Trinitas Cranford Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 51990 Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that: 1) the quality of water and dialysate provided to hemodialysis patients is within the Association for the Advancement of Medical Instrumentation’s (AAMI’s) standards ensuring the Reverse Osmosis (RO, a water treatment system) Water Purification and Storage System Room is locked and secured (Tag V-184); 2) chlorine/chloramine testing is performed in accordance with facility policy in one of one observation (Tag V-196); and 3) chemical disinfection of the RO in six out of six RO logs reviewed is documented in accordance with facility policy (Tag V-219). On 08/27/25 at 10:00 AM, an IJ was identified for the facility’s failure to ensure the RO room was locked and secured, restricted to authorized staff and personnel. At 1:43 PM, the IJ template was presented to the Director of Renal Services, and a Removal Plan was requested. An acceptable Removal Plan was received on 8/27/25 at 3:00 PM. The facility implemented the following: a Governing Body (GB) meeting was held to execute a Removal Plan for the immediacy of the IJ and staff education was provided. The RO door lock was changed to a functioning keypad lock and staff education was conducted. On 08/27/25 at 3:07 PM, the surveyors were able to verify implementation of the Removal Plan through facility staff interviews, review of the staff education documentation, and by conducting a tour of the Water Purification and Storage System Room. The IJ was removed on 08/27/25 at 3:10 PM and Condition Level non-compliance remains. Cross reference: 494.40(a) - Environment Secure & Restricted”

“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: 51990 Based on observation, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure the Reverse Osmosis (RO) Water Purification and Storage System Room is locked and secured. Findings include: On 08/27/25, during a tour of the Hemodialysis (HD) Treatment Floor, the following was revealed: At 10:00 AM, the door to the “R/O (Reverse Osmosis) Room,” where the RO water purification and storage system is present, located off the HD Treatment Floor, was unlocked and unsecured. The surveyor was able enter the room, unaccompanied by facility staff, and determined that there were no staff members present inside. The RO room door did not restrict unauthorized persons from entry into the area. At 10:12 AM, interviews were conducted with Staff (S)2 and S3. S3 stated, “We never lock the RO door, we just keep it closed.” S2 then stated, “Some of us do lock it.” At 10:15 AM, during an interview and tour with S1, he/she demonstrated the RO room door handle locking mechanism to the surveyors and stated, “You have to physically lock the door by pushing in the lock button on the inside handle.” S1 then explained that this process had to occur prior to closing the door and that staff should be verifying that the door is locked after closure. S1 further stated the door should be kept locked at all times. At 10:20 AM, an interview was conducted with S4, who stated that he/she was in the RO room at 9:30 AM. S4 further explained that he/she had conducted chlorine testing in the room and when asked by the surveyors whether he/she had locked the door upon exit, S4 stated, “I assumed that door had a slam lock, I must have made a mistake, and I don’t recall whether or not I checked to see if the door was locked after I left the room.” An interview with S5 was conducted at 10:28 AM. S5 stated that the RO room should always be kept locked. Facility policy titled, “RO Equipment and Physical Safety,” revised 02/2023, stated, “... Policy: ... Access to the RO room should be restricted to authorized personnel, and must be kept closed at all times ...””

“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: 51990 Based on one of one observation of total chlorine testing, staff interview, and review of facility documents, it was determined that the facility failed to ensure that chlorine/chloramine testing is performed in accordance with facility policy. Findings include: On 08/27/25 at 12:27 PM, in the “R/O [reverse osmosis] Room,” Staff (S)10 performed total chlorine testing. S10 obtained a water sample in a cup and swished (a gentle back and forth movement) the RPC (Reprocessing Products) Ultra-Low Chlorine Test Strip in the water sample for 15 seconds. S10 then removed the test strip, waited 15 seconds, then read the test strip and compared the result to the RPC Ultra-Low Chlorine Test Strip’s color chart. During an interview at 12:37 PM, upon completion of the testing, S10 stated that the test strip is swished in the water sample for 15 seconds and the wait time to read the test strip was also 15 seconds. This was not in accordance with facility policy. A review of S10’s personnel file contained a document titled, “Initial and Annual Procedure and Skills Assessment,” completed on 02/01/25, that included Water/Dialysate training. Facility policy titled, “Total Chlorine Testing with RPC Ultra- Low Total Chlorine Test Strip,” formulated 09/2018, stated, “Policy: ... Staff must use a timer to accurately verify wait times described in procedure ... Procedure: ... 4. ... Remove one test strip from its foil package and swish it in the sample for 20 seconds ... 7. ... Wait 20 seconds for the test strip color to develop ... 8. ... After the 20 seconds wait period, immediately compare the strip color to the K 100-0118 color chart ...””

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 51990 Based on a review of facility documents and staff interviews, it was determined that the facility failed to ensure that chemical disinfection of the Reverse Osmosis (RO) Water Purification System in six out of six RO logs reviewed, is documented in accordance with facility policy. Findings include: During an interview on 08/27/25 at 12:54 PM, Staff (S)5 stated that the RO is disinfected monthly with Minncare (a chemical disinfectant) by a Patient Care Technician (PCT). On 08/28/25, a review of facility logs titled, “Daily Log for R/O and Water System from March 2025 to August 2025 did not contain documented evidence that RO disinfection with Minncare was performed by the PCT. Upon review of the log at 10:45 AM with S5, he/she stated that RO disinfection was performed on the following dates: 03/09/25, 04/06/26 [sic], 05/05/25, 06/08/25, 07/06/25, and 08/10/25. The “Renal Tech [technician] Comments” section of the log on these dates only stated, “M,” and did not specify that monthly RO disinfection was completed with Minncare. During an interview on 08/28/25 at 11:00 AM, S2 stated that the RO chemical disinfection was performed every first Sunday of the month and confirmed that the log did not have Minncare disinfection documented. A follow-up interview at 1:15 PM was conducted with S1 and S9, who both confirmed that there was no documented evidence of monthly chemical disinfection for the above dates. Facility policy titled, “Disinfection of Osmonics R/O [sic] System-[Name of Facility],” revised 02/2017, stated, “... Procedure ...5. Add 24 ounces, 3/4 bottle of Minncare cold sterilant disinfect solution into container or until 1% strength dilution is reached, ... 42. After all (15) renal stations are flushed and cleaned of disinfectant (0-PPM readings) a complete daily log entry of operations is to be recorded into the log book to indicate disinfection was performed ...””