JnA -36C25620A0035 - BioMerieux BPA.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: 36C256-20-AP-1268_______

1. Contracting Activity:

Department of Veterans Affairs South Central VA Health Care Network (SCVAHCN) Central Arkansas Veterans Healthcare System Contracting Office (90C) North Little Rock, AR Network Contracting Activity: 16

2. Nature and/or Description of the Action Being Processed: The proposed action by SCVAHCN is for a follow-on, sole-source, short-term Blanket Purchase Agreement (BPA) to BioMerieux, Inc. for a VISN-wide Cost Per Test (CPT) BPA for VISN 16 Medical Centers for the period of April 1, 2020 through March 31, 2021. BioMerieux currently meets and satisfies the needs of VISN 16 facilities. A firm-fixed price CPT BPA for instrumentation, repair, reagents and consumables for automated microbiological identification and susceptibility analysis instrumentation and testing will be established. The basis for the sole source award is Federal Acquisition Regulation (FAR) FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements.

BioMerieux currently meets and satisfies the needs of VISN 16 Medical Center laboratories. A CPT BPA will be established for 1 year to fulfill recurring requirements. The award of a short-term bridge BPA to BioMerieux for VISN 16 will continue to secure price reductions and volume discounts for Medical Centers for automated microbiological blood culture instrumentation and testing until such time as a new competitive, long-term BPA using FAR 8 procedures is awarded. In order to ensure adequate time is allotted to remove competitive barriers and ensure compliance with all procurement review requirements, an award period of 1 year is being requested. Laboratory subject matter experts have been identified for both this procurement and the procurement for automated microbiological Identification and susceptibility analysis instrumentation and testing as these procurements are typically competed simultaneously. Draft documents have been prepared;

however, the work has been paused due to the illness and resulting loss of the VISN Clinical Champion for Microbiology. The previous champion served in this role for VISN-wide BPAs for over 15 years. A new champion will be identified. Following completion of the VISN-wide Whole Blood Glucose Point of Care solicitation packet, the SMEs will resume acquisition packet development for a competitive VISN-wide standardized CPT BPA. The award of a short-term BPA will provide the continuity of contract coverage needed to ensure critical patient care testing needs are not interrupted during the long-term competitive BPA acquisition process and allow sufficient time for QA and legal review of the submitted procurement packet as well as time for a new BPA to be solicited, awarded and sufficient lead time provided for a new contractor (if applicable) to meet security and connectivity requirements. The award of a short-term BPA to BioMerieux for VISN 16 will allow labs to continue to perform critical patient care testing while continuing to secure price

OFOC SOP Revision 08 Page 2 of 4

Revision 08 Date: 04/18/2018 discounts for Medical Center laboratories for automated microbiological identification and susceptibility analysis instrumentation and testing until a competitive BPA for this testing is competed and awarded.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: BioMerieux will continue to provide highly specialized instrumentation, equipment repair, reagents and consumables to each participating Medical Center laboratory listed on Attachment A. Award of a new short term BPA will ensure the vendor continues to provide instrumentation and testing reagents and supplies under a CPT agreement. It will also ensure the vendor continues to meet all licensing and accreditation requirements, permits, certifications required by the FDA and the Government. All provisions within the original BPA and Statement of Work will be incorporated into the new short term BPA, including use of specialized equipment (testing instrumentation, automation/robotics, UPSs, water purification systems), preventative maintenance, emergency repair, training, technical expertise, reagents, controls, calibration materials, replacement parts, etc. The period of performance will be April 1, 2020 through March 31, 2021.

4. Statutory Authority Permitting Other than Full and Open Competition: BioMerieux will continue to provide instrumentation, repair, reagents and consumables to each participating medical center laboratory listed in attachment A. Award of a new short term BPA will ensure the vendor continues to provide instrumentation and testing as defined for Cost per Test (CPT) Program. It will also ensure the vendor continues to meet all licensing and accreditation requirements, permits, certifications required by the FDA and the Government. All provisions within the original BPA and Statement of Work will be incorporated into the short-term BPA, including use of equipment (testing instrumentation, automation, data management systems, interfacing of test results, (as applicable), UPSs, water purification systems, etc.), training, preventative maintenance, emergency repair, adapters, replacement parts, etc.

(b) ESTIMATED DOLLAR VALUE: $313,159.50 (1 year) $156,579.75 (6-month extension, if executed) $469,739.25 (Estimated total 1.5 yrs.)

(c) REQUIRED DELIVERY DATE: April 1, 2020 through March 31, 2021

( 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 BioMerieux has successfully provided Automated Microbiological identification and susceptibility analysis instrumentation, OFOC SOP Revision 08 Page 3 of 4

Revision 08 Date: 04/18/2018 training, repair, reagents and consumables to all VISN 16 medical center laboratories.

Instrumentation in use has already been extensively validated by the laboratory in accordance with accreditation requirements. Testing instrumentation is interfaced at several of the labs to the VistA laboratory package eliminating the need to manually input patient test results. Without the provision of equipment and supplies for blood culture analysis, labs would be unable to perform critical patient testing. Instrumentation detects and alerts operators to the regarding the detection of microorganisms in blood which requires rapid clinician notification. The instrumentation includes the provision of a data management system which pulls individualized reports specific to aid in tracking and reporting as required by VHA, the College of American Pathologists and Joint Commission. Equipment is validated and already in place, procedures are written, staff is trained, competencies are accessed, test files are built in VistA and discounted pricing is established, awarding of a short term BPA will prevent an interruption in the provision of patient care testing without unnecessary time and expense to the government.

BioMerieux blood culture analysis instrumentation is already in use at each participating VISN 16 Medical Center. Biomerieux will continue to provide usage of equipment, training, service and repair, reagents and consumables at current BPA CPT pricing. Cost avoidance for FY19 was over $700,000 when compared to FSS pricing.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A non competitive procurement is planned utilizing FAR 6.302 1 for this short term agreement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: BioMerieux will continue to honor terms and conditions of the previous BPA to include use of equipment, service, repair, training, technical expertise and consumables. Current BPA is further discounted from previous FSS pricing, which has already been determined by the NAC to be fair and reasonable.

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 for the long term competitive BPA and revealed there is adequate competition among FSS contract holders.

However, due to the nature of this requirement, extensive market research determined not to be feasible, as it is in the best interest of the Government to use existing BioMeriuex specialized instrumentation currently on site at VISN 16 Medical Centers and award a short term 1 year BPA to incumbent contractor. This award will prevent a disruption in the provision of laboratory testing needed for direct patient care. A notice of intent for a sole source award for this requirement to BioMerieux was posted in FBO on 2/19/2020.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Due to a backlog and other competing actions, the Program Office and Contracting are working to complete competitive solicitation packets. VISN 16 CSPO continues to work with NCO16 to work down the backlog of VISN standardized RFQs and installation of new equipment across the network resulting from the three (3) VISN wide BPAs competitively awarded in FY2019.

Access to timely, accurate testing results is critical to the mission of the laboratory.

Approval of this sole source action is necessary to ensure that patient care is not interrupted.