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Page 1 of 8 STATEMENT OF WORK HISTOLOGY STAINING SYSTEMS This Sources sought notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information ... Page 1 of 8 STATEMENT OF WORK HISTOLOGY STAINING SYSTEMS This Sources sought notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Sources Sought 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. Capability Statement and Documentation: Companies are invited to provide their capabilities, experience, and knowledge in providing Environmental Microbiology Laboratory Analytical Services. Sources must provide the following information: Company name, address, telephone number, website, DUNS number, CAGE code, business type, socio-economic status (e.g., SDVOSB, VOSB, Woman-Owned, Disadvantaged Small Business, 8(a), general small business, large, business, etc.), and person of contact (including telephone number and email address). Indicate and explain your capability of providing this service in accordance with the Draft Statement of Work (SOW) attached. Indicate your company s size under NAICS 334516. Please indicate any government contracts held including government agency, contract number, dollar value, period of performance, and government contact information. In addition to a Capability Statement which includes the above information, submissions can include specifications, brochures, etc. as attachments. Information regarding your company s capabilities to provide such services are to be submitted electronically on or before Monday, 08/17/2020 by 4:00 PM (EST) addressed to Robert Neal, Contract Specialist at: kevin.balser@va.gov. GENERAL: The Contractor shall provide Special Staining, Immunohistochemistry (IHC)/In Situ Hybridization (ISH) Staining Systems for VA Medical Center in Pittsburgh, Pennsylvania as outlined below. All work shall be performed in accordance with the guidelines established by Federal, State and local ordinances with the Food and Drug Administration (FDA) and manufacturer s guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein. 2. SCOPE: The U.S. Department of Veterans Affairs, Pittsburgh VA Medical Center anticipates a Reagent Usage Agreement from this Request for Quote using FAR Part 12 Commercial Item procedures. Pittsburgh VAMC will issue a reagent usage (Reagent Rental) for instrument use, supplies, installation, training, and servicing of the equipment (for the life of agreement) as identified below. 3. PERIOD OF PERFORMANCE: The Reagent Usage Agreement will consist of a 5 Year Indefinite Quantity contract. The performance period will commence upon the Contracting Officer s signature and will expire within five (5) years unless canceled, terminated, or extended. 4.Reagent Rental: The contractor shall furnish Pittsburgh VAMC four (4) laboratory instrument system(s) reagents to include detection kits for IHC and for probes/in-situ hybridization (ISH) and reagents for Simple and Complex Special Stains. The contractor will provide technical support necessary to operate the contractor s equipment, hardware and software upgrades, training for personnel and equipment maintenance necessary to fulfill the test requirements. Pittsburgh VAMC will pay for the test assays performed on the contractor s equipment. The Reagent Rental price shall include (a) equipment use (reagent rental), (b) detection kits, simple stains and complex stains, (c) all necessary maintenance to keep the equipment in operating condition, (d) operational hardware and software upgrades, (e) user training for government personnel, (f) complete service support, and (h) reagent delivery costs. The contractor shall deliver, install, and disassemble equipment (upon contract expiration at no additional cost to the VAMC). 5. EQUIPMENT: The purpose of this section is to identify the salient characteristics of the IHC/ISH Staining System and Special Stain System, and specify functionality and performance-based requirements of this system. Each proposal shall include descriptive literature that meets the following specifications (as a minimum): Requirements of Services to be provided: Note: * defines those items that if not present will negate selection Required Characteristics/ Functionality and Performance Specifications for Special Stainer: Automated baking and deparaffinization of paraffin sections Barcode driven technology to allow automatic input of data for the reagent delivery system with the associated slide protocol label Individual micro controlled slide heating with slide heater pads which are precision heated and maintained at various temperatures in the same staining run to facilitate staining reactions Liquid Coverslip is automatically applied to slides during a staining run and forms an incubation chamber on each slide, preventing the aqueous reagent from evaporating to facilitate the staining reaction Utilization of Heat and Air Vortex Mixing for even stain quality by preventing sample wash off and dehydration Clock-wise and counter clock-wise air mixing pattern of the reagents on the slides during staining reactions Self-contained ready to use staining kits; reagent vials are pre-filled with reagents optimized for the system All the following Special Stains must be fully-automated and available at the time of submission: AFB, Alcian Blue, Alcian Yellow, Congo Red, Elastic, Giemsa, GMS Fungus, GMS Pneumocystis, Iron, Jones Methenamine Silver, Mucicarmine, PAS lt. green, PAS diastase, PAS Alcian blue, Reticulin, Steiner, Masson s Trichrome III Blue and Trichrome Have a slide carousel for 1-20 slides with independent temperature control for each position, have a reagent carousel with 25 reagent positions and be CSA, EMC, CE compliant The system(s) should be modular flexible with ability to reconfigure modules, and scalable to allow for volume increase in throughput and fit in limited space Capability of remote instrument support to include: real-time remote instrument monitoring, remote troubleshooting and training, system software upgrades over a secure internet connection and proactive customer contact to maintain optimum instrument performance levels Computer system (CPU, Monitor, Keyboard, Printer, Speakers), Ebar label system, software revision upgrade. C&A requirements do not apply and a Security Accreditation Package is not required since the computer is not connected to a VA network and the contractor will not have access to Protected Personal Information (PPI). Electrical characteristics 120 VAC plus or minus 10%, 4 amps, 50/60 Hz. Characteristics/Functionality and Performance Specifications for Immunohistochemical Stainer: General instrument characteristics include automated IHC, ISH, FITC, baking, deparaffinization, cell conditioning, proteolytic enzyme digestion and staining, 1-30 slides with individual slide access and independent temperature control for 25 X 75mm, 1 x 3: or 26 x 76 mm, 35 reagent positions in carousel, up to seven bulk reagents, floor mounted using 20 liter waste bottle, CE and CSA compliant. Must be capable to perform different staining protocols on each slide simultaneously in each staining run with independent random slide access Must function as a continuous and random access IHC and ISH platform. Slides, reagents and self-contained waste system can be simultaneously accessed as the system is processing samples. Slides can be removed and added continually during normal operation Individual slide drawers, individually plumed bulk reagents with arch design of the reagent dispensing carousel for efficient and continuous access processing Slides, reagents and self contained waste system can be simultaneously accessed as the system is processing samples Individual microcontrolled slide heating with 35°C incrementally to 42°C and Ambient antibody incubation, ambient to 100°C in under three minutes and 100°C to 35°C in under seven minutes Must be able to run paraffin embedded slides, non-paraffin embedded slides, slides using different type 1 cell conditioning and/or type 2 cell conditioning with and without enzyme digestion and enzyme digestion by itself The systems should utilize flash memory technology and barcodes on dispensers or other similar system to track reagents and for quality control and quality assurance Physical characteristics of instrumentation include modular, flexible, with the ability to reconfigure modules, and scalable to allow for volume increases in throughput and to fit in limited bench space Electrical characteristics 120 VAC plus or minus 10%, 4/2amps, 50/60 Hz Computer system (CPU, Monitor, Keyboard, Printer, Speakers), Ebar label system, and software revision upgrade. The computer is not connected to a VA network and contractors will not have access to PPI (LIS future capability would be a plus) The systems should be barcode driven, random access, have a precision reagent delivery, precision heat induced staining reaction, horizontal kinetic mode Immunohistochemistry, and Chromogenic in situ Hybridization The systems should use Liquid Coverslip, Air Vortex Mixing, and Buffer Jet Slide Washing to include strict protocol timing to assure run-to-run consistency to improve overall staining quality, minimize slide- to-slide variability, and reduce background staining. Should use air vortex mixing where jets of air are precisely applied to create a clock-wise and counter clock-wise mixing pattern of the reagents on the slides during staining. This mixing increases the reaction kinetics of antibody and probe to their respective binding sites. The system(s) should use buffer jet slide rinsing to remove reagents between steps in the protocol to decrease background artifacts on the slides and increase reproducibility. Capability of remote instrument support to include: real-time remote instrument monitoring, remote troubleshooting and training, system software upgrades over a secure internet connection and proactive customer contact to maintain optimum instrument performance levels. The systems should utilize self-contained, pre-diluted, Antibodies and Detection kits that are ready to use out of the box Use no more than 100 uL of reagent per slide Must have at least 30 individual slide drawers and capability to run IHC, ISH, and FITC simultaneously with individual random slide access Must be able to hold at least 35 reagents for dispensing Must have ability to use detection that is not polymer and does not use AB blocker The self-contained dispenser vials should be environmentally safe. The systems should have a self-contained waste system. The systems should utilize flash memory technology and barcodes on dispensers or other similar system to track reagents and for quality control and quality assurance The systems must improve overall productivity in the Histology Lab; reduce need for repeat testing thus reducing reagent waste. The system should not require monitoring during a run and should be 100% walk-away system. 6. GENERAL REQUIREMENTS: The contractor is required to provide new state-of-the-art staining equipment; discontinued models are unacceptable. The contractor shall provide all operational upgrades to the equipment hardware and operating system software that materially affect the performance of the equipment at no additional charge to the government. These enhancements to the contractor s equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability. Note: The C& A Requirements do not apply. A Security Accreditation Package is not necessary. All models shall perform satisfactorily at any laboratory temperature between 59 and 86 degrees Fahrenheit (15 and 30 degrees Celsius). All models shall perform satisfactorily at any laboratory relative humidity between 10 and 70%. The contractor shall provide an electronic operator s manual with each supplied model. Trade-in of existing equipment will be negotiated by the Contracting Office and is not included in the scope of this contract. a. Site Preparation: Specifications shall be furnished in writing by the contractor as part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer s claimed specifications. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation, which are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the government, shall be made at the expense of the contractor. b. Ownership of Equipment: The contractor shall maintain ownership of all equipment resulting from award of this solicitation. All accessories (hardware and software) 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, will remove the equipment. The contractor will disconnect the equipment (gas, water, air, etc.) and will be responsible for all packing and shipping required to remove the equipment within ten (10) business days. c. Standard and acceptance of performance shall begin on the installation date. It shall end on the earlier date of when a certificate of acceptance is signed or the equipment meets the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor s technical specification or as quoted in any contract at an effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue on a daily basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the VA may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4(m) Contract terms and conditions Commercial Items, Termination for cause. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fine attempt to contact the contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The VA shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operational use time and downtime shall be measured in hours and whole minutes. Government Responsibility: The VA site will perform routine maintenance per manufacturer operation and maintenance manuals. Training of Operating Personnel: The contractor shall provide a qualified technician at the time of equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Technical Representative (COTR) to provide on-site orientation and training to designated personnel in: (1) operation and care of equipment; (2) techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the contractor s warranty. This training shall include at least two (2), two-day on-site training sessions, all day, upon installation and acceptance of equipment and later, for refresher training. Installation procedures: The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling, if applicable. Upon award, the contractor must notify the COTR of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be suspended until the cause of delay is rectified. The contractor shall continue performance within 24 hours after notification is received from the government. Final acceptance of the equipment and installation is based upon an inspection and test performed within ten (10) calendar days from the installation date. Quality of Reagents, Supplies and Disposables: The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality slide product. The reagent quality (as a minimum) must satisfy proficiency-testing standards of the College of American Pathologists (CAP) and The Joint Commission. In the event that the supplies to include detection kits, stains, and/or consumables are defective and unsuitable or the contractor failed to comply with the requirements herein, the contractor shall deliver ample supplies (under normal government test load volume) within 24 hours after notification at no additional cost to the VA. DELIVERY LOCATIONS: The Pittsburgh VAMC projects the following estimated number of slides processed on the individual equipment: * Instruments and Estimated Slide Quantities per Year Facility Instruments Slides Pittsburgh VAMC 3 IHC 2 SS 10,000 2,900 * The totals are only an estimate and should not be considered a guarantee for future orders MAINTENANCE: The contractor shall provide maintenance (labor and parts) to maintain the equipment in satisfactory operating condition and subject to security regulations. The VA shall provide access to the equipment in order to perform maintenance services. The contractor shall perform emergency repairs within 48 hours after notification from the COTR. The contractor will provide all parts and labor needed to repair the malfunction. Travel, per diem and other associated repair expenses are borne by the contractor. The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a) date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. TRAINING AND TECHNICAL SERVICE: The contractor shall provide training at a government location for two operating personnel at the time of installation of the contractor s equipment at no additional charge to the VA. Additionally, the contractor, at his/her discretion, may make training available at his/her facility on terms and conditions mutually agreed upon by the VA and the contractor. In addition, the contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of the upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: The VA shall require the contractor to deliver the equipment ordered under this contract not later than Sixty (60) calendar days after award. The VA reserves the right to thoroughly inspect and investigate the contractor and manufacturer business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance. Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training. The VA reserves the right to request a ninety (90) day test and evaluation of equipment prior to placing an order. If the test and evaluation is unsuccessful as determined by the CO and COTR for this VA, the VA will not be required to continue with placing orders under this agreement, and no default or penalty will accrue. SERVICE: The Contractor shall provide maintenance services within 48 hours notice from the Contracting Officer or designee. Emergency service must be provided within 8 working hours of notification; telephone responses will not satisfy this requirement. During the warranty period, service will be provided during regular working hours (Monday Friday, 8:00 am 4:30 p.m., excluding weekends and holidays). AVAILABILITY OF SERVICE: The contractor guarantees availability of servicing and replacement parts during performance period. CONTRACTOR TESTING AND INSPECTION: The contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services conform to contract requirements. Government testing and inspection will not unduly delay contractor performance, nor will it create a defect in services covered by the award. REGULATORY REQUIREMENTS: If the product(s) included in this SOW are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all equipment conforms to all common industry standards. MANUFACTURED PRODUCTS: Materials shall conform to current productions of manufacturers regularly engaged in manufacture of such items. Contracting Officer will approve deviations from products and manufacturers as shown in the schedule of items. The shelf life of all consumables shall be at least ONE (1) YEAR from shipping date unless FDA specifies a different expiration date. Reference Specifications and Publications: Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement. CONTRACT ADMINISTRATION: The Contracting Officer (CO) is the only person authorized to approve changes or modify the statement of work or any of the contract requirements. Only the CO is authorized to issue changes that affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in contract price to cover any increase in costs incurred as a result thereof. AREA OF RESPONSIBILITY and Place of Performance: The VISN 4 Medical Center COR is listed below. Pittsburgh VA Medical Center University Drive C Pittsburgh, Pa. 15240 Loc: 2NE106