Heme LSJ 9425 Redacted.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C256-26-AP-0221

(1) Contracting Activity:

Department of Veterans Affairs, VISN 16 South Central VA Health Care Network (SCVAHCN) Network Contracting Activity (NCO) 16

(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). South Central VA Health Care Network (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, Beckman Coulter, Inc., for the continued provision of automated hematology in trumentation, reagents. calibrator, controls, training, troubleshooting, service and interfacing for V16 medical center and outpatient clinic laboratories. VISN 16 laboratories are currently obtaining these services using locally funded and awarded delivery orders against BPA 36C25625A0008 expiring September 30, 2025.

Participating laboratories, the required test menu, and estimated annual volumes are provided in Attachment A. The BPA will be effective for the period of October 1, 2025, through December 31, 2025.

Order against: FSS Contract Number: V797D-70260

Name of Proposed Contractor: Beckman Coulter, Inc.

Street Address: 250 S. Kraemer Blvd.

City, State, Zip: Brea, CA 92821 Phone: 714-872-6271

(3) Description of Supplies or Services:

The estimated value of the proposed action is

Base Period- (3 months)

Total Estimate

Award of a new short-term BPA will ensure the contractor continues to provide instrumentation and testing can be performed as defined for CPRR (cost per reportable result) in the Federal Supply Schedule FSC Group 66 III CPT/CPRR program. It will also ensure the contractor 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

VHAPG Part 808.405-6 Limiting Sources Page 3 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________ the required method of 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 set up 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 competence 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 Beckman to prevent significant delays in care for our Veterans and increased costs to the Government.

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:

Beckman testing instrumentation is already in use at each participating VISN 16 Medical Center and outpatient clinic laboratory. Beckman will continue to allow usage of equipment, service and repair, reagents, consumables and remote troubleshooting at current BPA pricing. Current BPA pricing is discounted from the contractor’s FSS pricing. Annual cost avoidance is approximately $ .

(6) Describe the Market Research Conducted

VETCERT:

The search within VETCERT utilizing NAICS 334516 yielded 234 SDVOSB’s/VOSB’s

VHAPG Part 808.405-6 Limiting Sources Page 5 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________

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, 2025, could force laboratories to discontinue urinalysis testing in-house. Access to routine and stat testing are required for all medical centers and urgent care centers.

(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 of 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 source sought notice will be posted to assess of instrumentation of potential automated hematology instrumentation and testing contractors. Award of this short-term bridge BPA will allow for the continuation of automated hematology instrumentation and testing for 8 medical centers and 20 outpatient clinic laboratories so that patient care is not negatively affected.

(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, is accurate and complete to the best of my knowledge. I understand that processing of this limited source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

DATE

VHAPG Part 808.405-6 Limiting Sources Page 6 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________

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