SOURCES SOUGHT
A -- Pathology Peer Review and Pathology Support for the Divisions of the National Toxicology Program (NTP) and Intramural Research (DIR) at the National Institute of Enviromental Health Sciences (NIEHS(
- Notice Date
- 4/2/2014
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Office of Acquisitions, Office of Management, 530 Davis Drive, Durham, North Carolina, 27713, United States
- ZIP Code
- 27713
- Solicitation Number
- NIHES2014009
- Archive Date
- 5/1/2014
- Point of Contact
- Carolyn N Flowers, Phone: 919-541-0425
- E-Mail Address
-
flowers3@niehs.nih.gov
(flowers3@niehs.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. THIS IS STRICTLY FOR MARKET RESEARCH. BACKGROUND The NTP Pathology peer-review process has been in place for over 30 years and is viewed as the international gold standard by agencies such as EPA, FDA, NIOSH, and IARC. Veterinary pathology support for NIEH'S NTP and DIR laboratories including, but not limited to, evaluation of histologically prepared tissue (including special stains), immunohistochemistry, laser capture microdissection, electron microscopy, and interpretation of molecular pathology data, have been in place for well over a two decades. PURPOSE/OBJECTIVE There are two main objectives for this requirement. 1. The first objective is to provide ongoing and recurring support for pathology peer review of NTP animal (rats and mice) studies. Peer review includes evaluation of pathology records, evaluation of the pathology diagnoses and comparison with the histological material, and evaluation of clinical pathology specimens and clinical pathology data. 2. The second objective is to provide ongoing and recurring support for veterinary pathology evaluations for the Divisions of NTP (DNTP) and Intramural Research (DIR) projects. Pathology support projects include, but are not limited to, providing on-site staffing, necropsy services, histology services, special techniques (such as special tissue handling, histochemistry and immunohistochemistry), obtaining digital images, electron microscopy services (including electromicrograph evaluation), interpretation of molecular pathology data, training, assistance with manuscript preparation, and histopathology evaluation for NTP and NIEHS investigations. PROJECT REQUIREMENT Since pathology results are crucial endpoints for most NTP studies, and a program of the magnitude and diversification of the NTP requires cooperation and collaboration of numerous testing laboratories throughout the nation, the requirement is essential to provide assessment of uniformity, consistency, and accuracy of pathology data, diagnostic criteria, and procedures. The NTP/NIEHS requires the assistance of an organization highly experienced in providing technical and management support for all phases of pathology peer review and pathology support. The awarded contract will define the process to provide all the services required to conduct pathology peer review for the NTP. 1. Support for pathology peer review of animal studies will include the following: Pre-QA Pathology Data Review (PDR) is comprised of the following: (a) reviewing pathology data to identify deviations from historical control data, duplications of diagnoses (using different terms for morphologic variants of the same lesion), inappropriate use of topographies in the diagnoses, and tissues with low tissue accountability; (b) drafting a report of PDR review with recommendations for tissue/lesion review and beneficial special studies; (c) holding meeting with NTP staff to review the draft PDR report; (d) submitting a final PDR report. Audit of Pathology Specimens is comprised of the following: (a) examining the designated residual formalin fixed wet tissues, paraffin blocks and microscope slides to evaluate the accuracy of animal identification, the adequacy of the necropsy and gross trimming of the tissues, and the possible presence of gross lesions which were not described at necropsy or trimmed for microscopic examination; (b) ensuring required tissues are present and have been consistently sampled and that the slides have been examined for tissue accountability and histotechnical quality; that the paraffin blocks are properly labeled and that all blocks have been sectioned; and that there are corresponding microscope slides available for examination; and (d) submitting a final APS report. Pathology Quality Assessment is comprised of the following (a)automating the receipt of pathology data in electronic form and transferring the pathology data to QA tables and QA reports for use in the pathology QA process; (b) formatting and printing the QA tables; (c) performing microscopic examination of designated tissues/lesions (as designated in the PDR) to evaluate the consistency and accuracy of the histopathological diagnoses and to ensure that all treatment-related effects are reviewed and identified. This may include a review of mammary gland whole mounts for some studies; (c) evaluating the histotechnical quality (e.g., the quality of the staining and tissue sectioning) and accuracy of the original tissue counts. (d) preparing a detailed report on the pathology QA. Pathology Working Group (PWG) / Pathology Peer Review is comprised of the following: (a) generating PWG tables and submitting to staff to have specific tissues with lesions pulled and ready; (b) scanning the PWG slides using an Aperio slide scanner or one compatible with the Spectrum software or other as specified by the COR and uploading to Spectrum; (c) annotating the scanned images; (d) preparing PWG worksheets (one set for each participant); (e) planning, scheduling, inviting participants to the PWG and performing any other administrative activities necessary to include leading the Pathology Working Group (PWG) reviews (f) preparing and submitting a draft report to the NTP pathologist for review and approval and (g) a subsequent final report; (h) updating the anatomic pathology data stored on NTP/NIEHS designated computerized data management system. Data Entry: Enter pathology data generated from the initial study pathologist histopathological evaluation of protocol-required tissues from NTP studies, and the peer review (PWG or PPR) of such studies with NTP provided software. Clinical Pathology Data Quality Assessment: Conduct peer review of clinical chemistry, hematology, and/or vaginal cytology may occasionally be performed. The government anticipates that support for pathology peer review for NTP animal studies will be required on 25 to 30 studies per year, including but not limited to chronic, subchronic, RACB, MOG, immunotoxicity, and developmental neurotoxicity studies. The goal of the pathology peer review is to verify and establish consistency in pathology results. The awarded contract will define the process to provide all the services required to conduct pathology peer review for the NTP. Reports will be required on all tasks. Additional deliverables are administrative and expenditure reports required monthly, quarterly and annually. 2. Support for veterinary pathology evaluation projects will include Initial Histopathological Evaluations which is comprised of recording findings, preparing summary tables of the histopathological findings and preparing and submitting to the government a descriptive and interpretative narrative that summarizes the results of these evaluations. Supplementary Pathology Reviews will be provided as requested for Step Sections and Ovarian Follicle Counts. Necropsies: Complete necropsies will be conducted as designated. Histology/Histopathological Evaluations: Provide a variety of histological services. Histology requirements shall include the following: tissue trimming, processing (fixation, dehydration, clearing and infiltration) and paraffin embedding, microtomy and histochemical staining of rodent or other tissues to produce high-quality tissue sections mounted on glass histology slides. The extent of the histology project assignments will vary to include: the preparation of paraffin or plastic tissue blocks, the preparation of stained (Hematoxylin and Eosin or special stains) and/or unstained tissue sections from wet tissue, trimmed tissues in cassettes or paraffin-embedded tissue blocks. The Contractor shall record findings, prepare summary tables of the histopathological findings and prepare a descriptive and interpretative narrative that summarizes the results of these evaluations. Specialized Pathology Evaluations: Perform a variety of specialized and sophisticated techniques on pathological specimens. These services shall include, characterization of non-neoplastic and neoplastic lesions by special stain techniques, ultrastructural examination, or routine immunohistochemistry, such as for the determination of cell proliferation indices using bromodeoxyuridine (BrdU) or Ki-67 or proliferation cell nuclear antigen (PCNA) immunohistochemistry, and the adaptation of new immunohistochemical methods for evaluation of pathology specimens using formalin-fixed, paraffin embedded sections and/or frozen tissue. Interpret molecular pathology data or consult investigators on matters regarding molecular pathology study design. Record and prepare a report of findings that includes methods, tables, a descriptive narrative and any visuals pertinent to the interpretation of the data. Data Entry Enter histopathologic or other data from special studies (as part of an NTP study), or from smaller, in-house studies, or other studies into an NTP designated system or into electronic file using an NTP designated format as directed by the COR. Other requirements Provide full time Veterinary Anatomic Pathologist(s), preferably ACVP-certified, on site at NIEHS to serve as staff expert(s) and consultant(s) in research and investigations relating to pathology, electron microscopy, toxicology and carcinogenesis. Further, the pathologist(s) will manage the evaluation of the pathology and toxicology research data from NTP toxicity studies performed through contract laboratories and in-house studies for clarity, accuracy, and identification of target tissues and determination of the most appropriate descriptive terminology. Provide full-time technicians to work on site at NIEHS in the Data Coordination Unit to serve as the Clinical Pathology Data Coordinators, Provide full-time histologists/histotechnicians and full time immunohistologists/immunohistotechnicians on-site at NIEHS facilities on an as-needed basis as determined by the COR to perform all aspects of preparing high quality histologic and immunohistochemical slides from rodent tissues Provide administrative and technical support for laboratory animal medicine management within the Cellular and Molecular Pathology Branch. Personnel fulfilling this task may be required to be on-site. Provide training in the NTP's peer review process for new NTP and contract pathologists evaluating NTP studies. Make frequent (once or twice daily) courier service trips to the NTP Archives and to the NIEHS for the delivery and pickup of pathology slides, data, and other materials. Assist with the preparation of manuscripts, scientific posters, and educational materials such as atlases, informational DVDs, or documents on the NTP peer review process. Investigate emerging technologies or techniques that advance pathology evaluations as requested by the COR. Travel-related activities as part of the routine work of this contract Provide logistical support for invited PWG members (except for Federal Government and contract employees) to include arranging for hotel lodging and assisting PWG members with travel arrangements visit NTP-designated contract laboratories to conduct on-site training in necropsy or histotechnique or other specialized procedures as directed by the COR. The Government anticipates 15-30 support projects per year. Reports will be required on all tasks. The contract will define the process to provide all the services required to provide pathology support for the NTP and NIEHS. Additional deliverables are administrative and expenditure reports required monthly, quarterly and annually. ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is to be determined but it is expected to be a base period with nine (9) option years. OTHER IMPORTANT CONSIDERATIONS The government will require proof of compliance with FDA GLP regulations as specified in 21 CFR 58 "Good Laboratory Practices for Non-clinical Laboratory Studies" and a location within 45 minutes driving time of NIEHS, Research Triangle Park, North Carolina, 27709, for the duration of the contract performance period. CAPABILITY STATEMENT/INFORMATION SOUGHT: To be deemed capable of providing the requirement, organizations shall submit a written capability statement demonstrating ability and experience in performing the requirements noted in this notice. Organizations must demonstrate experience, capabilities, qualified personnel, and expertise in (1) conducting pathology peer reviews and (2) providing the pathology evaluation support tasks specified in this notice; and, (3) providing capable, suitable, adequate, and available facilities, equipment, and other resources necessary to carry out the requirements. INFORMATION SUBMISSION INSTRUCTIONS Interested qualified business organizations should submit a tailored capability statement for this requirement, not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Statements should also include the eligible business concerns name, point of contact, address and DUNS number. NIEHS does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received. If you have questions regarding this notice please submit them electronically (via email) to Ms. Carolyn Flowers, Contract Specialist, at flowers3@niehs.nih.gov in MS Word or Adobe Portable Document Format (PDF), by April 11, 2014, 11:59 am. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Ms. Carolyn Flowers, Contract Specialist, at flowers3@niehs.nih.gov in MS Word or Adobe Portable Document Format (PDF), by April 16, 2014, 11:59 am. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIEHS/NIHES2014009/listing.html)
- Place of Performance
- Address: At the contractor's facility. The contractor will be required to make frequent (one or twice daily) courier service trips to the NTP Archives and to the NIEHS for the delivery and pickup of pathology slides, data, and other materials., United States
- Record
- SN03327306-W 20140404/140402235019-f060329209431430bc5b20837e3b5eb8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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