P03 - Brand Name Only Justification - Redacted.docx

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME ONLY JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

1. Contracting Activity: Department of Veterans Affairs, Network 23 Contracting Office, 316 Robert St N, Ste 506, St. Paul, MN 55101 Requesting Activity: Minneapolis VA Medical Center, One Veterans Drive, Minneapolis, MN 55417

2. Nature and/or Description of the Action Being Processed:

This procurement is for supplies in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This is a firm-fixed price procurement for FDA-approved CEDIA and DRI Drugs of Abuse reagents, calibrators, and controls for the Oxycodone, Ecstasy, Heroin (6MAM), and Hydrocodone assays for the Minneapolis VA Medical Center (MPLS VAMC) Toxicology Laboratory. A Brand Name Only solicitation will be issued for this procurement.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

This is a follow on supplies contract for FDA-approved CEDIA and DRI Drugs of Abuse reagents, calibrators, and controls for the Oxycodone, Ecstasy, Heroin (6MAM), and Hydrocodone assays for the MPLS VAMC Toxicology Laboratory.

Schedule of Items:

The proposed action is a base year plus four option years IDIQ.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The MPLS VAMC is the sole national provider of pre-employment and random employee drug testing for all VA Hospitals and their affiliated CBOCs. The Toxicology Laboratory within the Pathology and Laboratory Medicine Service at the MPLS VAMC is certified by Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, hereinafter referred to as HHS SAMHSA, to conduct the Federal Workplace Urine Drugs of Abuse Testing Program for all the VA hospitals and their affiliated CBOCs. The MPLS VAMC Forensic Toxicology Laboratory in the Pathology and Laboratory Medicine Service meets the mandatory guidelines for Federal Workplace Drug Testing Program.

The MPLS VAMC Toxicology Laboratory requires highly specialized FDA-approved CEDIA and DRI Drugs of Abuse reagents, calibrators, and controls for the Oxycodone, Ecstasy, Heroin (6MAM), and Hydrocodone assays, as specified in the schedule of items. These items are used with the Beckman AU480 analyzers that are used by the MPLS VAMC. The Minneapolis Forensic Toxicology Laboratory is highly regulated and inspections are required every six months. It is one of only nineteen laboratories in the world to perform this testing. The reagents and quality control are standardized for laboratories in the program. The schedule reagents are the only reagents that have been validated in the Minneapolis Forensic Toxicology Laboratory to meet HHS SAMHSA standards. All required validation experiments have been performed, and that data has been reviewed and been approved by the program inspectors for use in the Minneapolis Forensic Toxicology Laboratory within the Federal Workplace Drug Testing program. Only the schedule reagents have been approved directly by HHS SAMHSA for use in this laboratory. The use of any reagents other than the schedule items would trigger revalidation and reevaluation as well as introducing unknown risks for how the new reagents would perform over time against the program’s requirements. The schedule reagents have been reevaluated every year since they were selected over all others for their superior performance when the program began and have performed successfully through four cycles of proficiency testing each year since.

The costs associated with being forced to pick a new vendor is prohibitive to the VA. Validating new reagents is a rigorous and labor-intensive process that would take years to accomplish which would create a significant hardship for the laboratory, which is already short-staffed. Revalidation would require additional technologist and director evaluation time increasing the cost to the VA. New reagents may not pass inspection or meet proficiency testing requirements of the program. Proficiency testing deficiencies can incur additional costs including fines for failures or requiring the laboratory to cease testing. It would be detrimental to the Federal Workplace Drug Testing program as any disruption in service will result in national delays in the Human Resources hiring process, and employee on-boarding nationwide would be delayed or stalled.

The schedule items are manufactured solely by Microgenics Corporation, making this a Brand Name Only requirement. The MPLS VAMC currently has a sole source contract with Microgenics (36C26320D0011) for these items that is expiring on 12/07/2024. Thermo Fisher Scientific is the parent company of both Microgenics and Fisher Scientific, who is an authorized distributor, and the items can be purchased directly from Microgenics, or they can be purchased through Fisher Scientific. There are no other vendors authorized to distribute the schedule items.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Market research was conducted, and the findings are detailed in Section 8 of this document.

Contracting considered the possibility of using different equipment; however, this equipment is required for the MPLS VAMC to remain certified by the HHS SAMHSA without triggering revalidation and reevaluation. This equipment has also been validated in the Minneapolis Forensic Toxicology Laboratory to meet HHS SAMHSA standards. Even if new equipment was able to pass the revalidation and reevaluation requirements, the laboratory would still need to spend years revalidating and reevaluating all of the reagents to be used with the new equipment. This is also very cost prohibitive.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Market research quotes were obtained from both Microgenics and Fisher Scientific for a base plus four option years contract. The market research quote from Microgenics includes a 3% annual increase for each option year to account for inflation and changes in the market. The Contracting Officer determined that the anticipated cost to the government from the market research quotes will be fair and reasonable based on comparison to the pricing on the current Microgenics contract 36C26320D0011.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Searched NAICS Code 325413 on VetCert to identify verified capable SDVOSBs and VOSBs – 89 results were returned. Used the Dynamic Small Business Search tool – 8 VOSB and 111 SDVOSB results were returned.

Received a sourcing email from parent company Thermo Fisher stating that these products are manufactured and distributed by Microgenics with Fisher Scientific as an authorized distributor of the required items. After determining that a Brand Name Only solicitation will be issued, since an entirely new system of equipment is not a viable option, no further market research was deemed necessary.

BAA applies to this requirement. Microgenics affirmed that the required products are manufactured in the US at the Fremont, CA facility.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

The MPLS VAMC is currently required to use the Beckman AU480 analyzers, and the schedule items for this procurement, in order to remain certified by the HHS SAMHSA without triggering revalidation and reevaluation that requires years to accomplish and would incur great cost to the Government. The agency is restricted by the certification requirements that allow them to remain the sole national provider of pre-employment and random employee drug testing for all VA Hospitals and their affiliated CBOCs. If revalidation and reevaluation of the program was triggered, the program would not be able to operate for years until the program requirements could be reattained and the laboratory could be recertified. At this time no actions by the Agency can be taken to remove or overcome the barriers preventing competition for this requirement. However, the Agency has chosen to utilize a base plus four option years IDIQ instead of a 5 year IDIQ with ordering periods to allow for reevaluation prior to each option year in the event that the program requirements change. Market research will be conducted for future acquisitions to determine if market conditions have changed that would allow for additional competition to fulfill this requirement going forward.