Questions and Answers Solicitation HT941026Q2065 ManoScan ESO Z Catheters.pdf
PDF 147 KB Posted
- Attached to
- Brand Name - ManoScan Catheters
- Solicitation number
- HT941026Q2065
- Issued by
-
Defense Health Agency
About this file
This is a Questions and Answers document for solicitation HT941026Q2065 addressing inquiries regarding the procurement of ManoScan ESO Z Catheters for federal medical facilities.
The solicitation is a Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside requiring brand-name-only Medtronic products. The Government relies on the Small Business Administration's class waiver for Surgical and Medical Instrument Manufacturing (NAICS code 339112) for Nonmanufacturer Rule compliance. The acceptable manufacturer part numbers are MSC-3890-Z and #3890 (legacy identifier), which are interchangeable designations for the same product. Specialized on-site training is required exclusively at Tripler Army Medical Center (TAMC), with no training required at NMCSD. The training must include seven Registered Nurses—two receiving refresher training and five receiving complete new training. The HRM Catheter Extended Warranty (Part Number 80372) provides a 12-month coverage period that commences immediately upon expiration of the standard manufacturer's warranty, ensuring continuous coverage. Quoters may submit a general authorization letter from Medtronic rather than one specific to this RFQ. Country-of-origin certification and Buy American/Balance of Payments compliance statements are not required with quotations.
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Questions and Answers Solicitation HT941026Q2065 ManoScan ESO Z Catheters
1. The solicitation is an SDVOSB set-aside, incorporates FAR 52.219-33, and requires brand-name-only Medtronic products. Has SBA issued an individual Nonmanufacturer Rule waiver for this procurement, or is the Government relying on an existing class waiver? If applicable, please identify the waiver.
a. The Government is relying on the Small Business Administration (SBA) class waiver for Surgical and Medical Instrument Manufacturing (NAICS code 339112). Nonmanufacturer Rule (NMR) compliance will be administered under standard Federal Acquisition Regulation (FAR) provisions.
2. The RFQ identifies the ManoScan ESO Z Catheter as Medtronic part number 3890. Medtronic product literature may identify the impedance catheter as MSC-3890-Z. Please confirm the exact manufacturer part number that will be accepted.
a. MSC-3890-Z and #3890 are the same. 3890 is the legacy/short identifier and MSC-3890-Z is the modern manufacturing SKU.
3. Section I of the Statement of Work states that the contractor shall provide all training necessary. Is formal training required under this procurement? If so, please identify whether training must be onsite or remote, the required duration, number of attendees, and whether training must be provided at both NMCSD and TAMC.
a. Yes, specialized training is required, but it is structured to account for our existing clinical competencies. • Location: Training must occur strictly on-site at TAMC (Tripler Army Medical Center). No training is required for NMCSD.• Scope: The vendor will proctor staff to validate current training, clinical competency, and unit capability.• Personnel: A total of seven (7) Registered Nurses (RNs) must be trained in person.• Structure: Two (2) RNs will receive a refresher course (as they are familiar with the system), and five (5) RNs will receive complete, new training.
4. Please confirm whether HRM Catheter Extended Warranty part number 80372 provides the required minimum 12-month warranty or whether it begins after expiration of a separate standard manufacturer warranty.
https://govtribe.com/file/government-file/sow-manoscan-eso-catheters-nmcsd-tripler-dot-pdf
The HRM Catheter Extended Warranty (Part Number 80372) provides a 12-month coverage period. This extended warranty period is additive and will commence immediately upon the expiration of the standard manufacturer's warranty (or upon acceptance of the equipment if no separate standard warranty period is included with the base catheter purchase), ensuring continuous coverage for a full year of clinical use.
5. Must the OEM authorization letter specifically identify the quoter and RFQ HT941026Q2065, or will a current general authorization letter from Medtronic be acceptable?
a. A general authorization letter from Medtronic SHALL BE acceptable https://govtribe.com/file/government-file/sow-manoscan-eso-catheters-nmcsd-tripler-dot-pdf
6. Is a country-of-origin certification or Buy American/Balance of Payments compliance statement required with the quotation?
a. The country-of-origin certification or Buy American/Balance of Payments compliance statement IS NOT required on the quotation.
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