Attachment 1 - Draft Statement of Work AARC.pdf

Statement of Work

Archives and Repository Contract (AARC): Management and Support of an Archives and Repository for the National Toxicology Program (NTP) and the National Institute of Environmental Health Sciences (NIEHS) Divisions of Translational Toxicology (DTT) and Intramural Research (DIR)

DATE

The National Institute of Environmental Health Sciences (NIEHS), located in Research Triangle Park, North Carolina, is one of 27 research institutes and centers of the National Institutes of Health. NIEHS is a multidisciplinary research institution with the primary mission to discover how the environment affects people in order to promote healthier lives. NIEHS focuses on basic science, disease-oriented research, global environmental and population health, clinical research, and multidisciplinary training for researchers. The Division of Translational Toxicology (DTT), and the Division of Intramural Research (DIR) are intra-agency divisions of NIEHS.

1.0 INTRODUCTION/OVERVIEW

1.1 Background

The DIR comprises 10 Branches and Laboratories that conduct in-house research that contributes to the understanding of biological and chemical processes, the role(s) of environmental agents in human disease and dysfunction, underlying mechanisms of environmentally-associated diseases, and how intervention and prevention strategies can reduce the effects of exposures to environmental agents.

The DTT conducts toxicology research that aligns with real-world public health needs to translate scientific evidence into knowledge that can inform individual and public decision making. The DTT research portfolio is organized and executed based on three objectives: 1) accelerate the progress toward becoming a more predictive, precise, and preventive science through application of a translational toxicology pipeline of capabilities, 2) provide an evidence-based approach to identifying and understanding potential environmental contributors to contemporary and common diseases, 3) improve the ability to conduct and communicate substance-based hazard evaluations that are more translational, innovative, and responsive. The DTT has four programmatic areas of focus: Exposure-based research, Health Effects Innovation, Responsive Research, and Strengthening Capabilities. There are specific research programs within each focus area. All research programs are team-based. DTT scientists identify key environmental health research gaps, develop and execute research using a portfolio of internal and external laboratory and non-laboratory-based resources.The DTT is the principal component supporting the interagency National Toxicology Program (NTP). The NTP is an interagency partnership of the Food and Drug Administration, National Institute for Occupational Safety and Health, and NIEHS. The goals of the NTP are to collaborate with public stakeholders and global partners to identify public health issues, generate and communicate trusted scientific information to support decision making on environmental hazards of public health interest, lead the transformation of toxicology through the development and application of innovative tools and strategies, and educate and train the next generation of translational scientists to be innovative leaders in the field. Select studies conducted using DTT resources support NTP research programs. A majority of the existing records in the Archives and FTB are considered to be from NTP studies.

1.2 SCOPE

The research programs of the NIEHS generate large volumes of data and biological and environmental specimens that require safe, secure, short- and long-term management and storage under specific environmental conditions. The collections comprise a variety of materials, and depending on the type of study, the quantities of study materials range from several hundred items to several millions.

Examples include—

• Analog records: temporary hard copy paper or paper generated prior to digital options, electronic data media, film slides, microfiche, and digital image files, etc.;

• Biological samples: formalin fixed, wet-tissue and paraffin-embedded (FFPE) tissue blocks;

histological glass slides, frozen tissues, blood and blood fractions, RNA and DNA, secreta and excreta, hair and nails, etc.;

• Environmental samples: Dust, water, soil, nutrition sources, etc.

1 1.3 OBJECTIVES

Independently, and not as an agent of the Government, and in accordance with the terms set forth herein, the Contractor, shall furnish all services, facilities, qualified professional, technical, administrative or clerical personnel as well as materials, equipment (other than those furnished by the Government as specified herein), needed to perform the work set forth below:

• Management and support of the NTP Archives (Ref SOW 2.1)

• Management and support of the NTP Frozen Tissue Bank (Ref SOW 2.1)

• Management and support of the NIEHS Data and Specimen Repository (Ref SOW 2.2)

The Contractor shall store, manage, distribute and maintain data, materials, and biological and environmental samples of the NTP Archives and Frozen Tissue Bank (FTB), and from a variety of NIEHS DTT- and DIR-conducted research studies. The Contractor shall maintain current knowledge of state-of-the-art technologies related to the requirement and recommend best practices to the Contracting Officer Representatives (CORs). The Contractor shall develop a complete set of Standard Operating Procedures (SOPs) for all defined tasks and procedures specific for this contract. Prior to use, SOPs must be reviewed and approved by the CORs.

To facilitate feedback to DTT and DIR research programs and ensure that project needs are clearly understood and being achieved by the Contractor, it is essential to have regular interactions between the Contractor and NIEHS staff. The Contractor staff shall meet regularly with the CORs and attend meetings with DTT, DIR, and other contractor staff and investigators as needed to discuss the state of the contract, project conduct, status, and any issues that have the potential to affect the functioning of the contract.

The Contractor shall conduct tasks for administration of this contract, including, but not limited to, the provision of cost estimates for all assignments, milestone schedules, and monthly, quarterly, and annual reports, or other required reports and deliverables.

1.1. Period of Performance

The Period of Performance shall be for one (1) Base Period of 12-months, four (4) 12-month Option Periods.

1.2. Information Technology

The contractor shall follow all IT Security guidelines for NIEHS, NIH and HHS, as specified in Section TBD of the contract.

2.0 REQUIREMENTS

1.3. Place of Performance

The Contractor shall establish and maintain all required offices, equipment, laboratory and technical facilities (hereafter collectively referred to as “the facility” or “the facilities”) within a 25-mile drive of the main campus of the NIEHS located at 111 TW Alexander Drive, Research Triangle Park NC 27709, for the duration of the contract performance period for the following reasons:

1. The 25-mile drive geographic restriction enables timely and economical transfer of labile biological and environmental samples, and limits the time spent by personnel traveling between NIEHS, the Archives, FTB, Repository, and other contractor sites, thus allowing the Government to save money in travel and shipping costs, and to better safeguard samples and materials from damage or loss. Original histological slides and paraffin blocks, as well as original data and specimens, are irreplaceable. Ensuring that these materials are not lost or damaged is essential and of primary concern.

2. The requirements of the contract necessitate that the Contractor make frequent daily courier service trips to the NIEHS and to other nearby support contractor sites to deliver and pickup tissue samples preserved and stored in formalin, histological slides and slide sets, paraffin-embedded tissue blocks, pathology reports and records, primary data, other specimens, and materials. Other support contractors with NIEHS are also required to make frequent, daily courier service trips to the Archives, FTB, and Repository. The Contractor Project Director, and Key and Critical Staff shall have frequent, in-person meetings and occasional site visits with the CORs, NIEHS staff, and other support contractor staff to review repository materials receipt, retrieval, distribution, and disposal projects; queue and timeline; pathology data and materials related to the Pathology Peer Review process; and to discuss project progress, issues, and problems that can have an impact on the contract requirements. These meetings may occur on short notice to meet critical deadlines.

The facilities must be fully operational and ready to initiate transition activities by the date of contract award. All facilities shall be subject to approval by the CO as to suitability and adequacy.

1.4. Applicable Documents/Links

• DTT Study Types - https://ntp.niehs.nih.gov/go/type, (Ref SOW 1.1)

• Toxicity and Carcinogenicity Specifications; Jan 2011.

https://ntp.niehs.nih.gov/ntp/test_info/finalntp_toxcarspecsjan2011.pdf

• Reproductive and Developmental Toxicity Specifications; May 2011 https://ntp.niehs.nih.gov/ntp/test_info/finalntp_reprospecsmay2011_508.pdf

• Immunotoxicity Study Pathology Specifications; Oct 2016

2016Specifications[https://ntp.niehs.nih.gov/ntp/htdocs/levels/finalntpitoxspecs_508.pdf]

• New bag labeling https://ntp.niehs.nih.gov/ntp/test_info/finalntp_toxcarspecsjan2011.pdf(Ref

SOW 2.1.2.2.3)

• New bag labeling https://ntp.niehs.nih.gov/ntp/test_info/finalntp_reprospecsmay2011_508.pdf, (Ref SOW 2.1.2.2.3)

• NTP (see Appendix TBD) and NIH Office of Management Assessment Chapter 1189

(https://policymanual.nih.gov/1189), (Ref SOW 2.1.2.3.4 and Appendix TBD)

• Chemical Effects in Biological Specimens (CEBS) ( https://tools.niehs.nih.gov/cebs3/ui/), (Ref

SOW 2.1.3.5)

• Provantis (http://www.instem.com/solutions/provantis/), (Ref SOW 2.1.3.5)

2.1 Facility Space Requirements

Space Requirements common to both DTT and DIR The Contractor shall provide a facility with the space to manage and store pathology, biological, and environmental specimens, data, and records in analog/hard copy and electronic/digital formats from past, present, and future in-house and contracted DTT and DIR research, and the NTP Archives and FTB. In addition, the facility requires space for housing and operating digital imaging equipment, and servers for electronic storage of digital images including whole slide scans and other modes of photographic materials. The facility shall allow for expansion of additional storage space as required https://ntp.niehs.nih.gov/ntp/test_info/finalntp_toxcarspecsjan2011.pdf https://ntp.niehs.nih.gov/ntp/test_info/finalntp_reprospecsmay2011_508.pdf https://ntp.niehs.nih.gov/ntp/test_info/finalntp_toxcarspecsjan2011.pdf https://ntp.niehs.nih.gov/ntp/test_info/finalntp_reprospecsmay2011_508.pdf https://policymanual.nih.gov/1189 https://tools.niehs.nih.gov/cebs3/ui/ https://tools.niehs.nih.gov/cebs3/ui/ http://www.instem.com/solutions/provantis/ over the life of the contract (see Attachment TBD). The entire facility shall be equipped with the appropriate state-of-the-art environmental controls for the stored inventory and equipment, to maintain a comfortable range for working personnel when all equipment is operational, smoke detection systems, thermal detection systems, alarms, fire protection, air quality monitoring for chemicals such as formalin, an emergency power source, and back-up systems; these systems shall meet local and state requirements. The Contractor shall arrange the primary storage areas such that different material types and/or collections can be physically separated from each other as required by the CORs, and protected with fire doors and walls, and equipped with a primary automatic fire suppression system with a backup sprinkler system. The Contractor shall secure and control access to the facility.

The Contractor shall provide, over the life of the contract and until such time as the COR authorizes disposal or transfer, proper space for the following:

2.1.1.13 Space for the daily functioning of the Archives and Repository as follows:

2.1.1.6 Space for receipt and temporary holding of materials and records—under the required environmental conditions—until the materials can be inventoried and transferred to the designated storage space according to required archival protocols.

2.1.1.8 Space for temporary holding of materials identified for disposal until the COR has given final approval for the disposal of said material.

2.1.1.13.3 Workspace, separate from the audit rooms, for review of materials, and equipped with microscopes, computer, and rotary-base microfiche reader.

2.1.1.13.4 Appropriate office and laboratory space for personnel required for daily operation of the facility.

NTP/DTT-Specific Space Requirements (Additional DIR-Specific Space Requirements are detailed in Section TBD)

2.1.1.1 Histologic Slide Archive—existing and future histological glass slides stored separately from other materials.

2.1.1.2 Paraffin Embedded Tissue Block Archive—existing and future paraffin blocks contained in standardized cartons of uniform size and stored separately from other materials.

2.1.1.3 NTP Wet Tissue Archive—existing and future formalin-fixed tissues contained in heat-sealed plastic bags packaged in plastic-lined cardboard boxes of a specified uniform size, and stored separately from other materials.

2.1.1.4 NTP Analog (Paper) Data Archive—existing paper records, stored separately from other materials.

2.1.1.5 Physical Data Media Archive—CDs/DVDs, microfiche, film negatives, prints, and film slides, stored separately from other materials.

2.1.1.1 NTP Frozen Tissue Bank—existing and future non-human biological samples stored separately from other materials.

2.1.1.2

2.1.1.7 DTT Data and Specimen Repository—Study materials and samples from in-house/intramural DTT research studies, stored separately from NTP Archive materials. See Repository Section TBD.

2.1.1.10 Laboratory space with one or more microscope system(s) to allow NIEHS, Contractor and/or visiting pathologists/staff (as approved by the COR) to view wet tissues, film, glass slides, and digital images, and to scan histologic slides and/or to capture digital images of tissues. Appropriate environmentally controlled space to house and operate up to three (3) digital imaging systems (including one existing Hamamatsu 360 scan scope), with high-speed LAN connection to the image processing server.

2.1.1.12 Computer equipment for management, maintenance, and support of an image management system and an associated Web-accessible digital electronic database for archiving of digital image data files and associated metadata, and managing the access, review, and downloading of said data. The Contractor shall propose upgrades to the space recommendations, firewall system, power equipment, computer hardware, and storage equipment to handle current and future needs of the Program, and to remain in compliance with current state and local safety codes.

Expectations for this space should match or exceed the following specifications:

2.1.1.12.1 A firewall system with a high-speed, fiber optic internet connection of no less than 65 Mbps synchronous band width. A secure website with SSL certification for access to the DTT Image Database is also required.

2.1.1.12.2 An equipment room for housing computer hardware equipped with a backup generator with a 120V and 20-amp outlet, and a 3-ton HVAC system capable of maintaining an ambient temperature of 70°F.

2.1.1.12.3 The equipment room shall house two or more racking systems (measuring approximately 84"h x 24"w x 40"d) containing four 1U rack-mount servers, one (1) web server, 5 image database servers, one image processing server, and six storage nodes (one of which is used as a backup). All equipment shall be connected to large, uninterruptible power supply/supplies which provides clean voltage and temporary power in cases of power outages until the backup generator engages. A KVM interface, monitor, keyboard, and mouse are needed to manage the rack-mount servers and firewall.

2.1.1.12.4 A separate room located in the same facili ty behind a 1-hour rated fire wall and equipped with a backup generator with a 120V and 20-amp outlet, and an HVAC system capable of maintaining an ambient temperature of 70°F is also required. The room shall contain additional backup storage nodes and an uninterruptible power supply for clean voltage and to provide temporary power in cases of power outages until backup generator engages.

2.1.1.12.5 All spaces shall be adequate to accommodate anticipated expansion of this system during the contract period including additional racking, servers, and backup storage nodes. The required storage capacity is 22 Terabytes (TB) of images with backup capacity to add 12 TB of additional images. Over five years, it is expected that storage capacity will increase to 45-60 TB with backup capacity of 90 - 120 TB.

2.1.1.13.1 Adequate space to comfortably accommodate DTT officials, auditors, and support contractors who will use the Archives almost on a daily basis, and for outside parties who require use of the Archives.

2.1.2 Support Requirements

Support Requirements Common to NTP Archives, FTB, and NIEHS Repository:

The Contractor shall assume management of existing inventory and records in the NTP Archives, FTB, and NIEHS Repository. Appendix TBD provides information about current holdings. (For proposal purposes, refer to Attachment TBD—“Additional Business Proposal Instructions” which provides information about anticipated rate of expansion of collections).

The Contractor shall provide all aspects of materials management according to best practices and industry standards, handling and storing all materials under best conditions as to preserve the integrity and value of the materials. The Contractor shall provide the following:

2.1.2 Staff Availability Requirement—The Contractor shall provide an appropriate level of staffing during core hours of 8:00am—5:00pm eastern time during regular work weekdays, as well as appropriate on-call staff 24 hours per day to respond immediately to power outages, equipment failures and other emergencies.

2.2.1.1 Maintain secure, current, computerized inventory records of samples and materials submitted to the Repository, in specified order for filing or storage, in such a manner that records and materials can be easily located within 24 hours of a request and retrieved. The computer and database system(s) shall be utilized solely for NTP Archives, FTB, and NIEHS Repository activities.

2.2.1.2 Recommend, establish, and implement inventory system(s) where none exists.

2.2.1.4 Provide secure access to the inventory reports to the COR, and authorized users as designated by COR in writing (email), for purposes of reviewing the status of data and specimens.

2.1.8.6 Maintain and operate cold-storage equipment to appropriately store biological and environmental samples, and all other associated equipment necessary to cover a range of storage temperatures including climate-controlled ambient, 4°C (±10°C), -20°C (±10°C), -80°C (±10°C), and -190°C (liquid nitrogen vapor phase; ±20°C).

2.1.8.7 To safeguard the integrity of the stored materials, the contractor shall maintain the appropriate standby/backup cold-storage equipment (refrigerators and freezers), coolant supply, and electrical power equipment (e.g. diesel generator) for use in the event of a loss of electrical power or refrigeration capacity of any area of the FTB. The Contractor shall provide data regarding failures, and appropriate backup freezer requirements.

2.1.8.8 Maintain storage units in good working order and provide for preventive maintenance and prompt repair/replacement of malfunctioning equipment.

2.1.8.9 Propose a lifecycle schedule for upgrades, modifications, or replacements of the existing storage equipment to meet current and future needs.

2.1.2.1 Manage and provide the transfer, acceptance, unique identification, inventory tracking, barcoding, storage, retrieval, distribution and disposal of materials and data from and for the NTP Archives, FTB, and DTT and DIR in-house and contracted research in a manner such that the materials can be readily located and retrieved, and that preserves the integrity, safety and security of the materials and data. The Contractor shall notify the COR via email in the event of the following:

2.1.2.2.1 Detection of omissions/discrepancies in materials and information submitted, subsequent to receipt and inventory.

2.1.2.2.2 Identification of materials that are poorly organized or packaged in a manner that does not meet the contracted requirements. The COR may direct the Contractor to return improperly organized or packaged materials to the sender or instruct the Contractor to make necessary corrections.

2.1.2.2.3 Identification of damaged material. The COR may direct the Contractor to return damaged materials to the sender, or to repackage for storage according to DTT Specifications per e-mail approval from the COR. For example, if a bag containing formalin-fixed, wet tissues is found to be leaking, the Contractor shall re-bag the material in thermally sealed double bags suitable for storage, taking care to preserve the old label. If it is not possible to preserve the old label, the Contractor shall create a new bag label in accordance with current DTT specifications found at the websites listed below or any updated/revised DTT specifications published during the lifetime of the contract:

https://ntp.niehs.nih.gov/ntp/test_info/finalntp_toxcarspecsjan2011.pdf https://ntp.niehs.nih.gov/ntp/test_info/finalntp_reprospecsmay2011_508.pdf

2.2.2.1 Maintain appropriate security measures to protect the confidentiality and privacy of all human subjects data in accordance with Privacy Act requirements; conduct, document and ensure proper training for and provide oversight of all who will handle data, records, and samples; provide contract staff with required and applicable safety, certification, privacy and ethics training with regard to human subjects data and samples, Health Insurance Portability and Accountability Act (HIPAA) issues, good practices and standard operating procedures for safe handling of personal and private information, and biological and environmental specimens.

Provide documentation of required training and experience for Contractor staff.

2.2.2.5 Coordinate and manage distribution of materials including documenting NIEHS investigators’ requests, providing required forms and assistance to investigators, and distributing materials to requestor or designee within the time specified by the COR in writing (e-mail).

2.1.2.3.2 When materials and/or data are loaned or transferred to individuals outside of the DTT or DIR, the Contractor shall inventory the materials before sending out and re-inventory any materials returned. Any discrepancies shall be reported via email to the COR.

2.2.2.2 Adhere to all regulations and requirements concerning the transportation, handling, privacy, storage, and disposal of biological and environmental samples, particularly etiologic agents. Handle, store, and transport materials in a manner that prevents contamination and https://ntp.niehs.nih.gov/ntp/test_info/finalntp_toxcarspecsjan2011.pdf https://ntp.niehs.nih.gov/ntp/test_info/finalntp_reprospecsmay2011_508.pdf degradation, using sterile techniques and universal standard precautions according to industry standard Health and Safety guidelines, such as OSHA Blood-borne Pathogens Standard, CDC Biosafety Levels (BSL), and according to the Privacy Act, 5 U.S.C. Subsection (e).

2.2.2.3 Ensure that all proper packaging procedures are followed and documented, and respond to questions from governmental agencies regarding sample shipments.

2.2.2.6 Coordinate the disposal of materials as directed by the COR in writing (email) and in accordance with guidelines set forth by the contract (see Appendix TBD) and NIH Office of Management Assessment Policy (Chapter 1189). The Contractor shall not transfer any study materials for disposal without written approval from the COR. A formal notice must be signed by the NIEHS/DTT Director prior to disposal of any NTP Archive and FTB materials.

2.2.2.7 The Contractor shall not store radioactive materials or samples requiring higher than

BSL-2.

2.1.2.3 The contractor shall use secure, integrated, computerized data management systems to allow detailed tracking (unique identification, receipt, inventory, storage, retrieval, distribution, and disposal) of the samples and materials, and provide controlled and limited web-based access to authorized users of the inventory systems.The contractor shall:

2.1.2.3.1 Use Government approved computer-based inventory management systems (e.g., Archives Retrieval Management System, Biospecimen Inventory System, Freezerworks) to maintain and update inventory records of all materials with regard to identification, location, status, transfers, and disposal. The inventory system shall provide sample identification that is unique (no two samples can share the same identification number), handle barcode identified samples, and able to integrate electronic records of other electronically stored inventory data. The inventory system shall support computerized searches based on associated records fields. The inventory system shall be compatible with PC or MAC computer systems so that searches and inventory lists can be electronically accessed.

2.1.2.3.3 Maintain records of all loaned materials to allow recall of materials not returned on time. Information maintained includes, but is not limited to, the type(s) of materials loaned, requesting individual’s name, date of request, date of transfer, date of scheduled return, etc. The COR shall be notified by email if the materials are not returned on schedule.

2.1.2.3.5 Retain records of all persons who visit the facility. These records shall include name, affiliation, reason for visit, date, and time of the visit. This information shall be https://policymanual.nih.gov/1189 included in the quarterly reports to the COR. Visits from persons not affiliated with NIEHS require prior approval by the COR.

2.1.2.3.6 Provide histology support to repair damaged study slides or slides not optimally prepared, for trimming wet tissues, processing and preparing tissues for histology, and preparing slides for microscopic examination including selected special staining procedures.

2.1.2.3.7 Provide clerical support for all Archives, FTB, and Repository activities including generation of reports.

2.1.3 Support Requirements Specific to both NTP/DTT Pathology Data Coordination Unit

The Contractor shall provide personnel to support a central distribution/transfer point for coordinating the flow of materials and data from DTT in-house studies, to and from the Archives. This requirement may require personnel to be on-site at NIEHS. The Data Coordination Unit (DCU) maintains the status of pathology data and specimens from NTP and DTT contracted work. This requirement includes tracking the flow of pathology and associated data from the testing laboratories to the Archives, and facilitating distribution through each of the pathology data review processes that lead to publication of a technical report or other DTT publication. Specific requirements include the following functions:

2.1.3.1 Coordinate and manage the flow and distribution and receipt of materials and data to and from DTT pathology support contract laboratories, DTT pathologists, and other staff. This function shall include maintaining records for the materials disbursed or on loan from the DTT Archives to DTT and DIR scientists within a time specified by the COR in writing. When approved by COR in writing, distribute DTT materials and data to facilities and individuals outside of the DTT for research purposes. Disbursed materials may include—

• Formalin fixed wet tissue

• Paraffin embedded tissue blocks

• Histology slides

• Original individual animal pathology data

• Relevant correspondence

• Computer generated data

• Reports related to Pathology Peer Review

- Audit of Pathology Specimen Reports

- Pathology Data Review (PDR) Reports

- Quality Assessment (QA) Reports

- QA Reconcilliation Reports

- Pathology Working Group (PWG) Reports

• Audit Reports

• Various laboratory and support contractor reports generated during the conduct of DTT Pathology Peer Review process.

2.1.3.3 Assist designated DTT staff in managing and coordinating the various aspects of Pathology Peer Review for studies:

• All activities related to Audit of Pathology Specimens

• Pathology Data Reviews

• Pathology Quality Assessment and discrepancy review and/or reconcilliation

• Pathology Working Group reviews

• Pathology data management, correction, verification

• Update and audit of pathology data

• Electronic and hard copy (if requested) distribution/routing of summary tables and reports of the above.

This function shall also include coordinating the meeting support logistics associated with preparing for in-person and virtual Pathology Peer Review meetings (usually at NIEHS) including scheduling meetings, reserving the meeting room, arranging and hosting virtual meeting invitations, providing access to digital whole-slide scans, registering visitors, preparing hard copy and electronic participants attendance documents (signature page), setting up microscopes, etc.

2.1.3.4 The Contractor shallpopulate, and maintain appropriate tracking data for each study under Pathology Peer Review using a NIEHS/DTT provided database or program management software. This data shall include, but not be limited to scheduling and tracking the status of the various aspects of the Pathology Peer Review process that includes the draft/final versions of the reports, memos, email communications, etc. This function shall also include inventory and distribution of pathology records and organizing records chronologically for transfer to the DTT Archives and other related duties.

2.1.3.5 Access and utilize online integrated electronic databases including Chemical Effects in Biological Specimens (CEBS), Provantis, Slide Review Module (SRM), and other DTT internal tracking systems to perform the following critical tasks: create and/or generate pathology tables from CEBS, Provantis and SRM; store, update, and upload draft, preliminary, and approved final versions of the study reports, pathology data tables and other pertinent toxicology and pathology data. The Contractor shall routinely distribute electronic reports (or https://tools.niehs.nih.gov/cebs3/ui/ https://tools.niehs.nih.gov/cebs3/ui/ printed as needed) from these systems to DTT staff and contractors working on the preparation of government Technical Reports and related publications.

2.1.3.6 As needed, assist DTT pathologists and scientists in locating and retrieving data stored in online integrated databases such as NELI, CEBS, and Provantis. Coordinate receipt of unaudited clinical pathology data for DTT toxicology and carcinogenicity studies. This includes responding to searches for material as pertain to Freedom of Information Act requests in a timely manner.

2.1.3.7 Perform clinical pathology tasks including—

2.1.3.7.1 Review blood and bone marrow smears for acceptability of identification, preparation, and staining.

2.1.3.7.2 Provide Quality Assessment audits of Clinical Chemistry and Hematology data submitted from DTT contract study laboratories and to in-house investigators to assure compliance with Good Laboratory Practices.

2.1.3.7.3 Assist in the compilation of clinical pathology data for rats and mice based on data from contract laboratories and the NIEHS Clinical Pathology Laboratory.

2.1.3.7.4 Provide monthly and quarterly reports for clinical pathology to summarize all work completed by the CMPB Clinical Pathology Core Laboratory.

2.1.3.7.5 Perform quarterly quality control inspections of the CMPB Clinical Pathology Core Laboratory to assure adherence to established Clinical Pathology Laboratory standards.

2.1.3.7.6 Assist the NIEHS/DTT Clinical Pathology Discipline Leader with special tracking, developing clinical pathology SOPs and researching pricing for acquisitions of reagents and supplies.

2.1.4 Optical and Digital Imaging

The Contractor shall provide the following services and support as required:

2.1.4.1 Capture digital images of lesions and other areas of interest from DTT and NIEHS studies for use in various technical reports, project reports, and scientific publications from digital whole-slide scans or using state-of-the-art photomicroscope and associated computer hardware and software. The Contractor shall assist pathologists in identifying lesions and salient features of the lesions to capture, selecting the proper field/magnification to demonstrate these lesions, capturing digital color images of the identified lesions, and preparing suitable legends for the photographs. Typically, lesions shall be captured to demonstrate morphologic features at low, medium, and high magnifications and at varying orientations. New equipment and associated computer systems and software are anticipated during the term of this contract.

The Contractor shall maintain current knowledge of state-of-the-art technologies related to this requirement and recommend upgrades and/or replacements to the COR that would enhance capabilities/functionality when requested or as needed.

2.1.4.2 Capture digital whole-slide scans of histologic tissue sections mounted on glass slides using furnished, state-of the-art, high-speed, high-precision, high resolution scanning equipment and associated software. This function shall include establishing the appropriate metadata and annotations for identification of each scan to facilitate archiving and storage in an image database. The current equipment includes a high throughput whole-slide scanner (Hamamatsu NanoZoomer S360 Digiital Slide Scanner, Hamamatsu Corporation) and associated computer equipment and software. New whole-slide scanning equipment and associated computer systems and software are anticipated during the term of this contract. The Contractor shall maintain current knowledge of state-of-the-art technologies related to this requirement and recommend upgrades and/or replacements to the COR that would enhance capabilities/functionality when requested or as needed.

2.1.4.3 Propose/recommend a state-of-the-art, robotic telepathology/cytology system to facilitate remote, web-based real-time pathology for the purposes of diagnostic consultations, education and research.

2.1.4.4 Adjust digital images for inclusion in presentations, publications, posters, or other purposes using government furnished image editing graphics software. This task shall be restricted to adjusting the quality (contrast, brightness, sharpness, size) of the images as appropriate for publication of selected areas of interest in government technical reports or scientific journals; for presentation in PowerPoint or poster at internal and external scientific meetings; and review of selected lesions or areas of interest by pathologists in preparation for and presentation at Pathology Working Group meetings.

2.1.4.5 Manage and maintain currently stored film slides, photographic prints, and corresponding negatives of gross and histopathologic lesions. On a continuing basis and as directed by the COR, retrieve and convert film slides to digital electronic format (ex. TIFF, JPEG) and transfer the digital images to the digital image database management system for storage.

2.1.5 Digital Image Database Management

2.1.5.1 Manage and maintain an existing Web-based, web-accessible digital electronic system and database (Proscia Inc. Contentriq® DX) for efficient archiving (inventory, cataloging, storage, management) of all formats of image files such that they can be readily identified and retrieved for use. This requirement shall also include managing the access, review, and downloading of a broad range of digital image data sets, files, and collateral documents pertaining to DTT and NIEHS studies. The database shall support several image and file formats including JPEG, TIFF, SVS, PNG, PPT, and DOC/DOCX. The Government shall furnish computer hardware and software for these tasks. The Contractor shall maintain current knowledge of state-of-the-art technologies related to this requirement, and recommend upgrades and/or replacements to the COR that would enhance capabilities/functionality when requested or as needed. This modalities shall also include magnetic resonance imaging (MRI), MR histology, micro computerized tomography (micro-CT), micro-PET, ultrasound, etc.

2.1.5.4 Provide secure network connectivity with high speed access to the image database and digital image files from anywhere in the world. The connectivity shall be independent of the existing NIH/NIEHS network. Services shall be compliant with Federal Information Security Management Act Certification and accreditation requirements.

2.1.5.5 Manage and support user access to the images, data sets, and collateral documents from multiple sites with commonly used personal computers and modes of internet access. At the direction by email of the COR, the Contractor shall grant and control access to the database.

This function shall also include user training to access still images, whole slide scans, and collateral metadata and documents. The COR and DTT/NIEHS pathology staff shall have complete access to the database for the purposes of reviewing and downloading images and files. The Contractor shall propose how this requirement is best achieved.

2.1.5.6 The Contractor shall propose how the image management system can be organized to facilitate secure, limited, direct public search and download access to the image database independent of the database administrators, for purposes of reviewing and downloading stored images and files.

2.1.5.7 The Contractor shall propose a schedule for upgrades/modifications or replacement of the current image management system and software to meet current and future needs. The contractor shall propose contingency plans to manage possible disruption of services.

2.1.6 Graphics Support

Provide graphics support for DTT/NIEHS pathologists for design of 2D or 3D schematics, illustrations and animations, e.g., to depict animals, organs, tissues, cells, cellular organelles and processes and procedures that can be used in scientific posters, publications and presentations, and for training.

2.1.7 Technical and Professional Pathology Support

2.1.7.1 Provide professional and technical pathology support and consultation for program and contractor pathologists, toxicologists, and other program staff to address specific pathology issues by review of pathology data, performing histopathological evaluations and examination of tissue specimens stored in the Archives. This may include, but is not limited to, major retrospective reviews of specific lesions to establish diagnostic criteria, and to verify the accuracy and appropriateness of previously made diagnoses from DTT studies.

2.1.7.2 Provide professional pathology support to perform a variety of histopathological evaluations of tissues from NIEHS in-house research programs.

2.1.7.3 Provide professional and technical pathology support for the developme nt and generation of DTT Global Toxicologic Pathology Training Program educational modules to address current issues, directives, findings, educational needs and methods of importance to the DTT. This may include, but is not limited to, creating training module PPT presentations, capturing gross and histologic images, annotating images to illustrate structural and diagnostic features, and identifying and including additional relevant information to the module, with a focus towards a trainee audience. These materials may also be used to prepare pathology atlases and the development of workshops and symposia. The scope for these modules shall be determined by the COR in consultation with pathologists of the CMPB.

2.1.7.4 Provide support for the publication and presentation of histopathological images, diagnostic criteria, nomenclature, and pathology methods followed by the DTT, and to establish instructional information on pathology endpoints in written publications electronically on web accessible sites in support of the mission of NIEHS/DTT.

2.1.7.5 Provide trained and experienced personnel onsite at NIEHS when requested by the COR. This requirement shall include pathologists, research associates or technical staff.

2.1.8.5 Provide technical support (including training for contract laboratory staff) for harvesting frozen samples at the site of origin (DTT and NIEHS contract testing laboratories, and NIEHS research laboratories) when requested by the COR via email.

2.1.8.11 Provide a B.S. or Master’s degree level research associate, either at the Archives or onsite at NIEHS, with experience in basic molecular biology techniques such as nucleic acid extraction protocols using various assays including PCR, and library construction for next generation sequencing studies using frozen or formalin-fixed paraffin-embedded tissues.

2.2 Option A: Rapid Addition of Data and/or Specimens

In addition to the predictable steady-state expansion of collections maintained in the Archives/ FTB and Repository, the Government may require increased resources and space for the addition of study materials, environmental and/or biological specimens related to rapidly-deployed large scale research studies, such as from environmental exposures related to disaster response, or related to a general unexpected growth in NIEHS’s needs due to unforeseeable events. To meet this need, Option A may be exercised up to five (5) times during the course of the contract to add additional resources and space to the contract. The Government may approve a location remote from the main facilities if the Contractor demonstrates that the proposed facility is within budget, meets all requirements of the contract, and maintains reasonable convenience and accessibility for NIEHS investigators and other staff.

3.0 DELIVERABLES SCHEDULE

Deliverables for this contract include data, materials and documentation for all activities supported and managed under this contract. See Appendix TBD for additional instruction as referenced in the following schedule:

DELIVERABLE REFERENCE FREQUENCY FORMAT SUBMIT TO

Monthly Technical Progress Report

Appendix

TBD – A.1.

Due on the 15th of month

Electronic TBD

Monthly Budget Summary Report

Appendix

TBD – A.2.

Due on the 15th of month

Electronic - MS Excel spreadsheets

TBD

Annual Fiscal Year Technical Progress Report and Budget Summary Report

Appendix

TBD – A.3.

Due on the 15th of October each year

Electronic TBD

Final Technical Report

Appendix

TBD – A.4.

Due 15 days prior to end of contract

Electronic TBD

Annual Specimen Inventory Report

Appendix

TBD – A.5.

Due per COR request (generally mid- June each year)

Electronic - MS Excel spreadsheets

TBD

Computerized Data Appendix

TBD – B.1.

Due 7 days after completion of activity

Electronic Requesting COR and COR-specified recipients

Study Materials and Documentation

Appendix

TBD – B.2.

Upon request Electronic, hard copy if requested

Requesting COR and COR-specified recipients

Study Specimens Appendix

TBD – B.3.

Individually determined by

COR

Delivered or Shipped

COR-specified recipients

Contract Management Plan

SOW Section

TBD

Draft due at award. Final due within 30 days of award.

Electronic TBD

Continuity of Service / Transition Plan - Initial

SOW Section

TBD

Due 3 days after contract award

Electronic TBD

Continuity of Service / Transition Plan - Closing

SOW Section

TBD

Due 8 months prior to contract expiration

Electronic TBD

IT Security Plan and other IT Related Deliverables

SOW Section

TBD

See SOW Section 9.0

Electronic TBD

Annual Section 508 Compliance Report

SOW Section

TBD

Due 30 days after PoP end

Electronic TBD

Work Request Estimates and Closeout Records

Appendix

TBD – B.5.

Due 3 days after receipt of a new Work Request and 5 days after completion.

Electronic Requesting COR and COR-specified recipients

4.0 MEETINGS

The contractor agrees to attend any post award conferences convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The Contracting Officer, Contracting Officer’s Representative, and other government personnel, as appropriate, may meet periodically (by telephone, teleconference or in person at the place of performance) with the contractor to review the contractor’s performance. These meetings will be at no additional cost to the government.

5.0 TRAVEL REQUIREMENTS

Travel for other than the Project Director, Managers, or Coordinators is not likely to be required. The Project Director, or other staff, shall attend meetings with collaborators/consultants when their expertise is needed on requirement-related issues. Travel costs pertaining to the requirement shall be covered by the Contract. The Government will not provide travel funds or reimbursement associated with attending any professional meetings or training workshops for Contract employees, without prior COR and CO approval.

6.0 FACILITIES/EQUIPMENT/GOVERNMENT FURNISHED PROPERTY

6.1 Facilities/Equipment: The Contractor shall provide all facilities and equipment not otherwise provided by the Government. To ensure success and facilitate management, the Contractor shall create and maintain a centralized coordination site for performing and managing requirement activities.

6.2 Government Furnished Property: A list of Government owned property in use on the current contract, which will be transferred to the Contractor, is provided herein. The Contractor shall provide the usual office and laboratory equipment and supplies.

The CO may approve the purchase, under the Contract, of equipment and/or specialized software for the exclusive use on the Contract. All such items will be the property of the U.S.

Government. The Contractor will be responsible for regular proper maintenance and necessary replacement of all Government owned property under the Contract. GFE laptops will be provided to personnel who need access to DTT/NIEHS programs and services such as CEBS, SRM, or similar program that requires an NIH badge to access.

7.0 CONTRACT MANAGEMENT PLAN

The Contractor shall prepare an overall Contract Management Plan that will ensure the successful performance of all contract requirements provided in the SOW. The Plan shall include a description of the proposed technical approach for overall project management and internal controls to ensure the safety and integrity of all aspects of the requirement. A preliminary draft plan shall be submitted with the proposal. A revised plan shall be submitted to the COR at the start of the contract for review and approval. A final approved plan shall be in place within 30 days of contract award. The Plan shall be updated and maintained throughout contract performance period. The Contract Management Plan shall specifically address the following key areas, and demonstrate a clear understanding of the distinction between Archival and Repository functions:

7.1 Schedule Management: Provide a plan which describes and implements a detailed schedule of events for all requirements of the contract, including activities for phase-in and phase-out events. Provide details on how work will be scheduled, how flexibility can be maintained to respond quickly to changes in priorities, and how progress will be monitored to ensure deadlines are met and results achieved.

7.2 Staff Management: Provide a staffing plan which details the mix of labor and level of effort required to accomplish the work. The staffing plan shall specify and describe the following:

• Roles and responsibilities for all personnel, including a chart of the organizational/management structure of the project.

• Planned subcontract and consultant staff and provide details of proposed subcontractors and consultants

• Plan for scheduling and monitoring progress, communication with Contractor, CO, and

COR.

• Management methods to maintain talented staff over the course of the Contract, and to ensure that appropriate procedures are followed for each function and staff are appropriately cross-trained.

• Plan for maintaining core hours and on-call staffing needs.

7.3 Facility Management: Provide a comprehensive plan for management of the facility that provides for the required operations, conduct, security, safety, and monitoring in accordance with NIEHS and NIH requirements.

7.4 Project Management: Provide a plan for the overall approach to coordinating, implementing, and completing the work of the contract, ensuring acceptable performance, monitoring progress, and communicating with the CORs, investigators, other contractors, and other researchers. Describe procedures for competition, selection, and oversight of any proposed subcontractors/consultants. Clearly define how any proposed subcontract/consultant arrangements would meet program needs. Discuss how these arrangements will be structured, organized, managed, and monitored.

7.5 Quality Management: Provide a comprehensive plan for quality control, quality assurance, and compliance, that will implement appropriate quality management procedures for all activities.

8.0 CONTINUITY OF SERVICE/TRANSITION PLAN

The work to be performed under this contract is a continuation of work presently conducted under contract HHSN273201800006C. The continuation of activities under this contract without interruption is critical, and transition planning both at the beginning and at termination are important to the success of the contract.

8.1 Initial Transition: Upon award of the contract, the Contractor shall exercise best efforts and cooperation to ensure the orderly, efficient, and safe transition of all contract activities and materials to the new contract and new facilities, if…