Driscoll Children’s Valley Dialysis Center

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 30177 Based on interview and review of the facility’s “Emergency Preparedness Plan (EPP),” the facility failed to ensure the EPP had strategies to mitigate potential cyber-attacks. This failure had the potential to expose the nine in-center hemodialysis patients receiving treatments at this facility to negative outcomes. Findings include: Review of the facility’s undated “Emergency Preparedness Plan,” revealed the plan did not contain strategies to mitigate cyber-attacks. The “Hazard Vulnerability Assessment” did not include cyber-attacks, which the emergency preparedness plan is built on the risk assessment. Interview on 11/20/23 at 1:15 PM, the Clinical Coordinator was asked to identify the potential hazards selected in the facility’s risk assessment and describe how the facility would handle cyber-attacks. The Clinical Coordinator stated the “Emergency Preparedness Plan” did not incorporate a process to mitigate cyber-attacks and revealed that he/she was unable to describe the facility’s strategy to manage cyber-attacks.”

“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: 30177 Based on observation, staff interview, review of manufacturer instructions for use (IFU), and review of the facility’s policy, the facility failed to ensure two of two staff members (the Biomedical Technician (BMT) and Charge Nurse) observed performing total chlorine testing followed the manufacturer’s IFU and facility policy. In addition, two of two employees failed to “Note the temperature of the incoming water to the RO [Reverse Osmosis-water purification system] system at the display monitor and ensure its documentation on the RO daily log.” The failure to complete the test correctly placed all nine in-center hemodialysis patients at risk of receiving water with chlorine/chloramine levels greater than 0.1 parts per million (ppm). Levels of chloramines in dialysis water greater than 0.1 ppm may cause severe injury or death to dialysis patients. Findings include: 1. Observation of the total chlorine testing with the BMT on 11/20/23 at 10:00 AM, who was responsible for chlorine checks daily during the weekdays, revealed BMT collected a 100-milliliter (ml) water sample from the test port used for the sample. BMT removed a test strip from the foil package without checking the expiration date of the strip, swished the test strip in the sample for 20 seconds, and failed to note the temperature of the incoming water to the RO). After removing the strip from the sample, BMT briskly shook the test strip seven times to remove excess water and failed to wait 20 seconds for the test strip color to develop. In an interview with the BMT on 11/20/23 at 10:15 AM, he/she was asked to review the “RPC [sic] Ultra-Low Total Chlorine Test Strips” IFU. When asked if he/she swished the test strip in the sample for the amount of time indicated according to temperature ranges on the IFU, he/she replied, “No.” When asked if he/she checked the expiration date prior to use, the BMT replied, “No.” The BMT was then asked if he/she shook the test strip once, briskly, to remove excess water, he/she replied, “No.” The BMT confirmed that he/she did not wait the 20 seconds for the test strip color to develop. The BMT agreed the chlorine test had not been performed according to the IFU and facility policy. 2. Observation of the total chlorine testing with the Charge Nurse on 11/20/23 at 10:30 AM, who was responsible for chlorine checks on the weekends when working. The Charge Nurse collected a 100- ml of water sample from the test port used for the sample. The Charge Nurse removed a test strip from the foil package without checking the expiration date of the strip, and swished the test strip in the sample for 20 seconds, and failed to note the temperature of the incoming water to the RO. After removing the strip from the sample, he/she failed to wait 20 seconds for the test strip color to develop. In an interview with the Charge Nurse on 11/20/23 at 10:40 AM, he/she was asked to review the “RPC Ultra-Low Total Chlorine Test Strips” IFU. When asked if he/she performed the chlorine test according to the IFU and facility policy, the Charge Nurse replied, “No.” A review of the “RPC Ultra-Low Total Chlorine Test Strips Instructions for Use,” the brand of test strips used by the facility, revealed, “Collect a fresh 100 ml sample of water ... Remove one test strip from its foil package and swish it in the sample for the amount of time indicated according to the temperature ranges ... Remove the strip and shake once, briskly, to remove excess water. Do not use a test strip after the expiration date ...Wait 20 seconds (in bold print) for the test strip color to develop ... After the 20 second wait period (in bold print), immediately compare the strip color to the (brand name) color chart to determine the total chlorine level in the sample.” A review of the facility’s policy titled “Daily Water System Total Chlorine Monitoring,” effective 01/01/20, revealed, “Dip the test strip into the water sample for 20 seconds ... The 20 second dip time for the total chlorine testing procedure is for water samples at approximately room temp or warmer. Note the temperature of the incoming water to the RO system at the display monitor and ensure its documentation on the RO daily log.””