National Laboratory Training Network in collaboration with the Centers for Disease Control and Prevention
September 1, 2012
July 30, 2014
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.
While the learner assumes the role of a laboratory technologist to complete the online training, this course is helpful for a diverse audience including:
- Laboratory professionals who direct, supervise, or perform molecular genetic testing;
- Laboratory professionals who are interested in molecular genetic testing for heritable diseases;
- Healthcare professionals who provide laboratory services for molecular genetic testing for heritable diseases and conditions;
- Programs that provide training in clinical molecular genetic testing.
This course is an interactive on-line course.
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.
At the conclusion of this program, the participants will be able to:
- Describe the application of CLIA requirements to molecular genetic testing
- Select quality management measures for molecular genetic testing that are consistent with good laboratory practices
- Develop procedures and processes for a molecular genetic test that are consistent with regulatory requirements and good laboratory practices
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:
The Association of Public Health Laboratories (APHL) is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. 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 ofcommercial services, or commercial supporters. Planners have reviewed content to ensure there is no bias.
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.
Course content is closed captioned where applicable and optimized for a screen reader.
If you have difficulty with the online registration process, please e-mail firstname.lastname@example.org or call 240.485.2727 between 8:00 a.m. and 4:30 p.m. (ET).