Pediatric Renal Center

“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: 47384 Based on observations made of the water treatment area and the treatment area with the facility’s Unit Supervisor (employee #2) and interviews, it was determined that the facility failed to monitor the environment to ensure that it is sanitary to reduce possible transmission of infectious agents. Findings include: 1.It was observed that the floor of the water treatment unit was wet. To the surveyor ask questions about the reason for the water on the floor, the water treatment technician answered that it was due to the draining of the day tank. 2. During observation of the water treatment area and treatment area between the first and second shifts with the facility’s Supervisor (employee #2) on 07/11/24 from 8:30 AM till 1:00 PM, wet gypsum board particles were observed behind the water purification tanks. This allows the generation of bacteria in the area.”

“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: 47384 Based on observations made of the water treatment and the treatment area with the facility’s Unit Supervisor (employee #2) and interviews, it was determined that the facility failed to monitor and test for chlorine, chloramine or total chlorine. Findings include: During observation of the chlorine test carried out in the first carbon tank and the evaluation of the procedure standard “ Procedimiento para hacer muestra de cloro y cloramina en los tanques de carbon”, it was identified that the personnel has a measurement of 0.5 ppm as a parameter. AAMI maximum level permitted for a test should be 0.1 mg/L.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 47384 Based on the review of documents related to Reverse Osmosis (RO) system monitoring, it was determined that the facility failed to secure to comply with parameters established by their own policies. Findings include: 1. During review of the document “ Registro Diario de Equipo Pre Tratamiento de Agua RO Central “ it was observed that the RO temperature parameters stated by the facility between 25 degrees and 35 degrees were not followed. The record of temperatures for the RO evaluated covers from July 1 to July 11, 2024, and in all lines the recorded measurements were below the lowest value of the parameter established. 2. During review of the document “ Registro Diario de Equipo Pre Tratamiento de Agua RO Central “ it was observed that the pre filter and post filter of 30 microns did not comply with parameters established by the facility.”

“DIST SYS-CULTURE/LAL/SITES/FREQ(NEW)/LOG CFR(s): 494.40(a) 6.3.3 Water distribution systems: culture/LAL sample sites/frequency (new)/log Water distribution piping systems should be monitored for bacteria and endotoxin levels. Bacteria and endotoxins shall not exceed the levels specified in [AAMI] 4.1.2. [(i.e., bacteria <200 CFU/mL and endotoxin <2 EU/mL] Bacteria and endotoxin testing should be conducted at least monthly. For a newly-installed water distribution piping system, or when a change has been made to an existing system, it is recommended that weekly testing be conducted for 1 month to verify that bacteria or endotoxin levels are consistently within the allowed limits. Monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop and the outlets supplying reuse equipment and bicarbonate concentrate mixing tanks. If the results of this testing are unsatisfactory, additional testing (e.g., ultrafilter inlet and outlet, RO product water, and storage tank outlet) should be undertaken as a troubleshooting strategy to identify the source of contamination, after which appropriate corrective actions can be taken. Bacteria and endotoxin levels shall be measured as specified in ANSI/AAMI RD62:2001 (see 2.3). All bacteria and endotoxin results should be recorded on a log sheet to identify trends that may indicate the need for corrective action. This Standard is not met as evidenced by: 47384 Based on the review of documents related to Reverse Osmosis (RO) system monitoring, it was determined that the facility failed to maintain bacteria and endotoxin levels as specified in The Association for the Advancement of Medical Instrumentation (AAMI). Findings include: During review of document related to the monitoring of the Central RO endotoxin monitoring it was identified that for the periods of 2022 to the month of July 2024 the facility identified at least five (5) times levels of endotoxins out of specifications of AAMI regulations. Dates of out of parameters endotoxin levels: 06/14/2022 - (0.921 EU) 09/22/2023 - (1.4 EU) 11/17/2023 - (1.91 EU) 02/17/2024 - (1.70 EU) 04/15/2024 -( 5.0 EU)”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 47384 Based on the review of documents related to training for personnel responsible for the water and dialysate systems and competencies it was determined that the facility failed to have a training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues as stated in AAMI RD 52. Findings include: 1. Facility failed to provide evidence of annual training for personnel responsible for the water and dialysate systems. 2. Facility failed to provide evidence of personnel certifications on water system management.”

“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: 47384 Based on observations made of the water treatment and the treatment area with the facility’s Unit Supervisor (employee #2) it was determined that the facility failed to implement and maintain a program to ensure that all equipment is maintained and operated in accordance with the manufacturer’s recommendations. Findings include: 1. During observation of the water treatment area it was noted that metal framing for both day tank and RO had rust due to contact with water on floor. 2. All four (4) water treatment tanks were observed with broken blue masking tape on the bottom part of the tank. 3. Mixing tank was observed in the room next to the water treatment room, this tank has not been in use since the dialysis machines had been changed to B-bags. During the survey the water technician filled the mixing tank which caused the units day tank to fall beneath the safe level and caused the water level alarm to activate.”