Justification for BetaSam.pdf

VHAPM Part 816.5—Indefinite-Delivery Contracts Attachment 1: Request for Exception to Fair Opportunity Memo Format

VHAPM Part 816.5—Indefinite-Delivery Contracts Page 1 of 4 Original Date: 08/30/2017 Date: 05/17/2021

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For

Exception to Fair Opportunity Memo

Acquisition Plan Action ID: ______36C242-21-AP-1877_______

1. Contracting Activity: Department of Veterans Affairs, VISN 2, Albany 528-21-3-8213-0050, Bath 528-

21-3-6307-0334, Buffalo 528-528-21-3-4307-0379, and Syracuse 528-21-3-7307-0603 Medical Centers Labs.

2. Description of Action: The Upstate New York VA Medical Centers of Albany, Bath, Buffalo, and Syracuse Pathology and Laboratory Medicine Service (PLMS) have a requirement for Blood Bank Anti- Body ID products for use with VA Medical Center owned Ortho Clinical Diagnostics ID-MTS Workstations. This shall be a firm fixed price five-year contract with a base year and four option years with a period of performance of June 28, 2021 through June 27, 2026.

3. Description of Supplies or Services: The following supplies will be required for monthly delivery:

1) ID-MTS Anti-Ig Gel Cards, Anti-Human Globulin, Estimated Quantity: 45 Boxes Per Year

2) Resolve Panel A, 0.8% Blood Bank Antibody ID Kit, Estimated Quantity: 39 Packages Per Year

3) Reagent 0.8% 2 Cells Selectogen, Estimated Quantity: 60 Packages Per Year

4) Selectogen 3% Blood Bank Antibody, Estimated Quantity: 26 Packages Per Year

5) Ortho Confidence System, Estimated Quantity: 13 Packages Per Year

6) Affirmagen 0.8% Bank Antibody, Estimated Quantity: 13 Packages Per Year

7) Gel Cards, Estimated Quantity: 10 Cases Per Year

4. Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section 41 U.S.C. 4106(c) as implemented by the Federal Acquisition Regulation (FAR) Subpart 16.505 Subpart 16.505(b)(2)(i):

( ) FAR Subpart 16.505(b)(2)(i)(A): The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

(X) FAR Subpart 16.505(b)(2)(i)(B): Only one awardee can provide the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

( ) FAR Subpart 16.505(b)(2)(i)(C): The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

( ) FAR Subpart 16.505(b)(2)(i)(D): It is necessary to place an order to satisfy a minimum guarantee.

( ) FAR Subpart 16.505(b)(2)(i)(E): For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source”. The statutory

VHAPM Part 816.5—Indefinite-Delivery Contracts Page 2 of 4 Original Date: 08/30/2017 Date: 05/17/2021 authority permitting an exception to fair opportunity for this action is 38 U.S.C. 8127(c), known as the Veterans First Contracting Program which provides the authority to directly contract with a Service- Disabled Veteran-Owned Small Business (SDVOSB) or a Veteran-Owned Small Business (VOSB).

5. Rationale Supporting Use of Authority Cited Above:

The equipment required for this testing has been in place since 2002. The two centrifuges and the two 37C incubators are owned by each of the four Lab Medical Centers that does testing from the required blood reagents supplies. Ortho Clinical Diagnostics has certified that it is the sole manufacturer of the reagents and supplies for the proprietary ID-Micro Typing System Gel technology reagent products and Ortho Red Cell Products. Ortho Clinical Diagnostics Inc., a large business, now partners with a service-disabled veteran owned small business (SDVOSB), Garrison Walker Group, Inc.

This SDVOSB is the only authorized distributor of Ortho products. If a contract were to be awarded for another brand, this would require the following: extensive correlation study, changes to standard operating procedures and testing procedures, staff training on the new equipment, and additional costs to either purchase the equipment from a new supplier or to lease the equipment from a new supplier.

6. Efforts to Obtain Competition: A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable.

This equipment currently owned by all four medical centers is FDA approved for use solely with Ortho Diagnostics reagent. There is competition among the manufacturer, Ortho Clinical Diagnostics, Inc.

and the small business distributor Garrison Walker Group, Inc.

7. Actions to Increase Competition: Describe actions taken, or that will be taken, to remove or overcome any barriers to competition before initiating any subsequent acquisitions for the supplies, or services required, including challenges to restrictive data markings, data rights, preparation of a performance based work statement, and etc.

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: Provide a description of the market research conducted among the contract holders and the results. If market research was not conducted, the reasons it was not conducted should be stated. When citing 16.505(b)(2(i)(b) or 16.505(b)(2)(i)(e), the only possible way to state in paragraph 5 of the J&A that there is only one contractor who can fulfill the agency’s needs is to conduct market research, and it should be summarized here.

Heather Merkley-Tamburello the Contracting Officer Representative (COR) from Albany has contacted blood bank reagent vendors to obtain information on specific reagents availability. Quotient Inc. and Bio- Rad Laboratories supply blood bank reagents but they are only intended for tube testing. Medion Diagnostics has gel methodology but per FDA requirements the reagent red cells must be used with the company testing medium and the company provided centrifuges and incubators.

VHAPM Part 816.5—Indefinite-Delivery Contracts Page 3 of 4 Original Date: 08/30/2017 Date: 05/17/2021

9. Other Facts: It would be cost and time prohibitive to buy centrifuges and incubators for each of the four Lab Facilities from another manufacturer.

10. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Name: Heather Merkley-Tamburello Date: 5/17/2021 Title: Contracting Officer Representative Facility: Albany VAMC

11. Determination that Anticipated Cost is Fair and Reasonable: A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable:

Since each of the four Lab Facilities owns the proprietary equipment there are no further actions that can be taken to try and obtain competition for these blood reagents supplies.

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

Name Date Title Facility

13. Approvals in accordance with VHAPM Part 816.505 Indefinite Delivery Contracts: Ordering.

a. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

NCO/PCO XX Duty Title

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

b. VHA Advocate for Competition/Head of Contracting Activity (HCA) REVIEW AND APPROVAL (over $750,000 to $15 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_816.505.aspx

VHAPM Part 816.5—Indefinite-Delivery Contracts Page 4 of 4 Original Date: 08/30/2017 Date: 05/17/2021

VHA Head of Contracting Activity (HCA)

c. VHA Head of Contracting Activity (HCA) Approval (over $15 million but not exceeding $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

VHA Head of Contracting Activity (HCA) Department of Veterans Affairs

d. VHA Senior Procurement Executive Approval (over $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

Angela Billups, Ph.D. Date Senior Procurement Executive (SPE) Department of Veterans Affairs