36C24119D0006-001.pdf

VHAPM Part 819.7007/7008 Sole Source Awards to a Verified Service-Disabled Veteran-owned Small Business/Veteran-owned Small Business

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT

VHAPM Part 819.7007/7008 Page 1 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:___VA241-18-AP-3406__

1. Contracting Activity: Department of Veterans Affairs, VISN 1, NCO1 for the VISN1 Network Consolidated Laboratory (NCL) on behalf of all VISN1 Medical Centers.

2237: 523-19-1-2765-0011

2. Nature and/or Description of the Action Being Processed: Solicit as an SDVOSB sole source to Hyperion Biotechnology, a VetBiz verified SDVOSB located at 12002 Warfield St., Ste 101, San Antonio TX 78216, for a new 12 month base plus 4 option year IDIQ FFP contract to obtain drugs of abuse toxicology laboratory testing services for all VISN1 Medical Centers located throughout New England.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Services are required to obtain off-site urine/serum drug confirmation laboratory testing for VISN1 Medical Centers located in CT, RI, MA, NH, ME and VT. This contract will cover urine/serum drug confirmation laboratory testing services and oral fluid drug screens for specific tests identified in the Performance Work Statement (PWS) test menu. Estimates are based on historical usage and are not guaranteed. Tests, which are ordered by VA practitioners, are entirely based on patient need. A mandatory two day turnaround time (TAT) from receipt of specimens is required.

Total estimated value for the 12 month base plus 4 option year IDIQ contract is $3,542,197.00. Base period of performance will be 10/1/2018 to 9/30/2019 with (4) 12 month options.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S. Code § 8127, as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

(X ) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or ( ) 819.7008 Sole source awards to a verified veteran-owned small business

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

Hyperion Biotechnology is currently providing similar services to other government agencies and commercial entities. They meet the criteria described in VAAR 819.7007 which allows VA to sole source to verified SDVOSBs. The total potential value of this procurement at $3,542,197.00 is under the $5MIL threshold. This justification will be posted after contract award, as required. Hyperion has been determined to be a responsible contractor as further described in #9 below. It is anticipated that a contract award can be made at a fair and reasonable price that offers the best value to the Government. They are a VetBiz verified SDVOSB contractor. The authority to allow sole source

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Revision 01 Eff Date: 04/23/2018 awards to an SDVOSB is based on 38 U.S.C. 8127. Based upon review of their sources sought response as well as follow on responses to questions regarding their capabilities, both the VA Pathologist Subject Matter Expert and VISN 1 Network Consolidated Laboratory Program Director recommend Hyperion as a viable source for this requirement.

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

A Sources Sought Notice was posted to FBO on 5/15/2018 to conduct market research and determine sources that could provide these specialized laboratory testing services.

Responses were received from the following:

a. Hyperion Biotechnology, VetBiz verified SDVOSB, SDB, EDWOSB

b. Mobile Cardiac Imaging (MC)I Diagnostic Center MCI Diagnostic Laboratory, VetBiz verified SDVOSB, HUBZone,SDB

c. MAJL Enterprises, LLC, VetBiz verified SDVOSB

d. Warrior Medical, SDVOSB Pending VetBiz Verification

e. Capgenus, SB

f. MAKO Medical Laboratories, SB

g. Northern New England Diagnostics, SB

h. Quest Diagnostics, LB

i. LabCorp, LB

j. Millenium, LB

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

A determination on price reasonableness will be made by comparing the proposed pricing to previously negotiated historical prices for the same toxicology laboratory testing services currently provided under another contract as an interim measure as well as the previous BPA NAC FSS contractor that performed these services for VISN1. Pricing will also be compared to current Medicare pricing for these specific CPTs.

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

Based on guidance resulting from the Supreme Court Decision Kindomware vs. United States which requires VA to utilize SDVOSB and VOSB if market research shows 2 or more can perform the work, a survey of the VetBiz database under NAICS Code 621511 with keyword laboratory showed there are 11 verified SDVOSBs listed under this NAICS nationwide. After visiting each vendor website, it was determined that Hyperion Biotechnology, a SDVOSB that is a CLIA certified laboratory appears most able provide these services at pricing that can be determined fair and reasonable at the best value for the government. Further communication provided after the Sources Sought Notice was posted confirms Hyperion will be able to provide the majority of the CPTs, can subcontract for the remaining tests in the interim until all tests can be brought in house within a 4 month timeframe after award. They also confirmed and committed to meeting the mandatory 2 day TAT. MCI Diagnostics Center, another verified SDVOSB that responded to the Sources Sought Notice is also CLIA certified and although they indicate they are a national reference laboratory provider, their capability statement and website shows their business appears to be focused on diagnostic testing rather than laboratory testing services. They describe the company as a distributor of medical laboratory products, services and equipment. A third VetBiz verified SDVOSB, MAJL

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Enterprises, provides healthcare, industrial and scientific supplies and equipment and does not appear to be a reference laboratory that can meet the need for these services. The same search on Vetbiz under VOSBs returned 6 listed under this NAICS nationwide. It was determined from researching each site that the only potential source was Physicians Laboratory Services, Inc.but they only service Nebraska and Iowa so they are not a viable option for this requirement either.

Search on GSA under Schedule 621 II Medical Laboratory Testing and Analysis Services, Category 621-204 Clinical Drugs of Abuse and Toxicology Services returned 10 results, 3 of which are small businesses: Cedar Diagnostics, LLC; Molecular Testing Labs and Pharmatech, Inc. Research pertaining to those firms found that it is not clear if all can provide the test menu at the mandatory 2 day TAT. There are 5 large businesses remaining on the GSA Schedule but review of each contractor’s terms and conditions shows they may not all be able to provide all of the toxicology testing services under their NAC FSS contracts.

A survey of the SBA Dynamic Business Search Tool under NAICS 621511 with keywords medical laboratory returned 20 results nationwide. 5 were determined to be potential sources: North Shore Medical Labs, Inc. NY; Northern New England Diagnostics ME; MedLab Inc IL, United Medical Laboratories, VA; and Vista Clinical, FL.

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

Hyperion Biotechnology has been determined to be a responsible contractor. A search in PPIRs showed Hyperion has 29 CPAR records and 5 Legacy CPAR records with ratings predominantly in the very good range with many exceptional and some satisfactory. There was one single marginal rating for schedule due to tardiness of an administrative contractor employee unrelated to a laboratory testing services requirement. That same CPAR record also showed a very good quality rating and satisfactory management rating. They are actively registered in SAM with no exclusions. No negative reports would found in FAPIIS accessed through PPIRs. Their Dun & Bradstreet Comprehensive Report shows they have low risk rating in all categories.

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

a. Hyperion Biotechnology, VetBiz verified SDVOSB, SDB, EDWOSB

b. MCI Diagnostic Center MCI Diagnostic Laboratory, VetBiz verified SDVOSB, HUBZone,SDB

c. MAJL Enterprises, LLC, VetBiz verified SDVOSB

d. Warrior Medical, SDVOSB Pending VetBiz Verification

e. Capgenus, SB

f. MAKO Medical Laboratories, SB

g. Northern New England Diagnostics, SB

h. Quest Diagnostics, LB

i. LabCorp, LB

j. Millenium, LB

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:

An annual review of performance will be completed to monitor compliance with the PWS requirements prior to the exercise of any options. VISN1 plans on bringing these specific toxicology CPTs in house but the timeframe is indeterminate at this time. If that comes to fruition, any outstanding options would not be exercised. If in the event that VISN1 in house plan does not take

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Revision 01 Eff Date: 04/23/2018 place, extensive market research will be performed prior to recompeting this requirement to determine if there are other sources that can provide these services.

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.

Janet Lane Date Network Consolidated Laboratory Program Director

VAMC VISN1

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.

Valerie J. DeAngelis Date Contracting Officer VAMC Providence, RI

b. QA Procurement Analyst

Carol Dominge Date Procurement Analyst VAMC Manchester, NH

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

Michael Corriveault Date VISN1 NCO1 Deputy Director VAMC Togus, ME

6-14-2018 Janet L. Lane 150483

Digitally signed by Janet L.

Lane 150483 Date: 2018.06.14 09:20:31 -04'00'

6/14/2018

Valerie J.

DeAngelis 908087

Digitally signed by Valerie J. DeAngelis 908087 Date: 2018.06.14 09:33:15 -04'00'

6/14/2018

VHAPROCORRIM

Typewritten Text 6/14/2018

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c. VHA SAO 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 Date SAOE Director VHA Head of Contracting Activity (HCA)