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Water Testing for Dialysis Unit VA Maryland Healthcare System Introduction/ Background Hemodialysis can sustain the life of a patient; however, it can cause life-threatening issues if the treatment wa... Water Testing for Dialysis Unit VA Maryland Healthcare System Introduction/ Background Hemodialysis can sustain the life of a patient; however, it can cause life-threatening issues if the treatment water is contaminated. Dialysis water testing for endotoxins is essential to patient safety. If certain amounts of endotoxin are introduced into the bloodstream or spinal fluid via a parenteral drug or medical device, fever, septic shock, organ failure, or even death can occur. The Association for the Advancement of Medical Instrumentation has published both standards and recommended practices that address both water and the dialyzing solutions. Some of these recommendations have been adopted into Federal Regulations by the Centers for Medicare and Medicaid Services as part of the Conditions for Coverage, which includes limits on specific contaminants within water used for dialysis, dialysate, and substitution fluids. Chemical, bacterial, and endotoxin contaminants are health threats to dialysis patients. SPECIFIC CONDITIONS/REQUIREMENTS A. Water and Dialysate Quality Monitoring: Microbiology and Endotoxin Sampling Tests Hemodialysis System Diagnostic: Testing 2 machines Heterotrophic Plate Count Hemodialysis: 5 machines x 2 sample points = 10 samples Microbiological Analysis for Hemodialysis (Dialysis/Dialysate) 5 machines x 2 sample points = 10 samples d. Shipping 5 machines Frequency: monthly (Base Year + 4 Option Years) Additional tests may be required if there is an outbreak (Optional) Number of machines: 5 (Total) Supplies: sampling supplies including alcohol pads, syringes, gloves, containers shall be supplied by the laboratory performing the test to VAMHCS All sampling shall be obtained per established procedure documented in Dialysis Services Policy and Procedures All samplings shall be documented using a physical and/or digital logbook Shipping: samples shall be prepared, labeled and transported per laboratory instruction. Testing laboratory will be responsible for shipping arrangements made in consultation with VAMHCS. Results shall be sent to VAMHCS Dialysis Unit Manager in hardcopy and digital version for entry into CPRS as suitable. 7. The testing facility MUST notify station by direct via preestablished Email chain upon finding any testing variable outside of acceptable range within 24hours: Jagman.chahal@va.gov Audrey.pinnock@va.gov Connie.williams@va.gov Stephen.seliger@va.gov All testing must comply with established industry standards. Objectives/ Requirements Validation of the water treatment and dialysis fluid production systems is a documenting process that occurs once a new system is installed and operated according to the manufacturer's recommendations to determine whether it consistently produces fluids of the required quality. Dialysate must be cultured weekly for new systems for a minimum of one month or until a pattern has been established (i.e., two consecutive tests have met the standards). Dialysate must also be cultured weekly if the acceptable limits are exceeded. The chemical contaminants within the water system are to be tested at least annually in combination with the evaluation of the source water (incoming feed water). Total chlorine should be monitored prior to each patient shift after the primary carbon tank to confirm that the concentration is below 0.01 mg/I. The dialysis storage water tanks and water distribution piping system should be monitored once a month, or as determined from the validation process, for microorganisms and endotoxin. The standard dialysis fluid from each dialysis machine within a facility should be tested at least once a year for bacteria and endotoxin, where regular testing is conducted on a different machine each month (machines are tested on a rotation). Ultrapure dialysis fluid is also tested monthly, but only for endotoxin. However, if the bacteria- and endotoxin-retentive filter is validated, operated, and monitored according to the manufacturer's instructions, this testing may not be necessary. Specifically for endotoxin-retentive filters, daily monitoring of the pressure across the filter is adequate in assuring endotoxin levels are within the limit. Additionally, for anyone who develops signs and symptoms during the dialysis session, blood cultures and dialysate (from the patient's machine) for cultures and endotoxin should be obtained as a routine part of the patient workup. Clinical symptoms may include fever (38.3°C/101°C), septic shock, chills (visible rigors), malaise, abdominal pain, nausea, vomiting, diarrhea, anxiety, confusion, and shortness of breath. Unlike in pyrogenic reactions, symptoms of septicemia typically do not resolve on cessation of dialysis treatment. Monitoring is only a small part of assuring quality dialysis and required for reimbursement by Medicare. Dialysis facilities need to have up-to-date logs that allow the technicians or supervisor to trend the chemical, bacterial, and endotoxin data. Facilities should also be proactive in disinfecting or conducting corrective measures when action levels have been reached, and certainly before the maximum contamination levels have been exceeded. Regular maintenance of the machines, knowledge of factors that impact dialysis quality, and pathways for corrective measures to be successful are additional keys for effective and safe dialysis. The monitoring data stay within the facility, but if there is an issue and State or CMS surveyors request reports, these data are required to be available for review. Conventional Municipal drinking Conventional dialysate/ Ultrapure Parameter water dialysis water Dialysis fluid dialysate Heterotrophic bacteria (HPC) S500 CFU/ml Total Viable Count CMS max allowable limit1 - <200 CFU/ml <200 CFU/ml <0.1 CFU/ml CMS action leve11.2 50 CFU/ml SO CFU/ml ANS max allowable limit3 ANS action leve123 - <100 CFU/ml SO CFU/ml <100 CFU/ml 50 CFU/ml <0.1 CFU/ml Endotoxin CMS max allowable limit1 - <2 EU/ml <2 EU/ml <0.03 EU/ml CMS action level1.2 1 EU/ml 1 EU/ml ANS max allowable limlt3 ANS action level23 - <0.25 EU/ml 0.125 EU/ml <0.5 EU/ml 0.25 EU/ml <0.03 EU/ml Monitoring and Reporting CRITICAL WATER AND DIALYSATE REQUIREl\IE!\"TS Watel' (pl'oduct) chemical quali · , Within maxinnun allowable levels per AAMI:RD 52 Table I (VI77) , Tested at least annually and as indicated (V20I) Wntel' (product) mic1·obioloi1cal quali · , Maxinuuu 200CFU'2EU: Action levels 50CFU1IEU (VI 78) , Distribution system disinfected monthly (V219} , Tested at least montltly from sites: actions taken if >action levels (\1213) Dialysate mic1·obiologkal quality , Mrutimtun 200CFU/2EU: Action levels 50CFUl1EU (VlS0) , Tested montltly from at least 2 HD machines: each HD m.,chine tested at least awmally: sampling methods: actions taken if >action levels (V253) CW01ine/chlo1 amines 1·emo, 11l (cn1·bon) , 2 caroon tanks (or banks of tanks) with sample port between (Vl92) , Sufficient carbon to remove chloriue1chlorrunioes: total EBCT 10 min verified by interview and or record review (Vl95) CW01-loe testing , Water after first carbon tank(s) tested for total chlorine prior to each ICHD shift or approx. q 4 hours d\lt'Uli the treatment day (Vl96) , If total chlorine test >O.lmg/L. "brcal."through". immediate actions taken (Vl97) Ren1·se Osmosis wrlt function and monito1ing , Function monitored and recorded daily by " rejection & conductivity or IDS: m1diblc & visible alarms (V199. 200) Deionization system monito1ing (if p1·esent or pn1·t of back-up plan) , Resisthity continuously monitored: audible & ,isiblc alanus in patient treatment areas: rcsisthity maintained >1.0 mcgohm'cm (V202, 203) , Automatic divert-to-drnin or automatic cut-off valve to prevent water flow to the HD machines (V203) , DI followed by ttltrafilter (V204) Dialysnte p1·opo11ionlng 1·atios match , Only matching dialysate propo1tiouiug ratios used 011 HD machine set at same ratio (V249) Dial ·sate pH & conducti\i · testing at HD machine p1ior to tl'entment , Dialysate pH & conducthity tested at the HD machine with an independent method prior to each u·eatJuent per machine manufac. DFU (V.250) Staff ta·ainiog and monitoring All staff who conduct water. dialysate testing Rlld technical opemtions sufficicntly trained: practices audited at least arumally (V260)