VENDOR QUESTIONS v2 - HEMODIALYSIS WATER TESTING.xlsx

XLSX spreadsheet 12 KB Posted

Attached to
H146--Hemodialysis Water Testing
Solicitation number
36C26225Q0554
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The document is a Vendor Questions spreadsheet for Solicitation 36C26225Q0554, addressing Hemodialysis Water Testing Services for the Department of Veterans Affairs Long Beach Healthcare System. The file contains a detailed technical discussion between a vendor and the government regarding specific testing standards and accreditation requirements. Key points of discussion include clarification on testing accreditation standards, with the vendor seeking more precise information about the required accreditation type, and questioning the reference to AAMI TIR-34 versus the newer AAMI 23500-1 standard for hemodialysis water testing.

The vendor highlighted technical nuances between AAMI TIR-34 (a broader document for medical device reprocessing water quality) and AAMI 23500-1 (a more specialized document focusing specifically on hemodialysis fluid preparation and quality management). The government confirmed TIR-34 as the applicable standard, despite the vendor's observation that the document appears to be an older format that may not fully align with the current scope of hemodialysis water testing requirements. The solicitation involves testing services for hemodialysis water, with Perry Johnson Laboratory Accreditation (PJLA) being referenced in the vendor's technical inquiry.

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Sheet1

Vendor Questions v2 - 36C26225Q0554 - Hemodialysis Water Testing
QuestionsResponses
The RFQ does not specify the exact type of testing accreditation required (e.g., DoD ELAP, cannabis testing, etc.), it’s difficult to determine whether a contractor can meet the stated requirements. Could you please clarify the specific accreditation you are seeking?
Perry Johnson Laboratory Accreditation (PJLA) - 23500-1:2024 - Preparation and quality management of fluids for hemodialysis and related therapies.
We asked “SOW, section 3.2, states (AAMI TIR-34), is this the correct standard for this requirement?” The government said yes. TIR-34 is for Sterile Processing and 23500 is for Dialysis, the SOW states Hemodialysis type testing. We don’t understand why an old format will be utilized when the scope of work references something completely different.AAMI TIR34 and the 23500 series are both guidance documents from the AAMI related to water quality for medical device reprocessing, but differ in their scope. TIR34 is a general document for selecting water quality for reprocessing different categories of medical devices, while 23500-1 focuses specifically on the preparation and quality management of fluids for hemodialysis and related therapies.

TIR34 is now 23500-1, TIR34 is a broader document addressing water quality for general medical device reprocessing, while 23500-1 is a more specific guide within that broader context, focused on dialysis -related applications.

AAMI 23500-1 previously TIR34, is a more specialized document within the 23500 series. It focuses on the preparation and quality management of fluids used in hemodialysis and related therapies.

File details come from the government source that posted it. Updated .