Lab Matters Summer 2018 - Page 86

APHL 2018 Annual Meeting Poster Abstracts Developing a Framework for a Quality Management Systems Training Curriculum for CDC Research Laboratories New Online Course to Help Laboratory Professionals and Healthcare Providers Improve Pre-analytic Processes of Biochemical Genetic Testing 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 B. Chen 1 , B. Su 2 ; 1 Centers for Disease Control and Prevention, Atlanta, GA, 2 Association of Public Health Laboratories, Silver Spring, MD 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 non- communicable 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. 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. 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, Proces 6W2`&6VGW&W2FFW'6Vf6ƗFW2B&fVVBFRG&&VFW2VƗGF2F47FF&G2B4W2vRFWfVVB2G&rG&&6VB&W2vFFR&W6V&6&&F'Ɩ涖rVƗGF2BG&rFVƗfW'f&G2vR7&VFV@66R7GVFW2FB&VFRFRVƗGF2B5D"&6W0FWfW'F7FfFW2b&W6V&6&&F'7FfbF6FWGVƗP266WG266W63FRG&rG&6W2&fFRg&Wv&FwVFRgWGW&R27W'&7VFWfVVB'D52F2v&FG&W76W2FR7&F6VVBf"7FF&FVBvV7vFR0G&rf"4D2&&F'7FfbvRvƖvBFR'F6PbFWfVr&w&2BFW&2FB&R6R@VFW'7FF&Rg&֖rVƗG2FVw&'Bb6GV7Fp5D"&W6V&6&FW"F26W&FR7FfG&W6VFW#W7FRW6VFW'2f"F6V6R6G&B&WfVFFFtSCBsCC2VâW6F2v`WFC4D2V&Ɨ6VBwVFVƖR( vB&&F'&7F6W0f"&6V֖6vVWF2FW7FrBWv&&67&VVrf W&FVBWF&Ɩ2F6&FW'>( #"66R#24D22&VV6&&FrvFFR766FbV&Ɩ2VF&&F&W0’FVvVWF2BWv&&67&VVr&&F&W2FV"VƗG&fVVB7FfFW2fFw2g&GvF67W76w&W2VB#2FVFfVBVVBf"G&rF7WVV@FRwVFVƖRFVWBF2VVBWrƖRG&r6W'6RFFV@( vB&&F'&7F6R&V6VFF2f"&6V֖6vVWF2FW7Fs&VǗF26^( v2FWfVVBVFW"FRФ4D26W&FfRw&VVVBFV&&F'&fW762@VF6&R&fFW'2&fR&RǗF2&7F6W2f"&6V֖6vVWF2FW7Fr&W7VG3F2VFVFƖR6W'6R2rV&Ɩ6ǒf&P4D2E$vV'6FRFR6W'6R667G2bF&VRW762VƗG77W&6Rf"FW7B&WV6F27V6V6V7F@7V&֗76&&F'6Ɩ66V6F3B&RǗF0VƗG76W76VB6WfW&66R66V&2&R6VFVBFW7G&FPrFR&V6VFVB&7F6W26&RW6VBF&fR&RЦǗF2VƗGBFVBWF6W2gFW"6WFrF26W'6R'F6G2v&R&RF&V6v旦RFR&RbV67FVFW w&WFR&RǗF2&6W76W266RFR&6VGW&W2F@&R667FVBvF&VwVF'&WV&VVG2BvB&&F'&7F6W26VV7BF6F'2f"&RǗF2VƗG76W76VG0BWFR6V6FVVG2bV67FVFW"w&W6FVrVGV6F7&VFG2&Rf&Rg&F26W'6Rg&VPb6&vR6VFrRW'2bFR4424R7&VFBBP6F7BW'2f"f&F&&F'Ɩ6V6VW266W63FRVƗG&fVVB&7F6W2F67W76VBF06W'6Rv&RVgVBǒf"&6V֖6vVWF2FW7Fp'WB6f"FW"&&F'&V2fVVF&6g&FP'F6G2v&R66VǒF&VBB6W'6RWfVF&W7VG0v&R&W6VFVBBF2VWFr&W6VFW#&W'F7R766FbV&Ɩ2VF&&F&W26fW"7&rBS#CCR#s#Vâ&W'F7T&pFV7&V6r7V6V66VF&FW2F&Vv7V&֗GFW"VGV6F2FV&W&rFVWRvw&vBBf6F7FFRFW'FVBbVFFƗ2&6w&VC&W"&VƖrb7V6V2BFVBFVFf6F&R7&F67FW2FRFW7Fr&6W72B&WV&VB'&VwVF'@"EDU%27VW"#V&Ɩ4VF'0&