#JandA-VMO-DurhamVAMC.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08 Page 1 of 5 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C246-20-AP-0588

1. Contracting Activity: Department of Veterans Affairs, VISN 6, 100 Emancipation Drive, Hampton, Virginia 23667; Requisition Number 558-20-1-304-0079.

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

A new Firm-Fixed Price contract is contemplated for award with a period of performance 1/1/2020- 12/31/2020, with four 1-year options for a total estimated value of $1,429,932.00. This will be a new contract. The previous contract is VA246-15-P-1379, which was awarded 1/1/2015 for a total value of $1,359.295.52. All options were exercised and the contract expires on 12/31/2019.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Veterinary oversight services 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.

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

Durham Veterans Affairs Medical Center (VAMC) is in need of Veterinary oversight services for their research program to serve as the Veterinary Medical Officer (VMO). The VMO provides mandatory support, advice, and instruction concerning the design and operation of research protocols using animal subjects; provides support, advice, and recommendations to the VA Facility Director and others regarding all aspects of the management and oversight of the animal research program;

serves a major role in preparation for oversight visits from entities such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) and the Office of Research Oversight (ORO); works with the Research Service to correct and implement any identified deficiencies, participates as a voting member of the Institutional Animal Care and Use Committee (IACUC); provides support and oversight for all employees engaged in animal care and husbandry;

provides support and oversight for the animal facility and its operations; provides clinical and preventive medical care for the animals; supports a disease surveillance program in the animal facility; and participates and contributes to administrative planning and operational meetings related to the overall function of the animal research program. The roles and responsibilities of the VMO are numerous and critically important to the research program. The major duties are needed to support the Durham VAMC program which has approximately $21.7M in research expenditures annually. The VMO’s mandatory responsibilities include:

1. Provide advice and instruction concerning the design and operation of research and development programs using laboratory animals;

2. Provide recommendations as needed to VA management, animal facility supervisors, and principal investigators to ensure compliance with all relevant federal, state, and local animal welfare regulations, laws, guidelines, and policies;

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Revision 08 Date: 04/18/2018

3. Assist in maintaining full Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation;

4. Provide support as needed in the planning and execution of research projects;

5. Provide advice on the proper selection of animal models;

6. Participate on the VA Institutional Animal Care and Use Committee (IACUC) of record as a voting member, once appointed;

7. Provide supportive oversight for ensuring compliance with occupational health, hazard containment, and zoonoses control programs;

8. Provide supportive oversight of surgical and post-surgical care programs;

9. Provide supportive animal facility management oversight;

10. Recommendations for veterinary care will be through VAMC personnel and investigators.

Any discrepancy over recommended veterinary care will be immediately conveyed to the VA IACUC of record;

11. Provide clinical care and preventive medicine expertise;

12. Use appropriate methods to prevent, control, diagnose, and treat diseases and injuries in animals;

13. Provide guidance to investigators in regard to selection of anesthetics and analgesics, and proper post-surgical and euthanasia methodologies;

14. Provide training to the animal care and research staff members;

15. Assist investigators with the development of research protocols as well as provide supportive guidance in selecting specific animal models, and provide veterinary pre-review of investigator Animal Component of Research Protocol (ACORP);

16. Provide on-site inspections of each animal facility to assess the health and well-being of all research animals;

17. Participate in administrative meetings for oversight of the VA animal research program.

Provide consultative advice on veterinary medicine program management issues to the Institutional Official as needed.

4. Statutory Authority Permitting Other than Full and Open Competition:

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) and 13.501(a), 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 justification will follow the standards and authority in accordance with FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

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

Durham VAMC has a long history of experiencing trouble employing a suitable VMO that is able to fulfill the necessary requirements and maintain the needed accreditations and certifications to run a productive and successful animal research program. The Durham VAMC prides itself on the amount of success that they have achieved since their shutdown by the Office of Research Oversight in 2006.

The current Veterinarian fulfilling this position has been with Durham VAMC since March 2007, and has been almost solely instrumental in re-instituting the animal research program. There have been no deficiencies found since the re-institutionalization of the animal research program by the Office of Research Oversight or AAALAC International since the full re-opening on March 28, 2007. Full

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Revision 08 Date: 04/18/2018 accreditation is successfully maintained. Durham VAMC’s current robust animal research program is now considered a model institution. The VMO has exemplary expertise with years of experience providing these services, and far exceeds all necessary qualifications. Additionally, the VMO is the only identified Veterinarian that meets the necessary qualifications, and will not require a training process. A training process for the VMO position would cause unacceptable delays in the current research projects. Training would also increase cost substantially, which would not be expected to be recovered through competition. The current VMO is employed by The McConnell Group, Inc.

with contract VA246-15-P-1379. The Veterinarian ends her employment with The McConnell Group, Inc. on December 31, 2019, the expiration date of contract VA246-15-P-1379. The Veterinarian will be employed by EmDX Research and Consulting Services, LLC, a small business vendor, on 1/1/2020.

EmDX Research and Consulting Services, LLC is the only vendor able to provide this service without unacceptable delays to current research projects and a substantial cost increase not expected to be recovered through competition.

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

Market research was conducted, details of which are in the market research section of this document. None of these efforts have yielded additional potential sources. There is no competition anticipated for this procurement.

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

Reasonable:

In accordance with FAR 13.106-1(b)(2) following the guidance as specified in FAR 6.303-2(b)(7), the Contracting Officer anticipates the cost will be fair and reasonable based on previous costs paid for this service, a review of current market prices, comparison to the independent government cost estimate (IGCE), and any other similar cost comparison identified. Prior to the award of this contract, cost or price information shall be obtained from the contractor and a price analysis will be performed and documented to sufficiently determine that the cost to the Government of the proposed acquisition will be both fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

The most recent contract for this service VA246-15-P-1379, awarded 1/1/2015, was solicited as a 100% small business set-aside, which yielded only one quote from The McConnell Group, Inc.

During the FY15 market research another small business was identified, Vanguard Veterinary Hospital, whom due to the inability to secure employment of a Veterinarian that met the qualifications and was unable to submit a quote. Current market research was conducted for this procurement. The VIP Database was searched using NAICS 541715, revealing 98 vendors. All identified VIP vendors were sent a Request for Information for capabilities on 11/27/2019. Only one vendor, Joint Strategic Technologies (JST), responded. When prompted, JST stated that they did not currently employ a Veterinarian that met the qualifications, and would need to hire one. Due to this circumstance, JST was determined to be incapable to currently provide service. An Intent to Sole Source with EmDX Research and Consulting Associates, LLC was posted on December 4, 2019 to Contract Opportunities, allowing vendors to respond until December 9, 2019. There were NO responses. The current VMO is employed by The McConnell Group under contract VA246-15-P- 1379 until 12/31/2019. The employee filling the VMO position is switching employment to EmDX Research and Consulting Associates, LLC on 1/1/2020. Therefore, EmDX Research and Consulting

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Revision 08 Date: 04/18/2018

Associates, LLC is the only vendor that has been identified that employs a Veterinarian meeting the requisite qualifications for the required dates of services.

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

The facility has experienced a long history of difficulty filling this position. The most successful provision of this service has been through contracting methods.

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

There was only one vendor that responded with interest for this acquisition during market research.

Joint Strategic Technologies (JST), an SDVOSB, responded to an RFI sent to all vendors found on the VIP database. JST stated that they did not currently employ a Veterinarian meeting the qualifications and would have to seek one out to provide the service. Due to the inability of JST to currently provide the service, JST was determined incapable.

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:

Market research will be conducted upon the end of each year of this service, prior to the exercise of any option or new acquisition. Durham VAMC Human Resources Department will post a vacancy annoncement for the position each year to determine if any viable candidates are found. Each time the contract is up for expiration, the market will be evaluated to determine the best way to meet the government’s need to fill this service.