This activity is part of the Essentials of Laboratory Management learning series. Save 10% when you purchase three or more courses in this series together. Below are the courses included in the series. Click here to see all courses in the series.
- Building a Quality Management System
- Critical Communication Practices for Laboratory Leadership
- Managing Laboratory Operations
- Planning and Executing New Test Systems
NOTE: This course includes 2021 CAP accreditation checklist requirements. Please check your current CAP accreditation checklists for the most recent updates.
It is the lab leader’s role to ensure new test and equipment implementation is thoroughly planned prior to execution to ensure a successful transition. This activity introduces the elements of new test and equipment implementation, including evaluating, planning, and executing a variety of tasks and responsibilities to lead the implementation of new tests and equipment in a variety of organizational settings.
This adaptive activity offers a unique learner experience. By answering a series of questions that determine your existing knowledge, you will be prescribed a customized pathway that focuses on individual learning needs.
After completing this activity, you should be able to:
- Establish the clinical need for a new test or technology through literature search, vendors, and communication with clinical stakeholders and test utilization meetings.
- Describe the contractual options for new tests and technology (capital purchase, cost per test, reagent rental).
- Reconcile the business case proposal with company mission and goals.
- Understand the regulatory requirements for verifying FDA-approved or -cleared tests and validating FDA-modified or laboratory-developed tests.
- Design the studies or experiments to verify or validate the test characteristics and document results.
- Determine the specifics and minimum requirements for establishing accuracy, precision, reportable range, reference intervals, analytical sensitivity, and analytical specificity.
Ericka J. Olgaard, DO, MBA, FCAP
Accreditation: The College of American Pathologists (CAP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
CME Category 1: The College of American Pathologists designates this internet enduring material educational activity for a
maximum of 3
AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CE (Continuing Education for nonphysicians): The CAP designates this educational activity for a maximum of 3 credit(s) of continuing education. Participants should claim only the credit commensurate with the extent of their participation in the activity.
This activity is approved for continuing education credit in the states of California and Florida.
The American Society for Clinical Pathology (ASCP) Board of Certification (BOC) Certification Maintenance Program (CMP) accepts this activity to meet the continuing education requirements.
Below, you will find the financial disclosure relationships for anyone who was able to affect the content of this educational activity.
The CAP mitigates all the relevant financial relations listed for these individuals.
The following authors/planners/reviewers have no financial interests/relationships to disclose:
Ericka J. Olgaard, DO, MBA, FCAP
Moira P. Larsen, MD, MBA, FCAP
The following authors/planners/reviewers have financial interests/relationships to disclose:
The following In-Kind Support has been received for this activity:
The following Commercial Support has been received for this activity:
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College of American Pathologists
325 Waukegan Road
Northfield, IL 60093-2750
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This activity and evaluation are available March 13, 2023 and expire December 15, 2025, at 11:59 PM (CT). Upon completion of the activity your credit will be awarded. Your certificate may be downloaded from your Transcript.