Full-Level: Developing a Quality Management System
Price: $59.95
6.0 Contact Hours. Online/work at your own pace
A Day in the Life of a Travel Phlebotomist: Practice, Safety, and Professional Excellence
Description
Developing a Quality Management System for the Manufacture of Laboratory Developed Tests!
6.0 Contact hours ($59.99)
Course Description
This course explores the vast industry responsible for developing Laboratory Developed Tests (LDTs)—including laboratory tests, reagents, and protocols used to detect and treat illnesses. We will examine the history of LDTs and the FDA’s proposed regulations aimed at minimizing errors, aligning LDT oversight with the standards applied to medical device manufacturers.
Additionally, we will discuss the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020, which was revived in response to concerns raised during COVID-19 testing. Learners will gain insight into proactive compliance strategies by exploring the steps needed to develop a robust Quality Management System (QMS) that meets regulatory requirements for LDT development.
This course will also provide a comprehensive understanding of accreditation, regulatory, and compliance requirements surrounding LDTs. Learners will engage in a crosswalk analysis, comparing existing QMS standardswith regulatory expectations. By identifying gaps in policies, procedures, and processes, participants will develop a QMS framework that aligns with CLIA standards, FDA regulations, and best practices—ensuring compliance and streamlining test development.
Who Should Take This Course
This course is ideal for laboratory technologists, technicians, administrators, quality roles and students looking to enhance their knowledge of quality management systems.
This Course Includes
- Engaging Instructional Videos – Gain in-depth knowledge through visual learning
- 10-Question Quiz – Test your understanding of key concepts
- Workbook, forms and links
- Course Assignment – Apply your newly acquired skills in a practical exercise
Course Agenda
- Introduction to Developing a Quality Management System
- Leadership & Training
- Pre-assessment of existing processes
- Phases of Development
- Design control & Process Control
- Stage Gate
- Process Validation
- Development of a Quality Management System
Learning Objectives
Upon completing this course, learners will be able to:
- Explain the importance of a proactive approach to LDT oversight and its impact on patient safety
- Interpret accreditation, regulatory, and compliance requirements related to Laboratory Developed Tests (LDTs)
- Convert regulatory requirements into practical, operational processes for building an effective Quality Management System (QMS)
Course Assignment
In this assignment, you will learn how to develop or enhance your existing Quality Management System (QMS) by identifying missing components and building a comprehensive framework for Laboratory Developed Tests (LDTs) that meets all regulatory requirements.
Note: This assignment includes a “QMS How-To” guide, which provides step-by-step instructions aligned with the course video presentations. Learners will follow along, completing each phase of the assignment, with action items prompting necessary tasks or activities.
The course also includes links to regulatory standards to support compliance and best practices.
Course Materials: How to Guide: Developing a Quality Management System: Quality Management System LLS Worksheet: Follow the lectures and complete assignments step by step: LDT QMS Workbook Forms
You must log in and have started this course to submit a review.
This course provides a comprehensive overview of the daily responsibilities and real-world experiences of a travel phlebotomist. Learners will explore the full scope of the role—from planning daily routes and adapting to diverse work environments to performing venipuncture in non-clinical settings and ensuring safe specimen transport. Emphasis is placed on patient interaction, independent practice, safety awareness, and professionalism. By the end of the course, students will be equipped with the practical knowledge and critical thinking skills needed to succeed in a mobile phlebotomy role.
Course Agenda: This Program Includes
✔ 6 Course Modules
Module 1: A Day in the Life
Module 2: Work Environment & Adaptability
Module 3: Patient Interaction & Communication
Module 4: Indépendance & Professional Responsibility
Module 5: Technical Skills in Mobil practice
Module 6: Travel Safety, and Field Changes
M
✔ Assignment –
Who Should Take This Course?
Learning Objectives
At the end of this course, you will be able to:
✔ Explain Lean principles, methodologies, and tools as they apply to clinical, administrative, and diagnostic healthcare workflows
✔ Apply Lean thinking to design a targeted improvement strategy within your healthcare or laboratory setting
✔ Plan and lead a 5S event, including preparation, implementation, and ongoing sustainment in a clinical environment
✔ Conduct a “Go and See” (Gemba) observation to uncover inefficiencies and identify opportunities for improving patient care and workflow
✔ Analyze waste and variation using a current-state value stream map to improve flow and reduce delays
✔ Apply the A3 problem-solving approach, understanding its structure and use in healthcare decision-making
✔ Plan and facilitate a Kaizen event, including defining objectives, engaging teams, and achieving measurable outcomes
This course equips you with practical Lean tools and techniques to drive continuous improvement, enhance efficiency, and improve patient outcomes across healthcare settings.
