B--Notice of Intent to Award a Sole Source

The U.S. Environmental Protection Agency (EPA) intends to award a sole source purchase order to Experimental Pathology Laboratories (EPL) under the authority of Federal Acquisition Regulation (FAR) Part 13, Simplified Acquisition Procedures for Histology, Histopathology, and Immunohistochemical Services. EPL is only one source reasonably available for the below listed studies to maintain scientific quality and consistency of pathology and immunohistochemical (IHC) data with pre-existing work. The Agency needs to be able to make direct comparisons between data from these studies and those of current and previous studies. Experimental Pathology Laboratories (EPL) has provided histology, histopathology, and/or IHC staining for earlier components of each study under the prior Blanket Purchase Agreement (BPA) with NHEERL. For histopathology work, it is necessary to have the same laboratory conduct the work to ensure consistent terminology, severity grades, and thresholds for lesion diagnoses. Studies 1 and 3, while distinct experiments, are part of a series of projects (including studies completed last year) that ultimately will be compared with one another; for Study 5, the requested histology and histopathology work will evaluate targeted changes in low- and mid-dose groups as follow-up to the initial survey of control and high-dose groups conducted previously at EPL. For all of the studies, having the laboratory read all of the treatment groups best ensures standardization and quality control of study data. For IHC work, it is necessary that technical details (e.g. antibody clones and dilutions, staining protocol, equipment) be the same as for prior IHC procedures to allow for cross-study comparisons of proliferation data using this same marker (Ki67) (for modeling purposes) and use of similar imaging and automated counting procedures (for staining quantitation). The equipment and specific protocols used at EPL for Ki67 IHC staining a re required to minimize variation in cell labeling that may be introduced by using other IHC procedures in other laboratories. The ability of EPL to provide the same protocols used in previous studies is a critical requirement of this procurement request and justifies a sole source purchase , if another vendor does the current analyses there may be a systematic bias in the results that may cause erroneous conclusions to be drawn. Therefore, EPL is the only one source reasonably available capable to provide consistent, comparable results with earlier sample sets. Study #1: Characterization of early key event markers for the constitutive androstane receptor (CAR) mode of action/adverse outcome pathway in the liver - Pathology needs o Histology for mouse liver samples  Work includes processing 230 samples to paraffin blocks, sectioning, and H&E staining of slides - Acceptance Criteria/Deliverable: Provide histology of 230 Parrafin blocks and H & E Slides to EPA within two months of award of the purchase order. O Histopathology for 230 mouse liver samples - Acceptance Criteria/Deliverable: Completion of Pathology report and provided to EPA within 2 months of award of the purchase order. Study #2: Proliferation thresholds for CAR-mediated tumorigenesis in the liver - Pathology needs o Work includes sectioning of 230 blocks and immunostaining of 230 slides for the Ki67 proliferation marker  Sectioning and Ki67 staining - Acceptance Criteria/Deliverable: Completion of 230 Parrafin immunostaining 230 slides with inventory sheet within 2 months of award of the purchase order Study #3: Characterization of early key event markers for androgen, estrogen, and glucocorticoid receptor modes of action/adverse outcome pathways in the liver - Pathology needs o Histology for mouse liver samples  Work includes processing 230 samples to paraffin blocks, sectioning, and H&E staining of slides - Acceptance Criteria/Deliverable: Provide 230 Parrafin blocks and H & E Slides to EPA within two months of award of the purchase order. o Histopathology for 230 mouse liver samples - Acceptance Criteria/Deliverable: Completion of Pathology report and provided to EPA within 2 months of award of the purchase order. Study #4: Effects of short-term steroid receptor agonists on proliferative responses in the liver - Pathology needs o Work includes sectioning of 230 blocks and immunohistochemical staining of 230 slides for the Ki67 proliferation marker  Sectioning and Ki67 staining - Acceptance Criteria/Deliverable: Completion of 230 Parrafin immunostaining slides with inventory sheet within 2 months of award of the purchase order. Study #5: Defined mixture disinfection byproduct study - Pathology needs o Histology for 360 rat thyroid and liver samples  Work includes sectioning and H&E staining of slides - Acceptance Criteria/Deliverable: Provide Sectioning and H& E Staining 360 slides to EPA (and return of paraffin blocks) o Histopathology for 540 rat thyroid and liver samples - Acceptance Criteria/Deliverable: Completion of Pathology report and provided to EPA within 2 months of award of the purchase order. Study #6: Target organ toxicity and toxicokinetics of bromochloromethane - Pathology needs o Histopathology for 133 rat liver and 133 rat kidney samples - Acceptance Criteria/Deliverable: Completion of Pathology report and provided to EPA within 2 months of award of the purchase order. The EPA is using exemption to competition FAR 13.106(b)(1), One Responsible source reasonably available. This is a notice of intent and not a request for competitive proposals. No solicitation is currently available for this requirement. All interested parties who believe they can provide the required services should fully explain their capabilities and qualifications in writing within 10 days from the date of this announcement and provide itemized pricing that is sufficient to make a determination that competition is feasible to [email protected]. A determination by the Government to compete this proposed purchase order based upon responses to this notice is solely within the discretion of the Government. All questions or comments regarding this procurement shall be addressed in writing to the Contracting Specialist Lisa Rogers at [email protected] or the Contracting Officer at [email protected].