected using a procedure demonstrated by the facility to be effective in routinely producing concentrate meeting [these regulations related to allowable bacterial and endotoxin levels]. The disinfection data should be recorded for each ...disinfection cycle using a dedicated log. This Standard is not met as evidenced by: 22676 Based on observation, interviews, and policy review, the facility failed to ensure that one of one bucket holding reverse osmosis (RO) water used to rinse acid container caps and wands was clean and failed to ensure 6 of 6 acid containers were rinsed and inverted to drain. This had the potential to cause harm to 58 of 58 in-center hemodialysis patients receiving care at the facility. Findings include: During a tour of the Storage Area on 07/16/25 at 10:30 AM, the following was found: 1. A gray bucket labeled “RO Water” was observed to have a buildup of a dark orange substance all around the bottom of the bucket. There were two caps and acid wands soaking in the bucket. 2. There were six empty acid containers all laying sideways on a cart and not inverted to drain. During an interview on 07/16/25 at 10:30 AM, Biomedical Technician 6 confirmed the above findings. Review of facility policy titled, “Acid Concentrate Storage and Handling,” dated 09/03/24, revealed, “. . . Place the rinsed containers on a shelf inverted to allow container to air dry . . .””

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 22676 Based on observation, interview, and review of the manufacturer’s direction for use, the facility failed to ensure that one of one bottle of Mesa lab 14.0 mS/cm (milli siemens per centimeter), used to check the conductivity of the Myron L[sic] D6 meter (a meter used to conduct the conductivity and PH), was not available for use after its’ expiration date. This had the potential to cause harm to 58 of 58 in-center hemodialysis patients receiving care at the facility. Findings include: During a tour of the Water Room on 07/16/25 at 9:00 AM, the following was found: 1. One bottle of 14.0 mS/cm conductivity solution with an open date of 05/09/25. Instructions on the bottle stated the solution expired 30 days from the date of opening. During an interview on 07/16/24 at 9:00 AM, the Administrator confirmed the conductivity solution was opened on 05/09/25 and expired 30 days after the date of opening. The Administrator stated they used the manufacturer’s instructions which were printed on the front of the bottle as the facility policy. Review of Mesa lab manufacturer’s instructions, dated 01/2023, revealed, “. . . 14.0 mS/cm solutions expire 30 days from opening . . .” These instructions were also printed on the front of the bottle.”

“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: 22676 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 seven sampled in-center dialysis patients (Patient (P3) and P5). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for 58 of 58 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P3’s “Treatment Detail Report,” located in the electronic medical record (EMR), revealed a prescribed Dialysis Flow Rate (DFR) of 800 milliliters per minute (ml/min). Review of two of six flow sheets from 07/02/25 through 07/17/25 indicated the following: a. On 07/10/25 from 9:05 AM - 11:49 AM, the DFR was documented at 500 ml/min. b. On 07/15/25 from 7:58 AM - 11:46 AM, the DFR was documented at 500 ml/min. There was no documentation for the change from the prescribed DFR. 2. Review of P5’s “Treatment Detail Report,” located in the EMR, revealed a prescribed Blood Flow Rate (BFR) of 400 ml/min. Review of three of six flowsheets from 07/02/25 through 07/16/25 indicated the following: a. On 07/02/25 from 6:23 AM until 11:05 AM, the BFR was documented at 450 ml/min. b. On 07/04/25 from 6:22 AM until 10:52 AM, the BFR was documented at 450 ml/min. c. On 07/07/25 from 6:33 AM until 11:01 AM, the BFR was documented at 450 ml/min. There was no documentation for the change from the prescribed BFR. During an interview on 07/18/25 at 11:00 AM, the Administrator confirmed the above findings and stated that staff did not follow the physician’s order for dialysis treatments. Review of the facility’s policy titled, “Pre-Intra-Posttreatment Data, Collection, Monitoring and Nursing Assessment,” dated April 2024, stated, “. . . identity, prescription, and machine settings are verified by teammate . . . f. Blood flow rate . . .””