APHL 2018 Annual Meeting Poster Abstracts
Quality Systems
Developing a Framework for a Quality Management Systems Training Curriculum for CDC Research Laboratories
J . Pompey , B . White , C . Potts , K . Kines , E . Dietrich , D . Riner , J . Ricaldi and A . Clayton , Centers for Disease Control and Prevention , Atlanta , GA
Background : The Centers for Disease Control and Prevention ( CDC ) aims to enhance the agency ’ s culture of quality , safety and excellence in science by implementing Laboratory Quality Management Systems ( LQMS ). CDC laboratories engage in investigational research activities ranging from infectious and noncommunicable diseases to environmental and occupational health . This diversity presents a challenge in instituting standardized LQMS training , as it can be hard to translate quality standards to actions relevant to the activities of laboratory staff . Our objective was to translate the view of LQMS from big picture guidelines to real , applicable bench-side practices , empowering laboratories to align their research activities with external accreditation or certification standards .
Methods : The Laboratory Leadership Service Class of 2016 ( LLS 2016 ) collaborated with the CDC Office of the Associate Director for Laboratory Science and Safety ( OADLSS ) to develop a framework for a training curriculum tailored to research laboratories . We developed the training around the concept that producing Sustainable , Trustworthy , Accurate and Reproducible ( STAR ) data is the foundation of all CDC laboratory research . LLS 2016 identified key domains that were common amongst all research laboratories in which quality management practices are essential for producing STAR data . Specific , plain language components for each domain were developed and measureable outcomes for each component were identified . Components were mapped to International Organization for Standardization ( ISO ) 9001:2015 QMS requirements , CDC / APHL QMS competency guidelines and Clinical and Laboratory Standards Institute Quality System Essentials ( QSEs ). To align training with staffing needs , we assigned personnel to functional roles based on their activities and responsibilities .
Results : LLS 2016 generated a quality domain matrix outlining six core laboratory domains : Materials & Resources , Processes & Procedures , Data , Personnel , Facilities and Improvement . The matrix relates quality domains to ISO standards and QSEs . We developed a LQMS training matrix based on roles within the research laboratory linking quality domains and training delivery formats . We created case studies that relate the quality domains and STAR principles to everyday activities of research laboratory staff to contextualize LQMS concepts .
Conclusions : The training matrices provide a framework to guide future LQMS curricula development by OADLSS . This work addresses the critical need for standardized , agency-wide LQMS training for CDC laboratory staff . We highlight the importance of developing programs and materials that are simple and understandable , framing quality as an integral part of conducting STAR research rather than as a separate activity .
Presenter : Justine Pompey , Centers for Disease Control and Prevention , Atlanta , GA , Phone : 404.718.4413 , Email : jpompey @ cdc . gov
New Online Course to Help Laboratory Professionals and Healthcare Providers Improve Pre-analytic Processes of Biochemical Genetic Testing
B . Chen 1 , B . Su 2 ; 1 Centers for Disease Control and Prevention , Atlanta , GA , 2 Association of Public Health Laboratories , Silver Spring , MD
Introduction : Biochemical genetic tests are associated with a wide range of pre-analytic variables , including test selection and ordering , patient conditions , quality and timing of specimen collection , handling of test requests and specimens by referring laboratories , specimen transport and communications with healthcare providers , patients and collaborating laboratories . Studies have shown that the pre-analytic phase might be the most error-prone during the total testing process in many laboratory disciplines including genetic testing .
Method : CDC published a guideline “ Good Laboratory Practices for Biochemical Genetic Testing and Newborn Screening for Inherited Metabolic Disorders ” in 2012 . Since 2013 , CDC has been collaborating with the Association of Public Health Laboratories ( APHL ) to help genetic and newborn screening laboratories in their quality improvement activities . Findings from two discussion groups held in 2013 identified a need for training to supplement the guideline . To meet this need , a new online training course titled “ Good Laboratory Practice Recommendations for Biochemical Genetic Testing : Preanalytic Phase ” was developed under the APHL- CDC cooperative agreement to help laboratory professionals and healthcare providers improve pre-analytic practices for biochemical genetic testing .
Results : This multimedia online course is now publicly available on CDC TRAIN website . The course consists of three lessons on quality assurance for test requisitions , specimen collection and submission ; laboratory-clinician communications ; and pre-analytic quality assessment . Several case scenarios are included to illustrate how the recommended practices can be used to improve preanalytic quality and patient outcomes . After completing this course , participants will be able to recognize the role of each stakeholder group in the pre-analytic processes , choose the procedures that are consistent with regulatory requirements and good laboratory practices , select indicators for pre-analytic quality assessments and explain the communication needs of each stakeholder group . Continuing education credits are available from this course free of charge , including 1.5 hours of the ASCLS PACE credit and 1.5 contact hours for Florida Laboratory Licensees .
Conclusions : The quality improvement practices discussed in this course will be helpful not only for biochemical genetic testing but also for many other laboratory areas . Feedback from the participants will be closely monitored and course evaluation results will be presented at this meeting .
Presenter : Bertina Su , MPH , Association of Public Health Laboratories , Silver Spring , MD , Phone : 240.485.2729 , Email : bertina . su @ aphl . org
Decreasing Specimen Cancellation Rates Through Submitter Education
S . Dalenberg , J . Madlem , N . Epie , K . Wainwright and J . Lovchik , Indiana State Department of Health , Indianapolis , IN
Background : Proper labeling of specimens and patient identification are critical steps in the testing process and required by regulatory
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