Fmc - Lake Clarke Shores Dialysis Center

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 51535 Based on administrative record review, clinical record review, and staff interview, the facility failed to consistently follow the established policy and procedures regarding the total chlorine test procedure for 1 of 3 months reviewed. This is evidenced by the staff failure to perform the total chlorine testing within 4 hours of the previous test. The findings included: The facility’s policy regarding Carbon Filtration Monitoring for In-center Central Water Systems published 02/03/2025 documented, “Total Chlorine test will be performed prior to initial treatment and every four hours. If unable to perform total chlorine testing within 4 hours of the previous test, treatments must be discontinued. Staff must follow the patient assessment and monitoring” Review of the facility’s Post Worker Carbon Tank Log revealed that the facility staff failed to provide evidence that the total chlorine testing was performed every four hours as follows: for six hours on March 14, 2025, between 08:00 AM and 2:35 PM. In March, the facility staff documented on the log 3/14/25 at 08:00. However, there is no documentation of the total chlorine test being performed again until 03/14/25 at 2:35 PM (6 hours and 35 minutes later.) There is no documentation that the staff performed total chlorine testing within the four hours, discontinued dialysis treatments, and followed the patient assessment and monitoring per policy. The clinical record review conducted on 03/19/25 revealed 10 patients received their full hemodialysis treatment between 12:00 PM and 14:35 PM. The treatment records do not provide an explanation for the deviation from the total chlorine testing of every four hours. An interview was conducted on 03/19/25 at approximately 11:50 AM with the Area Technical Operation Manager (ATOM). The surveyor reviewed with the ATOM the documentation on the Total Chlorine Log. He confirmed that there is no documentation of chlorine testing every four hours on 03/14/25 between 08:00 and 2:35 PM. The facility electronically documents the chlorine testing and results. However, when the staff are unable to electronically submit the testing results, the staff will utilize paper. The facility also did not provide written evidence that the staff conducted chlorine testing every 4 hours on 03/14/25.”

“ACID CONC DIST-CONC LABELED & COLOR-CODED RED CFR(s): 494.40(a) 5.5.3 Acid concentrate distribution systems: labeled & color-coded red Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary. More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains. This Standard is not met as evidenced by: 22517 Based on observation and staff interview, the facility failed to ensure that the Acid Concentration distribution system at the valve panels (wall boxes) are appropriately labeled to clearly indicate the type of acid concentrate coming through the line. The facility has acid concentration distributed through the central delivery system to the valve panel/wall box. Acid solutions centrally delivered to treatment stations, outlets must be clearly labeled to identify specifically the chemical make-up of the solution being delivered. The findings included: An observation of the water room as conducted on 03/18/25 at 9:30 AM revealed that the facility had drums containing 2K 2.5 Ca (potassium, Calcium) that was then transferred to a storage tank which distributed the acid concentration to each dialysis station on the treatment floor. An observation on the treatment floor was conducted on 03/18/25 beginning at 10:20 AM revealed that the facility’s 13 stations valve panel/wall boxes were label acid concentration but the label did not specifically identify the acid concentration being distributed. An interview was conducted on 03/20/25 at approximately 2:00 PM with the Area Technical Manager (ATOM). He confirmed that the wall boxes did not identify the acid concentration and he would be ordering supplies to correctly identify the acid concentration.”

“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: 51535 Based on observation and staff interview, the facility failed to ensure supplies were maintained and operated in accordance with the manufacturer’s recommendations, as evidenced by the staff failure to ensure supplies are readily available and are not available for use beyond the manufacturer’s documented expiration date. The findings included: Observation of the treatment floor, laboratory, and storage supply room conducted on 03/18/25 at 12:03 AM revealed the following supplies remained available for use beyond the manufacturer’s documented expiration date: suture removal tray which expired 07/31/2024, recirculation connector which expired 11/30/2020, BD green top vacutainers which expired 02/28/2025, vacuette red/yellow top expired 10/31/22 and located inside storage drawer on treatment floor. An interview with the Registered Nurse was conducted on 03/18/25 at 12:03 AM, she confirmed the items were expired. She reports that she will discard the expired items.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 51535 Based on clinical record review and interview, the facility failed to provide evidence that they identified and completed a comprehensive interdisciplinary assessment for 1 of 5 patients reviewed (Patient #2), who experienced multiple extended hospitalizations, extending greater than 15 days in a 30 day period. The findings included: The following are unstable criteria: a) Hospitalization of more than 15 days with discharge occurring within the last 30 days, or b) More than 3 admissions in the last 30 days OR marked deterioration in health status, Interdisciplinary Team (IDT) to identify and document specific reasons. Patient #2 was admitted to the facility on 03/15/22. A review of the facility’s hospitalization log revealed Patient #2 had the following hospitalizations: 06/18/24-06/27/24 (9 days) 07/9/24-07/22/24 (13 days) 07/27/24-08/07/24 (8 days) 08/15/24-09/05/24 (15 days) 10/5/25-10/16/24 (11 days) 01/18/25-02/05/25 (18 days) A review of the clinical record revealed that the last comprehensive interdisciplinary assessment and Plan of Care (POC) was dated 05/23/2024. This annual POC identified the patient as stable. The facility did not provide evidence that the patient was identified as unstable when she experienced extended hospitalization of greater than 15 days in 30 days, nor did the facility perform the appropriate comprehensive interdisciplinary assessment upon the patient’s return to the facility. An interview was conducted with the Clinical Manager (CM) on 03/19/25 at 3:24 PM. The CM stated she recognized that Patient #2 was not made unstable. She felt that the patient was chronically unstable. However, she confirmed that the facility did not identify or complete an assessment to determine that the patient was unstable after the patient experienced multiple extended hospitalizations.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 22517 Based on clinical and administrative record review and staff interview, the facility failed to ensure the appropriate time monitoring during treatments; failed to ensure the appropriate time elapsed after the administration of heparin and initiating the treatment and the facility staff failed to ensure the nurse completed a post treatment assessment. This failure affected 2 of 5 sampled patients (Patient # 3 and # 4). The findings included: Review of the facility’s policy regarding Patient Assessment and Monitoring, published 05/01/2023, documented, “The Registered Nurse will assess/reassess any findings addressed pre or during treatment as needed. Lungs sounds, edema, heart sounds, the Registered Nurse will assess/re-assess post treatment as indicated. During treatment - Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state state regulations. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations. The facility’s policy on Heparin Bolus Administration published 11/01/2021 documented regarding Administering Heparin, “Allow heparin to circulate within the bloodstream for a minimum of 3-5 minutes before initiating treatment to prevent blood from clotting in the dialysis circuit.” 1) Review of the clinical record for Patient # 4 revealed that the patient was admitted to the facility on 04/23/21 and is prescribed to receive dialysis treatment 3 times a week for 3 hours and 50 minutes. The physician also prescribed for the patient to receive Heparin 6000 units bolus. Review of 12 treatments dated 02/19/25 to 03/17/25 revealed the following irregularities: On 02/19/25 and 02/24/25, the staff failed to wait 3-5 minutes before initiating the treatment after the Heparin was administered. On 02/19/25, the nurse documented she administered the heparin at 11:56 AM. The treatment was started at 11:58 AM (2 minutes). On 02/24/25, the nurse documented she administered the heparin at 11:45 AM. The treatment was started at 11:47 AM (2 minutes) On 02/26/25, the nurse failed to document a post nursing assessment. 2) Review of the clinical record for Patient # 3 revealed that the patient was admitted to the facility on 12/02/18 and is prescribed to receive dialysis treatment 3 times a week for 3 hours and 30 minutes. Review of 12 treatment sheets dated 02/29/25 to 03/17/25 revealed the following irregularities: On 03/12/25, the staff failed to monitor the patient every 30 minutes. The staff documented they monitored the patient at 1:07 PM. However, the staff did not monitor the patient again until 2:01 PM, 54 minutes later. On 02/26/25, the nurse failed to perform a post treatment assessment. An interview was conducted on 03/20/25 at approximately 2:30 PM with the Clinical Manager. The above irregularities were discussed and confirmed.”