Anatomic Pathology Services BPA JA_Signed_Redacted.pdf

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

For Official Use Only (FOUO)

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David Grant Medical Center (DGMC) has a need for pathology and consulting services to diagnose and treat cancer patients. The testing services required include immunohistochemistry (IHC) and special stains, flow cytometry, Fluorescence In Situ Hybridization (FISH), cytogenetics, molecular markers, solid tumor profiling, next genetic sequencing and consultation services.

Required Tests/Services:

IHC

ISH

IHC panels (MMR or Breast Triple, etc) Special Stain Flow Cytometry with Interpretation FISH testing Cytogenetics Study with Interpretation Molecular tests (KRAS/BRAF) Molecular tests (NGS ALK/NTRK) Molecular tests (RAS/RAF Panel) Head & Neck Tumor Profile Lung Tumor Profile Melanoma Profile Ovarian Tumor Profile Pancreas Tumor Profile Thyroid Profile Lymphoma Profile Breast Tumor Profile PD-L1 tests Bone Marrow Evaluation with full diagnostic morphology consult Lymphoma Consult

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

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NeoGenomics has comprehensive diagnostic methodologies for tissue-based and liquid biopsy testing. These methodologies provide diagnostic, prognostic, and predictive answers to cancer testing and treatment therapies. Their paper, phone-based, and on-line ordering process provide simplicity and uncomplicated flow of testing through resulting from the technician, administrative staff, pathologists, and oncologists.

Maintaining diagnostic pathology services with less manning and shortage of supplies/reagents made possible by having NeoGenomics that guarantee availability of all diagnostic testing, with reliable client services, with 2 alternate couriers for daily specimen pickup and efficient transcribing results through their secured web-based resulting to 60 MDG's 2-yr old information system. Additionally, NeoGenomics has a unique capability of in-house liquid based testing when the patient's sample is less invasive. To date, NeoGenomics has been the only regional vendor capable of offering the full extensive list of testing services requested by David Grant Medical Center and has provided consistent and reliable turn-around times of lab results through their logistical capabilities making them the only ones uniquely capable (see Market Research conducted for further details validating it's competitors inability to meet the Government's needs).

Historically, previous acquisitions were solicited as unrestricted on GSA and FBO without receiving offerors from any viable vendors other than NeoGenomics. It can be concluded that this requirement can not be accomplished by means of small business as NeoGenomics is a large business and the only one that has been responsive to the Government's needs.

Recently

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

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After originally being solicited in previous acquisitions as unrestricted on GSA and FBO without receiving offerors from any viable vendors other than NeoGenomics it was concluded that the requirement could not be accomplished by means of small business as NeoGenomics is a large business and the only one capable of responding to the MTF's needs at Travis AFB.

Current market research was conducted with other diagnostic pathology companies. It was determined that Diagnostic Pathology Medical Group, Inc. and Integrated Molecular Diagnostics Laboratory's test menu capabilities did not include all the tests required IAW with the Performance Work Statement. Additionally, LabCorp Management, which partners with Integrated Oncology and has a DOD contract, was utilized by 60 MDG in the past and ultimately the MTF experienced various hindrances with inconsistent results and delayed turn-around times, to include complicated ordering process, difficulty in test result transcription to the laboratory's information system, poor customer service, and lack of communication. Another local company, Precision Pathology was also researched, however the test menu did not include all the required tests as outlined in the PWS and has no definitive process in-place for liquid-biopsy. Additionally, Precision Pathology did not have a cage code and setup to do business with the Federal Government.

60 MDG Pathology Laboratory's requirement to test and treat patients for potential cancerous conditions can only be met by a company that offers the full extensive list of testing services and provides consistent and reliable turn-around times of lab results. Based upon the findings in the above sections, sole source award to NeoGenomics Inc. is the only viable solution to satisfy this requirement as they are the only ones uniquely capable.

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

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