SPS Water Testing Services for Clement J. Zablocki VA Medical Center located in Milwaukee, WI.

Vendor Questions/Answers How many of the 26 samples need endotoxin testing? 3 at AER s require Endotoxin Per Table 2, 4, 5, and 6 no Endotoxin testing on Utility water is required? See answer to question 1. There are special circumstances for those areas. How many of the 26 samples need pH, Alkalinity, Hardness, and Conductivity? Follow tables 5 and 6. (4, 2 hot and 2 cold) Will any Ionic contaminant testing be needed following table 2 of the standard? Yes.

Will this RFP request sampling at the Water Generation systems outlined in Table 5? This is considered where the city water enters the building and where hot water exits the hot water heaters. Will field tests for pH, Conductivity, Hardness, and Alkalinity be permitted per table 5 and 6 or will this need to be tested at a lab? Field tests are fine. There is not an indication for the number of retests that can be expected per quarter.

Can the government provide historical information regarding retests for the past 3 years? This is a completely new process. I have no data to determine the potential number of retests. Will the government issue a PO for retests or should retests be included in the YR CLIN? Retests should be included in the YR CLIN. If one parameter is out of specification and requires a retest, does the government intend to retest the whole panel, or solely the parameter that was out of specification?

We would require only the retest for the one problem and not the entire panel. Should the government request a retest of only those parameters that are out of specification, would the government consider splitting the CLIN table into each parameter quantity per year for routine and retests?

No. The table provided on page 8 indicates utility water is not tested for endotoxin, however, in the Scope of Work it is stated that The contractor shall provide colony count and endotoxin results by phone if above the Alert Limit. Can the government please confirm that endotoxin will be tested for all sources except the steam condensate? See answers to questions 1 and 2, above. Bacteria needs to be tested at all 26 points. Only 3 samples will require endotoxin testing.

Can the government provide photos of the equipment to be tested and the ports available to pull from for those who were not able to attend the site visit? Photos can be provided upon request. Is the contractor responsible for providing the contractor personnel with appropriate PPE? Basic PPE Provided. Can the government provide a list of the appropriate PPE required for this SPS facility? Basic PPE will be provided. (Full body coverall, shoe covers, mask, eye shields, gloves, hair bonnet.)

Are all the sources within a single location within the SPS facility? 25 locations are In one connected area, Steam collector is in a separate room on the same floor. Will the contractor personnel be required to make multiple PPE changes during the collection event? No. Does the government require each SPS source to be flushed before collection? Yes. Per AAMI recommendation, each source should be flushed for at least 60 seconds prior to sampling.

Does the government require the port from each source to be disinfected with an alcohol swab prior to collection? Yes. All ports that require bacteria sampling do require an alcohol swab. If the source port is to be swabbed, will the government provide the alcohol swabs? Yes. This can be provided. The RFQ mentions endotoxin sampling, but it only lists Utility and Steam sample locations. ST108 does not require Endotoxin sampling unless it is on a Critical Water source. Please advise.

See answer to questions 1 and 2. Due to the potential for sub micron-filtered utility water to be the final rinse, we are testing for endotoxins at 3 points. Does this VA have any critical water systems/POUs that will require sampling? No. (It is already being done.) Is this VA utilizing Utility Water for Critical applications, and they need endotoxin samples to be taken at each Utility POU? We are proceeding with great caution because there is a gray area with scope processors.

We are sampling endotoxins at 3 points. See answers for questions 1 and 2. There is a slight discrepancy in what the project is asking for and what ANSI AAMI ST108 is asking for. We would appreciate confirmation on the following to ensure full compliance with ANSI/AAMI ST108 and appropriate service alignment: Question 1:Â Â That no critical water systems or point-of-use filtration/treatment fixtures are part of the testing scope; Correct. Question 2:Â That there is no requirement for full annual validation testing beyond the outlined quarterly testing; Correct.

Question 3: That only one steam condensate sample is required per quarter; Correct Question 4: That 25 utility water point-of-use samples are to be tested quarterly, and whether endotoxin testing is explicitly required for each utility water site (as this exceeds ST108 s standard quarterly testing parameters). Reduce this to 3 points for endotoxin testing. Since ST108 does not mandate endotoxin testing for utility water on a quarterly basis, I want to confirm that the inclusion of endotoxin analysis at utility POUs is an intentional facility-specific requirement. Reduce to 3 points for endotoxin testing.

Water Quality Monitoring Bacteria and Endotoxins: The scope mentions testing for bacteria and endotoxin(s) in relation to water quality monitoring. Could you please specify which particular bacterial, and endotoxins are required for testing? This will help us ensure the appropriate analytical methods and accredited laboratories are utilized. Please refer to ST108. It would be all of them.

Protective Equipment for Sterile Processing Areas: The document references the use of protective equipment for entering sterile processing areas. Could you confirm the specific PPE required for access to these areas? Additionally, should we anticipate providing all PPE for our personnel, or will any of this be furnished by the facility? Basic PPE will be provided. (Full body coverall, shoe covers, mask, eye shields, gloves, hair bonnet.) Is there any incumbent/recompete or this is a brand-new project?

If yes, could you please provide us with their award number or even if the customer bought similar services in the past. No. This is a new process. What is the Place of Performance? The Place of Performance shall be Milo C. Huempfner Green Bay HCC located in Green Bay, WI.