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This document is a justification for other than full and open competition (JOFOC) for a pathology and laboratory services contract. The Department of Veterans Affairs intends to award a sole source, firm fixed price contract to Pathology Associates to provide critical pathology and laboratory services to the VA Central California Healthcare System. Services include specimen pickup within two hours for processing, analysis of various specimens including Pap smears and biopsies, and a turnaround time of twelve to twenty-four hours for interpretation and reporting of results by VA pathologists. The period of performance is from January 2020 to September 2020 for an estimated total price of $500,000. A market survey yielded four responses but none could meet the turnaround time requirements. The justification cites 41 USC 3304(a)(1) and FAR 6.302-1 for restricting competition due to Pathology Associates being the only responsible source capable of meeting the agency's needs within the required timeframes.

36C26120Q0252 JOFOC_VACCHCS Pathology Lab Services_Redacted.pdf

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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 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: 36C261-20-AP-0743

1. Contracting Activity: Department of Veterans Affairs, Sierra Pacific Network VISN 21, through its

Network Contracting Office (NCO 21) is contracting for services for VA Central California Health Care System (VACCHCS). VACCHCS requires Pathology and Laboratory out services for its region.

2. Nature and/or Description of the Action Being Processed: Approval is requested for a new sole source contract to Pathology and Associates to provide out services for the PATHOLOGY AND LABORATORY SERVICES, VACCHCS. The anticipated contract will be firm-fixed-priced priced contract award. This procurement is in accordance with FAR 13.5 Test Program 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.

Purchase Request Number: 570-20-2-223-0076

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This service is to provide the critical Pathology and Laboratory Services to the VA Central California Healthcare System.

Contractor shall provide services including but not limited to the ability to pick up routine specimens within two (2) hours for processing. These pathology services shall provide but not limited to processing and analysis of Pap smear, Cytology and Histology specimens, various special stains, bone marrow kit and complete analysis. This critical specimen testing to Veterans with a diagnosis of leukemia and other cancers require immediate Turn Around Time (TAT), to receive the results with an interpretation within twelve (12) to twenty-four (24) hours to be read, interpreted, and reported by VA staff pathologists.

The expected period of performance is from 01 January 2020 through 30 September 2020.

Total estimated contract price is

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1.

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

( ) (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;

OFOC SOP Revision 08 Page 2 of 4

Revision 08 Date: 04/18/2018

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

( ) (7) Public Interest per 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 authority cited in paragraph 4 must be used because no other vendor is capable of providing the technical and turn-around-time that is required to maintaining patient care. This is a follow-on contract for continuation of highly specialized services. Pathology Associates is located within 20-mile corporate radius of the main campus, is fully vetted and credentialed and as well as providing all laboratory results in one concise report to the VA Central California Healthcare System. They have proven to exceed all the minimum requirements of the VA Central California Healthcare System in which has resulted in providing the best care for our Veterans.

If award was made to another source, the Department of Veterans Affairs would incur significant delays and inaccurate reporting of the results. This would lead to possible risk of loss of public confidence in our ability to provide lifesaving care to Veterans. If it was required to locate another sole source provider or issue a competitive solicitation, in the interim the Agency would be forced to send specimens to separate labs, outside of the commuting area for results. This would only incur significant increase TAT for results to be received from all facilities and the increased potential of specimen damage during lengthy transport. Receiving separate reports will also increase the risk of transposing errors, thus requiring a new specimen to test and perpetuating the delay. This delay will increase the time VA staff pathologists wait to receive the results to then schedule the treatment plans for these patients at the San Francisco or Palo Alto VA Healthcare Systems.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Federal Business Opportunities (FBO) sources sought, 36C26119Q0635, was issued on 13 May 2019, yielding four (4) responses from interested and capable service providers.

From the review of the four responses, the determination was made that these sources were able demonstrate their ability to provide the required certified pathology testing. On further review, the VA was not able to determine the ability to provide the specific requirements of the Turn Around Time (TAT) as well as provide all pathology and laboratory results in one concise report. The VACCHCS Pathology Service is clarifying these specifications in that these required services in the future may be available for competition. Further market research will also be conducted to the maximum extent possible to fully survey the availability of these services within the corporate area.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the Government for this action will be determined fair and reasonable by the Contracting Officer using price analysis based upon a comparison of prices found reasonable on prior contracts within the market area and against Federal Supply Schedules. In accordance with FAR 13.106-3 – Award and Documentation, the CO anticipates finding the prices to

OFOC SOP Revision 08 Page 3 of 4

Revision 08 Date: 04/18/2018 be fair and reasonable as a comparison of the previously proposed historical prices were significantly lower than those posted on FSS contracts on GSA Advantage.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research has been ongoing for some time for this specific requirement and does have similar requirements across other VISN facilities. The results are typically similar due to the specific nature of this requirement for the specific type of testing and the immediate response of the results that are required. The results of the market research report have demonstrated that multiple vendors have been directly contacted and their responses have been synopsized. Market Research was conducted to the maximum extent possible in is relation to the specific needs of needs of VACCHCS.

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

N/A

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

Pathology Associates (SB) Northeastern Oklahoma Physicians Group LLC(SDVOSB) MCI Diagnostics Center (SDVOSB) Cedar Diagnostics (SB) Quest Diagnostics (LB)

As indicated above, the service is currently reviewing their requirement and conducting additional market research to determine if this requirement is ultimately available for competition in the future. This sole source action wil be processed at this time to prevent an interruption of services.

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: A potential contractor would need to develop a solution to overcome the primary need to provide the results within the defined testing turnaround times and singular reporting. This contractor would have to be able to provide the required specialized testing as specified by VACCHCS.

OFOC SOP Revision 08 Page 4 of 4

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.

Christine Darmanian Date Laboratory Supervisor VA CCHCS P&LM Service

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.

Joleo Dianala Date Contracting Officer Network Contracting Office (NCO) 21

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.

Gary T Basile Date Chief, Health Care Resources I Network Contracting Office (NCO)21

12-17-2019

Gary T Basile 228349 Digitally signed by Gary T Basile 228349 Date: 2019.12.16 07:35:45 -08'00'

CHRISTINE M. DARMANIAN

199815

Digitally signed by CHRISTINE M.

DARMANIAN 199815

Date: 2019.12.17 13:08:37 -08'00'

Joleo B. Dianala 1494727 Digitally signed by Joleo B. Dianala 1494727 Date: 2019.12.17 13:12:28 -08'00'

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