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Starting June 3, 2013, this course will be hosted by the Centers for Disease Control. Please note by clicking the registration link above you will be redirected from APHL website to the Centers for Disease Control Training Program website. You will need to follow the registration prompts including creating an account on the CDC TRAIN portal. Help can be obtained by sending an email to labtraining@cdc.gov or by calling 404-498-6022.
>Sponsor:
National Laboratory Training Network in collaboration with the Centers for Disease Control and Prevention
Registration Fee:
FREE
Origination Date:
September 1, 2012
Expiration Date:
December 31, 2013
Hardware/Software:
Computer-Internet; Speakers are recommended but not required. Program is best viewed using Internet Explorer 7.x and greater. Pop-up blockers must be turned off.
Target Audience:
While the learner assumes the role of a laboratory technologist to complete the online training, this course is helpful for a diverse audience including:
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Laboratory professionals who direct, supervise, or perform molecular genetic testing;
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Laboratory professionals who are interested in molecular genetic testing for heritable diseases;
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Healthcare professionals who provide laboratory services for molecular genetic testing for heritable diseases and conditions;
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Programs that provide training in clinical molecular genetic testing.
Prerequisites:
None
Format:
This course is an interactive on-line course.
Description:
This on-line learning module is intended to help laboratory professionals understand recommended good laboratory practices and enhance competencies for molecular genetic testing. The course presents a life-like situation in which a laboratory is planning to introduce its first molecular genetic test for a heritable disease. A team of laboratory staff including the laboratory director, a medical geneticist, and senior technologists is formed to address all quality management needs and develop procedures for ensuring the quality of laboratory services for the new test. Topics covered by this comprehensive training course include regulatory compliance and adherence to good laboratory practices, personnel qualifications and responsibilities, establishment and verification of test performance specifications, preparation of new test information for clinical users,
informed consent, molecular genetic test requests, quality control practices, proficiency testing and alternative performance assessment, test reports, retention issues, and
quality management practices. The learner enters the course as a member of the laboratory team and will complete tasks and assignments throughout the course.
Objectives:
At the conclusion of this program, the participants will be able to:
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Describe the application of CLIA requirements to molecular genetic testing
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Select quality management measures for molecular genetic testing that are consistent with good laboratory practices
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Develop procedures and processes for a molecular genetic test that are consistent with regulatory requirements and good laboratory practices
Subject Matter Experts:
Bin Chen, B. Med., Ph.D., FACMG,
Centers for Disease Control and Prevention
Carol Greene, MD,
Centers for Disease Control and Prevention
Debra Kuehl, MS, M(ASCP),
Centers for Disease Control and Prevention
Barbara Zehnbauer, SM, Ph.D., Centers for Disease Control and Prevention
Penny Keller, BS, MP (ASCP), Center for Medicare and Medicaid Services
Continuing Education Credit:
Participants who successfully complete this
program will be awarded 1.5 contact hours. This course has
been approved for 1.5 contact hours in the category of
Supervision Administration, Quality Control/Quality
Assurance and Safety for Florida Laboratory Licensees.
The Centers for Disease Control and Prevention designates
this educational activity for a maximum of 2.0 AMA PRA
Category 1 Credits™.
CDC, our planners, and our content experts wish to disclose
they have no financial interests or other relationships with
the manufacturers of commercial products, suppliers of
commercial services, or commercial supporters. Planners
have reviewed content to ensure there is no bias.
Disclaimer:
Content will not include any discussion of the unlabeled use if a product or a product under investigational use. CDC does not accept commercial support. For the purposes of this training module, the manufacturer details are fictional and do not indicate CDC’s support for any commercially available product or service.
Special Needs:
Course content is closed captioned where applicable and optimized for a screen reader.