J_ AToxicology Reagents Microgenics TNeubelt Rev1 JL VD MC.pdf

OFOC SOP Revision 09 Page 1 of 3 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT O ETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: VA-20-00076346

Contracting Activity: Department of Veterans Affairs, VISN 01, Medical Centers.

Nature and/or Description of the Action Being Processed: This is a request for a 5-year BPA for the purchase of Ethyl Glucuronide (ETG), pH, and Specific Gravity reagents to support the chronic opioid screening protocols and VISN1 Toxicology patient screening orders. This is a follow up to contract VA241-17-D-0140 which expires on 9/30/20 for the purchase of Microgenics reagents for patient drug testing.

Description of Supplies/Services Required to Meet the Agency’s Needs: ETG reagents are for the qualitative and semi-quantitative determination of Ethyl Glucuronide in human urine at cutoffs of 500 ng/mL and 1000 ng/mL. These reagents are for use in drug abuse testing and are designed for use in automated testing equipment currently being used in the VISN1 Labs.

Estimated total cost for the 5 year BPA is $ .00.

Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;( )

(6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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

ETG reagents for the qualitative and semi-quantitative determination of Ethyl Glucuronide in human urine at cutoffs of 500 ng/mL and 1000 ng/mL. This assay provides only a preliminary analytical test result. The DRI® Ethyl Glucuronide Assay is supplied as a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect Ethyl Glucuronide without any significant cross-reactivity to other glucuronide compounds. The assay is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase (G6PDH), and free drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in

OFOC SOP Revision 09 Page 2 of 3 Original Date: 03/22/11 Revision 09 Date: 04/17/2020 urine and enzyme activity. Active enzyme converts NAD to NADH resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

This reagent is compatible with the Abbott Architect Chemistry analyzers and already standardized at each VA laboratory in VISN 1. rapid test, card or kit does not meet the requirement for qualitative and semi-quantitative determination of Ethyl Glucuronide in human urine at cutoffs of 500 ng/mL and 1000 ng/mL.

Buprenorphine, pH and Specific gravity tests were validated with this contractors reagents and found to correlate well with the current analyzer.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An internet search of required products showed limited sources for these reagents. Only Microgenics was able to provide a product that could be used on the existing laboratory equipment. Other information found on ETG reagents are for rapid kits which are not compatible with the standardized automated equipment we have in place in VISN 1 so therefore these kits are not acceptable. ThermoFisher Microgenics products were tested along with similar products from other v ndors. The VISN 1 labs determined these products correlated better than the other contractor reagents and have been validated.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The pricing from the prior contract as well is being carried over to new contract and makes this a fair value for VISN1 and all the VA laboratories.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: An internet search provided 4 companies that can provide reagents for specimen validity when used for Drug of Abuse testing. Those companies are:

Microgenics , Thermo Fisher (a distributor for Microgenics), Transmedco and Craig Medical. All 4 of these vendors have reagents but only 2 of them, Microgenics and ThermoFisher (Microgenics is a subsidiary of ThermoFisher) have those reagents in the needed form. Both Craig Medical and Transmedco utilize “dip sticks” for this testing

. This is a manual system and takes to much time for a high volume lab. Reading the coloring of the dip stick once put into the specimen can fluctuate due to the amount of time the dipstick is inserted into the specimen to when the dipstick is finally read. There is also subjectivity of comparing a color to a point score. For example- a 1 is bright red, a 2 is less bright red, 3 is redish pink and 4 is pink. There is also the problem of possible manual data entry mistakes made by technologists when entering the numbers into the computer. Automated entry from an automated analyzer not only improves testing throughput but insures accurate results and mis-diagnosis.

Other information found on ETG reagents are for rapid kits which not compatible with the standardized equipment we have in place in VISN 1 herefore th kits are not acceptable.

Thermo Fisher products were tested along with similar products from other vendors. The VISN labs determined these products correlated better than the other contractor reagents. Microgenics

Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Page 3 of 3 Original Date: 03/22/11 Revision 09 Date: 04/17/2020 provides the best solution for automated specimen validation for the drug of abuse testing performed in VISN 1

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The Microgenics product has already been validated throughout the VISN 1 labs and it would take a tremendous amount of time to bring in and use alternative reagents.

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

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: None

12. 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 and belief.

Name: David McElwee Date Title: Medical Technologist Facility: VISN1 – Brocton VA

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name: Julie Lemire Date Title: Contracting Officer Facility: NCO1- Manchester VA

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Name: Linda Ward Date Title: Supply 1 Branch Chief

Facility: NCO1- Manchester VA

David G.

McElwee 142454

Digitally signed by David G. McElwee 142454 Date: 2020.09.18 12:21:35 -04'00'

Julie A. Lemire 149432 Digitally signed by Julie A. Lemire 149432 Date: 2020.09.18 13:03:13 -04'00'

Linda J. Ward 155235 Digitally signed by Linda J. Ward 155235 Date: 2020.09.18 13:34:48 -04'00'