SSJ for AB Sciex.pdf

United States Department of Agriculture Sole Source (Including Brand Name) Justification under

Simplified Procedures for Certain Commercial Items (FAR 13.5)

1. Identification of the agency and the contracting activity.

Contracting Activity:

Karen Petty, karen.petty2@usda.gov Contracting Officer USDA, FSIS, Administrative Services Division Procurement Management Branch 5601 Sunnyside Avenue, Maildrop 5230 Beltsville, MD 20705-5230

Requesting Activity:

Ivan Lenov, ivan.lenov@usda.gov, Technical Contact USDA, FSIS, Office of Public Health Services 4300 Goodfellow Boulevard, Bldg 105-D St. Louis, MO 63120

2. The nature and/or description of the action being approved.

USDA proposes to enter into a sole source, firm-fixed price contract with AB Sciex, LLC using simplified procedures for certain commercial items under Federal Acquisition Regulation (FAR) Part 13.5.)

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

USDA-FSIS is seeking to procure an AB Sciex QTRAP-ready 7500 Liquid chromatography mass spectrometry (LCMS) system. The AB Sciex QTRAP-ready 7500 LCMS system is a highly sensitive triple quadrupole mass spectrometer system and is an exclusive product of AB Sciex.

The instrument is quoted at a cost of $601,721.75. This includes necessary startup and training of staff. A purchase of another brand LC-MS/MS system from a different manufacturer will require the Midwestern laboratory to train staff on another separate system, have multiple sets of protocols for the types of tests being conducted, utilize multiple software packages depending on the instrumentation that was used for the testing, perform annual revalidation on multiple systems.

4. The statutory authority permitting other than full and open competition.

41 U.S.C § 1901 - Simplified Acquisition Procedures up to $7.5 million, as authorized by FAR 13.500(a) and implemented by FAR 13.501(a).

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

This equipment is intended for use in the Midwestern Lab, as part of a workflow developed by the other two labs, specifically on this system. While other manufacturers may meet sensitivity and specificity requirements in the SOW, it would not be possible to employ within the already established workflow. The Eastern and Western Lab already have this specific piece of equipment and are currently validating a workflow that requires this brand and this model. If the Midwestern Lab were to procure a different manufacturer, or even a different model from the same manufacturer, that would meet the specifications listed in the SOW, the workflow would have to change dramatically to accommodate. This would include significantly altering the validation – the validation is ongoing at this time in the other two labs, with a deadline of method publication by the end of Fiscal Year 2024.

These are very sophisticated pieces of equipment which require many months, if not years, of experience to operate. The daily operation of the laboratory is performed by different individuals and therefore they rely on consistency of protocols and the ease of use of these protocols. There are a number of companies which manufacture LC MS/MS systems. While the hardware manufactured by all the companies is pretty compatible, the key to the ease of use of the system is the software on the systems which drive the operation of the instrument. Every manufacturer has different software and these are totally different. It takes a very long time (months) to train individuals to become familiar with the operation of the software which drives competent use of the LC MS/MS system. Furthermore, the hardware components and maintenance protocols and schedules are very different.

Given this background and the work environment in the Midwestern laboratory, we are required to purchase a system from AB Sciex for the following reasons:

1. The laboratory will need to train personnel and then maintain their competency on a totally different system than the two other systems in the Eastern and Western laboratories would be costly.

2. Lack of compatibility of our methods if we have 1 system from one manufacturer and 2 other systems from totally different manufacturers separate validations protocols will be needed. In addition, protocol are revalidated yearly, so the separate validation for a LCMS/MS instrument from a different manufacturer would require an additional revalidation.

3. The Midwestern laboratory will have to maintain a separate parts inventory if a different system is procured.

While other manufacturers, such as Agilent and Thermo Electron, LLC may meet sensitivity and specificity requirements in the SOW, it would not be possible to employ within the already established workflow to meet scheduled deadlines.

6. A description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

For this procurement, there were no efforts made to ensure offers were solicited on www.ebuy.gov or www.sam.gov from other potential sources due to the need of having compatible systems in all three laboratories due to testing protocols and validations and knowledge of operation equipment. When the opportunity presents itself to change testing protocols, we will ensure other sources are considered.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The anticipated cost will be determined by comparing the prices on previous purchase order 123A9423P0080 for the AB Sciex Triple Quad 7500 Systems for the Eastern and Western labs, and searching the GSA and AB Sciex websites to compare prices of the AB Sciex LC-MS/MS system and components.

8. A description of the market research conducted and the results or a statement of the reason Market Research was not conducted.

In checking the Required Sources, the Contract Specialist has confirmed that only the LC-MS/MS system is under AB Sciex’s Federal Supply Schedule (FSS) GSA # GS-07F-0092X but the installation, software and training are not offered under AB Sciex’s FSS and that no IDIQs or BPAs exist for which an order could be issued against.

The CS found that per the research of the GSA FSS, there are no 8(a), HUBZone, SDVOSB, or WOSB that can provide the LC-MS/MS system or components.

Both the Eastern and Western labs ordered the AB Sciex LC-MS/MS under Purchase Order 123A9423P0080, dated 8/1/2023, and this PO was used as a research document.

9. Any other facts supporting the use of other than full and open competition.

NA

10. A listing of the sources, if any, that expressed a written interest in the acquisition.

NA

11. A statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

The USDA-FSIS will perform market research to determine if the same barriers remain, and if this can be done through a competitive procurement process if another LC-MS/MS system is needed in the future to remove any barriers to competition.

Certifications & Approvals

Supporting data which form the basis for and included in this justification are certified accurate and complete.

Matt Hall, COR

Matthew Hall, Contracting Officer’s Representative

The information contained in this Justification for Other Than Full and Open Competition is certified accurate and complete to the best of my knowledge and belief.

Karen R. Petty, Contracting Officer 062724