Davita Northeast Dialysis

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 32234 Based on observation, interview, and record review, the facility failed to ensure one of two isolation rooms and all the equipment in the isolation room were clearly labeled as “isolation”. This failure had the potential for the staff to use the equipment in other areas of the facility resulting in transmission and spread of infectious diseases to patients and staff. Findings: During a concurrent observation and interview on 11/8/24 at 3:30 p.m. in Isolation Room # 2, with Clinical Manager (CM), the Isolation Room # 2 was not labeled as “Isolation.” A blood pressure (BP) cuff was noted to be unlabeled as “Isolation.” CM stated Isolation Room # 2 and the BP cuff inside Isolation Room # 2 should have been labeled as “Isolation.” CM stated the facility had two isolation rooms. During an interview on 11/8/24 a 4:30 p.m. with Facility Administrator (FA), FA stated, “We have three Hepatitis B (an infection of the liver caused by the Hepatitis B virus and is a contagious liver infection spread from person-to-person via blood or body fluids) isolation patients.” FA verified and stated all the isolation rooms and all isolation equipment needed to be labeled as “Isolation.” During a review of the facility’s policy and procedure (P&P) titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” dated 4/24, the P&P indicated, “Dialyzing Confirmed Positive or Suspected/Unknown Status. . .Location. . .Isolation room or designated isolation area. . .Duration. . . Long term use. . .19. Equipment/ Supplies a. Dedicated ancillary supplies such as blood pressure cuffs. . .b. Such supplies will be labeled “isolation” and will remain in isolation room/area or station and will be disinfected after every patient use with a 1:100 (one to one hundred) bleach solution.””

“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: 32234 Based on interview and record review, the facility failed to follow their policy and procedures (P&P) titled “Routine Total Chlorine Testing Log” when one of six chlorine tests on 10/12/24 was not completed. This failure had the potential for unsafe chlorine levels which has the potential for adverse effects to the patients. Findings: During a concurrent interview and record review on 11/8/24 at 2:55 p.m. with Clinical Manager (CM), the facility’s log titled “Routine Total Chlorine Testing Log (RTCT),” dated October 2024 was reviewed. The RTCT indicated for the week of 10/7/24 to 10/12/24 the total chlorine test was missing and was not done on 10/12/24 at 4 p.m. CM stated the water system total chlorine testing should be done every four hours (total of six times a day) by the Patient Care Technician (PCT) with the licensed nurse. CM stated, “All chlorine test is signed by the PCT and the licensed nurse.” During a review of the facility’s policy and procedure (P&P) titled, “Daily Water System Total Chlorine Monitoring,” dated 10/24, the P&P indicated, “. . .Total Chlorine testing is done on a daily basis prior to the use of dialysis quality water for any process and the start of dialysis treatment(s) and within every four (4) hours until all activities that require use of dialysis quality water are completed. . .11...Record results on the “Routine Total Chlorine Testing” log which contains entries for day, date, test number, test time, signature of person performing the test, test results, and signature of licensed nurse verifying that each test on the daily log is complete and results appropriate.””