Sources Sought The purpose of this synopsis is to gain knowledge of potential qualifed sources and their size classification (hubzone, 8(a), small, small disadvantage, veteran owned small business, service disabled veteran owned small business, or large business) relative to NAICS 325413. Responses to this synopsis will be used by the Government to make appropriate acquistion decisions. After review of the replies to this sources sought synopsis; replies will not be considered adequate responses to the solicitation announcement. General Requirements: Supply Roche Coaguchek XS Plus, XS Professional, and XS Pro Point of Care INR Testing meters/strips/supplies/consumables or equal. The desired system must have the capability of performing or reporting the clinical parameters as defined in Services and/or Supplies, Equipment and Products. The vendor is required to supply items on the below table per need basis. Base Period CLIN Description Catalog No. NDC No. QTY Unit 1 CoaguChek XS Plus Meter Care Kit 05021537001 65702-0164-10 93 Each 2 CoaguChek XS Pro Meter Care Kit 05530199160 65702-0398-10 3 Each 3 CoaguChek XS PT Test Strips 04625315160 65702-0128-10 865 2x24/vial 4 CoaguChek XS Plus Quality Control 04625382160 65702-0129-10 As needed 2 levels/box 5 CoaguChek XS Plus Rechargeable Battery Pack 04805640001 NA 96 Each 6 CoaguChek XS Plus Base Unit 04805658160 NA 77 Each Option Period 1 CLIN Description Catalog No. NDC No. QTY Unit 1 CoaguChek XS Plus Meter Care Kit 05021537001 65702-0164-10 As needed Each 2 CoaguChek XS Pro Meter Care Kit 05530199160 65702-0398-10 As needed Each 3 CoaguChek XS PT Test Strips 04625315160 65702-0128-10 865 2x24/vial 4 CoaguChek XS Plus Quality Control 04625382160 65702-0129-10 As needed 2 levels/box 5 CoaguChek XS Plus Rechargeable Battery Pack 04805640001 NA As needed Each 6 CoaguChek XS Plus Base Unit 04805658160 NA As needed Each Option Period 2 CLIN Description Catalog No. NDC No. QTY Unit 1 CoaguChek XS Plus Meter Care Kit 05021537001 65702-0164-10 As needed Each 2 CoaguChek XS Pro Meter Care Kit 05530199160 65702-0398-10 As needed Each 3 CoaguChek XS PT Test Strips 04625315160 65702-0128-10 865 2x24/vial 4 CoaguChek XS Plus Quality Control 04625382160 65702-0129-10 As needed 2 levels/box 5 CoaguChek XS Plus Rechargeable Battery Pack 04805640001 NA As needed Each 6 CoaguChek XS Plus Base Unit 04805658160 NA As needed Each Option Period 3 CLIN Description Catalog No. NDC No. QTY Unit 1 CoaguChek XS Plus Meter Care Kit 05021537001 65702-0164-10 As needed Each 2 CoaguChek XS Pro Meter Care Kit 05530199160 65702-0398-10 As needed Each 3 CoaguChek XS PT Test Strips 04625315160 65702-0128-10 865 2x24/vial 4 CoaguChek XS Plus Quality Control 04625382160 65702-0129-10 As needed 2 levels/box 5 CoaguChek XS Plus Rechargeable Battery Pack 04805640001 NA As needed Each 6 CoaguChek XS Plus Base Unit 04805658160 NA As needed Each Option Period 4 CLIN Description Catalog No. NDC No. QTY Unit 1 CoaguChek XS Plus Meter Care Kit 05021537001 65702-0164-10 As needed Each 2 CoaguChek XS Pro Meter Care Kit 05530199160 65702-0398-10 As needed Each 3 CoaguChek XS PT Test Strips 04625315160 65702-0128-10 865 2x24/vial 4 CoaguChek XS Plus Quality Control 04625382160 65702-0129-10 As needed 2 levels/box 5 CoaguChek XS Plus Rechargeable Battery Pack 04805640001 NA As needed Each 6 CoaguChek XS Plus Base Unit 04805658160 NA As needed Each Estimated Total (5 years) Services and/or Supplies, Equipment and Products: Vendor provide Food and Drug Administration (FDA) approved analyzer and testing strips that must include the following capabilities: a) Equipment designated by the Food and Drug Administration (FDA) as CLIA-waived to perform protime/INR testing and capable of interfacing with VistA. b) Option for equipment designated by the Food and Drug Administration (FDA) as moderately complex to perform protime/INR testing and capable of interfacing with VistA. c) Code chip programming for reagent strips. d) Barcode scanning or option for manual entry for operator and patient IDs. e) Nine character specimen identifier that is alphanumeric (letters and numbers). f) On board quality control and patient data storage and reporting capabilities. g) Operator and QC lockout capabilities. h) Bi-directional, bar-coded computer interface with ability to read standard barcode format such as Code 128 and Code 39. . i) Procedure manuals, troubleshooting manuals, and operator manuals. Procedures should be in Clinical and Laboratory Standards Institute (CLSI) format. Customizable format preferred. j) Upgrades to equipment hardware at no additional charge to the Government. k) Vendor will notify all facilities of any recalled reagents of equipment components within twenty-four (24) hours. Replacement items will be provided at no additional cost. l) Technical support specialist to assist in equipment set-up, correlation studies, normal range studies, staff training and methodology problems and questions. Technical assistance to perform these studies in accordance with the College of American Pathologists (CAP) at the parent hospital. Vendor to supply all reagents/supplies. m) Automatic software upgrades that maintain Laboratory Information System (LIS) compatibility as available. n) Technical support available twenty-four hours per day, seven days per week. o) Equipment that cannot be repaired via service hotline will be replaced at no cost. For security purposes, no equipment will be returned to the vendor. p) Roche CoaguChek XS PT test strips to be purchased on as needed basis. Support Features: a) Computer Interfacing Requirements The fully operational/bi-directional interface (both hardware and software) must be immediately available. The vendor must be able to provide 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. b) Commercial marketing The equipment models being offered shall be in current production as of the date the offer is submitted. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Refurbished, used or current in house equipment is not acceptable. In response to this announcement, please complete the information below: Company Name: DUNS: Contact Name: Phone Number: Email:

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