Lab Matters Summer 2018 | Page 86

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