Amendment Attachment 1 - Vendor Questions and Answers.docx

Attachment 1

Vendor questions are in black text.

Answers to vendor questions are in red text.

Governing standard:

The PWS specifies AAMI TIR34.1:2014(R)2017. AAMI has since revised and replaced TIR34 with ANSI/AAMI ST108:2023, which is the current water standard AAMI references for medical device processing. A few of the limits in Table 1 also differ from ST108:2023 (for example, Critical Water pH of 5–7 vs. ST108's 5.0–7.5, and Utility Water pH of 6–9 vs. 6.5–9.5), and the endotoxin row for Critical Water lists two values (<20 and <10 EU/mL).

1. Where the two documents differ, which standard governs acceptance of test results? Use ANSI/AAMI ST108: 2023. SOW updated to reflect that standard.

2. For Critical Water endotoxin, which value is the acceptance limit? <10. SOW Table 1 updated to reflect standard.

3. Will the Government accept testing and reporting performed to ST108:2023 methods and limits? Yes – SOW updated to reflect that standard.

Sample locations The schedule lists annual quantities but no sample-location detail. PWS/SOW updated to reflect locations of point-of-use sites in Table 2.

4. How many points of use (POUs) are in the Building 47 SPS, and how are the monthly bacteria samples distributed across them? There will be 11 point-of-use sites. PWS/SOW updated to reflect those in each category in Table 2.

5. For the chemistry parameters (pH, conductivity/resistivity, hardness), does the Government expect testing at a single representative point, or at every POU? At every POU as indicated in Table 2 of the SOW.

6. For bacteria and endotoxin, does the quantity reflect every POU sampled monthly? Actually, due to inconsistent results of the RO system, we are requiring POU sites sampled weekly for bacteria and monthly for endotoxins. PWS/SOW updated to reflect those in each category in Table 2.

On-site vs. laboratory testing

7. Does the Government expect the contractor to perform the field-capable parameters (pH, conductivity, hardness) on-site, or to send all parameters to an external lab? ST108 expects pH to be read within 15 minutes of collection. On site.

8. Is bench space available within the SPS for on-site testing? There is space in SPS to conduct on-site testing.

Test categories

9. Item 0004 lists "Resistivity." ST108 uses conductivity (µS/cm). Will the Government accept conductivity measurements in lieu of resistivity? Govt will accept conductivity. PWS/SOW updated to reflect that standard.

10. Item 0002 lists 48 TOC tests/year. ST108 places TOC in the performance-qualification panel, not routine monitoring. Is TOC intended as recurring routine testing, or part of system qualification? TOC was removed as routine monitoring. It will be part of system qualification. It was removed from Table 2.

11. ST108 includes total alkalinity in routine monitoring, but it isn't a priced line item. Should it be added? Yes. PWS/SOW was updated to include sampling for alkalinity in Table 2 for each POU site.

Emergency testing

12. Are the 12 emergency bacteria and 12 emergency endotoxin tests intended to cover event-driven scenarios (construction, repairs, loop openings, boil-water events), with additional events handled by modification? Exactly – we intended to have a price for 12 additional bacteria and 12 additional endotoxins in reserve to cover event-driven scenarios and handle any additional events beyond those to be provided at the contracted rate via modification.