033503 Gila River Dialysis West

“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: 22676 Based on observation, interview, review of the “Daily Water Treatment Logs,” and the facility’s policy, the facility failed to ensure the staff monitored the chlorine after the first carbon tank every four hours as required by the regulations and facility policy for one days of 52 days reviewed (06/03/24). This deficient practice had the potential to cause harm to all 65 patients receiving dialysis at the facility by exposing them to harmful chlorine. Findings include Review of the facility’s electronic “Total Chlorine Log” from 06/01/24 through 07/31/24, located in the paper Chlorine logs, revealed the facility failed to conduct the chlorine test every four hours as required by Federal Regulations and facility policy as evidenced by the following: On 06/03/24, the staff conducted the chlorine test at 4:33 AM and did not recheck the chlorine until 10:02 AM. Five hours and 29 minutes later. During an interview on 08/28/24 at 1:30 PM, Clinic Director 2 and the Biomedical Technician 6 confirmed the staff are required to conduct the chlorine test every four hours. They both confirmed the staff did not conduct the chlorine test as required every four hours. A review of the facility’s policy titled, “In-Center Total Chlorine Monitoring,” dated 06/24, indicated, “Total Chlorine testing is performed before the first patient is put on and every 4 hours thereafter.””

“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: 22676 Based on observation, interview, and review of the manufacturers direction for use, , the facility failed to ensure three of three oxygen concentrators had the dust filter covering the air intake area of the casing cleaned at least weekly. This deficient practice had the potential to allow debris to enter the oxygen concentrator and could affect the patients breathing. Findings include: During observation on the treatment floor on 08/29/24 three of three Invacare Oxygen Concentrator dust filters appeared to have a dusty black filter located on the back of the concentrator. During an interview on 08/29/24 at 10:15 AM Certified Hemodialysis Technician (CHT) 12 was asked how often the dust filter on the Invacare Oxygen concentrator was cleaned or replaced. CHT12 stated the facility had someone to come in and check the concentrator. When asked if the dialysis staff ever changed or cleaned the filter, he/she stated was not sure and would have to ask Nurse. During an interview with Registered Nurse (RN) 8 on 08/29/24 at 10:20 AM he/she confirmed the staff does not change or clean the filter. He/she stated that he/she believed it was done yearly when the company comes in to check all equipment on an annual basis. During an interview on 08/29/24 at 12:40 PM, the Director stated he/she stated they did not have a policy but followed the manufacturer’s instructions. The Director confirmed that they had not been cleaning the filters at least weekly as required by the manufacturer. Review of the manufacturer directions for use for the “Pertecto2 V Oxygen Concentrator by Invacare” (sic) Model IRC5POV)” indicated, “Remove the filter and clean at least once a week depending on environmental conditions. NOTE: Environmental conditions that may require more frequent cleaning of the filters include but not limited to high dust, air pollutants, etc.””