DESCRIPTION
This online course provides targeted education in regulatory requirements related to point-of-care laboratory compliance and examines the quality of point-of-care testing (POCT) throughout different regulatory agencies. Participants will gain an in-depth understanding of Individualized Quality Control Plan (IQCP) development and discover successful communication skills that reach across disciplines.
Participants can download online course materials as laboratory resources and revisit these lectures through December 31, 2025.
TARGET AUDIENCE
This activity is designed to meet the needs of lab supervisors, lab directors (and/or assistant directors), lab managers (supervisory and/or non-supervisory), medical technologists, point-of-care coordinators, in-training individuals, and other laboratory professionals overseeing/conducting quality improvement.
LEARNING OBJECTIVES
Upon completion of this course learners will be able to:
- Understand fundamental differences in the regulatory agencies related to laboratory testing and POCT.
- Identify common deficiencies found in POCT and laboratory regulatory inspections.
- Learn communication skills for success when working with multidisciplinary teams.
- Understand and develop quality through an Individualized Quality Control Plan (IQCP).
COURSE OUTLINE
An Overview of POCT Regulation and Requirements and How to Communicate Them to Your Healthcare Team
Faculty: Jeanne Mumford, MT(ASCP)
Navigating regulatory standards for your lab to stay compliant can be overwhelming. It takes the entire healthcare team to achieve compliance so effective communication is essential. This module provides helpful tips and resources to help communicate successfully with cross-functional teams.
Upon completion of this course learners will be able to:
- Understand regulatory standards applicable to competency, validation, and quality control
- Identify different regulations and guidelines among different agencies
- Apply successful communication techniques with healthcare teams to enhance a collaborative relationship
Navigating Regulatory Requirements: A Case-Based Approach
Faculty: Elia Mears, MS, MT(ASCP)SM
Regulations are constantly changing and understanding the impact this has on your lab is crucial. In this module, learn how to prepare for inspections and get the latest updates from Centers for Medicare and Medicaid Services (CMS).
Upon completion of this course learners will be able to:
- Understand the differences among regulatory agencies
- Learn how to apply quality improvement tactics to meet requirements
- Identify common deficiencies to meet requirements
One Size Does Not Fit All: Individualized Quality Control Plan for POCT
Faculty: Sharon Ehrmeyer, PhD, MT(ASCP)
Individualized Quality Control Plans (IQCP) are required and can seem overwhelming. Learn why IQCPs are necessary and how you can implement, update, and/or manage your institution’s plans to stay compliant.
Upon completion of this course learners will be able to:
- Understand the need for IQCPs
- Understand the steps needed to develop an IQCP
- Summarize the differences among regulatory agencies for your IQCP
Course Faculty
Sharon Ehrmeyer, PhD, MT(ASCP)
Professor of Pathology Laboratory Medicine
University of Wisconsin Medical School
Elia Mears, MS, MT(ASCP)SM
Surveyor
Joint Commission on Accreditation of Healthcare Organizations
Jeanne Mumford, MT(ASCP)
Pathology Manager
Johns Hopkins Hospital
Course Planners and Reviewers
Kathleen David, BA, MT (ASCP)
POCT Manager
Ticore Reference Lab
Erika Deaton-Mohney, MT(ASCP) CPP
Compliance and Point of Care Coordinator
Bronson Methodist Hospital
DISCLOSURES AND STATEMENT OF INDEPENDENCE
The Association for Diagnostics & Laboratory Medicine (formerly AACC) is dedicated to ensuring balance, independence, objectivity, and scientific rigor in all educational activities. All participating planning committee members and faculty are required to disclose to the program audience any financial relationships related to the subject matter of this program. Disclosure information is reviewed in advance in order to manage and resolve any possible conflicts of interest. The intent of this disclosure is to provide participants with information on which they can make their own judgments.
The following faculty and planners reported the following relevant financial relationship(s) during the content development process for this activity:
Sharon Ehrmeyer, PhD, MT(ASCP)
- Consultant Fee and Speaker/Presenter Fee, Instrumentation Laboratory
Jeanne Mumford, MT(ASCP)
- Chair, CRI Board of Directors; President, KEYPOCC
The following faculty and planners reported no relevant financial relationship(s) during the content development process for this activity:
Kathleen David, BA, MT (ASCP), Erika Deaton-Mohney, MT(ASCP) CPP, and Elia Mears, MS, MT(ASCP)SM
CONTENT VALIDITY
All recommendations involving clinical medicine are based on evidence accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients; AND/OR All scientific research referred to or reported in support or justification of a patient care recommendation conforms to generally accepted standards of experimental design, data collection, and analysis.
ACCREDITATION STATEMENT
This activity is approved for 3.0 ACCENT® continuing education credits. Activity ID#2126. This activity was planned in accordance with ACCENT® Standards and Policies.
SUCCESSFUL COMPLETION STATEMENT
Verification of Participation certificates are provided to registered participants based on completion of the activity, in its entirety, and the activity evaluation. For questions regarding continuing education, please email [email protected].