Cephid MRSA Testing 553-17-1-058-00005

LIMITED SOURCES JUSTIFICATION

ORDER >$150,000

FAR PART 8.405-6



Acquisition Plan Action ID:__VA251-16-AP-4759_____



This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 - Federal Supply Schedules, is precluded for the reasons indicated below.



Restricted to the following source: Provide original manufacturer's name for material or contractor's name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.)



Manufacturer/Contractor: Cepheid Corporation

Manufacturer/Contractor POC & phone number: Jeff LaFave

Mfgr/Contractor Address: 904 E. Caribbean Dr. Sunnyvale, CA 94089-1189

Dealer/Rep address/phone number: 888-838-3222



1 The requested material or service represents the minimum requirements of the Government.



(1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs

John D. Dingell VAMC__________

4646 John R ____________________

Detroit, MI 48201



VISN: 10



(2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED:

Limited Source Justification for a Firm-Fixed Price purchase order to Cepheid Corporation for the purchase of supplies for molecular testing specifically concerning MRSA infections.









(3) (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED:



Swabs for MRSA testing 50/package. V797P5967X

MRSA test kits 10/package. V797P5967X







(b) ESTIMATED DOLLAR VALUE: $



(c) REQUIRED DELIVERY DATE: 10/10/16; 11/1/16; 12/1/16; 1/1/17; 2/1/17; 3/1/17; 4/1/17; 5/1/17; 6/1/17; 7/1/17; 8/1/17; 9/1/17.



(4) IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. (CHECK ALL THAT APPLY AND COMPLETE)



1 Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources.

Currently there are only 2 vendors for this type of testing. The technologies used by each of the vendors are not interchangeable. For each instrument, there is a cartridge which fits into the instrument. This cartridge holds the reagents necessary to perform the test. The cartridges only fit that particular instrument. The reagents and cartridges are manufacturer specific. Therefore, these are the only reagents that can be used with our specific equipment.



0 A patent, copyright or proprietary data limits competition. The proprietary data is:

(If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)











0 These are "direct replacements" parts/components for existing equipment.

____________________________________________________________________________

____________________________________________________________________________



0 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 existing system.













0 The new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.













0 An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.





















(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION:

This brand only requires approximately 5-7 minutes of preparation by a technologist (known as hands on time). The other product requires at least 20-30 minutes of tech hands on time which delays the reporting of patient results. Patients that are tested as Positive must be placed in isolation ASAP. This vendor provides the fastest turn-around-time for patient results. In addition, these are the only reagents that can be used with the installed equipment, if we were to compete it, we'd have to replace all the equipment which is not cost effective and the cost would not be recovered through competition.





(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

GSA and the NAC were searched. Cepheid is the only vendor that can provide this specific reagent. This instrument was acquired by the Detroit VAMC as a result of a grant from the VHA in 2008 to

Enhance our molecular testing platform, specifically concerning MRSA infections. The instrument uses laser technology and is very complex. Currently there are only 2 vendors for this type of testing, but only this vendor can provide the reagents for the equipment the VA owns.





(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

None















(8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE:

Once the VA Medical Center determines our current equipment is deemed unserviceable or outdated, we will look for future competition for replacement equipment as well as the cartridges that need to run on this equipment. Abrupt replacement for this equipment is not possible due to several months of transition needed to conduct proper reference testing and quality control measures. This transition period and requirement must be taken into account when proposing future replacement of these machines.







(9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor's supervisor, fund control point official, chief of service or someone with responsibility and accountability.)