SPECIFICATION lab stainer - Brand Name or Like.docx

FUNCTIONAL/PERFORMANCE/SPECIFCATION

Description & Salient Characteristics: The Fargo VA Medical Center has a need for the purchase of Histo machine Leica Histocore Spectra CV is used in the Histology lab to place a piece of glass over a tissue section on a microscope slide. It serves the purpose of protecting the specimen, enhancing optical clarity, securing the sample, and preserving the slide. It is essential for high-quality analysis and diagnosis. The Leica Histocore Spectra ST is an automated stainer used to stain slide with H&E or Pap stain. Its purpose is to automate the staining process to reduce human error and increase efficiency, standardize staining, and improve workflow. The stain enhances tissue visualization aiding in diagnostic accuracy. This stainer is used in conjunction with the Leica Histocore Spectra cv which coverslips the slides after staining. This request is a firm-fixed price.

Salient Characteristics Brand Name or Equal to:

Leica HistoCore SPECTRA CV No : 14051454200

The HistoCore SPECTRA CV is an automated high throughput benchtop coverslipper that can be used in conjunction with HistoCore SPECTRA ST to create an automated workstation.

· Consumable management system automatically monitors the status of all consumables.

· Allows a minimum of 2 racks (60 slides) to be processed at the same time.

· Integrated to a workstation, stained slides will be automatically transferred from HistoCore SPECTRA ST to HistoCore

· SPECTA CV.

· Ability to process up to minimum of 360 slides per hour.

· No external oven needed. Has built-in hot air oven.

· Oven can process up to 6 racks at the same time.

· Has precise reagent management using RFID-monitored consumables.

· Uses color-coded technology, color-coded slide rack hangers.

· As integrated suction/fume control system.

· Has a touch screen that is solvent resistant.

· Features an unload drawer the provides capacity to store up to 9 racks (270 slides).

· Continuous manual rack loading/unloading is accomplished without opening the instrument lid using the motorized load/unload drawers on the HistoCore SPECTRA CV.

· HistoCore SPECTRA CV is a closed system using validated plug & play mounting media and cover glass.

· In workstation mode, the color-coded slide racks can be assigned to the applicable staining program on HistoCore SPECTRA ST.

· Color-coded slide rack hangers with transponder which allows automatic selection of coverslipping parameters

· In workstation mode, the color-coded slide racks can be assigned to the applicable staining program on HistoCore SPECTRA ST.

HistoCore SPECTRA CV COVERGLASS 24X50 HistoCore SPECTRA X1 Mounting Median Basic Instructions 4 racks for 30 slides, pack of 3 1 rack handle for 30 racks, yellow, pack of 3 1 Rack handle for 30 slide racks, light blue, pack of 3 1 Rack handle for 30 slide racks, red, pack of 3 1 Rack handle for 30 slide racks, white, pack of 3 2 Reagent vessels assy. consisting of:

1 Reagent vessel 1 Reagent vessel lid 1 Cuvette clamp 1 Prime bottle consisting of:

1 Laboratory bottle, 150 ml 1 Cap nut 1 Insert for Prime bottle 1 O-ring 28 x 3 mm 1 Cleaning bottle 1 Needle cleaning container, pack of 2 3 Rack storage rails for output drawer 1 Exhaust air hose set consisting of:

1 Exhaust air hose, 2 m 1 Hose clamp 1 Pair of cut resistant gloves, size M 1 Tool kit consisting of:

1 Slotted screw driver, 5.5 x 150 1 Leica brush 2 Fuses T16A 1 Set of Charcoal filters consisting of:

2 Charcoal filters 4 Suction cups 2 Cover glass waste tray 2 Label covers "s" 2 Label covers "blank" 1 IFU-Bundle HistoCore SPECTRA CV consisting of:

1 Instructions for use for HistoCore SPECTRA CV, printed, DE/EN 1 CD including available languages 1 IFU-language order sheet

HistoCore Spectra ST No : 14051254354

· Stand-alone slide stainer.

· Continuous rack loading/unloading, without opening the instrument lid, is accomplished using motorized load/unload drawers with 5 stations each.

· A maximum for 12 slide racks can be processed at the same time.

· Has a minimum of 52 stations available, of those a minimum of 6 can be used as rinse stations with one or 2 water supplies.

· Has the ability run programs provided by the vendor and customized programs.

· The reagent management system automatically monitors the conditions of all reagents.

· Informs operator when reagents need changing.

· Must be able to customize programs.

· Has color-coded slide rack hangers.

· Has status screen that shows all active programs.

· Integrated suction/fume control system with an activated carbon filter.

· Has ability to select incubation periods.

· autostart capability through color-coded rack recognition.

· Provides consistent staining from minimum 1 slide to maximum 1,600 slides.

HistoCore SPECTRA Workstation Kit No : 14051254355

Dimensions (W x D x H):

1354 mm x 785,5 mm x 615 mm 53,3 x 30,9 x 24,2 inches 610 mm / 24 inches from rear to front feet 1060 mm / 41,7 inches heights with lid open Dry weight: 165 kg, 363 lbs Overall weight (with reagents and accessories):215 kg, 473 lbs Nominal supply voltage: 100240 V/ 5060 Hz Ambient temperature: 18 °C to 30 °C Humidity: 80 % RH noncondensing (Max), Standard delivery:

1 Basic instrument 1 Accessory kit consisting of:

1 Set of cuvettes consisting of:

46 Cuvettes, assy., incl. cuvette lid 6 Water rinse cuvettes, assy. including 6 O-ring 7x2 for water cuvette connector 1 Inscription cover-kit consisting of:

10 Inscription covers, blanc 5 Inscription covers, "H20" 5 Inscription covers, "S" 5 Inscription covers, "A" 1 Set of Charcoal filter cartridges, (pack of 2) 1 Drain hose 1 Hose clip 1 Water connection kit consisting of:

2 Water inlet hose, 10 mm, 2.5 m 1 Extension hose 1.5 m 1 Y junction 2 Double nipple G3/4 G3/8 1 Filter housing 1 Filter cartridge POROPLAST 1 Pipe coupling G 3/4 1 Blind cap G3/4 1 Seal washer 1 Single head wrench SW30 DIN894 1 Exhaust air hose, 2 m 1 Hose clip DIN3017, 5070 rf 1 Slotted screwdriver 5.5 x 150 3 Racks for 30 slides, pack of 3 1 Rack hanger for 30 slide racks, yellow, pack of 3 1 Rack hanger for 30 slide racks, dark blue, pack of 3 1 Rack hanger for 30 slide racks, red, pack of 3 1 Rack hanger for 30 slide rack, white, pack of 3 2 Fuses T16 A 1 Molykote 111, grease, 100 g 1 IFU-Bundle HistoCore SPECTRA ST consisting of:

1 Instructions for use for HistoCore SPECTRA ST, printed, EN 1 CD including available languages 1 IFU-language order sheet

HistoCore SPECTRA CV COVER GLASS 24501 No : 3800152 Ready to use cover glass cartridges

HistoCore SPECTRA CV X1, Mounting Medium No : 3801733

· Rapid drying, xylene based mounting media

· An antioxidant is added to prevent stain fading and prevent rings

· Sets up quickly so slides can be handles immediately after mounting

Power Cord various NEMA520 C19 No : 14041149613

Installation and Instrument Setup

Installation, adjustment and level alignment of the instrument are carried out as part of the instrument installation by a service technician certified by Leica only.

This service does not involve the storage, generating, transmitting, or exchanging of VA sensitive information.

“Privacy training is required if the contractor(s) will be working in areas with sensitive Veteran information with an increased risk of inadvertent disclosures. These are areas where only authorized personnel are allowed (nurse’s stations, PACT team areas, Laboratory, Pharmacy, etc.) and where visitors would typically be escorted and not be allowed to roam around freely (4B, ER, 3M, ICU, CLC, etc.). The contractor(s) must read and sign TMS 20939, VA Privacy Training for Personnel without Access to VA Computer Systems or Direct to or the Use of VA Sensitive Information, prior to beginning work in these areas.”

Delivery Location

Delivery and Installation

1. The vendor will be responsible to deliver the materials 60 days ARO Materials of all pieces to which make the equipment fully functional, including all accessories must be present upon delivery.

Contacts:

2. All items to be shipped F.O.B. destination. Shipping shall be included in the product price and shall not be billed separately.

3. No tools during deinstallation or installation will be supplied/provided by the VA.

TRAINING REQUIREMENTS: TMS 20939 NO ACCESS

NARA Records Management Language for Contracts (July 10, 2019) https://www.archives.gov/records-mgmt/policy/records-mgmt-language

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VA records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their VA contract.

1. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

1. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

1. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

1. Fargo VA Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Fargo VA Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Fargo VA Medical Center. The agency must report promptly to NARA in accordance with 36 CFR 1230.

1. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Fargo VA Medical Center control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

1. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Fargo VA Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

1. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Fargo VA Medical Center policy.

1. The Contractor shall not create or maintain any records containing any non-public Fargo VA Medical Center information that are not specifically tied to or authorized by the contract.

1. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

1. The Fargo VA Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Fargo VA Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

1. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Fargo VA Medical Center provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of Requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

1. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.