P03 Sole Source JA Incyte FY 20 (005) (002).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 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: 36C260-19-AP-4740

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) VISN 20, The Mann Grandstaff VAMC. Located at 4815 N. Assembly St., Spokane, WA 99205. This procurement is funded by Laboratory (113) Purchase Request 668-20-1-139-0010 in the amount of $609.999.96 for Period of Performance 5/29/2020 – 4/30/2021.

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

The Laboratory Department at the Mann Grandstaff VA Spokane Health Care System is requesting approval for a sole source procurement as a requirement for a one-year bridge to continue their annual pathology and cytology reference lab testing. This procurement is conducted 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. This action will be a new firm-fixed-priced procurement.

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

The Laboratory Department at the Mann Grandstaff VA Spokane Health Care System is requesting a one-year bridge which is necessary to continue to provide critical patient care testing and allowing time to submit a new package for a new long-term procurement.

This contract will cover the annual pathology and cytology reference lab testing services required at the Mann Grandstaff VAMC. The reference lab shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification, patient specimen testing for the specific range of referral testing within their capability. The contract for Reference Lab Services is on an as-needed basis for the Lab Department. The Joint Commission on the Accreditation of Healthcare Organizations (JHACO) requires that reference labs be certified; VHA labs do not perform this type of lab testing.

This procurement is to be bulk funded as these reference lab services are on an as-needed basis for the Laboratory Department. The total funding amount is for $609.999.96 with a period of performance of 5/29/2020 – 4/30/2021.

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

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), only one source reasonably available.

OFOC SOP Revision 08 Original Date: 03/22/11

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

Pathology and Cytology reference laboratory testing services are essential to the daily operations of the Spokane Mann Grandstaff VAMC and cannot be interrupted without causing major disruption to patient care. Incyte Diagnostics is the incumbent contractor currently providing these services.

Incyte Diagnostics has extensive knowledge of this requirement, the existing infrastructure and can continue to perform these essential reference lab testing services during the current COVID-19 international pandemic. Any delay in attempting to compete this requirement could result in a lapse in reference lab testing services of weeks or more which would be detrimental to the mission of the Mann Grandstaff VAMC. Thus, it is necessary that the Spokane Mann Grandstaff VAMC continue to provide laboratory reference testing services without interruption during these difficult and unprecedented times and mitigate risk by continuing to do business with the incumbent.

Therefore, in order to maintain these critical services, it is the determination of the Contracting Officer that Incyte Diagnostics is the only source reasonably available to provide these services from 5/29/2020 – 4/30/2021 in the midst of the COVID-19 pandemic and while a new long term agreement is properly solicited, evaluated and awarded.

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

Market research was conducted by the Contracting Officer Representative (COR) between May 16th and June 7th, 2018. Only one local vendor was noted to be able to meet the minimum requirements. One vendor had signed a non-compete clause with our current contracted vendor. NCO20 has multiple award BPA for refence laboratory testing. However, none of the current BPA holders is able to meet the turnaround requirements for results as their laboratory test processing strategy is to require the specimens to be collected by VA and mailed to the processing location, causing unacceptable delays to the processing time.

Due to the need date, this requirement was designated as a candidate for a bridge contract in order to meet the needs of the Mann Grandstaff VAMC while still looking towards full and open competition to follow.

Therefore, a new requirement to solicit as many potential sources will be submitted within quarter 4, no later than 9/30/2020. This future procurement will be competed as full and open for all potential offerors.

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

Reasonable:

The current Incyte pricing is considered to be fair and reasonable based on past procurement bridge contract 36C26019P0330 which was determined to be fair and reasonable at time of award.

Additionally, Incyte has extended their current pricing from 2019.

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

OFOC SOP Revision 08 Original Date: 03/22/11

Market Research Was Not Conducted:

Market research was conducted according to FAR Part 10. This included searching; VetBiz, SBA, FPDS, SAM. A sources sought notice was posted to FedBizOpps on 2/22/19 and closed on 2/28/19. The posting included the Statement of Work identifying all technical requirements for the laboratory reference services. One vendor reported interest in that they could provide services. However, it was found that they did not have the required capability to provide the required interface with the VA IT Electronic Health Record system (EHRS). No other positive results were discovered.

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

The requirement is to provide The Mann Grandstaff VAMC with reference lab testing with standard case turnaround time of no more than two (2) days. Currently Turn-around-Times (TAT) with current BPA holders have not been met, which put Veteran care at risk. Incyte a local Laboratory Vendor to the area is available to perform the services based on the following. The pickup and processing of specimens collected by the VA within the required turnaround times specific in the statement of work requires a local laboratory presence. Mailing specimens to national laboratories would cause the turnaround time to exceed the Government’s minimum requirement and negative impact patient’s diagnosis and treatment.

In order to provide fair opportunity among other potential vendors with a similar TAT, the VA needs to allow time for electronic interface to be established between the VA’s Vista system and its own EDI system to deliver lab orders to the reference lab and to deliver results to the VA. This interconnection must be approved by VA IT security and refences ranges loaded into the system.

This is a VA administrative burden that will take a minimum of six (6) to ten (10) months to complete for any vendor. Attempting to use a Lab contractor without this task completed would require each test to be manually entered into the vendors system, allowing for the potential for human error and resulting in an unacceptable level of risk to VA patient care.

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

None.

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:

The primary barrier to provide fair opportunity among other potential vendors with a similar Turn-around-times (TAT), the VA needs to allow time for electronic interface to be established between the VA’s Vista system and its own EDI system to deliver lab orders to the reference lab and to deliver results to the VA. Future requirements with a longer lead time may allow potential vendors to gain entry into competition.

A new requirement to solicit as many potential sources will be submitted within quarter 4, no later than 9/30/2020. This future procurement will be competed as full and open for all potential offerors.

This J&A will be published to FBO after award to notify future potential vendors of the required electronic interface to be established between the VA’s Vista system and its own EDI system.

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, OFOC SOP Revision 08 Original Date: 03/22/11 which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Jeanie Thompson Date Laboratory Manager Mann Grandstaff 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.

Name: Jacob Jackson Date Title: Contracting Officer, Ancillary Patient Care Facility: Network Contracting Office 20 (NCO 20)

Name: Bethany Ireton Date Title: Branch Chief, Ancillary Patient Care

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.

Name: Peggy Bowen Date Title: Division Chief, Division 1

RPO-West JOFOC Tracking Log Number: 2020-05-20T11:53:43

JEANIE J.

THOMPSON

1610904

Digitally signed by JEANIE

J. THOMPSON 1610904

Date: 2020.05.27 12:04:24 -07'00'

Jacob P. Jackson 457690

Digitally signed by Jacob P. Jackson 457690 Date: 2020.05.27 12:31:22 -07'00'

Bethany D. Ireton 282396 Digitally signed by Bethany D. Ireton 282396 Date: 2020.05.27 13:12:53 -07'00'

Peggy L. Bowen 1568934 Digitally signed by Peggy L. Bowen 1568934 Date: 2020.05.27 13:22:09 -07'00'