36C24120Q0362_1.docx

Contract Opportunity Justification and Approval Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

DELIVERY/TASK ORDER NUMBER

(Required when using Statutory Authority FAR 6.302-1(c))

BASE NOTICE TYPE

ARCHIVE

DAYS AFTER THE POSTING DATE

RECOVERY ACT FUNDS

NAICS CODE

CONTRACTING OFFICE

ADDRESS

DESCRIPTION

See Attachment

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

STATUTORY AUTHORITY

AWARD NUMBER

(Not required when using Statutory Authority FAR 6.302-1(c))

MODIFICATION NUMBER

AWARD AMOUNT

LINE ITEM NUMBER

AWARD DATE (MM-DD-YYYY)

(Not required when using Statutory Authority FAR 6.302-1(c))

AWARDEE NAME

AWARDEE ADDRESS LINE 1

AWARDEE ADDRESS LINE 2

AWARDEE ADDRESS LINE 3

AWARDEE ADDRESS LINE 4

AWARDEE CITY

AWARDEE STATE

AWARDEE ZIP CODE

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

AWARD INFORMATION

ADDITIONAL INFORMATION

GENERAL INFORMATION

* = Required Field Contract Opportunity Justification and Approval Notice 523-20-3-1866-0048---Leica Microsystems Reagent Supplies new

IDIQ 2020

05009 36C24120Q0362 36C24120A0049 S N 325130 Department of Veterans Affairs VAMC White River Junction

215 North Main Street White River Junction VT 05009 Contract Specialist Edward M Sullivan Edward.Sullivan@va.gov

(802) 295-9363 ext 6281

FAR1

36C24120A0049

750,000.00

06-17-2020

LEICA BIOSYSTEMS IMAGING, INC

1360 PARK CTR DR

VISTA

CA

92081

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-20-AP-1644

1. Contracting Activity: Department of Veterans Affairs, VISN1, VA Boston Healthcare System (VABHS), 150 South Huntington Avenue, Building 1A-127, Jamaica Plain, MA 02130. The PTSD Brain Bank and Pathology lab. Total value is $750,000.00

2. Nature and/or Description of the Action Being Processed: Research reagent supplies for the PTSD Brain Bank and Pathology lab. These supplies are for the Bond RX Stainer that was purchased in2016. The device is Leica Brand and it is recommended that only Leica brand supplies be used. It is therefore recommended it be awarded to this manufacturer.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The following supplies from the original manufacturer are necessary in varying quantities for the continued use of the stainer purchased in 2016 which is essential to the processes conducted regularly in the PTSD Brain Bank and Pathology lab:

100 Bond Polymer Refine Detection No : DS9800 200 Bond Polymer Refine Red Detection No : DS9390 300 Bond Polymer Refine Red Detection No : DS9390 400 Bond Research Detection System No : DS9455 500 Bond Research Detection System 2 No : DS9777 600 BondTM Wash Solution 10X Concentrate, 1L No : AR9590 700 BOND Printer Ribbon & Labels Cxi (1Pack) No : S21.4604.C 800 Bond™ Mixing Stations No : S21.1971 900 Bond Open Containers 7ml No : OP79193 1000 BOND Universal Covertiles (pack of 160) No : S21.4611 1100 Bond Dewax Solution No : AR9222 1200 Bond TM Epitope Retrieval 11L No : AR9961 VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

1300 Bond TM Epitope Retrieval 21L No : AR9640 1400 Bond Enzyme Pretreatment Kit No : AR9551 1500 Bond Slide Labels and Printer Ribbon No : S21.4564 1600 Bond Aspirating Probe Cleaning Kit No : CS9100 1700 Bond Titration Kit No : OPT9049 1800 Bond™ Reagent Tray No : S21.1003 1900 Bond DAB Enhancer 30ml No : AR9432 2000 Bond Open Containers 30ml No : OP309700 2100 Reagent Tray Storage No : S21.1987 2200 Reagent Container Storage No : S21.1986 2300 SLIDE BOND APEX ADHESIVE No : 3800040

4. 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 FAR6.302-3;

( ) (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;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

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 reagents required are proprietary to the manufacturer, Leica, and are required for the use of the Leica instrument in the PTSD lab. This is a highly specialized system used regularly for PTSD research. It is core to the processes being conducted and any delay would cause lapses in critical research. This requirement is the continuation of IDIQ VA241-17-D-0059 for VISN 1. The incumbent, who is the manufacturer, is the only source for this follow up contract for this highly specialized set of supplies to support the in-place equipment. Accordingly, Leica Biosystems is the only firm capable of providing the supplies and services described in Section above.

Full automation of these assays assures less repeats, consistent staining and preserves precious tissue integrity. All of which are essential to the scientific process in our laboratory. In reference to the Perkin Elmer Opal kit, multiplex fluorescence, Advanced Cellular Diagnostics duplex and triplex kits, Bond RX is the only fully automated solution to achieving these results.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: VIP, FPDS, NAC contracts, SAC contracts were all checked for any “in place” agreements which would fit the needs of the requirement and none were found. 3 sources were found under just “Leica”, they are not equipped to supply reagents from the company’s Biosystems division and supply mostly items from Microsystems division. NAC contract is in place for microscope equipment from Microsystems division. None of these are capable sources for these reagents, confirmed by Advanced Staining Account Manager for Leica Biosystems Northeast Region.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The prices quoted by the manufacturer are in line with previous acquisitions and are below retail cost commercially. A discount above and beyond normal pricing of 25% was applied across the board on all required items with the exception of adhesive which is discounted 45%.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: VIP search was conducted. FPDS was consulted for prior award involving Leica Biosystems product. NAC contracts were searched. SAC contracts were searched. Manufacturer product literature was consulted. RFI was sent to manufacturer to obtain a letter of exclusivity.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Leica is the manufacturer of both the equipment purchased in 2016 and all the subsequent supplies purchased to support it. Exclusivity letter from the OEM was refreshed on May 13th, 2020 stating they are the only source for these products. Any substitution would possibly risk grey market acquisition and it is unlikely any other source would be able to discount the items 25-45% off retail cost.

10. 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.

Bertrand Huber

Digitally signed by Bertrand Huber Date: 2020.05.21 11:37:45 -04'00'

_ Date

Page 1 of Bertrand Huber, MD, PhD PTSD Brain Bank Director

Page 1 of

11. 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.

William A. Prenzler 145645

Digitally signed by William A. Prenzler 145645 Date: 2020.05.27 12:02:45 -04'00'

Page 1 of William Prenzler Date Branch Chief NCO 1

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.

Tammy A Fox 706200 Tammy Fox

Digitally signed by Tammy A Fox 706200 Date: 2020.05.28 12:50:04 -04'00'

Division Chief- NCO1 Date

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

JOSEPH MALETTA 1347841

Joseph Maletta

Digitally signed by JOSEPH MALETTA 1347841 Date: 2020.06.01 09:35:57 -04'00'

Executive Director, Regional Procurement Office-East (RPO-E)

Date Page 1 of image1.png image2.png image3.png image4.png image5.png image6.png image7.png image8.png