The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing on-site pathology services for the services described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.
The associated North American Industry Classification System (NAICS) Code is‐ 541990 All Other Professional, Scientific and Technical Services; Small Business Size Standard is $14.0 million.
The FDA/NCTR/ requires On-site pathology services in support of FDA's mission, , on various animals in, but not limited to, the following areas: 1) major services and functional support; 2) gross pathology; 3) histology; 4) pathologist services; 5) Clinical Chemistry; 6) immunohistochemistry and special procedures;7) molecular pathology and methods development; 8) digital imaging; 9) data management; 10) archive management (wet tissue and block/slide); 11) internal quality assurance; 12) quality control; and 13) administrative services and management.
The anticipated performance period is a base year with up to four (4) 1-yearoption periods.
Part I: Background:
The U.S. Department of Health and Human Services, Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Office of Scientific Coordination has a requirement for pathology services in support of FDA's mission. NCTR is located at the Jefferson Laboratories of the FDA in Jefferson, Arkansas, approximately 35 miles south of Little Rock and 28 miles north of Pine Bluff. NCTR is an internationallyrecognized FDA research center that conducts toxicological research studies andother research activities designed to support the FDA's mission to protect the public's health. NCTR investigators collaborate with researchers elsewhere in the FDA as well as other government agencies, industry, and academia. FDA/NCTR andthe National Institute of Environmental Health Sciences (NIEHS) have had an interagency agreement (IAA) since 1992, through which the FDA collaborates with theNational Toxicology Program (NTP) to design and conduct toxicological studies involving compounds of regulatory interest to the FDA. Many of the studies at NCTR must follow the FDA's Good Laboratory Practices (GLP) guidelines. NCTR is comprised of six research divisions and has facilities including: 132 general or special purpose research laboratories; a phototoxicology research center; an imaging center including microPET, MRI, and CT scanner; a nanotechnology core facility; an inhalation toxicology facility and Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)-accredited animal facilities, including,but not limited to, rodent facilities accommodating conventional housing, specific pathogen free rodent production colony, isolators for germ-free rodents, andquarantine; a non-human primate research center; a zebrafish production facility.
General Information
The Contractor shall conduct the pathology serviceson each study to the requirements/parameters established by the NCTR Principal Investigators (PIs). The Contractor shall work closely with the Contracting Officer's Representative (COR) and PI to plan, implement, perform, report and archive the research protocols. Planning includes, but is not limited to, developing cost estimates, schedules, and work plans to be performed for each study. Research protocols written by the PIs will determine the pathology support requirements, which range from necropsy of a few animals and collection of a few tissues to complete necropsy (collection of ≥44 tissues) of over a thousand animals requiring special handling of tissues, histopathology, special staining or other techniques (immunohistochemistry, digital imaging, etc.), hematology, urinalysis, and/or clinical chemistry. Other required techniques include, but are not limitedto, teratology techniques, reproductive and developmental toxicology techniques, respiratory pathology techniques (inhalation toxicology studies), sperm morphology and motility analysis, vaginal cytology, vaginal smears for sperm evaluations, and mammary whole mounts. Some protocols may include requirements for histopathological processing, including immunohistochemistry, of human tissues or cells. Pathologists will not be expected to provide diagnoses for human tissues. TheContractor shall ensure that all protocol pathology requirements are followed with particular attention to detail.
On-site pathology services for the animal studies performed at NCTR have been obtained through contracts since the Center's inception in 1972. In 2014, 2015, 2016, 2017, and 2018, the numbers of studies per year with pathology requirements were 56, 43, 39, 40, and 33, respectively. At any given time, pathology services are being conducted on approximately 10-15 different studies. The majority of pathology studies are conducted on rodents; however, some studies involve non-human primates, other mammals, and/or zebrafish. Facilities, property, and utilities have historically been government-furnished. A complete list of GFP will be included in any resultant solicitation.
Part II Work Requirements Summary
NCTR requires on-site pathology services, for a base period plus up to four (4) -year option periods, on various animals in, but not limited to, the following areas listed below. The Contractor shall conduct the pathology services following all applicable rules, policies, regulations and guidelines set-forth hereinand in each individual protocol. The responsibility of the Contractor to be knowledgeable and trained on the standards of operation of the studies to produce quality results.
The contractor shall be required to meet the following performance requirements:
(1) Major Services and functional Support - The Contractor shall provide alllabor to include but not be limited to supervision, administrative, and technical support, to plan, schedule, coordinate, and assure effective completion of all services.
(2) Gross Pathology - Necropsy services will be protocol-dependent. The Contractor shall perform rodent and zebrafish necropsies in the Pathology facilities, unless the protocol requires that the necropsies be performed in a different location. The Contractor shall perform non-human primate necropsies in the restricted Non-human Primate facility shall follow the requirements of the protocol. The Contractor shall provide colony maintenance for rodent and non-human primate colonies and the zebrafish production facility.
(3) Histology - The Contractor shall perform histology techniques including,but not limited to: trimming tissues into cassettes; processing tissues (dehydrating, clearing, and infiltrating); embedding tissues; sectioning blocks or frozen tissues; preparing slides; and staining slides. Each approved protocol shall dictate the parameters for tissue processing, embedding, and slide preparation. Some protocols will require specialized techniques, including, but not limited to: non- immersion tissue sues for ribonucleic acid (RNA) isolation.
(4) Pathologist Services - The Contractor shall provide pathologists to monitor all necropsies, read slides and make diagnoses, and write pathology reports describing all pathological findings. Contractor pathologists shall be availableto provide information on meetings (e.g. the TSSRC, QAS, PWG meetings).
(5) Clinical Chemistry - The Contractor shall perform analyses (hematology, clinical chemistry and coagulation) on blood samples and urinalysis as dictated by each approved protocol. Approved protocols shall require analyses of other samples including, but not limited to, spinal fluid, semen, vaginal smears, feces,amniotic fluid, synovial fluid, and bile. Hematology shall include, but not be limited to a complete blood cell count, with differential, packed cell volume (PCV), reticulocyte count, and staining for manual differential counts. Clinical chemistry shall include, but not be limited to, cholesterol, triglycerides, bloodurea nitrogen, creatinine, glucose, total protein, albumin, alanine aminotransferase, aspartate aminotransferase, amylase, creatine kinase, calcium, inorganic phosphorus, sodium, potassium, chloride, sorbitol dehydrogenase (SDH), total bile acids, quantitative urine creatinine, protein and glucose. Urinalysis shall include, but not be limited to, urine volume, specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin blood and microscopic analysis of the sediment. Coagulation shall include, but not be limited to, protime, activated partial thromboplastin time (aPTT) and thrombin. Approved protocols will require any number of additional analyses, requiring enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA) or other assay methods.
(6) Immunohistochemistry and Special Procedures - The Contractor shall perform immunohistochemistry (IHC) on slides as dictated by approved protocols. IHC targets may include, but not be limited to, specific immune cell types (e.g., CD3, CD2, or CD21), cancer or other disease biomarke K-7), and other specific proteins (e.g., glutathione or TdT).
(7) Molecular Pathology and Methods Development - The Contractor shall develop molecular pathology methods as required by approved protocols. The Contractorshall research techniques and reagents to best provide the analyses needed. Methods development shall involve, but not be limited to, IHC, ELISA, and RIA.
(8) Digital Imaging - The Contractor shall provide high quality digital images gross specimens and high-resolution digital images of glass slides as required by approved protocols. The digital images shall be archived and maintained in an accessible database system. The Contractor shall provide analysis of these images as required by approved protocols. At the request of the PI l be made available on a network server provided by the Government.
(9) Data Management - The Contractor shall use the Government-provided database systems to manage histopathology data associated with each animal on each protocol. Necropsy data, including, but not limited to, animal receipt, and body and organ weights, shall be entered into GPS. GPS reports include Individual Animal Necropsy Reports (IANR), Protocol Definition reports, and IANR Lists. Pathologists' readings of the slides shall be entered into either the Micropathology Data Collection System (Micropath). Micropath is the NCTR database system for collecting and maintaining histopathological data. Micropath shall be used primarilyto collect histopathology observations and notes and to generate reports. GPS and Micropath are owned and maintained by NCTR. The Contractor shall be responsible for ensuring proficiency in using GPS and Micropath.
(10) Archive Management (Wet Tissue and Block/Slide) - The Contractor shall perform archiving services for all study (protocol) materials. The Contractor shall control access to archived study materials, provide a system to catalog materials, and track custody of materials that are "checked out" of the archive areaby authorized personnel (authorized personnel would include Contractor staff a need to use or examine the study materials and the PI or his/her designee).
(11) Internal Quality Assurance - The Contractor shall provide Quality Assurance (QA) for the portion of each GLP protocol performed by the Contractor. ThisQA shall ensure that the processes followed by the Contractor for GLP studies are performed correctly and documented properly. In addition to internal QA auditing performed by the Contractor, the NCTR QAU shall periodically perform QA audits/inspections of the Contractor's procedures and records pertaining to GLP studies. Pathology reports for GLP studies are subject to audit by NCTR's QAU as a part of the review of the study reports.
(12) Quality Control - The Contractor shall provide all quality control for services performed under this contract, ensuring that the results produced are complete and accurate. The Quality Control program shall be designed to ensure that the Contractor is providing pathology services in compliance with establishedSOPs, approved protocols, and applicable GLP requirements. The Contractor shallwrite, implement, and enforce a Quality Control Plan (QCP), which shall be reviewed and approved by the CO. The Contractor's final QCP shall be submitted within 30 calendar days of contract award. The QCP shall be designed to monitor all functions in pathology services to confirm that results are complete, accurate, and in compliance w ed protocols, and applicable GLP requirements.
(13) Administration Services and Management - The Contractor shall provide qualified professional, technical, administrative personnel to fulfill complete pathology services as outlined above. The Contractor shall provide s, education, and experience to complete the services. The Government requires all laboratory personnel on this contract, including pathologists, to submit to the medical examinations or procedures listed below annually as a condition of employment. Possible adverse health outcomes as a result of exposures in the laboratory environment are monitored to ensure that contract employees may safely continue towork in the laboratory. Physical Examinations - The Government requires all laboratory personnel on this contract, including pathologists, to submit to the medical examinations or procedures listed below annually as a condition of employment. Possible adverse health outcomes as a result of exposures in the laboratory environment are monitored to ensure that contract employees may safely continue to work in the laboratory. All of these medical procedures will be provided by the NCTR, or a third party designated by NCTR at no cost to the Contractor or employee on an annual basis as long as the employee continues to work in the laboratory. Upon transfer to a non-laboratory position, one additional examination will be provided. Medical examinations or procedures other than those approved by the NCTR or an NCTR-designated third party will be at no cost to the Government.
- Periodic blood and urine samples as dictated by the safety and occupational health program.
- Periodic examination for the presence of potentially pathogenic bacteria and viruses.
- Follow-up examinations as determined necessary.
Contract Type: Commercial Item - Labor Hour
Period of Performance: All on-site pathology services shall be at 3900 NCTR RD, Jefferson, AR 72079. The estimated period of performance listed below.
Base Period: May 1, 2020 through April 30, 2021
Option Period 1: May 1, 2021 through April 30, 2022
Option Period 2: May 1, 2022 through April 30, 2023
Option Period 3: May 1, 2023 through April 30, 2024
Option Period 4: May 1, 2024 through April 30, 2025
Instructions to Prospective Respondents
Responses to this source soughtshall unequivocally demonstrate that respondent has the capability, staff (ability to recruit and maintain), experience, property management processes, and accounting system to perform the services under any type of contract. Though the target audience is small businesses, all interested parties may respond. At a minimum, responses shall include the following:
• Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address;
• Three (3) years of past performance information for the serviceof same or substantially similar projects similar to task areas 1-13 above to include date of services, description, dollar value, contract type (e.g., fixed-price, cost reimbursement, time-and-materials, labor hours, etc.), details demonstrating ability to recruit, retain, and fairly compensate suitable professional employees as defined in 29 CFR 541, client name, client address, client point ofcontact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address;
• Evidence that accounting system has been determined adequate for determining costs applicable to a cost reimbursement contract or otherwise suitable for a time-and-materials or labor-hour arrangement;
• Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing;
• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement;
• If a large business, identify the subcontracting opportunities thatwould exist for small business concerns;
• Although this is not a request for quote, informational pricing can be provided;
• The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.
The Government is not responsible for locating or securing any information, not identified in the response.
Interested Parties must respond with capability statements which are due on November 21, 2019 by 12:00 pm (Central Time in Jefferson, Arkansas) to roosevelt.walker@fda.hhs.gov Reference #FDA-SSN-1218123.
Notice of Intent
Responses to this source sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures
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 respondentsfor 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 solicitation may be published via FedBizOpps. 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).
Primary Point of Contact:
Roosevelt Walker
roosevelt.walker@fda.hhs.gov
Phone: 8705437405
Contracting Office Address:
3900 NCTR Road, HFT-320
Bldg 50 | Rm 423
Jefferson, Arkansas 72079
United States
CITE: https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-SSN-1218123/listing.html