Limited Sources Justification over SAT_ Redacted.pdf

VHAPG Part 808.405-6 Limiting Sources Request for Limited Sources Justification Format >SAT

Effective Date: 02/01/2022 Page 1 of 6

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:

(1) Contracting Activity:

Department of Veterans Affairs (VA), Network Contracting Office 16 (NCO 16), located at the Galleria Financial Center, 5075 Westheimer Road, Suite 750, Houston, TX 77056 in support of the South Central VA Health Care Network (SCVAHCN), Veterans Service Network 16 (VISN 16), located at 715 S. Pear Orchard Road, Plaza 1, Ridgeland, MS 39157.

(2) Description of Action:

This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). SCVAHCN-VISN 16 intends to award a short-term, fixed-price Blanket Purchase Agreement (BPA) under the statutory authority as implemented by Federal Acquisition Regulation (FAR) Subpart 8.405-6 (b)(3) to the incumbent contractor, Tosoh Bioscience, Inc., for the continued provision of automated hemoglobin A1C instrumentation, reagents, calibrators, controls, training, service, and interfacing for VISN 16 medical centers and outpatient clinic laboratories. VISN 16 laboratories are currently obtaining these services using locally funded and awarded delivery orders against BPA 36C25619A0058 expiring September 30, 2024. Participating laboratories, the required test menu, and estimated annual volumes are managed using the VISN 16 A1C Workbook. A BPA with a six (6) month base and a six (6) month option period is being requested. The BPA will be effective for the base period of October 1, 2024, through March 31, 2025. The option will be exercised at the Government’s discretion.

Order against: FSS Contract Number: V797D-40130

Name of Proposed Contractor: Tosoh Bioscience, Inc.

Street Address: 6000 Shoreline Court Suite 101 City, State, Zip: South San Francisco, CA 94080 Phone: 1-800-248-6764

(3) Description of Supplies or Services:

The estimated value of the proposed action is

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Base Period - (6 months)

Option 1 - (6 months)

Total Estimated Value

Award of a new short-term BPA will ensure the contractor continues to provide instrumentation and testing can be performed as defined for Cost Per Reportable Result (CPRR) in the Federal Supply Schedule (FSS) Group 66 III Clinical Analyzers, Laboratory, and Cost-Per-Test program.

It will also ensure the contractor continues to meet all licensing and accreditation requirements, permits, certifications required by the Food and Drug Administration and the Government. All provisions within the original BPA and Statement of Work (SOW) will be incorporated into the short-term BPA, including use of equipment (all testing instrumentation, UPSs), preventative maintenance, emergency repair, reagents, controls, calibration materials, remote troubleshooting, etc. Under the BPA Tosoh will continue to provide instrumentation for 7 medical centers and 16 outpatient clinic laboratories. The BPA will continue to provide 2 automated hemoglobin A1C G8 high performance liquid chromatography (HPLC) instruments, 501RP+ reporting software for 21 labs, reagents, calibrators, controls, training, preventative maintenance, equipment repair, and interfacing of test results into the VA VistA lab package for clinician viewing in the electronic medical record.

Instrumentation is currently in place and validated for use for patient testing at each participating laboratory. Appropriate staff has been trained, competency assessed and procedures written for clinical use of this instrumentation for patient care. Testing instrumentation is bi-directionally interfaced through data innovations to the VA VistA lab package. Key stakeholders include the Lab Directors and Medical Technologists performing testing at each VISN 16 medical center and outpatient clinic laboratory, clinicians utilizing test results and Veterans benefitting from access to critical testing across the network.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays.

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

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Tosoh has successfully provided automated A1C HPLC testing instrumentation, repair, reagents and consumables to the VISN 16 medical centers and outpatient clinic laboratories.

Instrumentation includes testing instrumentation for automated A1C analysis for monitoring and management of diabetes at VISN 16 laboratories. Testing instrumentation is interfaced to VistA through Data Innovations Middleware eliminating the need to manually program patient tests and manually input patient test results into the VistA laboratory package. The contractor provides high quality reagents and calibrators for A1C testing utilizing HPLC instrumentation.

Due to staffing shortages in the clinical laboratory, the program office is proposing A1C testing no longer be procured individually and be included in the chemistry/immunochemistry instrumentation solicitation. The change would require a methodology change from the previously standardized automated ion exchange HPLC to automated immunoassay. This is pending VISN Clinical Laboratory Consultant concurrence before consideration and submission to the VISN Lab Directors for voting. Adding the test to the chemistry/immunochemistry testing menu will eliminate the need for a separate instrument and data management system just for performing A1C testing. This will increase efficiency as this would reduce maintenance, troubleshooting, reviews and documentation required for the instrumentation. The program office will establish a workgroup of clinical laboratory scientists to serve as Subject Matter Experts (SMEs) for the development of an acquisition packet for a long term BPA. Due to the dollar value of a five-year chemistry/Immunochemistry BPA, extensive reviews will be required following the submission of the packet. The award of a short-term BPA will provide the continuity of contract coverage needed to allow sufficient time for a new BPA to be solicited, awarded and sufficient lead time provided for installation of new instrumentation. This should also allow for required method validation and correlation studies required when new instrumentation is placed, or new tests are to be performed. The need to continue to provide these laboratory tests to Veterans is critical. Without this award, the laboratories will not have equipment or reagents available for the performance of these critical tests required for patient care. Once a new, long-term BPA is awarded and before existing equipment can be replaced, extensive installations and validation/correlation studies are required. If a new contractor is selected, new test files will need to be set up in the lab package and test files for interfacing must be setup in the middleware for interfacing of test results into the lab package. Key Operators at all participating labs will go off-site for training; upon their return, all remaining staff will be trained. New testing procedures and staff competencies must be written and approved by the lab director. Staff competency will be assessed and documented. All of this must occur before any patient testing can be performed and any results reported to be used for patient care. Clinical staff must be educated on any changes associated with the new testing instrumentation. It is necessary to award a short-term BPA with Tosoh to prevent significant delays in care for our Veterans and increased costs to the Government.

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FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value:

Consistent with FAR 8.404(d) to aid the Contracting Officer in making this best value determination: Tosoh testing instrumentation is already in use at each participating VISN 16 medical centers and outpatient clinic laboratories. Tosoh will continue to allow usage of equipment, service and repair, reagents, consumables and interfacing at current BPA pricing.

Current BPA pricing is discounted from contractor’s FSS pricing. Annual cost avoidance is approximately .

(6) Describe the Market Research Conducted:

Intent to sole source notice number 36C25624Q1123 was posted on the Governmentwide Point of Entry (GPE) known as Contract Opportunities on July 9, 2024 and closed on July 15, 2024. The intent of the notice was to allow vendors the opportunity to identify their interest and capabilities. Any interested party that believed they were capable of fulfilling the requirement was encouraged to respond. Upon closing of the intent to sole source notice, no companies responded. In addition to the intent to sole source notice; market research was conducted by database queries to General Services Administration (GSA) eLibrary, SBA’s Dynamic Small Business Search (DSBS), and SBA’s Veteran Small Business Certification (VetCert).

The search of GSA eLibrary under FSS 66-III, category 605-1A identified 8 vendors. However, only 3 have instrumentation and reagents to perform automated A1C testing utilizing HPLC.

According to the FSS schedule only Tosoh and Arkray have instrumentation and reagents to perform testing utilizing ion exchange HPLC methodology.

The three (3) potential contractors are Biopool (Small Business), Tosoh (Large Business), and Arkray (Large Business). Each has the ability to provide automated testing instrumentation, reagents, training, service, and connectivity with VA VistA utilizing CPRR pricing.

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However, the Biopool instrumentation utilizes borate affinity HPLC and not ion exchange HPLC. Tosoh is the only contractor able to meet the instrumentation and testing requirements for all 23 laboratories effective October 1, 2024. If the methodology change and consolidation of A1C testing with the chemistry/immunochemistry solicitation test menu is approved, there are five (5) contractors that have automated A1C immunoassay testing available on proprietary instrumentation.

(7) Any Other Facts Supporting the Justification:

Due to a backlog and other competing actions, the Program Office, Contracting and VISN SMEs are working as time allows to develop the long term solicitation packet. There are other VISN wide laboratory procurements and new VISN wide installations ahead of this requirement in the queue. VISN 16 continues to work closely with NCO 16 to work through VISN standardized procurements and installation of new instrumentation and associated equipment across the network resulting from the new BPA awards.

Patient support is our number one priority and approval of this sole source action is necessary to ensure that this support is seamlessly continued and patient care is not negatively impacted.

Current BPA pricing has produced significant cost avoidance to the Government of approximately .

Under the current BPA, laboratories annually obligate funds using a purchase order for CPRR monthly invoicing in arrears. If the short-term BPA is not awarded, the 23 participating laboratories would be required to prepare and submit individual sole source procurements. This is a difficult and time-consuming task and would be over burdensome on laboratory staff and contracting. The award of a short-term BPA with the incumbent ensures continued access to timely, accurate automated A1C HPLC instrumentation, testing, service and related item to support patient care needs.

This requirement has a high potential of negatively impacting Veteran care. Non award of a VISN standardized bridge BPA to the incumbent effective October 1, 2024, will force laboratories to cease testing in-house. Timely access to routine A1C testing for monitoring and management of diabetes is critical to Veteran care.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

Competition is planned among FSS contract holders for the new long-term BPA. As part of the market research for a long term solution a sources’ sought notice will be posted to assess of instrumentation of potential automated A1C instrumentation and testing contractors. Award of this short-term bridge BPA will allow for a continuation of automated hemoglobin A1C instrumentation and testing for 7 medical centers and 16 outpatient clinic laboratories so that patient care is not negatively affected.

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(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

(This signature is the requestor’s supervisor, fund control point official, chief of service, or someone with responsibility and accountability.)

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.