LSJ 36C256-24-AP-3875 Redacted_Redacted 101124.pdf

Effective Date: 02/01/2022 Page 2 of 6

Request for Limited Sources Justification

Award of a new short-term BPA will ensure the contractor continues to provide instrumentation and testing as defined for CPRR (cost per reportable result) in the Federal Supply Schedule FSC Group 66 III CPT/CPRR program. The bridge contract will also ensure that 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 (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 Beckman Coulter will continue to provide instrumentation for 8 medical centers and 20 outpatient clinic laboratories.

The BPA will continue to provide 39 automated hematology instruments, 8 slide maker stainers, 7 automated digital imaging systems, 2 automation lines, 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.

On October 1, 2024, instrumentation is 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. Beckman has a current, VA approved Memorandum of Understanding/ Interconnectivity Security Agreement (MOU/ISA) and established remote troubleshooting of instrumentation will continue to be provided. 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;

Beckman has successfully provided automated hematology testing instrumentation, slide maker/stainers, digital imaging, repair, reagents and consumables to the VISN 16 Medical Center Laboratories. Instrumentation includes testing instrumentation for performing automated complete blood cell counts, automated 5 part differentials, slide maker/stainers, digital slide imaging 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

Effective Date: 02/01/2022 Page 3 of 6 reagents and controls for the performance of the testing. 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 solicitation for automated hematology instrumentation and testing. 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 short term contract will 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 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

Effective Date: 02/01/2022 Page 4 of 6 pricing. Current BPA pricing is discounted from contractor’s FSS pricing. Annual cost avoidance is approximately

Describe the Market Research Conducted:

VETCERT:

The search within VETCERT utilizing NAICS 334516 yielded 213 SDVOSB’s/VOSB’s

SBA CERT:

The search within SBA utilizing NAICS 334516 yielded 503 SBA’s FPDS search “Hematology” yielded 22 results, however, 6 of the results were similar in nature but not the exact requirement GSA eLibrary:

Search of SIN 605-2a in 66III in the GSA elibrary identified 6 contractors within the SIN however only 4 have instrumentation and reagents to perform automated hematology instrumentation and testing under a CPT/CPRR agreement and are considered potential vendors.

The CO and SME search of SIN 605-2a in 66III in the GSA elibrary identified 6 contractors within the SIN however only 4 have instrumentation and reagents to perform automated hematology instrumentation and testing under a CPT/CPRR agreement and are considered potential vendors.

The search identified Grifols, a large business. The posted contract and price list was not accessible. An internet search of Grifols located their website. They do not have automated hematology (CBC) instrumentation, slide maker stainers, digital imaging technology or automation lines. They have automated blood typing instrumentation which does not meet this requirement. They also have ELISA testing for auto immunity and infectious diseases however they are not approved for use in the US. They also have A1AT genotyping. Search also identified Ortho Clinical Diagnostics however they do not have automated hematology (CBC) instrumentation, slide maker stainers, digital imaging technology or automation lines. They have blood banking (immunohematology) and blood typing instrumentation however they do not meet this requirement. The four (4) remaining potential contractors Abbott (LB), Beckman (LB), Siemens (LB) and Sysmex (LB) had automated hematology testing instrumentation. Review of Abbott’s FSS contract indicated they did not have slide maker stainers or digital imaging systems. Siemens had the slide maker stainer but did not have digital imaging systems. Only 2 contractors, Beckman and Sysmex, had automated hematology instrumentation, slide maker stainers and digital slide imaging. However it should be stated it is unknown whether or not the Sysmex instrumentation meets all the technical requirements of VISN

Beckman and Sysmex have the ability to provide automated testing instrumentation, reagents, training, service, and connectivity with VA VistA utilizing CPRR pricing however Beckman Coulter currently has instrumentation validated and in use at each of the participating V16 laboratories. Clinical laboratory scientists are trained on existing instrumentation and systems. Competencies have been assessed, procedures have been written and approved by the laboratory medical directors and instrumentation is bi-directionally interfaced to VA VistA for interfacing of test results.