OSIST SOW_12-2025.pdf

Occupational Safety, Policy, and Laboratory Quality Support; Primary Barrier Maintenance and Support; Industrial Hygiene; Information and Data Management Support; and Training Development and Management (OSIST)

STATEMENT OF WORK

BACKGROUND

The Food and Drug Administration (FDA), a component of the U.S. Department of Health and Human Services (HHS), has a broad mission to protect and promote public health through ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food, cosmetics, and radiation-emitting products. To fulfil that mission, FDA facilities, laboratories, and workplaces must operate in ways that guarantee not only product integrity, but also employee and visitor health, workplace safety, and environmental stewardship.

Within FDA, the Office of Occupational Safety and Health (OOSH) under the Office of the Chief Scientist oversees the Agency’s environmental, occupational safety, and health (EOSH) program. The vision of OOSH is “for FDA to serve as a model of excellence for its robust and integrated laboratory science, laboratory security, environmental, and occupational safety and health programs.” Its mission includes ensuring that FDA’s laboratories and workplaces are operated in a safe and secure manner to protect employees, surrounding communities, and the environment; providing occupational health services in a timely manner; supporting high-quality laboratory results; and promoting a culture of shared responsibility and safety.

Industrial hygiene, the science and art of anticipating, recognizing, evaluating, and controlling workplace environmental factors or stresses that may cause illness, impaired health or discomfort, plays a pivotal role in the broader OSH framework. At FDA, industrial hygiene services are embedded within many of the Agency’s laboratory, inspection, and field operations to ensure that chemical, biological, radiological, noise, and other physical hazards are properly assessed, mitigated, and managed.

OSH support, training, and industrial hygiene services at FDA serve to safeguard the workforce and the broader mission by:

• establishing and managing policies, procedures and programs for occupational safety and health;

• providing industrial hygiene expertise (hazard recognition, exposure assessment, control strategies) across laboratory and field environments;

• developing and updating training for FDA personnel including lab-related training and the various hazards that could be encountered in performing job duties;

• ensuring that FDA’s scientific, inspection and regulatory operations comply with relevant legal, regulatory and best-practice standards for worker health and safety;

• promoting a safety culture that values shared responsibility, continuous improvement and proactive hazard control; and

• supporting the integrity and reliability of FDA’s laboratory and inspection work by controlling workplace risks.

FDA Headquarters is located at the Federal Research Center/ White Oak Campus in Silver Spring, Maryland, and it is comprised of 130-acres with several laboratory and administrative buildings.

a) Business Objectives The purpose of this Indefinite-Delivery-Indefinite-Quantity (IDIQ) contract is to obtain support services for the following: development of health and safety-related documents and marketing materials; maintaining and managing primary barrier equipment; providing an array of industrial hygiene services; providing curriculum development and training support pertaining to the Environment and Occupational Safety and Health (EOSH); supporting information management across OOSH; and supporting occupational safety and health initiatives with quality system management interwoven throughout these activities. Examples of support services include: providing technical advice on emerging issues and industrial hygiene best practices to OOSH staff; assisting FDA Centers, Offices, and Programs (COPs) with testing, certification, and repair of their biological safety cabinets, laboratory ventilation hoods, and down draft tables; assisting with validation and recertification of laboratory facilities supporting high-consequence, biological research projects; supporting the operations of the White Oak Radiation Safety Program; and assisting with the development of EOSH training courses, coordination of training to assist with compliance, and management of training records.

b) Scope

The Contractor shall provide technical support in the areas of Occupational Safety, Policy, and Laboratory Quality Support; Primary Barrier Maintenance and Support;

Industrial Hygiene; Information and Data Management Support; and Training Development and Management (referred to throughout as OSIST), to include but not limited to:

1. Initiation and execution of program and project management of the entire

OSIST requirement;

2. Successful transition of new contractor personnel supporting the OSIST requirement;

3. Safety engineering support for renovations, construction, demolitions agency-wide;

4. Industrial Hygiene support for program management, exposure assessment, and emerging issues that is Agency-wide and includes assessments / evaluations of field location requirements;

5. Perform preventative maintenance, repair, certification of primary barrier equipment in the laboratories including those in high-containment laboratories regardless of geographic location;

6. Development and implementation of occupational health and safety trainings and integration of systems that support safety initiatives; and

7. Development and execution of a robust Laboratory Safety, Quality and Security Management Program through communication, and standardization of policies and procedures in all FDA laboratory facilities.

Standards and guidelines that shall be considered in the execution of this IDIQ SOW include:

1. The Contractor shall comply with standards of the Occupational Safety and Health Administration (OSHA) Act of 1970.

a. Additionally, Contractor shall ensure that its Respiratory Protection Program complies with 29 CFR 1910.134.

2. The provision of all support services through this contract are therefore necessary for ongoing compliance with federal, state and local regulations, as well as integrating best practices in design, testing, commissioning and certification of laboratory facilities. In consulting on the design and layout of FDA’s laboratory facilities, the contractor must comply with any FDA required specifications, the National Institutes of Health (NIH) Design Requirements Manual (DRM), the Center for Disease Control (CDC) specifications for bio-lab design, Biosafety in Microbiological and Biomedical Laboratories (BMBL), and Federal Select Agent Program (FSAP) requirements. This list of regulations, policies, and standards is not all inclusive and additional constraints will be specified within individual Task Orders.

3. The Contractor shall comply with NSF/ANSI 49 for certification of biological safety cabinets.

4. The Contractor shall implement all programs and projects in accordance with American National Standards Institute (ANSI) Z-10, “Occupational Health and Safety Management Systems” while integrating other systems (i.e., ISO 9001, ISO 14001) as required and specified.

5. The Contractor shall comply with and ensure work products are aligned with existing Office of Laboratory Science and Safety Directives and Policies.

c) Technical Requirements

The Contractor shall provide occupational safety support and industrial hygiene services throughout the performance period. This will include providing Program and Project

Management Services; Transition Services; Occupational Safety, Policy, and Laboratory Quality Support; Primary Barrier Maintenance and Support; Industrial Hygiene Support Services; Information and Data Management Support; and Training Development and Management at the FDA White Oak Campus and multiple locations throughout the United States.

d) Reporting Requirements The Contractor shall provide a Monthly Status Report (MSR) to the assigned IDIQ Contracting Officer Representative (COR) incorporating all tasks at a high level and their progress. Within the first 30 calendar days after IDIQ award, the Government and the Contractor shall design and agree upon a standard reporting format and timeframe. At a minimum, unless otherwise specified within the individual order, each MSR shall contain the following information:

1. The previous month’s activities (completed and in-progress);

2. Deviation from previous month’s planned progress (either positive or negative);

3. The current month’s planned activities (complete and in-progress);

4. All current risks and planned mitigations;

5. Status of unfilled positions and actions taken to fill open positions;

6. Performance and Cost Report (P&CR): P&CR shall include all recurring and non- recurring costs, cumulative cost, total labor hours, and cumulative labor hours for each task area for the previous month;

7. The status of the action items from any Kickoff Meetings and other follow-on meetings, as appropriate; and The MSR must be submitted via email on the third business day of the month to the IDIQ COR.

PERIOD OF PERFORMANCE

The Government anticipates the award of a five (5) year IDIQ or GSA BPA, with individual FFP/Labor Hour/Time or combination task orders to be issued.

PLACE OF PERFORMANCE

Work performance will be conducted at various FDA laboratory facilities across the U.S.

Specific locations will be provided within each awarded task order. See Attachment for the current laboratories under this requirement. The list may be changed based on mission needs.

DESCRIPTION OF TASK AREAS

The Contractor shall provide Program and Project Management Services; Transition Services;

Occupational Safety, Policy, and Laboratory Quality Support; Primary Barrier Maintenance and Support; Industrial Hygiene Support Services; Information and Data Management Support; and Training Development and Management.

Additionally, the Contractor shall provide both IDIQ-level Program Management services and Order-level Project Management services to establish control, management, monitoring, and notification mechanisms for the OSIST IDIQ requirement. Moreover, the Contractor shall work with the Government Technical Lead (s) (GTL), COR, and Subject Matter Experts (SMEs) to ensure that tasks stay on track and important milestones are met.

Task 1: PROGRAM MANAGEMENT AND ORDER MANAGEMENT

The Contractor shall provide Program Management at the IDIQ level and order Project Management support for the OSIST IDIQ requirement. Program Management and Project Management support services includes: the effort to plan, structure, coordinate, schedule, manage, communicate, report, and steward all respective OSIST support services throughout the IDIQ period of performance. The Contractor shall provide both IDIQ-level Program Management services and order-level Project Management services to establish control, management, monitoring, and notification mechanisms for the IDIQ OSIST requirements.

Additionally, the Contractor shall provide both IDIQ-level Program Management services and Order-level Project Management services to establish control, management, monitoring, and notification mechanisms for the OSIST IDIQ requirement. Moreover, the Contractor shall work with the Government Contracting Officer (CO), GTL, COR, and SMEs to ensure that tasks stay on track and important milestones are met.

i. Program Management Plan (PMP) - The Contractor shall provide a PMP for the IDIQ as a part of any technical submission, as well as being tasked in an individual task order. This plan shall include, but not limited to:

(1) The management approach, staffing plan, and organizational chart identifying relationships, authorities, and responsibilities to be used to meet the IDIQ requirements throughout the contract’s period of performance;

(2) The process to oversee and manage work activities at the IDIQ level;

(3) The process to recruit, train, retain, and replace personnel at the IDIQ level; and

(4) A communication diagram illustrating all lines of communication between the

Government and the Contractor.

ii. Project Meetings - The Contractor shall participate in meetings and discussions that support the overall efforts the IDIQ requirement and the order work activities (e.g. kick-off and task related meetings). The Contractor shall participate in different capacities, such as leading discussions; contributing questions and answers; raising issues, risks and concerns; and developing and giving presentations. The Contractor shall prepare, and track meeting agendas, minutes, issues, risks, and action items as requested by the Government. Meeting minutes shall be of sufficient detail to accurately document meeting date and location, meeting purpose, items discussed, decisions made, attendees, and action items. Representative activities include, but are not limited to:

1. Coordinating quarterly project meetings to plan, strategize, and execute all programs and projects;

2. Preparing and distributing agendas to include call-in/teleconference information and review materials;

3. Completing and distributing meeting minutes and action items to meeting participants; and

4. Tracking of meeting minutes, action items, and associated materials relating to all meetings / calls.

iii. Risk Management - The Contractor shall identify, report, and address for resolution to the Government any issues that prevent the Contractor from performing the work activities in any individual order that the Contractor is unable to resolve independently. For each individual order, the Contractor shall document and report the risks and opportunities within a risk registry. The Contractor shall maintain the risk registry and provide it to the assigned IDIQ COR, CS, and CO on request. The risk registry shall contain, at a minimum, unless otherwise specified in the individual orders:

• Issue Number: a sequential numbering of all issues;

• Severity: assessment of issue severity i.e., likelihood and consequences

(High/Medium/Low)

• Date Found: – date that issue was identified by the Contractor;

• Duration: number of days that issue has been open;

• Status: representing issue status as open or closed. The Contractor shall maintain a complete list of all issues – no issues should typically be deleted from the Contractor’s delivered list;

• Title: short description of issue;

• Updated: date for updated status;

• Details: narrative description of activities that have been completed to resolve issue;

• Assigned To: identify Government Point of Contact (POC) or Contractor that is assigned to resolve the issue; and

• Solution or Workaround: description of the actions and activities taken to resolve or mitigate the issue.

Task 2: TRANSITION OF SERVICE - Transition activities take place to efficiently transition all activities to the new IDIQ Contractor. As tasked, the Contractor shall develop transition–in and transition-out plans and conduct transition activities for orders issued against this IDIQ vehicle.

Transition-In As specified within the individual order, the Contractor shall transition-in and assume the responsibility for activities and duties in a manner that does not interrupt or negatively impact FDA’s provisioning of OSIST operations. The purpose of the Transition-in requirement is to provide an orderly transition to the IDIQ Contractor.

For a period of time, as specified by the individual order, the Contractor shall work with the Government to ensure a smooth transition of work from the current service providers to the IDIQ Contractor.

Representative activities include, but are not limited to:

1. Developing a Transition-in Plan to ensure full operating accountability and responsibility of the individual order;

2. Conducting and coordinating all on-boarding activities, to include the badging for team personnel;

3. Reviewing objectives, processes, and requirements as related to the tasks and activities being performed;

4. Participating in Transition-in meetings (initially to be held jointly with the current service providers);

5. Participating in other information exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the current service providers;

6. Ensuring Contractor personnel are available to work immediately after IDIQ individual order award;

7. Certifying that employees working on the contract have completed a review of FDA and OSIST policies and understand the requirements, documentation, and processes prior to the completion of the Transition-in activities.; and

8. Verifying to the COR that all the Transition-in documents are available.

Transition-out As specified within the individual order, the Contractor shall conduct the transition-out of contracted activities and services to a follow-on Contractor by the end of the contract period of performance. If a follow-on Contractor has not been identified, the Contractor shall transition contracted activities and services to the FDA.

As specified by the individual order, the Contractor shall conduct transition-out activities. During this period, the Contractor shall ensure no degradation in support services provided under the order. Between the turnover date designated by the COR and the end of the contract period of performance, the outgoing Contractor shall ensure all order activities are closed out and it shall provide sustainment support to complete the transition.

Representative activities include, but are not limited to:

1. Developing and submitting a Transition-Out Plan and Schedule to the COR;

2. Providing the FDA with current versions of all documentation developed (e.g.

Standard Operating Procedures [SOPs] and Manual of Operations);

3. Providing the FDA with a current inventory of all Government-Furnished Equipment (GFE) and Government Furnished Information (GFI) utilized by the Contractor along with full support in the reconciliation of this inventory; and return to FDA all GFE that has not been transferred to the follow-on Contractor.

4. Providing the follow-on Contractor with the ability to “shadow” and participate in technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor.

Task 3: OCCUPATIONAL SAFETY, POLICY, AND LABORATORY QUALITY SUPPORT-The Office of Occupational Safety and Health (OOSH) oversees all aspects of occupational health and safety at the FDA and drafts policy and procedures to provide a framework for standards and best practices. In addition, OOSH provides leadership in the adoption of laboratory quality elements.

Representative tasks in this area may include, but are not limited to:

1. Assist with implementation of resources and guidance interpreting internationally recognized standards for safety and quality management in the laboratory through compliance with established FDA quality management documents and industry-wide quality systems (ISO 17025);

2. Assist in the development and implementation of a “culture of safety” survey to assess the FDA landscape and compile responses for analysis, recommendations and conclusions;

3. Provide program support to the Institutional Biosafety Committee, the Radiation Safety Committee Meeting, and the Council on Radiation Safety, as well as other related meetings pertaining to chemical, radiological, physical, and biological safety;

4. In supporting committee meetings, provide technical administrative support and coordination to ensure, but not limited to, the timely and robust review of applications by committee members, verifying quorums are met, securing conference rooms, etc.

5. Develop and update occupational safety and health manuals, guides, templates and surveillance program documents;

6. Develop and revise risk assessment workflows pertaining to chemical, biological, radiological, and physical hazards;

7. Assist with inspections and audits of FDA laboratories to include biological and chemical laboratories as well as audits and surveys to support the radiation safety program (e.g., machine-produced radiation and NRC licensed radioactive material programs);

8. Assist with facilitating, developing, and publishing digital display advertisements

(DDAs); graphic design capabilities are required using professional software such as Adobe Photoshop, Adobe IN Design, or Firefly;

9. Design and execute strategic and proactive communication strategies to promote occupational safety and health initiatives at the FDA.

10. Design and develop leadership presentations to communicate the status and future state of OLS programs and their objectives to both internal and external audiences;

11. Assist with the revision of OOSH operating documents including the 5-year Strategic Plan, the Operating Plan, and the Implementation Plan.

12. Facilitate and support outreach initiatives including National Safety Month (currently in June) and National Biosafety Month (currently in October).

13. Coordinate with industrial hygienists to conduct general and local exhaust ventilation studies, indoor air quality studies, and assessments of chemical, biological, and radiological usage and disposal.

14. Consult with laboratory personnel, OSHOs, and engineering staff on design requirements and layout of rooms and docks; general flow of traffic within the lab facility to minimize the exposure to any potential hazards (i.e., radiation, biological agents, compressed gases and chemicals); reviewing the placement of emergency and primary containment equipment; and assisting with engineering support as needed.

15. Coordinate with FDA OFEMS on projects involving new construction and renovations.

Task 4: PRIMARY BARRIER EQUIPMENT MAINTENANCE, TESTING, DECONTAMINATION, AND CERTIFICATION - The Contactor shall support the collection of information and facilitation of communication with all relevant stakeholders including laboratory and operations staff to understand the needs and challenges in relation to primary barrier equipment maintenance and repair.

The Contractor shall coordinate activities between laboratory scientists and maintenance engineering and facility staff (to include OFEMS and GSA).

Representative tasks in this area may include but are not limited to:

1. Conduct an assessment of the Primary Barrier Equipment at various FDA sites;

a. Identify and document Primary Barrier Equipment being employed by the FDA and each item’s certification (and repair) status;

b. Perform a needs analysis to determine the appropriateness of equipment being utilized within the Agency;

c. Test Primary Barrier Equipment to certify or document necessary repairs to achieve certification status; and Recommend equipment for surplus, replacement, or disposal.

2. Perform decontamination services, to include equipment, rooms, laboratories, suites, and corridors;

3. Conduct repair and certification of primary barrier equipment;

4. Develop a repository of all FDA primary barrier equipment that is repaired, tested and/or certified to account for all units and their functional state for access by FDA personnel for the purpose of monitoring equipment status and identifying equipment for transfer, surplus, etc., as needed.

Proactively monitor equipment certification expiration dates to ensure all certified equipment remains compliant;

5. Primary Barrier Equipment may include, but is not limited to:

a. Class I biological safety cabinets;

b. Class II, Type A biological safety cabinets;

c. Class II, Type B biological safety cabinets;

d. Class III biological safety cabinets;

e. Air exhaust, supply plenum, automated/fixed dampers, primary/secondary automation controls;

f. Autoclaves and autoclave vent/vent stack HEPA filters;

g. Vacuum and CO2 system HEPA filters;

h. Magnehelic HEPA equivalent filters;

i. HEPA filtered powered exhaust units (asbestos barrier filters);

j. Laboratory ventilation hoods;

k. Calibration of ventilation hood alarms;

l. Local exhaust ventilation systems (i.e., downdraft tables and sinks, slot hoods, and miscellaneous systems);

6. Laminar flow clean benches; and HEPA filtered animal care modules (e.g., animal racks and turbo units).

Task 5: INDUSTRIAL HYGIENE SUPPORT SERVICES - The Contractor shall serve as an expert in the management of Industrial Hygiene at the enterprise level. The contractor shall serve as an architect of FDA’s enterprise industrial hygiene program that provides strategic leadership and expert consultative industrial hygiene services to FDA’s COPs.

Representative activities include but are not limited to:

1. Draft and develop educational materials, written procedures, templates, plans, forms, and protocols to support the OOSH Industrial Hygiene Program;

2. Draft and develop educational materials, written procedures, templates, plans, forms, and protocols to support all FDA locations/operations to promote and implement an OOSH Industrial Hygiene Program; Apply relevant occupational safety and health management system requirements to FDA’s enterprise-level industrial hygiene program, including programs, plans, manuals, trainings, curriculums, job aids, checklists, flow charts, guides, posters, and other resources compatible with the American Industrial Hygiene Association’s (AIHA) “A Strategy for Assessing and

Managing Occupational Exposures,” AIHA’s ” Industrial Hygiene and Safety Auditing

- A Manual for Practice,” and ANSI Z-10, “Occupational Safety and Health Management Systems”;

3. Conduct an assessment at FDA laboratories and facilities of industrial hygiene program gaps, exposure assessment and job hazard analysis needs, exposure control deficiencies, and other opportunities for OOSH to improve the practice of industrial hygiene in the field, to include providing a written report summarizing findings at each facility visited, any best practices discovered, and opportunities for OOSH to provide services including, but not limited to, industrial hygiene program support, exposure assessments and job hazard analyses, training, technical assistance in contaminant control;

4. Provide Industrial Hygiene support services at field locations;

5. Coordinate presentations to local managers and FDA’s professional Occupational

Safety and Health staff to promote OOSH’s capabilities to provide industrial hygiene services in the field;

6. Performing ad hoc research and analysis activities, drafting of ad hoc presentations, and designing and developing leadership presentations to communicate the status and future state of OOSH programs and their objectives to both internal and external audiences; and

7. Completing quality assurance for reports, documents, and manuals.

Task 6: INFORMATION AND DATA SYSTEMS PROGRAM SUPPORT - The Contractor shall provide program and project management support to help plan, coordinate, and sustain the information and data systems that support environmental, occupational safety and health, and inventory activities across FDA. The purpose of this task is to ensure that systems are organized, accurate user friendly, and aligned with FDA information technology governance.

At the direction of the Government, the Contractor shall:

1. Program Planning and Coordination

• Work with program leads to identify business needs for databases, inventories, and tracking tools that support OSH programs.

• Develop and maintain project plans, schedules, and status updates for system related activities.

• Coordinate with FDA information technology offices to align activities with agency policies, security requirements, and hosting decisions.

2. Requirements and Process Documentation

• Document current work processes for inventory, certification, training, and other OSH program activities that require data collection.

• Develop user requirements, standard operating procedures, and job aids for each system or tool so that users know how and when to enter data.

• Recommend improvements that simplify data entry and reduce duplication across systems.

3. Data Quality and Inventory Support

• Support the collection, review, and validation of data related to equipment, chemicals, biological materials, radiological materials, lasers, and other managed assets.

• Compare current inventories against existing records and identify gaps or inconsistencies.

• Prepare summary reports for leadership on the status of inventories, records, and compliance items.

4. Transition and Change Management

• Assist with the rollout of new or revised tools, including developing communications, user guidance, and training materials.

• Track user issues and enhancement requests and provide the Government with recommendations for prioritization.

• Support the transfer or adoption of interagency or enterprise databases when directed by the Government.

5. Records and Compliance Support

• Develop or update records management approaches to ensure that equipment certifications, permits, training records, respiratory program records, and chemical hygiene related documents are maintained and easy to retrieve.

• Recommend approaches for a document repository that supports long term program oversight.

Task 7: TRAINING DEVELOPMENT AND MANAGEMENT - Environmental and Occupational Safety and Health (EOSH) Training support services are needed to ensure the protection of all FDA employees and regulatory compliance at the FDA.

The Contractor shall support the development and management of the FDA Safety Training Program. Overall, the support services utilized under this task area will assist OOSH in meeting regulatory training requirements and best practices.

Representative tasks in this area may include, but are not limited to:

Instructor Led Training Coordination and Delivery o Coordinate and host Environmental and Occupational Safety and Health (EOSH) training programs including, but not limited to, HAZWOPER certification training, powered industrial truck operations (including forklifts), hoisting/rigging/crane operations, marine safety, Resource Conservation and Recovery Act (RCRA) compliance, Department of Transportation (DOT), Basic Life Safety (BLS) Training, and other specialized EOSH training as required by FDA operations per regulatory mandates, industry best practices, and organizational safety objectives. Training delivery shall be flexible to accommodate in-person, virtual, or hybrid formats as needed to meet participant requirements and operational constraints.

o Manage training logistics including scheduling, venue coordination, instructor procurement, 508 accessibility compliance reviews, equipment setup, participant registration, and attendance tracking to ensure seamless delivery of all training programs across multiple delivery formats.

eLearning Development and Maintenance o Develop new eLearning training modules per regulatory mandates, industry best practices, and organizational safety objectives, following FDA EOSH Training Program development processes using industry-standard platforms such as Articulate, Lectora, or other approved eLearning authoring software tools to create interactive, engaging, and compliant training content.

o Update and review existing eLearning training content to ensure accuracy, regulatory compliance, and alignment with current FDA EOSH Training Program standards using established FDA EOSH Training Program development processes and approved software platforms.

o Conduct Section 508 accessibility compliance reviews for all eLearning modules, training materials, and digital resources to ensure full accessibility.

Training Resource Development o Create comprehensive training support materials including PDF resource guides, job aids, post-course examination questions, assessment tools, and other resources, as needed, (e.g., graphics and/or videos) that reinforce learning objectives and support knowledge retention.

o Develop training evaluation and feedback mechanisms to assess training effectiveness, participant satisfaction, and knowledge transfer outcomes.

Training Needs Assessment and Analysis o Conduct comprehensive training needs assessments to identify content and skill gaps, current and emerging regulatory requirements, and evolving safety challenges across FDA facilities and operations.

o Perform gap analysis comparing and documenting current training programs against regulatory mandates, industry best practices, and organizational safety objectives to prioritize training development efforts.

Compliance Tracking and Reporting o Maintain comprehensive training records and certification tracking systems to ensure all personnel meet required training standards and regulatory compliance requirements.

o Generate compliance reports and dashboards documenting training completion rates, certification status, renewal schedules, and regulatory adherence for management review and audit purposes.

Emergency Response and Incident-Specific Training o Develop or coordinate/host specialized training programs tailored to specific FDA facility risks, including but not limited to chemical spills, equipment failures, medical emergencies, and facility evacuations.

o Create incident-specific training modules based on lessons learned from actual events, near-misses, and industry incidents to enhance preparedness and prevent recurrence.

o Design scenario-based training exercises including tabletop exercises, drills, and simulations to test emergency response capabilities and identify areas for improvement.

Performance Standards and Metrics o Participate in ongoing performance monitoring and quality assurance oversight by FDA program management to ensure adherence to established quality standards, deliverable requirements, and established timelines.

o Notify FDA program management within 10 business days if deliverables cannot be met according to established timelines and provide proposed updates to timeline and deliverables; provide corrective action plans within 10 business days.

DELIVERABLES

Monthly Status Report (MSR) - The Contractor shall provide a Monthly Status Report (MSR) to the assigned IDIQ Contracting Officer Representative (COR) incorporating all tasks at a high level and their progress:

The previous month’s activities (completed and in-progress);

Deviation from previous month’s planned progress (either positive or negative);

The current month’s planned activities (complete and in-progress);

All current risks and planned mitigations;

Status of unfilled positions and actions taken to fill open positions;

Performance and Cost Report (P&CR): P&CR shall include all recurring and non-recurring costs, cumulative cost, total labor hours, and cumulative labor hours for each task area for the previous month;

The status of the action items from any Kickoff Meetings and other follow-on meetings, as appropriate; and The MSR must be submitted via email on the third business day of the month to the IDIQ COR.

Program Management Plan (PMP) and Order Management Plan (OMP) – The Contractor shall provide a PMP for the IDIQ.

This plan shall include, but not limited to:

The management approach, staffing plan, and organizational chart identifying relationships, authorities, and responsibilities to be used to meet the IDIQ requirements throughout the contract’s period of performance;

The process to oversee and manage work activities at the IDIQ level;

The process to recruit, train, retain, and replace personnel at the IDIQ level; and A communication diagram illustrating all lines of communication between the Government and the Contractor.

Project Meetings – The Contractor shall participate in meetings and discussions that support the overall efforts the IDIQ requirement and the order work activities (e.g. kick-off and task related meetings).

Representative activities include, but are not limited to:

Coordinating quarterly project meetings to plan, strategize, and execute all programs and projects;

Preparing and distributing agendas to include call-in/teleconference information and review materials;

Completing and distributing meeting minutes and action items to meeting participants;

and Tracking of meeting minutes, action items, and associated materials relating to all meetings / calls.

Risk Management - For each individual order, the Contractor shall document and report the risks and opportunities within a risk registry. The Contractor shall maintain the risk registry and provide it to the assigned IDIQ COR, CS, and CO on request.

The risk registry shall contain, at a minimum, unless otherwise specified in the individual orders:

Issue Number: a sequential numbering of all issues;

Severity: assessment of issue severity i.e., likelihood and consequences

(High/Medium/Low) Date Found: – date that issue was identified by the Contractor;

Duration: number of days that issue has been open;

• Status: representing issue status as open or closed. The Contractor shall maintain a complete list of all issues – no issues should typically be deleted from the Contractor’s delivered list;

Title: short description of issue;

Updated: date for updated status;

Details: narrative description of activities that have been completed to resolve issue;

Assigned To: identify Government Point of Contact (POC) or Contractor that is assigned to resolve the issue; and Solution or Workaround: description of the actions and activities taken to resolve or mitigate the issue.

Transition Plan and Activities – As tasked, the Contractor shall develop transition–in and transition out plans and conduct transition activities for orders issued against this IDIQ vehicle.

Transition-In

For a period of time, as specified by the individual order, the Contractor shall work with the Government to ensure a smooth transition of work from the current service providers to the IDIQ Contractor.

Representative activities include, but are not limited to:

1. Developing a Transition-in Plan to ensure full operating accountability and responsibility of the individual order;

2. Conducting and coordinating all on-boarding activities, to include the badging for team personnel;

3. Reviewing objectives, processes, and requirements as related to the tasks and activities being performed;

4. Participating in Transition-in meetings (initially to be held jointly with the current service providers);

5. Participating in other information exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the current service providers;

6. Ensuring Contractor personnel are available to work immediately after IDIQ individual order award;

7. Certifying that employees working on the contract have completed a review of FDA and OSIST policies and understand the requirements, documentation, and processes prior to the completion of the Transition-in activities.; and

8. Verifying to the COR that all the Transition-in documents are available.

Transition-out

As specified by the individual order, the Contractor shall conduct transition-out activities. During this period, the Contractor shall ensure no degradation in support services provided under the order.

Between the turnover date designated by the COR and the end of the contract period of performance, the outgoing Contractor shall ensure all order activities are closed out and it shall provide sustainment support to complete the transition.

Representative activities include, but are not limited to:

1. Developing and submitting a Transition-Out Plan and Schedule to the COR;

2. Providing the FDA with current versions of all documentation developed (e.g. Standard

Operating Procedures [SOPs] and Manual of Operations);

3. Providing the FDA with a current inventory of all Government-Furnished Equipment

(GFE) and Government Furnished Information (GFI) utilized by the Contractor along with full support in the reconciliation of this inventory; and return to FDA all GFE that has not been transferred to the follow-on Contractor.

4. Providing the follow-on Contractor with the ability to “shadow” and participate in technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor.

LABOR CATEGORIES

Labor Category Min. Yr. of Relevant Experience

Education

Program Manager 8 Master’s Degree in a business, public administration, or legal field from an accredited academic institution and PMP certified

Project Manager 5 Bachelor’s Degree in a business, public administration, or legal field from an accredited academic institution and PMP certified

Senior Professional Engineer 8 Four-year degree in engineering from an accredited engineering program.

Required: professional engineer (PE).

Highly desirable: (CIH, CSP, CBSP).

Professional Engineer 5 Four-year degree in engineering from an accredited engineering program.

Required: professional engineer (PE).

Highly desirable: (CIH, CSP, CBSP).

Biosafety Consultant 4 Bachelor's Degree in microbiology, occupational health and safety, or related field from accredited academic institution.

Highly desirable: (RBP, CBSP).

Safety Engineer I 1 Bachelor's Degree or equivalent in Engineering, Science, or other related field from an accredited academic institution.

Safety Engineer II 5 Master’s Degree in scientific or engineering discipline from an accredited academic institution

Industrial Hygiene Management Consultant

8 Master's Degree or equivalent in Engineering, Science, or other related field from an accredited academic institution and CIH or CSP

Certified Industrial Hygienist 5 Bachelor’s Degree in scientific or engineering discipline from an accredited academic institution. Required: Certified Industrial Hygienist

Industrial Hygienist 2 Bachelor’s Degree in a scientific or engineering discipline from an accredited academic institution

Analyst I 2 Bachelor’s Degree from an accredited academic institution

Analyst II 6 Bachelor’s Degree from an accredited academic institution

Communications Specialist 2 Bachelor’s Degree from an accredited academic institution Training Specialist 2 Bachelor’s Degree in education or

Instructional Design & Technology; or Bachelor’s Degree and certification in Instructional Design & Technology or Online Learning Professional or equivalent

Senior Health Physicist 10 Bachelor’s Degree in scientific or engineering discipline from an accredited academic institution. Required:

Certification by the American Board of Health Physics

Health Physicist 3 Bachelor's Degree or equivalent in Engineering, Science, or other related field from an accredited academic institution.

Attachment: FDA OSIST Facility Locations and Laboratory Size

Facility Region City State Center(s)

St Louis Field St. Louis MO CDER

Bedford Field Bedford IL HFP

GCSL Field Dauphin Island AL HFP

NCTR Field Jefferson AR OC/HFP

Detroit Field Detroit MI OC

WEAC Field Winchester MA OC

PRLNW Field Bothell WA HFP

San Francisco Field Alameda CA HFP

San Juan Field San Juan PR OC

Irvine Field Irvine CA OC/HFP

FCC Field Cincinnati OH OC

NRL Field Jamaica NY OC/HFP

Denver Field Denver CO HFP

SRL Field Atlanta GA OC/HFP

Kansas City Field Lenexa KS HFP

College Park NCR College Park MD HFP/OC

Muirkirk Road Complex NCR Beltsville MD HFP, CVM, CDRH

Ammendale NCR Ammendale MD CDER/HFP

White Oak Federal Research Center White Oak Silver Spring MD CDER, CBER, CDRH, OC

Attachment J-2: Laboratory Sizes

Region

Center

Lab Room

Area ft² Sum of Labs

Field CDER 17,546 38

CFSAN 16,801 61

ORA 331,244 795

Field Total 365,591 894 Jefferson, Arkansas NCTR 174,142 470

ORA 51,191 110

Jefferson Total 225,333 580 National Capital Region (NCR) outside White Oak (WO) CDRH 1,693 8

CFSAN 132,275 322

CVM 51,184 85

NCR Total 185,152 415

WO CBER 126,865 396

CDER 46,689 136

CDRH 72,008 174

OC 576 3

WO Total 246,139 709

Grand Total 1,022,215 2,598