National Laboratory Curriculum Framework Development

Description

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Training Education and Development (OTED) is announcing the availability of a cooperative agreement to be awarded under a Limited Competition. FDA can guarantee one year of funding with the possibility of up to four years of additional, noncompetitive support, dependent on performance and continued availability of federal funds.The national associations /organizations eligible to apply for funding under this cooperative agreement must be a national association/organization that represents State and local laboratories that conduct food and/or animal feed testing on behalf of State and local regulatory programs.The awardee will be required to sub award a minimum of 25% of the funds received under this award to at least two different associations to meet the goals of the cooperative agreement. One association must represent state manufactured food regulatory officials and the other association must represent state animal feed regulatory officials. Prior approval of the sub awards by FDA is required. Training for federal, state and local food safety agencies is critically needed to fully develop an integrated food safety system (IFSS) for laboratories and human food and animal feed regulators and assist FDA in meeting the requirements of the Food Safety Modernization Act (FSMA) Section 209 (a)(a)(1-7). The Partnership for Food Protection (PFP) is the action arm of the IFSS. PFP has representative membership across the country from federal, state, and local regulators and advances the mission of the IFSS. The PFP has multiple workgroups with specific strategic plans and charges. The PFP’s Training and Certification Workgroup is charged to develop the National Curriculum Standard (NCS) for the more than 30,000 IFSS feed and food safety professionals operating in over 2,500 jurisdictions nationwide. The Training and Certification Workgroup has spearheaded progress on the development of national curricula for IFSS food safety professionals, and to date is developing a curriculum framework for the jobs conducted by laboratorians and human/animal food regulators.PART 1:The laboratory curriculum framework outlines the domain topic areas necessary for competency (outcome) based training (competency statements, key performance indicators, and field/lab bench application exercises need to be developed to reinforce training and enhance proficiency) spanning five professional levels: entry, mid-level, expert, supervisor/manager, and senior administration (agency specific training content is addressed by each jurisdiction). Following completion of the entry level general education requirements, trainees will continue in the entry level beginning their professional laboratory track (chemistry and microbiology) and will able to conduct independent activities while continuing their training and work at the mid-level.Laboratorians will be expected to continue their training at the expert level and consider continuing through the supervisory/manager and senior administration levels as their desire, proficiency and opportunity enables them to do so.Awardee is expected to continue developing the IFSS Laboratory National Curriculum Standard on all five levels of the curriculum framework, beginning with the entry level and ascending as lower levels are completed utilizing the instructional design ideals espoused by FDA’s Office of Regulatory Affairs, Office of Training Education and Development (OTED):Course Integrity: Training content is designed utilizing best practices in adult learning to meet course goals, objectives (terminal and enabling) and learning outcomes. Instructional systems specialists, instructional designers and technical editors work with subject matter experts (SMEs) to align course content with effective and efficient training methods and modalities. Professional Staff: In the phases of analyzing, designing, developing and evaluating training needs and content, there is an expectation that corresponding professional skill sets are utilized to conduct these activities such as instructional system specialists and designers, technical editors, SMEs, program/project managers, industrial/organizational psychologists, and psychometricians.Analysis: Identifies the instructional objectives, training needs, learning environment, and learner's current knowledge and skill levels. Competencies addressing expectations for the newly acquired behavior, knowledge, and skill should be tied to the requirements for successful job performance. Needs Assessment, Job, task and/or competency analyses may be conducted to provide a foundation and validation of IFSS employee development programs.Proficiency Levels: Establish course learning outcomes (cognitive, affective, and psychomotor) and learning standards consistent with accepted learning taxonomy (i.e. Bloom’s Taxonomy, Krathwohl's Taxonomy and Harrow's Taxonomy). Learning Outcomes: Developed consistent with industry accepted practices and standards such as Mager’s Theories on Criterion Referenced Instruction and the use of performance-based learning objectives. Learning outcomes define the competency expectations and provide the specificity of the desired behavior; what will personnel be able to do/demonstrate after completing a specific course and to what level of proficiency? Where practical, objectives are written using the performance, condition and criterion based methodology.Behaviors: The regulator’s mindset and conduct in carrying out regulatory activities need to be included as a component of the training content and process as behavioral science is an important component to job performance.Delivery Approach: Training that is primarily focused on knowledge and comprehension should occur outside of the classroom (i.e. online courses or independent reading assignments), while the application and/or demonstration components take place in a classroom setting. Thus in the classroom, “lecture” is minimized and interactive learning is emphasized. Training occurs over multiple learning events using a blended approach. Reinforcement should be provided to the degree necessary for reaching mastery of the job tasks.Evaluation: A course evaluation process should be used to evaluate effective training and training effectiveness (i.e. Kirkpatrick Level 1 course evaluations and Level 2 with course assessments) of meeting course objectives. Legal Requirements: The design and development of training content needs to incorporate and adhere to 508 standards, FOI Act, Privacy Act, Plan Language, and Copyright (Title 17 and Fair Use) laws as applicable.Content Development: Course design documents, storyboards, web course templates utilizing Lectora 12 (software acquired by awardee(s)), and style guides: OTED will provide the format/layout and design requirements for all training content being developed such as web courses, presentations, reading assignments, exercises, manuals (participant and/or instructor), course evaluations, training and/or job aids; all course materials are required to conform to the course development templates. Once the competencies statements are validated and the performance indicators are developed for the topic areas for each of the 5 levels, then course design and development may begin for each completed level. It is important to assure that the tiers of topic area competencies and their performance indicators are sequential and logical and address the necessary tasks for the various laboratorian professional tracks such as chemistry and microbiology at each level. Project Life Cycle: Content development is progressive and systematic, beginning with the design document that includes details such as project title and description, target audience, goals, objectives, learning outcomes, methods and modalities. To assure the design document is followed as the project is developed; periodic reviews are needed such as SME/ISD review of course content and instructional integrity. Where content lies within an online interface, their functionality, technical and instructional reviews will be necessary followed by pilot testing. Classroom courses require a “course walk through” for further refinements and a pilot (first class offering) in order to make any final content and/or delivery adjustments.An overview of the NCS development status includes, but is not limited to:1. Adhere to FDA/OTED’s NCS development and instructional design approach (above)2. Facilitate the lifecycle approach of competency and curriculum frameworks as developed/updated for the main framework and each program area3. Competency domain topic areas address: a. Communication: Competencies related to communicating with diverse populations through verbal, written and non-verbal means b. Core: Competencies that cut across all domains c. Critical Thinking: Competencies related to objectively assessing information collected from a variety of sources by using a disciplined, analytical, and repeatable thought process while achieving a defensible conclusion d. Organizational Awareness: Competencies related to the understanding of the regulatory agency’s authority, structure, activities, and mission. e. Technical: Competencies related to the knowledge, skills, and abilities specifically relating to food and feed regulatory control4. Develop competency statements down to levels 5 (enabling learning objectives for each unit within a course). This is a process that takes over arching competencies for a domain area down to sub-competency statements of increasing specificity for each topic or unit under a domain5. Validate competency statements to a minimum of level 4 (terminal learning objective for each unit within a course).6. Use OTED’s templates for course design documents, story boards, web course templates, and/or style guides to develop cour

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