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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 23, 2015 FBO #4898
DOCUMENT

Q -- DIALYSIS WATER TESTING - Attachment

Notice Date

4/21/2015
 

Notice Type

Attachment
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 9;1639 Medical Center Parkway;Suite 400;Murfreesboro TN 37129
 

ZIP Code

37129
 

Solicitation Number

VA24915Q0436
 

Response Due

4/22/2015
 

Archive Date

6/21/2015
 

Point of Contact

Scheronica Cochran
 

Small Business Set-Aside

N/A
 

Description

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 MonitorWhat to Monitor/IntervalTypical Range of ValuesComments Water from wall.Bacterial growth/Monthly Association for the Advancement of Medical Instrumentation (AAMI) for chemical contaminants/ Bi-annuallyMaximum 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/lNurse collects with chlorine strips or equivalent. Water used for hemodialysis post-reverse osmosis at blue port on side of hemodialysis machine.Residual Chlorine/DailyExpected value: 0 ppmNurse collects using blue connector on hemodialysis machine with residual chlorine strip. Pressure Gauge at primary water source. Pressure/Daily Pressure/q6 months.>60PSI Action: <20PSINurse monitors daily and documents in book. Biomed will check q6 months. Reverse osmosis water quality.Quality of product water/DailyRefer to the WRO 300 Operator's Manual, 2006.Nurse monitors. Water from reverse osmosis machine.Bacterial growth and endotoxins/Monthly AAMI Chemical Contaminants/ Bi-annuallyMaximum 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 MonitorWhat to Monitor/IntervalTypical Range of ValuesComments Water from hemodialysis machine prior to dialysate setup (blue connector on side of machine).Bacterial growth and endotoxins/ MonthlyMaximum allowable Level: <100 CFU/ml Action Level: 50CFU/ml Endotoxins: Maximum allowable level: <0.25EU/ml Action level: 0.125 EU/mlNurse collects. Hemodialysis FluidPh and conductivity/ Daily with each patient and q4 hrs.Ph 6.9-8.0 Conductivity 13.5-14.5Nurse collects. Standard Hemodialysis FluidBacterial growth and endotoxins/ MonthlyTotal 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/mlNurse collects. Reverse OsmosisPreventative maintenance/ AnnuallyReverse 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 MachinesPreventative Maintenance/ AnnuallyHemodialysis machines will be inspected and documented. BioMed/Gambro Eyewash StationDailyNurse monitors. CLEANING/DISINFECTION Item for Cleaning/ DisinfectionElements to be Cleaned/Disinfected/IntervalCleaning/DisinfectionComments Reverse OsmosisInternal membrane/Weekly Internal membrane changed annually by Mar Cor. External surface/DailyDisinfection 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 LineWater 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: InternalInternal system/DailyVinegar 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: InternalInternal system/WeeklyHeat descale.50% Citric Acid Hemodialysis machine InternalInternal 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/ DisinfectionElements to be Cleaned/Disinfected/IntervalCleaning/DisinfectionComments Hemodialysis machineExternal surface/DailyBleach cleaning or disinfection.1:50 Bleach Solution Wands and connectorsWands 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 MachineTouch screen/After each use.Cleaning70% Isopropyl Alcohol, 1:50 Bleach Solution or Sani-Wipes Touch Screen of cardiac respiratory (CR) monitor and cablesTouch screen and cables/After each use.CleaningSani-Wipes Collection Assist DeviceCollection Assist Device/ DailyMinncare ® DisinfectionSoak in 1% Minncare ® Solution for 30 minutes prior to use.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NaVAMC/VAMCCO80220/VA24915Q0436/listing.html)
 

Document(s)

Attachment
 

File Name: VA249-15-Q-0436 VA249-15-Q-0436_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1997570&FileName=VA249-15-Q-0436-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1997570&FileName=VA249-15-Q-0436-001.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03705828-W 20150423/150421234949-d11be404eb68ea536c9aa5b24fb4df85 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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