SOW-STATEMENT OF WORK for IHC SS request.pdf

TECHNICAL SPECIFICATIONS/STATEMENT OF WORK FOR IHC STAINER,

SPECIAL STAINER, REAGENTS, RELATED STAINS, ANTIBODIES,

CONSUMABLES, AND SERVICE CONTRACT

The purpose of this contract is to provide two Automated IHC Stainers , and one Automated Special Stainer, all reagents, related stains, antibodies, consumables, decontamination of automated stainers (quarterly or per manufacturers recommendation) and a service contract to James H. Quillen VA Medical Center, Corner of Veterans Way and Lamont Street, Mountain Home, TN 37684. The above items are necessary to produce quality stained slides which are evaluated by pathologists and aid in making patient diagnosis. This is an immediate need for the Histology section of the Pathology and Laboratory Medicine Service. The special stainer which we have at Mountain Home will no longer be supported by Roche Ventana in the near future and the Benchmark Ultra at Mountain Home was placed at Mountain Home eight years ago.

1. BASIC REQUIREMENT:

The James H. Quillen VAMC, Pathology and Laboratory Medicine department has a requirement for two Automated IHC Stainers, one Special Stainer, all reagents, related stains, antibodies, consumables, and a service contract which includes decontamination services of the automated stainers on a quarterly basis or per manufacturers recommendation. The vendor must provide the following:

1. Vendor must offer both IHC and/or Special Stainer.

2. IHC and Special Stainer must be capable of completing multiple runs during an 8 hour day.

3. The vendor must offer bulk reagents.

4. Both the IHC and special stainer must be bar code driven.

5. Both the IHC and special stainer must have walk away automation.

6. Both the IHC and special stainer must have prepackaged reagent kits-no mixing.

7. Prefer Button and barcodes automatically register and locate staining kits and slides.

8. Both the IHC and special stainer must automatically track insufficient reagent quantity and alert for tests remaining.

9. The IHC must have continuous and random access.

10. Both the IHC and special Stainer must have easy slide insertion- with no extra pieces to position.

11. Both the IHC and special stainer must have no surprise extensions of time when slides are added during the run. The vendor must provide run times.

12. Both the IHC and special stainer require barcoded slide labels for fast slide ID.

13. Both the IHC and special stainer require easy to read, printable staining reports.

14. Both the IHC and special stainer require reduced exposure to harmful chemicals.

15. Both the IHC and special stainer must be free standing.

16. The equipment and reagents for both the IHC and special stainer must be FDA and IVD approved-NOT RESEARCH APPROVED.

17. Both the IHC and special stainer must offer multiparameter staining.

18. Both the IHC and special stainer must offer Automated Baking.

19. Both the IHC and special stainer must have barcoded reagents. Instrument 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.

20. Vendor must include preventive maintenance visits, visits to site to repair instrument when down, technical support call line, and Decontamination if possible, as part of the contract.

21. Vendor must provide one training slot for the Immunohistochemical stainer. If a separate vendor for special stainer, then a training slot is required for the special stainer. The class shall include Air flight, Hotel, transportation from the airport, breakfast, and lunch.

This will be a Firm Fixed Price Contract.

2. ESTIMATED QUANTITIES:

Instrument 2016 2017 2018 2019

IHC Detection 4,750 4,500 5,693 7,829

Special Stains 4,320 3,720 2,302 2,659

Estimate for FY 20 is 8,000 IHC Detection Slides and 2,800 Special Stain Slides

All products can be placed or requested on an “on demand, as needed” basis.

3. EFFECTIVE DATE/TERM OF CONTRACT:

This contract’s effective date is 10/1/2020. Contract contains base year plus 4 option years to renew, for a total contract period not to exceed five years. Agreement will be reviewed annually a minimum of thirty days prior to the anniversary date.

4. PRODUCT QUALITY

All products offered to James H. Quillen VAMC, Pathology and Laboratory Medicine Service must be of the same consistent high quality as would be offered to the general commercial public in the United States.

5. CUSTOMER SERVICE:

A company representative shall visit the James H. Quillen VAMC no less than once per Quarter to review account, provide product information, answer questions, provide Customer service, handle any defective merchandise, and take care of any other Issues that may arise.

6. PRODUCT SUBSITUTION:

No product substitutions will be accepted without the prior approval of the VA Medical Center Laboratory Service and the Contracting Officer. Any substitutions of product must have the written approval of the VAMC Histology Laboratory Service and the Contracting Officer or his/her designee.

7. ORDERING PROCEDURES:

Delivery orders will be made by contacting the company on-demand, as needed basis, by VAMC Laboratory personnel.

Purchase orders to the contractor shall be placed as follows:

Vendor:____________________________________________ Vendor Address:_____________________________________ Vendor Fax:________________________________________ Vendor Phone______________________________________ Vendor Number_____________________________________

8. DELIVERY:

Deliveries shall be made to:

James H. Quillen VA Medical Center Veterans Way @ Lamont Street Warehouse 204 Mountain Home, TN 37684-4000

All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain:

vendor’s name, purchase order number, date of order, date of delivery, itemized list of products furnished including product description and quantity shipped.

Shipping terms: Prepaid and add; FOB Distribution

9. CHANGES/MODIFICATIONS:

Changes in the terms and conditions of this contract may be made only by written agreement of the parties. Any and all modifications for changes in: the prices, terms or conditions of this contract, will be prepared for signature by the VA Contracting Officer.

10. RECALLED AND DEFECTIVE PRODUCTS:

The Contractor will immediately notify the Contracting Officer 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.

11. MSDS, HAZARDOUS MATERIALS AND WASTE ANALYSIS:

The offeror is required to provide a list identifying 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. 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. Contractor will also be required to provide additional subsequent waste analysis studies in the case of any new test or new test formation introductions. Documentation of all analysis will be provided to the VA Contracting Officer for review by the VISN 9 Green Environmental Management Systems (GEMS) Coordinator prior to contract award or introduction of new product after award.