36C25920A0035-007.pdf

OFOC SOP Revision 08 Page 1 of 4 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: 36C259-19-AP-3944 J&A Tracking Number: 2020-03-20T11:05:10

1. Contracting Activity: The U.S. Department of Veterans Affairs, Network Contracting Office 19 (NCO 19), 6162 S. Willow Dr., Suite 300, Greenwood Village, CO 80111, in support of the VA Salt Lake City VA Health Care System, VACO Genomic Medicine Service (GMS), 500 Foothill Drive, Salt Lake City, UT 84148, proposes to enter a short term firm-fixed price on the basis of other than full and open competition. This requirement is to provide genetic testing that is needed on a nation-wide basis.

2237: 660-20-1-109-0003 = $450,000 for a 6-month interim contract.

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

The Department of Veterans Affairs has an urgent need for genetic testing/analysis services in support of the Salt Lake City VA Medical Center (SLCVAMC), VACO Genomic Medicine Service (GMS).

The proposed procurement will be a new firm-fixed-price, emergency interim contract for specimen various genetic testing, reporting of results, and consultative services.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for genetic testing 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: GMS requires a genetic testing company to process specimens. The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, medical compliance and other items and services necessary and perform all services as defined in the SOW. Services shall include biospecimens processing, testing, result reporting, and analysis/communication. The period of performance will be April 1, 2020 through September 30, 2020. The estimated total value is $450,000.00.

Background: The demand for genetic testing has been increasing. Genomic care can provide early intervention and direct treatment planning for veterans and their families by detecting risks factors through genetic testing and family pedigrees. In the 21st Century access to genetic services is the community standard of care, is federally legislated, and a health care benefit to which all Veterans are entitled. 38 CFR § 17.38, specifically identifies that genetic counseling concerning inheritance of genetically determined diseases is a benefit that VHA must provide to veterans.

OFOC SOP Revision 08 Page 2 of 4

Revision 08 Date: 04/18/2018

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

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

(X) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Genomic medicine is seeking a sole source contract under (FAR 6.302-2, 6.303-2(a)(9)(ii)) Unusual and Compelling Urgency. GMS has direct knowledge of the services and performance of the SAM certified Invitae Corp (Invitae).

Invitae has the capability to provide the required testing panels along with the required genes, as well as meet the estimated volume that will allow for continued operation of GMS and genetic services to the Veteran. Invitae has demonstrated an ability to customize gene panels, provide a tailored online ordering portal and provide direct access to medical geneticists, genetic pathologists and genetic counselors. Turnaround time on test resulting has consistently been completed within the required timeframe; this has not been the case with other vendors providing these services.

Invitae has been responsive to clinical needs to customize panels. Customization is necessary to provide appropriate, timely care and to target genetic testing on personal and family history of the

Veteran. Customization of panels can reduce the likelihood of uncertain results, which can lead to increased anxiety in patients. In addition, Invitae allows for a custom panel to be resubmitted with additional genes added for no additional cost when the initial panel comes back inconclusive. This is a huge benefit in patient care as it allows the initial panel to focus on a smaller number of genes without the financial risk of a retesting cost.

It is important for GMS staff to have quick access to certified medical geneticists, genetic pathologists and genetic counselors to discuss result interpretation, test methodology and limitations. This access contributes to appropriate interpretation and diagnosis in a timely fashion.

Invitae provides access to all the previously listed individuals on inquiries for additional information.

Invitae already provides a GMS/VHA customized portal for online ordering that saves time and resources on the part of the Government. To initiate a portal build with a new vendor could take several months, require staff resources currently unavailable and result in a delay in testing.

To not award this emergency interim contract for an April 1, 2020 start date would put the

Government as risk for serious financial harm as well as possibly derail the advancement of the Salt

Lake City GMS nationwide program. The cost savings the Government receives by using the Salt Lake https://www.acquisition.gov/?q=/browse/far/6 https://www.acquisition.gov/?q=/browse/far/6

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Revision 08 Date: 04/18/2018

City GMS as a nationwide hub for genetic testing are significant and cannot be duplicated by a single

VA facility utilizing their own genetic testing contact. Moving forward without an interim in place would mean over 75 (and growing) VA facilities would be without genetic testing. This would mean the only option available would be to either have patients go without genetic testing (not an option) or utilize a GPC while they worked to put their own contract in place. This would result in an unacceptable increase in costs to the Government.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: In an effort to facilitate competition and award to a small business if possible, one of the previous contractors, Prevention Genetics, was contacted to obtain a quote based on the estimated test spreadsheet provided by the program office. However, their estimated total cost was $652,721.50, which is approximately 51% higher than the estimated total cost as quoted by Invitae.

Based on a comparison with the IGCE and historic prices paid for the same services, the prices quoted by Prevention Genetics could not be found fair and reasonable.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CO has determined the price to be fair and reasonable based on a comparison with both the IGCE as well as historic prices paid for the identical service.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Due to the urgent nature of the requirement, with no contract in place whatsoever, market research was limited to obtaining two (2) quotes from known contractors who previously provided genetic testing services. The rule of two was considered, but no known SDVOBs or VOSBs can provide the requirement in full or at a fair and reasonable price at this time. Time constraints required no further research into fulfilling the rule of two.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The GMS currently serves as the hub for submitting genetic testing nationwide for the VA. It serves over 70 VA facilities with more being added every year as other contracts expire throughout the nation. It is vital to not only patient care but the continued success of the GMS program that an interim contract with a responsible vendor be put in place by April 1, 2020.

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

Invitae Corp. Prevention Genetics 1400 16th Street 3800 S. Business Park Ave.

San Francisco, CA 94103 Marshfield, WI 54449 1-800-436-3037 715-387-0484

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: All future requirements of a similar nature will be competed to the fullest extent practicable. The interim contract resulting from this emergency justification will allow the time needed to fully compete the desired long-term contract.

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Revision 08 Date: 04/18/2018

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.

Date

Christopher Lee AO, Genomic Medicine Salt Lake City VAMC

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.

Ronnie Jones Date Branch Chief, Services 2

NCO 19

b. One Level Above the Contracting Officer (Required over $250K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Albert Williams Date Division Chief

NCO 19

3/23/20 http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx VHAECHWilliA Typewritten Text 23 Mar 2020