25 08 28 signed LSJ UA 9225_Redacted.pdf

Effective Date: 02/01/2022 Page 2 of 6 for CPRR (cost per reportable result) in the Federal Supply Schedule FSC Group 66 III CPT/CPRR program for the performance of patient testing in participating V16 laboratories. 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 (SOW) will be incorporated into the short-term BPA with the incumbent, including use of equipment (all testing instrumentation, UPSs), preventative maintenance, emergency repair, reagents, controls, calibration materials, etc. Under the BPA Beckman Coulter will continue to provide instrumentation for 8 medical center and 20 outpatient clinic laboratories. Instrumentation is operating at an acceptable level with no reported issues.

The BPA will continue to provide fully automated urinalysis IQ Workcells (integrated automated macroscopic chemical analysis instrumentation with automated digital urine microscopy instrumentation), stand-alone AX-4030 macroscopic urine chemical analysis analyzers, 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 deployed and validated for use for patient testing at each participating laboratory. Automated digital urine microscopy results from this instrumentation have been correlated to manual microscopy and verified for clinical use in each participating lab.

Appropriate staff has been trained, competency assessed, and procedures written for clinical use of this instrumentation for patient care per VHA and regulatory agency requirements. Testing instrumentation is bi-directionally interfaced through data innovations to the VA VistA lab package. It is necessary to award a short-term BPA to the incumbent for continued use of existing instrumentation as it is the best method of satisfying the Government’s requirement while preventing delays in care for our Veterans and increased costs to the Government.

Key stakeholders include the Lab Directors and Medical Technologists performing testing at each VISN 16 medical center and outpatient clinic laboratory as well as 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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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.

Beckman has successfully provided automated urinalysis testing instrumentation, troubleshooting, repair, reagents and consumables under a VISN wide CPRR BPA. The BPA was competitively awarded from solicitation 36C25619Q0225 to Beckman Coulter, Inc.

Instrumentation includes proprietary testing instrumentation for macroscopic analysis and automated digital microscopy of urine at VISN 16 laboratories. Testing instrumentation is interfaced to VistA through Data Innovations Middleware eliminating the need to manually program patient testing and manually input patient test results into the VistA laboratory package.

Instrumentation is operating at an acceptable level with no reported issues. The contractor shall continue to provide high quality proprietary reagents, calibrators, consumables and related items for the performance of the testing. The program office will establish a work group 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 urinalysis 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 should also allow for the required method verification 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, training and validation/correlation studies are required at each laboratory. 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 at each facility. Basic operator training to be provided to all staff by the Contractor. Advanced/key operators at all participating labs will go off-site for training on digital microscopy instrumentation; upon their return, all remaining staff will be trained. New standard operating 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 to the incumbent for continued use of existing instrumentation as it is the best method of satisfying the Government’s requirement while preventing delays in care for our Veterans and increased costs to the Government.

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

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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:

Urinalysis testing instrumentation is already in use at each participating VISN 16 Medical Center and outpatient clinic laboratory. Beckman will continue to provide usage of all instrumentation, service and repair, proprietary reagents, consumables and interfacing 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

SBA CERT:

The search within SBA utilizing NAICS 334516 yielded 484 SBA’s FPDS search “Urinalysis Instrumentation and Testing yielded 9 results, however, none of the BPA orders are within the 18 months research window.

GSA eLibrary yielded the following:

Beckman Coulter Inc. (LB) FSS# V797D-70260 Mark Watanabe mswantanabe@beckman.com 714-872-6271

Siemens Healthcare Diagnostics (LB)- FSS# V797D-30175 Cathy Knutsen cathy.m.knutsen@siemens-healthineers.com 714-665-3235

Sysmex America, Inc. (LB) V797D-40235 dunnS@sysmex.com 224-543-9376

Search of SIN 605-4a in the GSA elibrary identified 3 vendors in the SIN. They are Beckman (LB), Siemens (LB), and Sysmex (LB). Per the GSA elibrary each has the ability to respond to a solicitation for automated macroscopic urine chemical analysis instrumentation, automated digital urine microscopy instrumentation, reagents, training, service, and connectivity with VA VistA utilizing CPRR pricing. It is anticipated that each of the offers will respond to the sources sought notice, participate in vendor site visits and submit a technical quotation in response to the competitively posted RFQ in the future. Due to the various instruments listed on each of the offerors’ respective FSS contracts, functionality of equipment, different technical requirements within the SOW and testing needs of the participating laboratories it is unknown at this time if the combinations of instrumentation and reagents quoted by each offeror will meet the Governments requirements. This cannot be determined until an RFQ response is submitted and evaluated by the Source Selection Evaluation Team (SSET) against the technical requirements of the RFQ and technical evaluation factors.

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Beckman Coulter instrumentation is currently deployed and validated for patient clinical testing 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. Beckman is the only contractor that can meet the requirements for the 8 medical center and 20 outpatient clinic labs by October 1, 2025.

(7) Any Other Facts Supporting the Justification:

Due to challenges and other competing actions, the Program Office, Contracting and VISN SMEs are working as staff is available, and time allows to develop the long-term solicitation packet. There are other VISN wide laboratory procurements and upgrades ahead of this requirement in the queue. VISN 16 continues to work closely with NCO16 through VISN standardized procurements and installation of new instrumentation and associated equipment across the network. Patient support is our number one priority and approval of this sole source action is necessary to ensure that patient testing is seamlessly continued, and patient care is not negatively impacted. Current BPA pricing has produced important cost avoidance to the Government of approximately annually. Under the current BPA, laboratories annually obligate funds using a purchase order for CPRR monthly invoicing in arrears. If the short-term VISN wide BPA is not awarded, the participating laboratories would be required to prepare and submit individual sole source procurements. Pursuing separate procurements is inefficient, increases administrative burden, reduces economies of scale and results in the potential to pay higher prices. Another alternative would be to manually perform the testing however this would require hiring of additional staff to perform the testing and manually report the test results causing significant delays in turn-around times. The award of a short-term BPA with the incumbent ensures continued access to timely, accurate macroscopic urine chemical analysis instrumentation and automated digital urine microscopy instrumentation, service and related items 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, 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. A.

(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 VISN wide 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 urinalysis instrumentation and testing contractors. Award of this short-term bridge BPA will allow for continued use of automated macroscopic urine chemical analysis instrumentation and automated digital urine microscopy instrumentation for 8 medical center and 7 outpatient clinic laboratories and automated macroscopic urine chemical analysis instrumentation for 13 outpatient clinic labs so that patient care is not negatively affected.