The purpose of this amendment is to answer the following questions to solicitation # VA249-15-Q-0436. 1- The Scope of Services, Page 8 has "Cost per Suite of 9 tests (Clin 001-009) then "Cost of 12 Sampling Events", will they collect just one sample and order all 9 tests? Separate simultaneous samples are collected (see below) for AAMI chemical toxins and microbiologic/LAL testing from wall outlets, reverse-osmosis machines and hemodialysis machines. All tests are run from those samples. The vendor provides the sampling kits as part of the package. There are also tests of water pH, conductivity, and residual chlorine conducted locally which have no impact on contract costs those are mentioned, below, only for completeness. Clinics usually collect numerous samples per month and generally only request colony count and LAL and then do AAMI Profiles a few times per year. What calculations do we make for the sampling events? Can you estimate monthly volumes for each test? Ours is a three-station, acutes-only dialysis unit. There are and three wall water outlets and three reverse-osmosis water purification units that supply the three hemodialysis machines with AAMI-quality water. Monthly microbiologic culture samples are collected from the wall outlets and the dialysis and reverse osmosis machines. (Nine samples/month = 108 samples/year). Limulus lysate assay (LAL) samples for "endotoxins" are collected from the hemodialysis machines and the reverse osmosis machines monthly (six samples/month = 72 samples/year) 2- Also under scope of services, under Method for the AAMI Profile, it states "NLS EPA 200.8" - this method does not match the elements required by the AAMI Standard. The EPA method does not require mercury, calcium, potassium, sodium, magnesium and beryllium which the AAMI Standard does. Please clarify which standard is to be followed. Since mercury, calcium, potassium, sodium, magnesium, and beryllium are all potential toxins at excessive levels, we follow the AAMI standard, which is the dialysis community-of-practice standard reference. Abstracted from the attached MCM 118-13-15 "Hemodialysis Infection Control": MONITORING Item to Monitor What to Monitor/Interval Typical Range of Values Comments Water from wall. Bacterial growth/Monthly Association for the Advancement of Medical Instrumentation (AAMI) for chemical contaminants/ Bi-annually Maximum allowable level: <100 CFU/ml Action level: 50CFU/ml Nurse collects. Water exiting the first Carbon Filter from the reverse osmosis. Chlorines Chloramines (Total Chlorine)/Daily Expected value: <0.1mg/l Nurse collects with chlorine strips or equivalent. Water used for hemodialysis post-reverse osmosis at blue port on side of hemodialysis machine. Residual Chlorine/Daily Expected value: 0 ppm Nurse collects using blue connector on hemodialysis machine with residual chlorine strip. Pressure Gauge at primary water source. Pressure/Daily Pressure/q6 months. >60PSI Action: <20PSI Nurse monitors daily and documents in book. Biomed will check q6 months. Reverse osmosis water quality. Quality of product water/Daily Refer to the WRO 300 Operator's Manual, 2006. Nurse monitors. Water from reverse osmosis machine. Bacterial growth and endotoxins/Monthly AAMI Chemical Contaminants/ Bi-annually Maximum allowable level: <100 CFU/ml Action level : 50 CFU/ml Endotoxins: Maximum allowable level <0.25 EU/ml Action level: 0.125 EU/ml See AAMI table for contaminants values. Nurse collects. Samples taken from the reverse osmosis machine. Endotoxins and AAMI sent to outside Lab. Item to Monitor What to Monitor/Interval Typical Range of Values Comments Water from hemodialysis machine prior to dialysate setup (blue connector on side of machine). Bacterial growth and endotoxins/ Monthly Maximum allowable Level: <100 CFU/ml Action Level: 50CFU/ml Endotoxins: Maximum allowable level: <0.25EU/ml Action level: 0.125 EU/ml Nurse collects. Hemodialysis Fluid Ph and conductivity/ Daily with each patient and q4 hrs. Ph 6.9-8.0 Conductivity 13.5-14.5 Nurse collects. Standard Hemodialysis Fluid Bacterial growth and endotoxins/ Monthly Total Cell Volume (TCV): Maximum allowable level: <100CFU/ml Action level: 50 col/ml Endotoxin: Maximum allowable level: <0.5 EU/ml Action level: 0.25 EU/ml Nurse collects. Reverse Osmosis Preventative maintenance/ Annually Reverse osmosis units will be inspected; rejection/ bypass fraction documented and overall serviceability will be determined and documented in a permanent log. BioMedical Engineering (BioMed)/MARCOR® Reverse osmosis membranes will be replaced with new membranes annually. Hemodialysis Machines Preventative Maintenance/ Annually Hemodialysis machines will be inspected and documented. BioMed/Gambro Eyewash Station Daily Nurse monitors. CLEANING/DISINFECTION Item for Cleaning/ Disinfection Elements to be Cleaned/Disinfected/Interval Cleaning/Disinfection Comments Reverse Osmosis Internal membrane/Weekly Internal membrane changed annually by Mar Cor. External surface/Daily Disinfection per manufacturer guidelines. Internal: Minncare® used for chemical disinfection. When membrane fouling is suspected use 50% Citric Acid, then Minnclean® TF. See WRO 300 Operator's Manual. External surface: 70% Isopropyl Alcohol Inlet Water Line Water line from reverse osmosis machine to hemodialysis machine/Weekly Water hose changed annually by BioMedical Engineering (BioMed). Bleach disinfection. See Gambro Phoenix Operator's Manual for solution strength. Options: Manual/Weekly or End-to-End with a maximum of 20 treatments per year. See Gambro Phoenix Operator's Manual for End-to-End and Addendum, "Integrated Chemical Process." Hemodialysis machine: Internal Internal system/Daily Vinegar descale and bleach disinfection. See Gambro Phoenix Operator's Manual for solution strength. By its own disinfection circuit and program: Seven (7) minute vinegar or thirty (30) minute vinegar at end of day and bleach disinfection. Hemodialysis machine: Internal Internal system/Weekly Heat descale. 50% Citric Acid Hemodialysis machine Internal Internal system/End of week or for use when machine out of use for up to seven (7) days. Bleach disinfection. Use BactStat mode on hemodialysis machine. 1:7.50 Bleach Solution See Gambro Phoenix Operator's Manual. Item for Cleaning/ Disinfection Elements to be Cleaned/Disinfected/Interval Cleaning/Disinfection Comments Hemodialysis machine External surface/Daily Bleach cleaning or disinfection. 1:50 Bleach Solution Wands and connectors Wands and connectors. Daily after each patient use. Weekly, soaked in bleach solution. Cleaning and bleach disinfection. Daily: Rinsed in water. Weekly: Connectors and wands: 1:25 Bleach Solution for at least 30 minutes. Touch Screen on Hemodialysis Machine Touch screen/After each use. Cleaning 70% Isopropyl Alcohol, 1:50 Bleach Solution or Sani-Wipes Touch Screen of cardiac respiratory (CR) monitor and cables Touch screen and cables/After each use. Cleaning Sani-Wipes Collection Assist Device Collection Assist Device/ Daily Minncare® Disinfection Soak in 1% Minncare® Solution for 30 minutes prior to use.

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