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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 19, 2015 FBO #5017
DOCUMENT

66 -- ESTIMATED COST PER SLIDE CONTRACT FOR IMMUNOHISTOCHEMICAL TESTING SUPPLIES - Attachment

Notice Date

8/17/2015
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 02;1304 Buckley Road;Suite 101;Syracuse NY 13212
 

ZIP Code

13212
 

Solicitation Number

VA52815N0336
 

Response Due

8/21/2015
 

Archive Date

10/20/2015
 

Point of Contact

Allison Dubin
 

E-Mail Address

25-4400
 

Small Business Set-Aside

N/A
 

Description

THIS IS A SOURCES SOUGHT ANNOUNCEMENT FOR INFORMATION ONLY. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. In preparation for a future procurement, the VA Medical Center Buffalo, is performing market research to gain knowledge of potential qualified sources and their size classification (service disabled veteran owned small business, veteran owned small business, hub zone, 8(a), small disadvantage business, woman-owned, small business, or large business) relative to NACIS 334516 (size standard 500 employees) that can offer Benchtop IHC instrumentation for staining surgical pathology slides cut from tissue biopsies and Surgical Specimens.. The Government is seeking a system consisting of an instrumentation system, reagent test kits, quality control reagents, and training and technical support in a Cost-Per-Test (CPT) or Cost-Per-Slide (CPS) arrangement for a base year plus 4 (four) option years. Instrumentation needs: Brand name or equal to Dako Autostainer Link 48 System, Workstation, Monitor, Report Printer, Label Printer, UPS, Handheld Barcode Scanner, LAN Seats and PT Link (pretreatment Module). On-site installation and training must be provided. Proposed instrumentation must be bench mounted models. Floor mounted models are not acceptable due to current lab floor plan. Sufficient capacity and throughput at a minimum of forty eight (48) slides within three (3) hours or less to enhance turnaround time and allow for maximum productivity and service demands as defined in the Test Menu. Instrument Service: CPT/CPS must include unlimited on-site service and repairs 8 am to 5 pm Monday through Friday except observed holidays. Required preventative maintenance must also be included with all labor, travel, and parts included. Statement of Work: 1.0 Background: Immunohistochemical stains are necessary for the accurate diagnosis and optimal treatment for patients with abnormal biopsy results. The turnaround time and clarity of staining is paramount for proper management of patient diagnosis. The automated IHC system must be FDA approved, must meet an acceptable TAT as well as utilize a flexible open system (using antibodies from other vendors). It must be compatible to creating custom staining protocols, run multiple detection systems and chromogens in a single run while retaining optimal staining results. Contractors are required to provide a price for each test that can be performed on its equipment. The per slide price shall include costs covering (a) equipment use, (b) most reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor's equipment and necessary for the generation and reporting of a test result, (c) all necessary maintenance to keep the equipment in good operating condition. This element includes both preventive maintenance and emergency repairs, and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. Clinical Laboratory Immunohistochemistry (IHC) Analyzer - Automated system for staining and accurate analysis, data review, and reporting of IHC test results. 2.0 Standards The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Unexpected changes in methodology/technology/product shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals, lab chiefs, and the VISN program office. These individuals shall be identified upon award of the contract. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the SOW. The instrument shall be able to perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Industry Standards - Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Immunohistochemistry (IHC) equipment, supplies and services. 3.0 Instrumentation Specifications: 3.1 Operational/Technical Features - The instrumentation offered shall provide the below capabilities. Equipment shall be new, state of the art, and not used, recertified nor refurbished. Equipment shall be acquired for Clinical Laboratory located Veteran Administration Western New Your Healthcare System at Buffalo New York. The capability of performing analysis on 100% of the tests listed in Attachment A, Schedules and Volumes, or comparable/alternative tests in support of the IHC the contractor system. Sufficient capacity and throughput at a minimum of forty eight (48) slides within three (3) hours or less to enhance turnaround time and allow for maximum productivity and service demands as defined in the Test Menu. Method of performance/comparison/equipment shall be at the expense of the Contractor, shall include linearity material and reagents, be approved by the Food and Drug Administration (FDA) to perform the services/requirements as described and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act and related documents, College of American Pathologists (CAP) Standards and federal regulations and via validation of the VA. Instrument must be FDA approved. Sufficient safety features to avoid unnecessary exposure to bio-hazardous and chemical material. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. VA Safety regulations require strict control of chemical waste disposal. The system must separate hazardous waste form non-hazardous waste for GEMS and EPA compliance: 40 Code of Federal Regulations (CFR) Title 40: Protection of the Environment Part 261- Identification of Hazardous Waste. Provided analyzers shall be able to accommodate a 20% increase in workload during the period of this agreement. Minimal daily maintenance, e.g., the analyzer is not required to be down for more than one (1) hour per day. There shall be easy access to the analyzer for the technical operator to perform maintenance. The Contractor shall provide remote support for trouble shooting. Ease of use with reagent handling, i.e., barcoded reagents to prevent or reduce reagent mix up, ability to load reagents on as needed basis in an expeditious manner. Calibrations are to be stable per minimum CAP specifications and the procedure for performing calibrations must not be labor intensive. Pre-packaged bulk solution reagent kits with no mixing and continuous access to bulks and waste for improved workflow. 3.2 Hardware/Software Features Instrumentation, reagents, consumables and all other provided equipment shall have a total footprint that, when installed/stored in the laboratory shall save space and shall not negatively impact the functionality/operations of that laboratory. This footprint shall not require significant and/or costly infrastructure changes. The physical system must have a true benchtop footprint in order to meet the confined space of the existing laboratory space (34"W x26"D x 27"H or LESS). Hardware should include a 2D compatible digital barcode reader to provide positive identification for all specimen tube IDs. The equipment must also support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, a 10-character, alphanumeric specimen identifier (letters and numbers). Easy slide insertion with no extra pieces to position Have independently functioning slide staining chambers, or equivalent solution, to preserve sample integrity. Equivalent solutions must not be labor intensive. Have the ability to add short turnaround time (STAT) requests with no interruption to routine runs. Have the ability and flexibility to add/remove reagents without interrupting cases in process or impacting workflow including capability to prioritize the stains in process. Optimized protocols with flexible options including variable incubation times and temperatures. An on-board, adjustable monitor/screen that is easily readable. The system includes a printer that has the capability of printing clear, legible and easy to read staining reports. An uninterruptible power supply with line conditioner for each instrument will be provided. Equipment shall have accurate metering capability for monitoring reagent usage and reagent level detection. The Contractor may in the alternative provide another means of tracking reagent usage and reagent level detection if the metering capability is not practical. System will have an effective automatic detection and tracking of insufficient reagent quantities and alert for tests remaining. The instrument shall include buttons and barcodes that automatically register and locate staining kits and slides. Barcoded reagents in which the Instruments must have capability to ensure that one can't use reagents if they are expired or if the volume of the reagents is insufficient to complete the run. Provide two (2) compact disks (CDs) of the IHC "Operation Manual" at each facility or an online procedure manual in the instrument software. The procedure manual shall be formatted in accordance with current approved CLSI guidelines. 4.0 Test and Data Management: Method/Performance of Testing - Method of performance/comparison/equipment shall be at the expense of the Contractor, shall include linearity material and reagents, be approved by the Food and Drug Administration (FDA) to perform the services/requirements as described and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act and related documents, College of American Pathologists (CAP) Standards and federal regulations and via validation of the VA. Instrument must be FDA approved. 5.0 Support Features: 5.1 Installation/Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a Site Preparation Report after award. The report shall be provided to the CO at least ninety (90) days before installation of all other sites. The Contractor shall visit each site and propose the location of equipment and determine specific site prep requirements including but not limited to: "Space availability "Power availability "Availability of waste drainage systems "Increase heat load affecting air conditioning "Specialized ventilation if required "Special finishes required "Carts for non-floor standing instrumentation "Equipment shall be new, state of the art, and not be used, recertified or refurbished. "Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies and 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), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no additional cost to the Government. The Contractor shall perform all of the statistical analysis as stated in 2.4 and report data in an organized, clearly comprehensible format. The Contractor shall visit each Facility at minimum one (1) time per quarter to review the account, provide product information, answer questions, provide Customer Service, handle any defective merchandise, and take care of any other issues that have not been resolved. The schedule shall be created post-award directly with the point of contacts provided at the time of award. 5.2 Special Handling for Emergency Orders of Supplies - In the event that the supplies are found to be defective and unsuitable for use with the Contractor's equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within twenty-four (24) hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor's equipment for one (1) week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. 5.3 Service and Maintenance Plan - The Contractor shall provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation (or equivalent solution or better), as applies, and any incremental support equipment, e.g. water system, offered according to the following terms: A technical assistance center shall be available by telephone Monday through Friday during administrative hours with a maximum call back response time of four (4) hours. Equipment repair service shall be provided Monday through Friday during administrative hours. 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 service response time shall be no more than twenty-four (24) hours. A minimum of two (2) scheduled preventative maintenance calls per year at each facility, once every six (6) months unless otherwise stated within a deviation document. A deviation shall be granted if this deviation is in the best interest of VISN under CO discretion. 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. The Contractor will immediately notify the CO and Contracting Officer's Representative (COR) of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the Government. The Contractor may be liable for costs processing recalls, i.e. administrative and clinical services to replace recalled/defective products. A copy of each service/maintenance record shall be provided to the corresponding VA facility COR within five (5) working days of service/maintenance completion. 5.4 Training - The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility's services and minimally equivalent to the terms and conditions for training. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide on-site training for minimally one (1) operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant included in the Blended CPRR/CPT price. In addition, remote training shall be included. 5.5 Upgrade/Updates - The Contractor shall provide updates to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the art technology, at no additional charge to the Government. 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 updates" that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability. Should the facility decide to upgrade their current equipment, e.g., replace existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement. 5.6 Information Technology Considerations - Ancillary support equipment - The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. 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, tables/stands, etc. The Contractor shall be responsible for providing all hardware required for the connection; implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see requirements below). The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in the chart below. 5.7 Commercial Offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g. CD containing their procedure manual or an on-line procedure manual in the instrument software. 5.8 Characterization of hazardous waste - The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations (CFR) Title 40 "Protection of the Environment" Part 261 et al. In addition, the list shall also identify any "hazardous materials" defined as Hazardous under the latest version of Federal Standard No. 313 that may be provided as a part of this contract. Material Safety Data Sheets (MSDS) shall be submitted for all products. The Contractor will provide a complete chemical analysis of waste, to include mercury, sodium azides, carcinogens, reproductive toxins, acute toxins and all other waste that may be considered ignitable, corrosive, reactive or toxic. Subsequent waste analysis studies for any new test or new test formation introductions shall be provided. Documentation of all analysis will be provided to the CO for review. The description shall address the following: "Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) "Waste ignitability (Reference 40CFR261.21) "Waste corrosivity (Reference 40CFR261.22) "Waste reactivity (Reference 40CFR261.23) "Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31) "Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33) "The Contractor shall provide a written guide describing the proper disposal and care of all reagents, consumables and equipment. "The Contractor shall also provide their own reports of effluent studies associated with their instrument. The Contractor shall also provide documentation to the COR concerning any items in this acquisition that contain cyanide. 6.0 National Holidays: The Laboratory is not open on National Holidays Federal Holidays consist of: New Year's Day Martin Luther King's Birthday President's Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day 7.0 Designation Of Contract Officer Representation COR will be designated in writing. COR will be furnishing technical guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. Interested companies should submit an electronic statement outlining their company's capability and capacity to provide the product, the specifications of the therapy units, and the delivery time to deliver the product to each facility. Also, firms should provide their business size status in accordance with the small business administration guidelines (www.sba.gov) for the NAICS code they fall within. This Sources sought is for informational purposes and all businesses able to provide these supplies are encouraged to submit information regardless of Business size. Please email statements of capabilities to Allison Dubin no later than Friday, August 21st at 5:00PM Eastern time to Allison.Dubin2@va.gov. This notice is to assist the VA in determining sources only. A solicitation is not currently available. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Responses to this sources sought synopsis are not considered adequate responses to any future solicitation announcements.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/SyVAMC670/SyVAMC670/VA52815N0336/listing.html)
 

Document(s)

Attachment
 

File Name: VA528-15-N-0336 VA528-15-N-0336.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2257487&FileName=VA528-15-N-0336-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2257487&FileName=VA528-15-N-0336-000.docx

 

File Name: VA528-15-N-0336 P14 Antibody Optimization.xlsx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2257488&FileName=VA528-15-N-0336-001.xlsx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2257488&FileName=VA528-15-N-0336-001.xlsx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03841580-W 20150819/150817234951-3af877cf781701d98eb410515b98a4d2 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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