-16483.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: 36C242-19-AP-1476

1. Contracting Activity: Department of Veterans Affairs Veterans Integrated Services Network (VISN) Region 2 Down State James J Peters Veterans Affairs Medical Center 130 West Kingbridge Road Bronx, NY 10468

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

This Justification Request is for the approval to procure services through a sole source, firm fixed price, interim contract awarded to the incumbent, Biomerieux Inc. Biomerieuz Inc. is honoring the pricing from the conract that is currently in effect, VA243-13-A-0037. The estimated value of this proposed action is $ for the base period of 6 months, and an additional $ for an additional 6-month period if needed. The period of performance will include:

Base Period: 01 April 2019 through and including 30 September 2019;

Option Period One (1): 01 October 2019 through and including March 31, 2020

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

The estimated value of the proposed action is $,215.14

Cost-Per-Test (CPT) testing for Bacterial Id and susceptibility testing inclusive of the lease of equipment and the provision of all consumables, as well as the maintenance service needed for the effective operation of the equipment. This method will allow for pricing per reportable result on reagents for processing patient identification and susceptibility tests on Biomerieux Inc. Microbiology identification and susceptibility testing instruments. That are currently in use for patient testing at the New Jersey, Hudson Valley, Bronx, NY Harbor and Northport laboratories. This testing is critical to the care provided to the Veteran patients as the various tests are used by the medical professionals for patient diagnosis and treatment.

The current VISN 2 Downstate BPA number VA243-13-A-0037 will expire on March 31, 2019. A new long term VISN 2 Down State is in the process of being solicited. It is still in the market research phase. The facilities are requesting new instrumentation and therefore

OFOC SOP Revision 08 Page 2 of 5 Original Date: 03/22/11 Revision 08 Date: 04/18/2018 the package is not yet complete. The current instrumentation will best support the VISN 2 Down State short-term Bacterial identification and susceptibility requirement.

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

( 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;

( ) (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

This proposed action is for unique and highly specialized testing services. The Biomerieux Inc.

instrumentation are the proprietary equipment of Biomerieux Inc. As such only reagents provided by Biomerieux Inc. are compatible with the instrumentation currently in use at the New Jersey, Hudson Valley, Bronx, Northport and NY Harbor laboratories under FSS BPA number VA243-13-A-0037 Additionally, the Biomerieux Inc. analyzers have been specifically calibrated, the VISN 2 Down State laboratory personnel trained, and lab procedures written and implemented to produce consistent results and required testing. This functionality is crucial to the effective operation of VISN 2 laboratory testing and the successful completion of thousands of tests annually at the VISN 2 Down State medical facilities on Biomerieux Inc. equipment. The time-intensive process involved in the transition of equipment as well as the preparation of staff and procedures resulting from a new award instead of the sole source award to Bioimerieux Inc.

would result in critical mission failure in the VA medical professionals’ ability to provide the diagnostic and critical treatment to the Veteran patients.

Additionally, a long and complicated transition period is expected in the phasing out and demobilization of these analyzers once the new solicitation has been completed and a new vendor potentially awarded. In the interim patient testing cannot be interrupted. This instrumentation is used to provide urgent as well as routine testing. The introduction of a new contractor now in lieu of the sole source award of this interim contract to Biomerieux Inc. would result in a disruption of services in the Pathology and Laboratory Medicine departments and unacceptable delays in the VA’s care of Veteran patients.

We are currently in the Acquisition phase of a new contract and we anticipate completion of this phase by September 30, 2019. This interim contract will prevent a cessation of critical services for acquisition phase as well as the implementation phase of the new contract which is anticipated to take 6 months. The installation and implementation phase are time-intensive processes that include:

OFOC SOP Revision 08 Page 3 of 5 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

* A vendor assessment of all of the VISN 2 Down State laboratories for the preparation of the assignment of appropriate instrumentation;

* A lead time of at least one month for the ordering and delivery of equipment to all different VISN 2 Down State medical facilities;

* Changes to the laboratory facilities required to accommodate the new equipment which may include some minor construction;

* The phase in/out of new/old equipment involves both correlation and staff competency phases. In the correlation phase, the new equipment is installed;

concurrent tests are run on both old and new equipment;

reviews and analyses of the results are conducted;

In the staff competency phase, revisions to guidelines are initiated to educate the staff and ensure proper use of the equipment in the collection of data as follow:

o Policies are updated;

o Procedure manuals are revised; and

Training of multiple shifts of personnel in eight VISN 2 laboratory facilities

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

There were no efforts made at this time, due to the request for a sole source interim contract.

A solicitation will be posted for the long term procurement. This requested sole source contract is an interim one to ensure the award, transition of services, and implementation phases of a new five-year contract.

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

Biomerieux Inc. has offered to extend the same pricing from the current FSS BPA VA243- 13-A-0037 The most recent quarterly cost savings report reflects no additional cost to the various VISN 2 Down State medical facilities.

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

Market research was conducted through queries on the General Services Administration (GSA) e Library database, the US Department Veterans Affairs Office of Small & Disadvantaged Business Utilization Vendor Information Pages (VIP) of the Vet Biz website, and the Small Business Administration Dynamic Small Business Search.

OFOC SOP Revision 08 Page 4 of 5 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

Special Notices were posted to eBuy an FBO of the intent to sole source with no responses.

VIP and DSBS searches were conducted and no contractors found that could provide these specialized and unique services.

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

This requested sole source contract is an interim one to ensure the transition of services, award and implementation phases of a new five-year contract.

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

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:

This requested sole source contract is an interim one to ensure the transition of services, award and implementation phases of a new five-year award.

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.

February 11, 2019 Date

Name:

Title: Acting Supervisor Microbiology Facility: Bronx 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.

_____02/11/2019______ Date

________13-05'00'Name:

Title: Contracting Officer Facility: NCO2

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

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.

Date

_ Name:

NCO2/ Supervisor Supply Team 1

Facility: NCO2

Digitally signed by Date: 2019.02.12