Lab Matters Summer 2019 - Page 82

APHL 2019 POSTER ABSTRACTS Conclusions: Rotation-molded coolers and frozen water bottles give samples longer transit times at the target temperature range between the collection site and laboratory. These studies emphasize the importance laboratory quality research can have on improving sample quality from remote locations. Presenter: David Lowe, Centers for Disease Control and Prevention, Atlanta, GA, nqu9@cdc.gov Determining a Sustainability Path for the Public Health Laboratories of the Puerto Rico and US Virgin Islands Departments of Health D.M. Rivera Nazario 1 , M. Toro 2 , G. Gonzalez 2 , K. Kines 1 , J. Pompey 1 , B. Ellis 3 , E. O’Neill 1 ; 1 Centers for Disease Control and Prevention, 2 Puerto Rico Department of Health, 3 US Virgin Islands Department of Health Presenter: Danisha Rivera Nazario, Centers for Disease Control and Prevention, Atlanta, GA, lul1@cdc.gov Development of a Multi-Certification Laboratory Quality Management Program in a Complex Laboratory Structure K. Maldonado Mena 1 , D.M. Rivera Nazario 1 , K.A. Torres 1 , J. Perez 1 , J. Pompey 1 , K. Kines 1 , A. Muehlenbachs 1 , M. Korth 1 , G. Gonzalez 2 , M. Toro 2 , E. O’Neill 1 ; 1 Centers for Disease Control and Prevention, Puerto Rico Department of Health The Puerto Rico Department of Health (PRDOH) laboratories monitor public health threats among the island and through the Caribbean. The conglomerate of these laboratories is known as the Public Health Laboratories of Puerto Rico (LSPPR for its acronym in Spanish). The LSPPR is composed of two externally certified units (clinical testing with 15 laboratories and hygiene testing with 12 laboratories), two non-externally certified testing areas (Alcohol Toxicology and Rabies laboratories), and a Proficiency Testing Program. The LSPPR has several regional facilities located in San Juan (Central Region), Arecibo (North Region), Mayagüez (West Region) and Ponce (South Region). The LSPPR has four different quality assurance certifications, the Clinical Laboratory Improvement Amendments (CLIA), Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS for its 80 LAB MATTERS Summer 2019 Presenter: K. Maldonado Mena, Centers for Disease Control and Prevention, Atlanta, GA, nhc8@cdc.gov Validation? Verification? We Have a Template for That! C. Campion, C. Grimes and S. Blosser, Indiana State Department of Health Laboratories The Indiana State Department of Health Laboratories (ISDHL) Validation Team was founded in 2016 with the goal of providing both study design assistance and a streamlined review process for assay validations, verifications, and method comparisons. Prior to 2016, validations were reviewed ad hoc and only after the study was completed. Upon review, several studies were found with fundamental design errors that required the departments to perform additional testing. ISDHL administrators decided to develop a team to review the study plans before testing starts to ensure that the study is fundamentally sound and to minimize the need for additional testing. Since 2016, the Validation Team has formalized the process for the design, execution, summary and review of validations, verifications and method comparisons, including templates for each step of the process. A study plan outlines the use and justification of the new or altered assay, the cost of the study, and the validation strategy, which includes an isolate list, type of samples, range of results, acceptable limits and a detailed discrepancy analysis plan. By writing a study plan, departments save money on validations as troubleshooting steps and specimen lists are specified and agreed upon ahead of time. This level of planning also helps to eliminate interpretation bias and excessive retesting, which are red flags for QA-review and laboratory audits. Then, after the testing is completed, a write-up is created and submitted to the Validation PublicHealthLabs @APHL APHL.org Development of a sustainable public health laboratory (PHL) system is crucial for a Department of Health (DOH) to maintain services in the event of unexpected circumstances such as decreased funding or natural disasters. Strategic planning that includes writing grant proposals to fund multidisciplinary programs (Epidemiology, Laboratory and others) within the public health system with a focus on revenue generating activities (e.g., high volume testing that can be reimbursed by health insurance, proficiency testing, and others), will enhance their preparedness to restore or continue operations. With the help of subject matter experts in health economics, a detailed study on sample processing costs to the Puerto Rico and US Virgin Islands DOH-PHLs is necessary to determine which tests would generate the highest revenue, taking into consideration processing costs, volume of samples received, and the jurisdiction’s testing priorities. Given the current financial situation of these United States territories, a proposed sustainability path for the Puerto Rico and US Virgin Islands’ Public Health Laboratories is of utmost importance. acronym in Spanish), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA). In addition, all laboratory facilities must comply with the corresponding Occupational Safety and Health Administration (OSHA) regulations. Therefore it is necessary to develop a Multi-Certification Laboratory Quality Management Program (MC-LQMP) that will help standardize procedures and policies among all LSPPR, maximize resources (such as staff, reagents, materials, funds, etc.) while strengthening communication between all laboratories and ensuring compliance of all certification and regulatory agencies. Our project plan is divided in three phases: assessment, recommendations and re-assessment. During phase 1, we developed a gap analysis tool with a scoring system to assess all laboratories before any implementation. Overall, the LSPPR complies with all certifications, but needs improvement and strengthening on some parameters. We identified several parameters not in compliance that needed to be addressed immediately; some had easy solutions while others required a more complex approach. We were able to identify overlapping requirements like documentation policies, preventive maintenance, decontamination and disinfection, quality control verifications, biosafety, etc., between the different laboratory certifications and regulatory agencies. This information will be used for the development of MC-LQMP policies and procedures manual. Future work will focus on developing recommendations regarding an implementation plan (phase 2). Finally, the re-assessment (phase 3) will let us know the feasibility and sustainability of all implementations while evaluating if any improvements or a different approach is needed. An MC-LQMP will assure sample integrity, results reliability and harmonization of laboratory processes.