DRAFT_RFQ_AMENDMENT_3_Q&A.pdf

AMENDMENT 3

DRAFT RFQ SB134117RQ0418

Q&A

Question 1: What's the timeframe?

Answer 1: The timeframe for each deliverable is set forth in the SOW and the time frame for the total base line item and contract are set forth in the RFQ description. NIST is under no obligation to award a purchase order. However, it is expected that if one is awarded, it will issue prior to 9/30/2017.

Question 2: The temperature specifications set forth appear to have evolved since earlier market research efforts. Please provide context as to why.

Answer 2: The requirement is not firm until the release of the formal solicitation. Ongoing market research has resulted in evolution and refinement of the requirement, as may result from responses to this draft RFQ. The final RFQ will reflect NIST's priorities from a technical and budgetary standpoint.

Question 3: Line Item 011: 4b – what do you mean by more detailed programming? Can we have an example?; 5, 6 – Are these features required for everything or just the pipettor operations?

Answer 3: In Line Item 0011.4.a, the “user/operator mode” is required for users who will execute an existing process. For this, the user will typically load the required reagents and labware, as prompted by the software; the user will provide the software with some limited parameter information such as the number of samples to be run, and the names/locations for data file storage; and the user will start the process (press “go”). The user mode must be a graphical user interface. In Line Item 0011.4.b, the

“developer/programmer/integrator mode” is required for developers who will program new processes.

For this, the developer will program, for example, the detailed pipetting steps, and sequence of other operations like incubation, plate reading, plate sealing and de‐sealing, etc. The developer will also program, for example, the interactions between the user/operator mode of the software and the user, and the prompts presented to the user by the user/operator mode of the software. An example of more detailed programming would be programming the system to perform the protocol listed in section VIII of the SOW. The requirements for Line Item 0011.5 and 0011.6 are required for programming of the entire automated system.

Question 4: For Line items 0016‐0018, the optional 1, 2 and 3 year service contracts, it states “The

Service Contract shall cover all robotic systems and instruments.”. Does this mean that NIST requires the service contract options to cover all third‐party devices on the system as well as those provided directly by the integrator? I ask because there will be something like 10+ third party devices on this system and it is a considerable undertaking to obtain & consolidate multiple service contract options from so many different vendors. If you are able to answer this, please let me know what is required.

Answer 4: Optional service contract line items are no longer a part of this requirement and have been removed from the SOW accordingly.

Question 5: Re: Page 2: Can the 40 deck positions be achieved by stacking plates, off deck storage or by moving devices off deck?

Answer 5: No. For flexibility of method development, NIST requires at least a 40‐position deck inside the envelope of the liquid handler. The Draft SOW has now been amended for this clarity.

Question 6: Re: Page 2: What is the driver for these pipetting specifications.

Answer 6: NIST requires the best possible accuracy and precision for its measurements and developed its requirements to reflect this need.

Question 7: No vendor could guarantee [the pipetting specifications] for the specific liquids and labware, only specifications generated in a controlled environment irrelevant to the customers' workflow.

Answer 7: The required specifications are for pipetting performance in ideal, controlled environments.

Although NIST acknowledge that performance may vary based on the details of the liquids and labware to be used with the system, the only generally available and meaningfully comparable metrics for pipetting performance are for ideal, controlled environments.

Question 8: Would it be preferable to demonstrate how pipetting can be optimized to achieve the optimal pipetting?

Answer 8: If any vendor has specific technology which can provide improved pipetting accuracy and precision, NIST would be interested in learning about it. Also, if any vendor would like to suggest other specific, quantifiable metrics for pipetting performance that it believes are more relevant to NIST's requirement, NIST would be willing to learn about those as well. At this time, NIST does not anticipate having any sort of physical "demonstration."

Question 9: Re: Page 2: What are the liquid level detections being used for?

Answer 9: To detect the level of liquid in SBS plates, tubes, or other labware used with the system.

SOW amended for this clarity.

Question 10: Would it be equally preferable to track the liquid levels in the system which can be considerably faster than detection?

Answer 10: No.

Question 11: Re: Page 4 (heating/cooling (incubation)): What is the max RPM needed?

Answer 11: NIST encourages industry responses regarding RPM parameters so NIST may consider refining this portion of the requirement with more detail.

Question 12: Re: Page 4 (heating/cooling (incubation)): Do you have a capacity recommendation?

Answer 12: Beyond the SOW specifications that the absorbance plate readers must be compatible with

SBS format plates from 6‐well to 384‐well plates and up to 22 mm in height, NIST is unclear as to the context behind this query on "capacity" and welcomes supplemental input from interested vendors.

Question 13: Re: Page 4 (heating/cooling (incubation)): Do you already have a preferred vendor? If so, who is the vendor?

Answer 13: NIST does not prefer any vendor.

Question 14: Re: Page 4: (Electroporation, plate sealers, peeler/desealer): Do you have a preferred vendor already and if so, who is it?

Answer 14: NIST does not prefer any vendor.

Question 15: Re: Page 5: (Solid Waste Collection System): Do we need to decontaminate the trash?

Answer 15: No.

Question 16: Re: Page 5: (Solid Waste Collection System): Does the bin need to be autoclavable?

Answer 16: No.

Question 17: Will the bin be lined with biohazardous waste bag?

Answer 17: Yes.

Question 18: Re: Page 5: (Liquid Waste Collection System): Do we need to decontaminate the liquid?

Answer 18: No.

Question 19: Re: Page 5: What decontamination solution is required? (10% Bleach: H2O solution, etc.)

Answer 19: None.

Question 20: Re: Page 5: (Positive‐pressure enclosure): No need for Class II?

Answer 20: See the "stronger considerations" clauses and related discussion in the posted Draft RFQ.

Question 21: Re: Page 5: (For status lights): Would a single status pole be preferable or a full 360‐ degree indicator?

Answer 21: A 360‐degree indicator is not anticipated to receive stronger consideration in the best value tradeoff analysis.

Question 22: Re: Page 6: (Pos Pressure SPE): What density of plate? 96, 48, 24? Are there going to be multiple types or single type?

Answer 22: 96‐well only. The SOW is amended accordingly.

Question 23: Re: Page 6: (Pos Pressure SPE): Please provide manufacturer and model of SPE plates you intend to use.

Answer 23: NIST's initial plan is to use Agilent filter plates, part number 203980‐100. However, NIST is willing to change the disposable labware that it will use if it will better suit the automated hardware system. NIST's applications will require filer membranes with 0.2 um pores and filer plates that are available in sterile packaging. SOW is amended accordingly.

Question 24: Re: Page 6: (Active SBS Plate Position): Do you have a preferred vendor? If so, who is the vendor?

Answer 24: NIST does not prefer any vendor.

Question 25: Re: Page 6: (Thermocycler): Do you have a preferred vendor? If so, who is the vendor?

Answer 25: NIST does not prefer any vendor.

Question 26: Re: Page 6: (Thermocycler): Will all picking be from SBS format labware?

Answer 26: Colony picking from SBS format plates would meet the requirements. Also, colony picking that requires a round petri‐dish labware format would also meet the requirements if the automated system is capable of lidding/de‐lidding and moving the round petri dishes within the system.

Question 27: Re: Page 6: (Thermocycler): Is fluorescent detection required on the Colony picker as well?

Answer 27: No.

Question 28: Re: Page 7: (Extra Liquid Waste Collection): What are the intended components to discarded here? i.e., harsh solvents, infectious agents, radioactive substances, etc.?

Answer 28: Formamide (up to 50% in water) and formaldehyde (up to 10% in water). The SOW is amended accordingly.

Question 29: Re: Page 7: (Temperature Controlled Thermal Block): Do you have a preferred vendor? If so, who is the vendor?

Answer 29: NIST does not prefer any vendor.

Question 30: Re: Page 8: Is Windows 10 also acceptable?

Answer 30: Yes.

Question 31: Re: Page 8: Would a comprehensive system for capturing and reporting on data be required. E.g. tracking the sample IDs through the complex plate maps in the FAT protocol and this data be available for live reporting locally and remote?

Answer 31: No.

Question 32: Also matching of reader data to sample IDs and reporting locally plus remotely.

Answer 32: No.

Question 33: Also, LIMS integration possibility.

Answer 33: See the "stronger considerations" clauses and related discussion in the posted Draft RFQ.

Question 34: Re: Page 8: Are the terms of the FAT? SAT negotiable? In our experience, more time is often needed for an SAT than this for a method of this length. Can the supplier make a recommendation of test plan for risk management of the system?

Answer 34: To further the intent of the draft RFQ process, NIST encourages feedback regarding all draft

RFQ matter that will enable NIST to possibly further develop its requirement to meet its needs, align with industry standards/capabilities, and obtain maximum practicable competition.

Question 35: Re: Page 12: Orbital shaking at what RPM?

Answer 35: To further the intent of the draft RFQ process, NIST encourages feedback regarding all draft

RFQ matter that will enable NIST to possibly further develop its requirement to meet its needs and obtain maximum practicable competition.

Question 36: Re: Page 14: What RPMs for all 3 steps?

Answer 36: NIST encourages interested vendors to provide recommendations or other feedback in response to this draft RFQ for specifications that may be lacking material information such as that raised by this query.

Question 37: Are certain of the options of higher priority than others?

Answer 37: No. All of the options are minimum requirements. Any vendor that responds to the formal solicitation upon its official release must be capable of providing all optional items to be eligible for award.

Question 38: Regarding: Deliverables (and stated timelines in general) ‐ are "60 days" business days or calendar days?

Answer 38: All references to any particular number of days means calendar days unless otherwise stated.

Question 39: Re: optional line LINE ITEM 0009: ‐ Does the user intend to have each position independently temperature‐controlled (i.e. – 4 separate recirculators to provide individual temperature control).

Answer 39: No. The 4 positions need to be at the same temperature, controlled by the same recirculatory.

Question 40: Re: optional line LINE ITEM 0009: ‐ Does the user intend to rapidly change the temperature of the fixture(s) to accommodate different temperature requirements in a single workflow?

Answer 40: No. The temperature of the 4 positions does not need to change rapidly.

Question 41: In the SOW document, it mentions an initial one‐year warranty, but in the synopsis text on the FBO listing it states “Base Period: Delivery, installation training and warranty for the equipment shall be approximately twenty (20) months after award.” – this could use clarification.

Answer 41: The FBO description is now modified slightly to clarify.

Question 42: Regarding ‐ Total Small Business Set Aside (see Page 1 and 3 of posting): Are there any documentation/certification do we need to submit with the current response? What type of documentation/certification WILL we need to submit when we respond to the upcoming/eventual

Solicitation?

Answer 42: All interested vendors are directed to the Applicable provisions and clauses attachment to the Draft RFQ and are charged with becoming knowledgeable of its contents, included terms and conditions incorporated by reference. The answers to these queries are discoverable upon research of that matter.

Question 43: The synopsis makes reference to the document ‘NIST Sources Sought Notice No. NIST‐

MML‐17‐SS9’ posted in FBO on 2/2/2017. The posting document ‘DRAFT_RFQ_ATTACHEMENT_1_‐

_SOW’ is more simplified, in the requirements and protocols described, compared to the former, referenced document. Which set of requirements should we based (MOSTLY) our current response?

Answer 43: The response deadline for NIST‐MML‐17‐SS9 has already lapsed and was provided merely for historical context for those vendors who may have already reviewed the sources sought notice in the past. Please provide responses to only the Draft RFQ at this time. Please note that the Final RFQ may be revised again after NIST has taken the feedback received from the Draft RFQ under advisement.

Question 44: Are there any submissions listed/described here that are either required or expected for our current response?

Answer 44: NIST is not requesting a formal quote at this point. NIST is seeking feedback about the draft

RFQ (e.g., comments, suggested revisions, concerns, etc). As such, no submission limitation, restriction, requirement or guidance applies.

Question 45: Could you verify the main items that would be MOST helpful, even if not required/expected?

Answer 45: No. NIST has minimum requirements, and those that will receive greater consideration, but does not seek to structure any portion of the requirement as "most helpful". If the question refers to

"main items" NIST is seeking in response to this Draft RFQ, NIST welcomes any feedback or recommendations regarding the RFQ documents and will take such information under advisement when finalizing the RFQ.

Question 46: Line item 0001 ‐ The system must include four (4) identical absorbance plate readers each with the following capabilities and specifications… This requirement will likely increase the required footprint and will have an impact on line item 0002 (Line Item 0002 – Base Line Item: Quantity One (1)

Enclosure (g and h).

Answer 46: A 12' x 12' enclosure is now required in SOW (re: Line item 0002 g)) and with a 9'0" height

(re: Line item 0002 h)). However, stronger consideration for a 10' x 12' x 8'3" enclosure is now set forth in the draft RFQ description.

Question 47: Regarding the Draft response will it be suitable for us to submit the Draft proposal rather than the Small Business partner since there will be require further work directly with us before the final

RFQ is prepared to be submitted by the small business partner group?

Answer 47: NIST is not requesting a formal quote at this point. NIST is seeking feedback about the draft

RFQ (e.g., comments, suggested revisions, concerns, etc). As such, no submission limitation, restriction, requirement or guidance applies.

Question 48: Items 0001.14 and 0008: do the liquid waste collection systems need to be accessible by the 96‐head or just by the 8‐channel head?

Answer 48: Liquid waste collection needs to be accessible by both pipetting heads.

Question 49: Item 0004 – some otherwise well‐suited liquid handlers do not have options for on‐deck integrated positive pressure SPE units. In these cases, we can functionally approximate this option by locating a PP‐SPE device immediately adjacent to the liquid handler deck. The system robot or liquid handler gripper could access the device. Cellario may have to control it directly (instead of the liquid handler software), but that would not limit or perturb the intended flow of the protocol. Would this be a suitable alternative, to expand the options for liquid handler choice?

Answer 49: Yes. SOW amended accordingly (“Located on liquid handler deck” (previous item 1d ‐ in

Line Item 0004 is now deleted).

Question 50: Item 0005 – do you mean a clamp‐style hold‐down (affixes the base of the plate)? Or would you prefer a guard‐style hold‐down (for tube racks)?

Answer 50: Clamp‐style hold‐down for plates.

Question 51: Item 0005 – piercing with air‐displacement pipettors presents different volume maxima for different liquid handlers. Liquid Handler A has a limit of 150uL at a time (or 250 with filtered tips), Liquid Handler B has a limit of 50uL at a time (filtered or unfiltered tips). If piercing is added in the future, will there be a single‐transfer‐volume requirement that would invalidate Option B, or would you be able to do multiple transfers to accomplish higher‐volume steps that involve piercing?

Answer 51: NIST would be able to do multiple transfers. So, both Option A and Option B would be acceptable.

Question 52: Item 0005 – does it need to be robot‐accessible or actuated? Or will plates be loaded into it by hand?

Answer 52: It needs to be robot‐accessible and actuated.

Question 53: Item 0001.12: Are you open to loading some tips onto the deck along with the other reagents at pause‐points? If so, which ones? This can significantly reduce storage needs. Or do you require automated provision of all tip racks to the liquid handler?

Answer 53: Some tips could be loaded onto the deck during pause points, but the specification in Line

Item 0001.12 is for off‐deck, robot accessible storage. So, for example, the 15 racks/boxes of 300/500 uL filter tips indicated in 0001.12 would need to be automatically provisioned to the liquid handler, but other tips listed in the FAT/SAT protocol (VIII.1.k) could be manually loaded onto the deck during pause points.

Question 54: Protocol: There are many bulk dispense operations called out for pre‐dispense to a trough, followed by pipetting to a plate. In cases where it makes sense, process‐wise, would you be open to bulk dispensing the desired volume directly to a plate? This would offer significant advantages in timing, consumables usage, user experience with loading labware into the system, and simplifying

Cellario protocol design. We are including a volume verification device for bulk dispensers (which can read well‐by‐well volume added to a plate by a bulk dispenser).

Answer 54: Yes. We would be open to modifications to that protocol that optimize it for the specific hardware configuration provided. This feedback is precisely the type of information NIST is seeking in response to this Draft RFQ.

Question 55: As we are pulling together the proposal my team needs an understanding if we have to address the small business set aside component as a part of the draft response. Our preference would be to address this at final RFP submission stage as we have worked through multiple entities prior. It just takes some time to pull this together. We appreciate your input.

Answer 55: NIST is not requesting a formal quote at this point. NIST is seeking feedback about the draft

RFQ (e.g., comments, suggested revisions, concerns, etc). As such, no submission limitation, restriction, requirement or guidance applies.

Question 56: Line Item 0001.2.a: It is acceptable for all 4 of the fluid reagent sources that have components that contact the fluid be disposable and/or autoclavable?

Answer 56: Yes, if the components that contact the fluid reagents are autoclavable for all 4 of the fluid reagent sources, that is acceptable.

Question 57: Line Item 0001.7.e: Will this be a full height deep‐well plate? Do you have the height dimensions available? What volume would be required to be in this plate and would a half height plate be sufficient?

Answer 57: An adapter plate for any of the following deep‐well plates (96‐well plate with square wells and 2.0 mL capacity per well) would be acceptable: Eppendorf part number 0030 502.302; Corning part number 3960; Abgene part number AB‐0661; Greiner part number 780271.

Question 58: Line Item 0002: We want to confirm that a [company name omitted] filtered positive‐ pressure enclosure is acceptable for this system and that a full [company name omitted] enclosure is

NOT needed. This will greatly impact the overall price of the solution.

Answer 58: See the "stronger considerations" clauses and related discussion in the posted Draft RFQ.

Question 59: Line Item 0004.1.c: We want to confirm that the 110 mm in height requirement is the total height of the filter plate and the collection plate combined.

Answer 59: Yes.

Question 60: Line Item 0009.1: We want to confirm/inform that this for this temperature‐controlled station that all positions would be at the same temperature at the same time. While the recirculating bath will have the range of 0°C to 80°C it would be a single common feed to all positions.

Answer 60: Yes

Question 61: Can companies from outside USA can apply for this?

Answer 61: This is a total small business set‐aside (limited to domestic small businesses). All of your other questions either become inapplicable based on that or are specifically addressed in the draft RFQ documents (i.e., place of performance for particular portions of the requirement and email quote submissions). Kindly review the documents in full, to include terms and conditions incorporated by reference.

Question 62: [Do overseas companies] need to come over [to the U.S.] for meetings?

Answer 62: See response to Question 61.

Question 63: Can we perform the tasks (related to RFP) outside USA?

Answer 63: See response to Question 61.

Question 64: Can we submit the proposals via email?

Answer 64: See response to Question 61.

Question 65: The FBO website lists project SB134117RQ0418 as being in the presolicitation phase. Our company may not be able to participate in the draft RFQ. Does that prevent us from participating in the

Final RFQ process?

Answer 65: No.

Question 66: We saw this last week and I had a question for you. There are a number of base line items and option line items. I read where you post that the option line items may be exercised at award depending on the availability of funds but I would like to know if you would like us to send in a proposal for only the Base line items with the option line items listed separately. The option line items will alter the way the system is laid out so our thought was to show the system with only the base items and then a second layout with all of the options. We can work to remove options from that layout if need

be. Does that work for the end users?

Answer 66: Please note that at this stage (draft RFQ), NIST is NOT seeking actual quotations to be submitted, and is simply seeking industry feedback about the procurement documents in order to refine the documents to align with industry best practices. Any quotation submitted in response to the DRAFT

RFQ will not be evaluated for award; vendors must respond to the final RFQ, once posted, with a quotation. NIST intends, in the final RFQ, to encourage vendors to submit as many alternative solutions as is efficient and meaningful for contractors to produce and for NIST to evaluate. NIST anticipates that budgetary restrictions will determine the inclusion or exclusion of certain optional line items; however, the total evaluated price would be inclusive of ALL optional line items. Please also note that options (per

FAR 52.217‐7) are distinct from "stronger preferences" discussed in the evaluation criteria. A vendor needn't quote all "stronger considerations" in order to be considered for award; vendors MUST quote all optional items in order to be eligible for award.

Question 67: One thing I couldn’t find was #3 RFQ‐ Line item schedule which I assume will be sent in the final RFQ? Attachments: The following attachments apply to this draft solicitation: 1. DRAFT RFQ

ATTACHMENT 1 ‐ SOW; 2. DRAFT RFQ ATTACHMENT 2 ‐ APPLICABLE PROVISIONS AND CLAUSES; 3. RFQ

ATTACHMENT 3 ‐ LINE ITEM SCHEDULE (to be included with final RFQ)

Answer 67: Yes, per the parenthetical language, that document is not currently available and will be included at the final RFQ stage.

Question 68: If this is still considered market research, are we able to speak with the end user like we were during the RFI period or do we need to route questions through you?

Answer 68: At this point in the procurement process, information must be submitted to NIST via the methods advertised on the draft solicitation posting. Any other method of communication will not be entertained by NIST or approved by the Contracting Officer.

Question 69: Do you need a formal quote at this point or is a rough draft quote enough for now and when the formal RFQ is release we can send along the formal quote.

Answer 69: NIST is not requesting a formal quote at this point. NIST is seeking feedback about the draft

RFQ (e.g., comments, suggested revisions, concerns, etc). As such, no submission limitation, restriction, requirement or guidance applies.

Question 70: So we can submit a budgetary quote without all of the other administrative requirements for now, or we can just submit questions/comments, correct?

Answer 70: NIST is not requesting a formal quote at this point. NIST is seeking feedback about the draft

RFQ (e.g., comments, suggested revisions, concerns, etc). As such, no submission limitation, restriction, requirement or guidance applies.

Question 71: Could you please tell me what type of feedback is appropriate to provide?

Answer 71: NIST is not requesting a formal quote at this point. NIST is seeking feedback about the draft

RFQ (e.g., comments, suggested revisions, concerns, etc). As such, no submission limitation, restriction, requirement or guidance applies.

Question 72: Any indication you are able to give in the formal RFQ about preference of liquid handler would be a huge help in narrowing down our response.

Answer 72: NIST is not able to provide preference for liquid handlers at this time but will take this information under advisement.