BN Sole Source.pdf

JUSTIFICATION FOR SOLE

SOURCE

(Simplified Acquisitions LESS THAN S250K)

The service or material listed on <N6809621SBCJ04> is sole source and competition is precluded for reasons indicated below. There are no substitutes available for this material or service.

Restricted to the following source. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.)

Manufacturer: ... B ... 1""'0 ... -... RAP ............. _________________________ _

Manufacturer POC & phone number: James Cooke 0421-380-258

Mfr. Address: 446 Victoria Road Gladesville NSW 2111 Australia

Dealer/Rep MD Wholesale I Joseph Vitug

Dealer I Rep address / phone number. 442 Chalan San Antonio. Tamuning Guam 96913

671-649-5833

.K._ Description of the item or service required, the estimated cost, and required delivery date.

Bio-Rad #284 Mutliqual Prem Assay 1 Liquid Bio-Rad #285 Mutliqual Prem Assay 2 Liquid Bio-Rad #286 Mutliqual Prem Assay 3 Liquid Bio-Rad #397 Urine Chemistry, Level 1 Bio-Rad #398 Urine Chemistry, Level 2 Bio-Rad #360 Immunoassay Plus, Trilevel

The end user requires necessary assayed quality control material to operate the Ortho Clinical Diagnostics 5600 chemistry analyzer platform for the purpose of performing routine and ST A lr!clinical patient testing in support of out patient clinic, in-patient ward, surgical services and the Emergency Department operations in a timely manner.

Shipping schedule will be set with sequestered lots. Products must be delivered as close to the lot release date as possible to allow for maximum usage of products. Products must have at least 12 months of shelf life upon arrival.

...x_specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.).

The Bio-Rad brand provides an extensive range of quality controls(using minimum vials) covering analytes for immunoassay, therapeutic drug monitoring, chemistry, cardiac markers, diabetes and drugs-of-abuse which can be used to perform quality control testing on over 85% of our current chemistry test formulary. Additionally, the Bio-Rad brand is the only brand to supply worldwide peer group data information for our current Vitros analyzer in use.The end user requires necessary assayed quality control material to operate the Ortho Clinical Diagnostics 5600 chemistry analyzer platform for the purpose of performing routine and ST AT clinical patient testing in support of out-patient clinic, in patient ward, surgical services and the Emergency Department operations in a timely manner. Shipping schedule will be set with sequestered lots. Products must be delivered as close to the lot release date as possible to allow for maximum usage of products. Products must have at least 12 months of shelf life upon arrival.

K_ The requested material or service represents the minimum requirements of the government.

lL_ The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existjngsystem.

The Assayed Bio-Rad Quality Controls are liquid controls that can be placed directly on the analyzer for testing. All Bio-Rad QC has been validated for use on the Ortho Vitro 5600 which will eliminate an additional costs used to validate QC. Bio-Rad QC can be used on different platforms aside from what we currently have, which means we can continue using this QC in the future if we happen to purchase new analyzers from a different company.

x_ A patent, copyright or proprietary data Jimits competition. The proprietary data is:

Bio-rad is the only manufacturer to provide assayed quality controls with monthly world-wide peer group data reports using minimal controls to cover the broad range of our chemistry test formulary.

__ These are "direct replacemenls" earts/components for existing equipment.

� Other infonnation to support a sole source buy:

Market Research suggest that based on Guam's Geographical Location procuring from the US in not possible. Distribution of products are assigned by region. The nearest International Bio-Rad Distributor is located in Australia - Bio-Rad Laboratories Pty LTD has designated MD Wholesale located on Guam to be the only au1horized in channel distributor forv the pacific region.

I CERTIFY THAT STATEMENTS CHECKED, AND INFORMATION PROVIDED ABOVE, ARE

COMPLETE AND CORRECT TO THE BEST Of' MY KNOWLEDGE. I UNDERSTAND THAT THE PROCESSING OF THIS l. OURCE JU_�.TIFICATION PRECLUDES THE USE OF FULL AND OPEN COMPETlT

Requiring Activity Dept. Head/Commanding Officer

Edward John Ronquill.o

. 9. MIS (ASCPJSignature�

Title i.....-?o

Date

Contracting Officer Signature�

Date lo/" "l,.,/y, SOURCE SELECTION INFORMATION- SEE FAR 2.101 and 3.104