Lab Matters Fall 2023 | Page 94

APHL 2023 POSTER ABSTRACTS

gained dominance was used as a proxy for the level of public health concern posed by particular sublineages . Logistic growth rates of emerging sublineages were calculated weekly : low risk variants had logistic growth rates 0.13 . Only one sublineage had a log growth rate warranting a “ high risk ” designation ( BA . 1 ), 7 sublineages met medium risk criteria ( BA . 4 , BA . 5 , BA . 4.6 , BA . 2.75 , BF . 7 , BQ . 1 , BQ . 1.1 ). These metrics were considered alongside other epidemiological indicators to inform public health responses , like proof of vaccination requirements . The public-academic partnership at the heart of RIPHL has enabled innovative techniques to be quickly incorporated into public health responses , and continued innovation will be required to continue to respond to SARS-CoV-2 and other infectious threats .

Presenter : Hannah Barbian , hannah _ j _ barbian @ rush . edu

Barriers and Facilitators to Use of Quality Management System Tools and Resources for Next Generation Sequencing in Public Health Laboratories

A . Marshall 1 , A . Violette 2 , D . Arambula 1 , H . Stang 1 , M . Korth 3 , K . Nhim 1 ; 1 US Centers for Disease Control and Prevention , 2 Oak Ridge Institute for Science and Education , 3 Booz Allen Hamilton

Introduction : Next generation sequencing ( NGS ) technologies have advanced public health practice . Public health laboratories ( PHLs ) are currently adapting NGS for various applications ; however , there are several challenges PHLs face when implementing NGS . To address these , the US Centers for Disease Control and Prevention ( CDC ) and Association of Public Health Laboratories ( APHL ) launched the NGS Quality Initiative ( QI ) to develop an NGS-focused quality management system ( QMS ) that provides ready-to-implement guidance documents , customizable standard operating procedures and other tools that support implementing sequencing workflows . To assess barriers and facilitators to use of these products , CDC used NGS QI website data to identify a sample of nine PHLs who are current or intended users of the NGS QMS products for key informant interviews . Methods : CDC used Adobe Analytics to track the number of page views , downloads , unique visitors and locations of unique visitors to the NGS QI website . We used visitors ’ zip codes and addresses of PHLs as a proxy to identify users of the NGS QMS products and then got input from CDC and APHL NGS experts to ensure a representative sample of PHLs with diverse NGS experience and geographic location . CDC piloted the interview guide with three CDC staff with laboratory and NGS expertise to ensure applicability and utility of the questions . In early 2023 , CDC will interview nine individuals from the identified PHLs about facilitators and barriers to using NGS QMS products ( e . g ., as a reference or incorporated into practice ) and additional support needed on NGS workflows . Interview transcripts will be coded and analyzed using MAXQDA and the analysis will be informed by the Consolidated Framework for Implementation Research and Diffusion of Innovations theory . Results : Lessons learned from the pilot test of the instrument with CDC laboratories were used to inform changes to the interview guide for PHLs . Each PHL has a unique experience using NGS QMS products , including whether and to what extent they use them and for what purposes . We will present key themes on facilitators , barriers , needs and suggestions for improvement from the interviews with PHLs . Conclusion : In addition to informing NGS QI activities and QMS product development , these findings will provide valuable insights into how state , local and territorial PHLs adopt guidance and resources from scientific organizations into their quality practices , the challenges they face , and the resources they need to support implementation of such guidance . These data have a few limitations : 1 ) many staff are involved in the NGS workflow but we will only be able to interview one person from each PHL , which relies on that individual to collect information from others on their experience with NGS QMS products ; and 2 ) the experiences of these PHLs may not generalize to the barriers and facilitators experienced by other PHLs .

Presenter : Ashley Marshall , isg6 @ cdc . gov

Deficiency Dilemma - A Systematic Approach for an Audit Response

S . Smith , S . Orton , W . Glover , R . Pelc , M . Creech , A . Stanback , I . Hernandez , D . Pettit , S . Shone ; North Carolina State Laboratory of Public Health

CLIA-certified laboratories must undergo regular biennial surveys to meet regulatory requirements , but also to identify areas for operational and quality systems improvements . A successful , comprehensive deficiency response , especially within a limited time frame , requires strong leadership , teamwork , and multiple resources . In 2021 , the North Carolina State Laboratory of Public Health ( NCSLPH ) successfully responded to deficiencies cited in a routine recertification survey . Deficiencies , which required a response within ten days of the audit report , were primarily related to pre-analytical systems and related operations . During the survey , NCSLPH management met daily to discuss audit progress and potential deficiencies . At the exit meeting with the auditors , the NCSLPH took extensive notes and asked questions to ensure complete understanding of the CLIA team ’ s findings . This proactive approach enabled the NCSLPH to immediately begin an audit response plan before issuance of a final report . The NCSLPH Laboratory Director assembled a multi-disciplinary team to review audit findings , define needed resources , and identify specific team members to develop a system-wide corrective action plan . Team members included : executive leadership , quality assurance , and lab managers . Resources included : project management support to assist with organization and timeline , staff reallocation to complete needed studies , consumables for needed studies , records retrieval support , IT for website updates , and laboratory outreach to develop training materials and engage submitters . A multi-faceted approach to address pre-analytical issues included an analysis of previously reported results , review of specimen acceptability criteria based upon kit inserts or validation data , and identification of specimen stability studies needed to revise acceptability criteria for clinical assays . Existing state supported courier operations were adjusted to provide specimen transport to NCSLPH to ensure specimen acceptability . As a result of the audit response , all relevant documents containing specimen acceptability criteria ( laboratory guide to services , website , method SOPs , etc .) were revised and aligned to ensure consistent messaging . The laboratory information management system ( LIMS ) was reconfigured to run daily reports to verify specimens tested met acceptability criteria prior to resulting . Retraining of laboratory staff and outreach to all submitters ( webinars and training guides ) to relay specimen acceptability criteria and new processes for submission of specimens to NCSLPH was documented . In an extremely short timeframe , the NCSLPH instituted significant changes to specimen submission procedures