Questions for CDC 75D301-23-R-72608.docx

SCIEX Questions to CDC under solicitation 75D301-23-R-72608

Section C.4 - Technical Requirements

1. Section 2 – “Repair Service – 24-hour confirmation of request for repair; 48-hour response by service engineer; 5 working days timeframe to repair equipment. Routine repair service includes replacement or restoration of parts; all contractor services required to return installed CDC laboratory equipment to the operational and design specifications in accordance with OEM recommendations and requirements or exceeding them.”

a. SCIEX QUESTION - Are we okay with this if it comes to an escalation that extends post 5 days? An escalation can be extended past 5 days with proper communication of a timeline for the forthcoming solution

2. Section 2 subsection d – “Necessary replacement parts shall be “new” not “used” or “reconditioned” (unless mutually agreed to by the CDC program in advance and replacement parts are Shimadzu Reconditioned).”

a. SCIEX QUESTION - Most of our Shimadzu parts are new but we do use refurbished items if they need to be replaced, is factory refurb okay? Refurbished parts can only be used if new is not available and only if they come with the same OEM warranty.

3. Section 2 subsection h - h. “In the event that covered equipment is to be relocated to an alternate site, the Contractor shall provide appropriate service to ensure the safe transport, installation, and ensure the full operational condition of the equipment in the new location at no additional cost to the Government.”

a. SCIEX QUESTION – Can this be updated as we have in the past to limit relocation to sites on the same campus and up to 5 moves per contract year? Yes, this can be limited to same campus relocation only and limited to 5 moves per year

4. Section 3 – “Software Upgrades – The Contractor must provide and install software and firmware upgrades, version upgrades, or new applications designed to replace old applications within 6 months following release of the updated software. Any software presented under the contract, whether transferred to CDC via portable media (CDs, thumb drives etc.)”

a. SCIEX QUESTION – Is this intended to include SCIEX software such as Analyst or OS? If so, we request that this requirement be removed, as such upgrades are covered by the existing contract between SCIEX and the CDC. Additionally, these would not typically be included in an instrument service plan. However we do cover instrument firmware for free. Updates to instrument software/firmware to keep instruments up to date and compliant with accreditation requirements. This does not apply to Analyst or OS

5. Section 4 subsection a – “Preventive maintenance services include periodic inspections and on-site service of installed equipment, in accordance with OEM recommendations or exceeding them; including, but not limited to cleaning, calibration, adjustments, replacement or restoration of parts, as necessary, and all services required to return equipment to OEM operational and design specifications.”

a. SCIEX QUESTION: Our service procedures were developed from Shimadzu’s but might differ some, is SCIEX service procedures developed from Shimadzu okay? Sciex’s service procedures are allowable as long as they meet OEM specifications and ISO/CLIA accreditation requirements

6. Section 4 subsection e – “The contractor shall provide all consumables and reagents used for troubleshooting and performance verification testing both for preventative maintenance visits and repairs.”

a. SCIEX QUESTION – Can this be removed or altered? We do use some consumable items during PMs - seals, needles, plungers, rotors mainly. Other items like sample loops, check valves, electrodes, and tubing we charge customers for. If a seal, rotor, plungers, etc are needed outside of a PM (for instance, a repair call), then customers are responsible for those as well. This requirement cannot be altered or modified. It is very common for endusers to need replacement of these consumable items (eg seals, plungers, tubing, etc) outside of a PM. Requiring purchase of these items each time will be time consuming and burdensome to the program as well as endusers delaying requests to time the repairs with the PMs. This will not be a best practice situation.

7. Section 5 subsection c – “The service engineers shall provide (upon request) CDC with Shimadzu certificate of trainings requisite for DLS instrumentation in order to maintain records necessary for CDC equipment Clinical Laboratory Improvement Amendments (CLIA) certification.” The certifications will be supplied within 5 business days of request.

a. SCIEX QUESTION – Can “Upon request” be added as we have done previously? Please see track change above

Section C.7 Performance Requirements Summary

8. Section 10 – “Annual meeting to discuss service issues including account service manager, field service engineers, and CDC users in the meeting.”

a. SCIEX QUESTION – Can “Upon request Contractor shall offer” be added as we have done previously? Yes, as long as monthly or quarterly meetings are held with the COR, accoutn manager, Field service engineers and select CDC end users are held.

Instrument List

See attached spreadsheet, column N.

Note: Column B includes the nicknames given to the associated Mass Spec by CDC scientists. These names are helpful for SCIEX to use as a quick reference. For those cells that were left blank, we assigned these with the nicknames of SC-0 – SC-8. Feel free to update with the CDC nickname if one has been created.