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TRAINING SOLUTIONS Pharmaceuticals | Healthcare PART III – DEVELOPMENT
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Systems Approach to Training Evaluate
Flexible, outcome-oriented system Instructional system shall determine needs and priorities, develop effective and effective solutions to achieving these needs, implement them competently, and asses how well the outcomes meet the specified needs.
Implement
Develop Design
Analyze 07/FEB/2018
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Target Population Description (TPD), Learning Analysis (LA) and sequenced Learning Objectives (ELO, TLO) become the source documents for the DEVELOP phase
DEVELOP Course structure
Lesson Materials
Course Descriptive Data (CDD)
•
Purpose
•
Secure resources
•
Steps
•
Write lesson plan
•
Materials & media
Program of Instruction (POI)
Instructor guide
•
Detailed description of the course
•
Plan for satisfying requirements outlined in Individual Training Standard or Manual
Concept cards
•
Purpose
•
•
Categories
Construct tests
•
Elements
•
•
Methods, categories
Operational Risk Assessment
Validating instruction
Structure
Materials
Summary of resources required to administer a course
Assemble Master Lesson File (MLF) •
1 MLF for every class
Outputs
Course Structure
Lesson materials
Course Descriptive Data (CDD)
Concept Cards
Tests
Program of Instruction (POI)
Operational Risk Assessment
Validation
Master Lesson File (MLF)
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DEVELOP
Target Population Description (TPD), Learning Analysis (LA) and sequenced Learning Objectives (ELO, TLO) become the source documents for the DEVELOP phase
Course Structure Concept Cards Conduct an Operational Risk Assessment Lesson Materials Construct Tests
Validate Instruction Course Descriptive Data & Program of Instruction Assemble Master Lesson File 07/FEB/2018
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Develop Course Structure Review Source Material • Learning Objective Worksheet (LOW) • Terminal Learning Objectives (TLO) • Enabling Learning Objectives (ELO) • Delivery systems • Test items
Determine lesson and exam content
• Review objectives for complexity & domain • Select closely related objectives
• Consider target audience • Assign lesson and exam titles
Estimate instructional hours
• Estimate required time, do not exceed allocated time • All hours devoted to the instruction, review, evaluation and retesting
Assign lesson titles and codes
• Assign titles
• Designators: Quick codes to identify a lesson in corporate instructional system
• Directives, SOPs
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Concept Cards Course
title: First aid
Lesson/exam Hours
title and ID: CPR / ID T01-007
per method: 1 hr lecture / 2 hrs practice
Student
: instructor ratio: 1 instructor, 1 assistant, 4-6 students
Media: Lecture Learning
and practical demonstration
objectives: Perform CPR until ambulance arrival
Lesson
purpose: Learn to provide competent first aid in workplace prior to ambulance arrival Material requirements:
Defibrillator, dummy, projector
Exam:
Practical demonstration, a case study
Notes:
external instructor
References:
CPR manual, defibrillator instructions for use
Signatures:
Authorized person
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Operational Risk Assessment Training is the most important measure how to reduce risk of compliance failure, improvisation and human error; how to decrease intrinsic vulnerabilities including personnel turbulence; and how to increase the capacity to deal with external threats.
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Operational Risk Assessment Hazard identification
• Gather resources: MLF, manuals, SOPs mishap reports Subject matter expert’s input • Identify steps • Training vs. job
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Assess hazards
Make risk decisions
• Assess severity
• Assess probability • Assign RAC - Risk Assessment Code
• Prioritize high-risk, high-probability events • Control measures • Benefit:risk, cost
Implement controls Supervise • Record instructions • Implementation plan • Accountability & support • Cost:benefit • Document changes
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Operational Risk Assessment A hazard is a condition that has the potential to cause injury/illness, loss of assets (time, money, personnel), property damage, or affect mission accomplishment.
Hazard identification
Gather resources: technical manuals, MLF, instruction method, SOPs, ORA Worksheet, subject matter experts, data from past classes
Identify major steps: review learning objectives
Identify sub-steps: How training environment differs from real-world application
Identify hazards: Technical manuals, subject matter experts, concept cards, lesson plans, after-instruction reports, mishap reports
Hazards identified from technical manuals 07/FEB/2018
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Operational Risk Assessment Hazard assessment
Probability of occurrence
Probability of hazard occurrence A – likely, frequently (individual)/ continuously (group) B – probably, several times / frequently C – can reasonably be expected to occur D – unlikely to occur
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Severity
Severity of hazard I – death, loss of facility/asset, grave damage to business interest II – severe injury/illness, property damage, damage to business interest, degradation of efficient use of assets III – minor injury/illness, property damage, damage to business interest, degradation of efficient use of assets IV – minimal threat
Risk Matrix
Asses severity and probability of hazard and assign Risk Assessment Code
A
B
C
D
I
1
1
2
3
II
1
2
3
4
III
2
3
4
5
IV
3
4
5
5
Risk Assessment Code
1 – Critical 2 – Serious 3 – Moderate 4 – Minor 5 – Negligible 10
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Operational Risk Assessment Lifting a patient using a ceiling lift (NPR, 2015)
Make risk decisions
Prioritize more severe hazards that are more likely to occur
Benefit: risk assessment
Select control measures to mitigate the risk
Control measures
Record controls
Cease training criteria
Risk:benefit
Decision-making level that will oversee implementation
Cost
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The top five causes of increased workers' compensation, operating, and indirect costs are: Sharps and needle stick injuries, Slips, trips and falls, Workplace violence, Material handling (ergonomics) and Patient handling (ergonomics) (BSI, 2018) 11
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Operational Risk Assessment Cease Criteria
Clearly defined, concise
Communicated
Responsibility assigned
Decision-making in real time
Limit improvisation
Limit injury/illness and damage to assets
The Drug Trial; Emergency at the Hospital BBC Documentary 2017 11:50 to 13:36
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Operational Risk Assessment Risk mitigation measures
ACCEPT – risk low/acceptable
REDUCE – most widely used
AVOID – cancel/delay lesson
COMPENSATE FOR RISK redundant capability
DELAY – inclement weather
SPREAD – exposure distance, lengthening time
TRANSFER – to another entity or organization
REJECT – risk exceeds lesson benefits
Hazards looming at the office mainly include long sitting hours 07/FEB/2018
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Operational Risk Assessment Implement controls
Record instructions
Make the plan clear and concise
Establish accountability
Provide support
Supervise
Document the supervision plan
Supervise implementation
Review cost:benefit balance
Document changes
For healthcare workers fighting Ebola, the biggest battle is staying healthy (Newsweek, 2014) 07/FEB/2018
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Lesson materials MLF binder
Secure resources
Instructor preparation guide
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Student outlines
Lesson plans
Learning Objective Worksheet (LOW)
Lesson Plan: • Provides a detailed script • Establishes continuity • Ensures standardization • Record keeping
Student material
Media
Learning Analysis Worksheet (LAW)
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Writing a lesson plan
Introduction Gain attention (relevance for adult learners) Overview Learning objectives Method/media Evaluation Safety/cease training brief
Transitions, time, media & break cues Review ORA and integrate controls Lesson summary
07/FEB/2018 The Guardian, 2010
Title page Body – detailed script to master Learning Objectives Establish & sequence main ideas Insert content Provide examples Place methods
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Montgomery County Community College
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Constructing tests •
• • • • • •
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Determining mastery Assigning test items Arranging test items Grading criteria Scoring method Instructions for students Instructions for administrators
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Constructing tests
Relevance Conciseness Soundness Independence Arrangement Numbering Directions Spacing Typing
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Are the test items relevant? Simple, clear language Proper difficulty, free from defects No overlapping answers Appropriate grouping Correctness Concise, clear, complete Ease of reading Free from errors
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Validating instruction A process of trying the material prior to implementation and examine its effectiveness.
Methods
Collected Data
Steps Check SOPs
Review curriculum for objectivity Review technical data for correctness Review for appropriateness for target audience Pilot course
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Student feedback
Schedule revisions
Effectiveness of materials
Determine data collection procedures and techniques
Effectiveness of delivery systems Reliability of tests
Conduct validation Validation report Make revisions
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Outputs of DEVELOP Phase Course Descriptive Data
Program of Instruction
Master Lesson File
How does the concept meet organization’s training needs
Management tool for conducting a course
File that contains everything needed to conduct a lesson
Resource requirements
Consolidation of materials from previous phases
Responsibilities Purpose & Scope Length & Breakdown Capacity Student prerequisites Funding
Certification
Record of changes Course Descriptive Data
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Learning analysis worksheet
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Learning objectives worksheet
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Concept card
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Operational risk assessment worksheet
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Instructor preparation guide
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Lesson plan
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Student outline
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Supplemental student materials
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Media
Summary of hours Concept cards Student evaluation Distribution list
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Living document, continuously updated
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ARETE-ZOE, as a consultancy, provides solutions to complex problems in the high stakes and high consequence environment of Global Pharmaceuticals, including clinical research, healthcare informatics, and public health. We blend established, Pharma sector methodologies, innovation, and adaptations/transfers from other sectors to identify and resolve consequential practices that pose risk and often result in avoidable patient casualty. However, we are specifically, not a patient advocacy group but believe in optimizing organizational effectiveness and that smart business is agile, competitive and profitable, while intrinsically safe, secure, and resilient. We work within a global context because transnational interests influence national circumstances and choices at point of prescription.
ARETE-ZOE, provides full spectrum organizational and operational risk management consultancy. Our published materials provide a glimpse of some aspects of our services to demonstrate both knowledge and ongoing participation within the Pharmaceutical Industry. Our analysis and consultancy includes all channels of misuse, diversion, counterfeiting and illicit exploitation of pharmaceuticals, medical devices, and precursor chemicals. Our advisement is to manufactures, jurisdictional entities, insurers, legislators, litigators, patients, and health care providers. This scope also frequently segues into the nexus of crime and terrorism as significant influencers that undermine sector integrity differentiated from other criminal activity. Obviously, vulnerability assessment, information collection management and intelligence production supporting decision-making for risk reduction and interventions are routinely within the scope of our services as well as design and implementation of operational control measures.
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