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THIS REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT

DISCLAIMER

This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI In Accordance With (IAW) FAR Part 15.201(e).

SOURCES SOUGHT DESCRIPTION

This is NOT a solicitation announcement. This is a RFI/sources sought only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 334516 (size standard of 1000 Employees). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement.

The Department of Veterans Affairs (VA), VISN 15 Network Contracting Office, is seeking sources that can provide the following, :

Brand Name or equal: Leica Spectra ST Stainer and Spectra CV Coverslipper Lease
GENERAL REQUIREMENTS:
This is intended to be a lease consisting of a base year and 4 one-year options to be exercised at government discretion.
Operational Features -The instrumentation offered shall have the following:
Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and the unit must have the ability to be closed during H&E sample processing and contain appropriate filters to control fume exposure.
Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:
Instrument must be a programmable automated system capable of performing multiple programs.
Multiple H&E and special staining programs can be run simultaneously.
Capability to process up to minimum of 330 H&E slides per hour.
Must have the ability to select incubation periods from 1 second to 100 hours.
Must be a continuous loading unit.
Must have the capability to perform non-gyn PAP stains.
Must process H&E and special stains simultaneously.
Must have RFID tracking on coverslip consumables.
Must provide coverslipping drying time of no more than 5 minutes.
The coverslipper must have large workload capacity of at least 250 slides.
Must have dual glass coverslip lines to allow for a high throughput (at least 500 slides per hour).
Coverslipper must have a glass detection sensor to remove and transfer broken coverslips.
Vendor must have local service engineers.
Must allow to change medium volumes using automated features
Hardware Features- The instrumentation shall have the following:
Must have enough reagent receptacles to perform H&E staining and separated containers for non-gyn PAP reagents to avoid cross-contamination.
Unit must have the H&E Stainer attached to an automated cover slipper that utilizes glass coverslips
Provide constant agitation of staining racks.
Provide continuous rack loading and unloading without opening the instrument lid.
Should be a countertop model.
Size should be no larger than 84-inch width and 31-inch depth.
Should have at a minimum of two (2) hot air-drying ovens.
Should have solvent resistance color touch screen for operation of the analyzer.
Method Performance/Validation Requirements
Method Optimization assistance should be provided by the vendor for each stain program at the time of analyzer installation. Reagent expense shall be bored by the facility.
Documentation:
A current editable, electronic (Microsoft Word) copy of the instrument operating guide(s) and procedures shall be provided.
Support Features-The equipment models being offered shall be in current production as of the date this offer is submitted. Current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.
Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.
Commercial offerings. The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an online procedure manual in the instrument software.
Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.
Training.
Upon Installation: The Contractor shall provide advanced (key operator) instrument training program for at least two operators per facility at no charge to the Government that is coordinated with and timely with the equipment installation, sufficient to the size and scope of the facility s services. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair.
Thereafter: The Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. The training will be used for new employees or as a Refresher training .
Service Requirements- Equipment Preventative Maintenance/Repair Service.
The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g., water system, offered according to the following terms:
Service Requirements:
A technical assistance center shall be available by telephone on business hours, 5 days per week with a maximum call back response time of 1 hour.
Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.
Equipment repair response time shall be no more than 24 hours.
Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date.
A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: date and time notified, date and time of arrival serial number, type and model number of equipment, time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.
Each notification for an emergency repair service call shall be treated as a separate and new service call.
Equipment repair service shall include one (1) relocation of equipment, for each participating facility, during the life of the agreement.
Upgrades - The Contractor shall provide upgrades to the equipment hardware, bidirectional interface, and software to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government if sites are interested. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of the software, correction of a hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace the model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability.

Ancillary support equipment
The Contractor shall provide, install and maintain through the life of the agreement, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. universal interface equipment. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, etc.

Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

The information identified above are intended to be descriptive, not restrictive, and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications, or brand name equal.

If you are interested and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions:

Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)?
Is your company considered small under the NAICS code identified under this RFI?

Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above?

If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified?

Does your company have an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed above? If so, please provide the contract number.

Please submit your capabilities that show clear, compelling, and convincing evidence that you can meet the requirement described in the attached SOW.

Please provide your UEI number.
Responses to this notice shall be submitted via email to Tracie Raggs at tracie.raggs@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Thursday, October 27, 2022 at 2300 CST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this sources sought. Responses to this sources sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.

Attachments/Links