VENDOR QUESTIONS - HEMODIALYSIS WATER TESTING.xlsx
XLSX spreadsheet 13 KB Posted
- Attached to
- H146--Hemodialysis Water Testing Federal contract opportunity
- Solicitation number
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About this file
The file is a Vendor Questions document for VA Solicitation #36C26225Q0554 concerning Hemodialysis Water Testing, managed by the Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22. The document contains detailed vendor inquiries and official responses regarding technical specifications, testing standards, and specimen requirements. Key technical clarifications include confirmation that AAMI TIR-34 is the correct standard, vendors are not required to have CLIA certifications, and contractors must comply with ISO/IEC 17025 laboratory accreditation standards.
The testing protocol involves extensive monthly water quality monitoring, with 146 total specimens per month, divided into weekly and monthly testing categories. Specific testing parameters include water cultures with a maximum level of 100 cfu/mL and an action level of 50 cfu/mL, and endotoxin testing with a maximum level of 0.25 eu/mL and an action level of 0.125 eu/mL. The testing breakdown comprises 11 specimens per week for colony count and 11 specimens for endotoxin testing, escalating to 19 specimens per month for each testing type, totaling 38 monthly specimens across both testing categories.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| ATTACHMENT E - ISO-IEC-17025 - HEMODIALYSIS WATER TESTING.pdf | ||
| COVER PAGE - 36C26225Q0554 0001 - HEMODIALYSIS WATER TESTING.docx | DOCX document | |
| AMENDED SOW - HEMODIALYSIS WATER TESTING.docx | DOCX document | |
| SF30 AMENDMENT - 36C26225Q0554 0001 - HEMODIALYSIS WATER TESTING.docx | DOCX document |
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Text version
Sheet1
| Vendor Questions 36C26225Q0554 - Hemodialysis Water Testing | |
| Questions | Responses |
| SOW, section 3.2, states (AAMI TIR-34), is this the correct standard for this requirement? | AAMI TIR-34 is the correct standard for this requirement. |
| CLIA certifications are typically for human diagnostic or therapeutic testing. Since the requirement is not for these will the vendor be required to comply? | Vendors wil NOT be required to comply with CLIA certifications. |
| AAMI/ISO 23500 has a different alert limit than what is identify in section III paragraph d, please confirm the AAMI/ISO and alert limit requirement. | Water cultures Max Level = 100 cfu/mL Action level = 50 cfu/mL Endotoxin LAL Max Level = 0.25 eu/mL Action level = 0.125 eu/mL |
| Will the contractor be required to comply with ISO/IEC 17025, testing and calibration laboratories? | Contractors must comply with ISO 17025 and all other accreditation/certifications requirements identified in the solicitation and supporting documents. |
| Please confirm quantities of testing kits as this seems high compared to other VA requirements. | Weekly cultures – 11 specimen/week Monthly cultures – 19 specimens/month Total weekly specimens = 11 specimens – colony count / 11 specimens – endotoxin, total = 22 specimens/week times 4 = 88 specimens/month Total monthly specimens = 19 specimens – colony count / 19 specimens - endotoxin, total = total 38 specimens/month Overall Total specimens = 146 specimens / month |
https://www.iso.org/standard/66912.html
File details come from the government source that posted it. Updated .