Lab Matters Fall 2020 - Page 52

Quality Systems
Findings from an APHL-sponsored Quality Manager Focus Group Discussion
B . Su , Association of Public Health Laboratories , Silver Spring , MD
Introduction : In December 2019 , APHL hosted an in-person focus group discussion on quality and safety issues and gathering information about the gaps and needs of quality managers and quality management programs , including general safety , within public health laboratories . Participants ranged from laboratory directors who did not have designated quality manager position to public health laboratory quality managers who manage multiple quality staff . APHL collected in-depth qualitative information that will help guide the Association in the development of new resources , including training . The poster outlines some of the important findings .
Methods : During the one-day meeting , the 10 quality managers and laboratory directors answered qualitative questions regarding quality and safety , specifically focused on the following topics :
• challenges related to quality and safety experienced at different organizational levels at the laboratory ;
• strategies for tackling the challenges identified ; and
• skills , competencies and trainings needed for quality and safety staff
APHL staff captured important discussion points on each topic using white flip chart paper . Participants ranked discussion points to prioritize need and future projects .
Results : The focus group participants stressed the importance of all levels of public health laboratory staff understanding the importance and value of quality and safety , not just when audits are occurring . Two important jobs aids were identified as a priority needa standardized position description and a learning map . Position descriptions not only help justify the position , but also reinforces the need of quality and safety at the laboratory and clarifies roles and responsibilities . The participants emphasized the value of being empowered and having support from laboratory management to move forward with implementing quality system improvements on a staff-wide level . Additionally , they prioritized the impact of culture , and the need to hold hands-on trainings and drills on a regular basis to ensure that staff know the proper protocols when issues arise , e . g . non-conforming events , spills , emergency situations .
Conclusions : Building and nurturing a culture of quality and safety ultimately improves the quality of the data that the laboratory produces and creates a safe working environment for the staff . APHL will work with the participants to address the gaps that were identified during the focus group discussion . Next steps include creating a position description for quality managers that aligns to public health laboratory competencies , a learning map for quality managers that outlines what trainings new quality managers should take and resources they should be aware of ; and collection model practices of hands-on exercises that can be adopted for trainings and drills .
Presenter : Bertina Su , Association of Public Health Laboratories , Silver Spring , MD , bertina . su @ aphl . org
New Online Course on Analytical Validation of a Biochemical Genetic Test Using Liquid Chromatography — Tandem Mass Spectrometry
B . Su 1 , B . Chen 2 ; 1 Association of Public Health Laboratories , Silver Spring , MD , 2 Centers for Disease Control and Prevention , Atlanta , GA
Introduction : Biochemical genetic tests ( BGTs ) are highly specialized laboratory procedures for the evaluation , diagnosis , and clinical management of inherited metabolic diseases . Over the last two decades , the advent of expanded newborn screening ( NBS ) for inherited metabolic disorders using tandem mass spectrometry ( MS / MS ) and other technologies has presented an increasing demand for biochemical genetic testing in diagnosing presumptive cases detected through NBS . However , BGTs are highly complex procedures performed on a wide variety of patient specimen types . Biochemical genetics laboratories need easily accessible training materials in developing and implementing new tests using the MS / MS technologies .
Method : Since 2013 , CDC has been collaborating with the Association of Public Health Laboratories ( APHL ) to help genetic and NBS laboratories in their quality improvement activities . Findings from two discussion groups held in 2013 identified topic areas in which training resources are desired , including user-friendly online courses on developing and validating new test procedures ( https :// www . aphl . org / aboutAPHL / publications / Documents / CDCRecommendationsGoodLabPractices _ OCT2014 . pdf ). To meet this need , experts in biochemical genetic testing and MS / MS technologies were enlisted to develop a new online course titled “ Validating a New Test Using Liquid Chromatography - Tandem Mass Spectrometry ( LC-MS / MS ) in a Biochemical Genetics Laboratory .” Pilot testing was conducted by laboratory professionals to ensure its usefulness for the target audience .
Results : This intermediate-level multimedia online course discusses a stepwise plan for setting up and validating a new LC-MS / MS based assay for application in a biochemical genetics laboratory . A specific example of quantifying methylmalonic acid in human plasma is used to describe each of the steps required to develop and validate the method . An outline of the validation report is provided that includes how to review , interpret and document validation tests , quality control results , and proficiency tests . Continuing education credits are available from this course free of charge , including 1.5 hours of the ASCLS P . A . C . E . credit . The course is expected to be publicly available on CDC TRAIN website at https :// www . train . org / cdctrain / home in Summer 2020 .
Conclusions : This online training module is intended to help laboratory professionals understand the regulatory environment of a biochemical genetics laboratory , define the steps required to develop and validate an assay based on LC-MS / MS , and describe the contents of the validation report . Course evaluation results and feedback from the participants will be closely monitored to assess the utility and learning outcomes .
Presenter : Bin Chen , Centers for Disease Control and Prevention , Atlanta , GA , bkc1 @ cdc . gov