A13 Single Source Justification Kmarshallsigned.pdf

Version 11.24

SINGLE SOURCE JUSTIFICATION IN ACCORDANCE WITH FAR 13.106-1(b) (Over Micro-Purchase Threshold but not exceeding SAT)

1. a. Contracting activity: Centers for Disease Control and Prevention, Office of Acquisition Services.

b. Center/Institute/Office:

2. Description of required supplies or services:

Total estimated value:

3. Rationale for soliciting from single source or brand name:

a. FAR 13.106-1(b), only one responsible source is reasonably available based on the following:

Restrictive Rights – The source has established proprietary rights, limited rights in data, patent rights, etc. for the required item or service.

Exclusive Licensing Agreement – The required item or service is only available from the original equipment manufacturer (OEM) or there is only one authorized distributor/source for the OEM.

Urgency – An urgent and compelling need exists and soliciting from more than one source would result in an unacceptable delay would result in serious injury to the Government.

Brand Name – Required item must be a brand name product particular to one manufacturer.

Other Reasons

b. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

4. Description of market research conducted and results or statement why market research was not conducted:

5. Requirements certification: I certify that the requirement outlined in this justification is a bona fide need of the Centers for Disease Control and Prevention and that the supporting information under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

6. Contracting Officer’s certification: Procurement will proceed in accordance with FAR 13.106-1(b). I certify that the forgoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

Title:

Cepheid's limited warranty states that they will not cover modifications or repairs done by other than Cepheid or a Cepheid authorized service provider. Cepheid does not warrant any defects in the Instrument caused by (i) improper installation, removal or testing, (ii) Purchaser's failure to provide a suitable operating environment for the Instrument, (iii) use of the Instrument for purposes other than that for which it was designed, (iv) unauthorized attachments, (v) unusual physical or electrical stress, (vi) modifications or repairs done by other than Cepheid or a Cepheid authorized service provider, or (vii) any other abuse, misuse, or neglect of the Instrument. The Instrument is designed and certified with applicable regulatory authorities as part of an integrated instrument/reagent/consumable system. Use of unapproved parts, reagents or other materials with the Instrument will void any warranty and any service contract between Cepheid and the Purchaser that pertains to the Instrument.

Text25: Cepheid is the original manufacturer of this equipment and as such are the only vendor capable of servicing the equipment to their specifications, and supplying the associated computer required for operating the equipment. We did investigate if we could add this to an already existing CDC BPA with REMI group, but REMI was unable to support this piece of equipment. REMI cannot service this instrument due to Cepheid's warranty policy which states “states that they will not cover modifications or repairs performed by other than Cepheid or a Cepheid authorized service provider. Cepheid does not warrant any defects in the Instrument caused by (i) improper installation, removal or testing, (ii) Purchaser's failure to provide a suitable operating environment for the Instrument, (iii) use of the Instrument for purposes other than that for which it was designed, (iv) unauthorized attachments, (v) unusual physical or electrical stress, (vi) modifications or repairs done by other than Cepheid or a Cepheid authorized service provider, or (vii) any other abuse, misuse, or neglect of the Instrument. The Instrument is designed and certified with applicable regulatory authorities as part of an integrated instrument/reagent/consumable system. Use of unapproved parts, reagents or other materials with the Instrument will void any warranty and any service contract between Cepheid and the Purchaser that pertains to the Instrument.” Program once again did an internet Google search and checked GSA Advantage to determine if there were other approved vendors who could provide a MA for the Cepheid GeneXpert. No additional vendors were found.

Text28: Public Health Analyst, COR II