Lab Matters Summer 2019 - Page 80

APHL 2019 POSTER ABSTRACTS Quality Systems Analytical Results Can Only Be as Good as the Test Portion! N. Thiex 1 , A. Price 2 , Y. Salfinger 3 , 4 , J.M. Cook 5 , H. Hickes 6 , L. Novotney 7 , C. Ramsey 8 , M. Swarbrick 9 , S. Webb 10 ; 1 Association of American Feed Control Officials, 2 Canadian Food Inspection Agency, 3 Association of Food and Drug Officials, 4 Association of Public Health Laboratories, 5 Jo Marie Consulting, 6 Montana, 7 South Dakota Agriculture Laboratory, 8 EnviroStat, Inc., 9 Minnesota Department of Agriculture, 10 University of Kentucky, Division of Regulatory Services Presenter: Robyn Randolph, Association of Public Health Laboratories, Silver Spring, robyn.randolph@aphl.org Update on the Online Course to Help Laboratory Professionals and Healthcare Providers Improve Preanalytic Processes of Biochemical Genetic Testing B. Chen 1 , B. Su 2 ; 1 Centers for Disease Control and Prevention, 2 Association of Public Health Laboratories Introduction: Biochemical genetic tests are associated with a wide range of preanalytic 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 preanalytic 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 (http://www.cdc.gov/ mmwr/pdf/rr/rr6102.pdf). 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 (https://www.aphl.org/aboutAPHL/publications/Documents/ CDCRecommendationsGoodLabPractices_OCT2014.pdf). To meet this need, an 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 preanalytic practices for biochemical genetic testing. 78 LAB MATTERS Summer 2019 Conclusions: The quality improvement practices discussed in this course are helpful not only for biochemical genetic testing but also for many other laboratory areas. Knowledge improvement and evaluation results will be continuously monitored to assess the effectiveness of this online course and to inform future training development needs. 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. Chen 1 , B. Su 2 ; 1 Centers for Disease Control and Prevention, 2 Association of Public Health Laboratories Introduction: Biochemical genetic tests 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 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 newborn screening. However, biochemical genetic tests 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 newborn screening 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. PublicHealthLabs @APHL APHL.org Laboratory activities are focused on analytical methods, and often insufficient consideration is given to the selection of the test portion. Equal attention should be paid to the selection of the test portion, as it generally introduces substantially greater error than analytical error. Representative sampling requires control of all errors. The types and sources of error in laboratory sampling, as well as approaches for mitigating the errors, are addressed in the publications entitled “Guidance on Obtaining Defensible Test Portions” or “GOOD Test Portions.” Laboratory sampling should also not be overlooked in the in the laboratory quality system. In some cases, quality assurance and quality control will be similar to what is incorporated for analytical methods, and in other cases, it will be fundamentally different. Approaches for validation and verification of sampling protocols and appropriate quality control events can also be found in “GOOD Test Portions.” Results: This multimedia online course has been publicly available on CDC TRAIN website at https://www.train.org/cdctrain/ course/1072447 since December 2017. The course consists of 3 lessons on quality assurance for test requisitions, specimen collection and submission; laboratory-clinician communications; and preanalytic quality assessment. Several case scenarios are included to illustrate how the recommended practices can be used to improve preanalytic quality and patient outcomes. Continuing education credits are available from this course free of charge, including 1.5 hours of the ASCLS P.A.C.E. credit and 1.5 contact hours for Florida Laboratory Licensees. As of September 25, 2018, 119 learners have completed the course with post test scores averaging 97%, reflecting a significant knowledge improvement from their average pre-test scores (63%). Approximately 89% of the participants stated that this training course addressed a gap in their knowledge or skills.