ABSTRACT
Community pharmacists' roles have expanded in recent years to include offering test and treat programs where they perform testing on Clinical Laboratory Improvement Amendment (CLIA)-waived point-of-care testing (POCT) devices to diagnose specific acute infectious conditions, such as influenza and group A streptococcus (GAS) pharyngitis, and then potentially prescribe and dispense appropriate antimicrobials. Availability of these services in pharmacies has several benefits, including increased access to care, decreased overutilization of other health care services, and decreased antimicrobial resistance. States have different requirements for collaborative practice agreements and reimbursement for these clinical services in community pharmacies. Several studies have looked at outcomes related to community pharmacies implementing test and treat programs for influenza and/or GAS. Other studies looked at outcomes related to implementing testing for SARS-CoV-2 and referring for treatment. Most studies described successful implementation and barriers to integration of these programs into pharmacy workflow. Some studies showed that patients want these services to be offered in community pharmacies and are willing to pay for the services. Data show that these services are cost effective compared to physician provider-based treatment. Newer CLIA-waived POCT technology may increase implementation of these services, but studies are needed to evaluate their utility in community pharmacies. Pharmacy schools should implement widespread training on these devices, and research should continue in this area to test the use of newer technology (i.e., multiplexed devices) and their economic impact.Copyright © 2023 Pharmacotherapy Publications, Inc.
ABSTRACT
African Americans (AA) have higher incidence and mortality rates for several cancer types in comparison to their European American (EA) counterparts. Increasing participation in clinical research and patient registries, related to precision cancer medicine, will significantly improve cancer health equity. Many AA cancer patients are treated in community oncology clinics. Unfortunately, these health systems have limited access to Clinical Laboratory Improvement Amendments (CLIA) next generation sequence (NGS) germline and somatic DNA and RNA testing that are used to inform oncologists on the best treatment and/or clinical trial options for cancer patients. Indeed, AA CLIA NGS sample sets are poorly represented, which could presumably result in incomplete knowledge of genomic variants that could affect their treatment and overall outcomes. Hence, it is crucial to implement CLIA NGS efforts for all cancer patients. To address these disparities, Morehouse School of Medicine has formed the Comprehensive Approach to Reimagine health Equity Solutions (CARhES) consortium with Tuskegee University that has engaged community oncology practices in Alabama and Georgia - two of five Black Belt states. The CARhES consortium aims to implement precision cancer medicine to underserved and underrepresented communities that will improve the standard of cancer care by providing access to CLIA NGS testing, clinical trials, and personalized cancer care. Here we describe the first proof of concept of this approach with community oncology partners, i.e., Grady Health System, Wellstar Health System, Georgia Urology, Midtown Urology, and Maui Memorial Medical Center. At the time of consent, saliva, buccal, and tumor samples were collected from participants. Germline and somatic CLIA NGS was performed, and medical reports were returned to practitioners within 14 days. Prior to the COVID pandemic, the study enrolled over 880 patients with a 88% consent rate (n = 1000) in the first 11months of the program. At the start of the COVID pandemic, recruitment efforts were suspended for four months with a slow restart by June 2020. A decrease in the number of staff, office visits (67% reduction), and increase in COVID cases significantly limited recruitment efforts. During this slowdown, we established and improved eConsenting capabilities, which exist today. Community anxiety, due to the pandemic and SARS-CoV-19 vaccine efforts, resulted in a significant reduction in consent rates (88% to 60%). Nevertheless, this study began in April of 2019 and consented 1,750 participants in less than 2 years. Taken together, our study shows that a community-focused precision medicine approach requires meeting people where they are and providing them with access and understanding the benefit of clinical trial participation. The approximate 2,000 clinically annotated genomic AA datasets will greatly contribute to our understanding of cancer health disparities and among the first steps to democratize precision medicine.
ABSTRACT
Introduction: The emergence of the SARS-CoV-2 virus, the cause of the COVID-19 pandemic, in late 2019 put every country on high alert and led to major changes in global diagnostic testing capability in infectious disease. From the outset it was apparent that local health authorities were under-prepared and under-staffed to cope with the rapid onset and spread of the disease. Demand for SAR-CoV-2 testing soared, highlighting the limitations of capacity in existing infectious disease laboratories along with requests from governments to support growing testing need. We partnered with US and UK Governments to establish, supply, staff and operate three large-scale, high-throughput SARS-CoV-2 testing facilities. These were ultimately established in Valencia, CA, offering testing of up to 150k samples per day, and in Loughborough and Newport, UK, offering a combined testing of up to 70k samples per day. The biggest challenge faced globally was the unprecedented scale of testing required and the timeframe to deliver a reliable and sensitive high-throughput assay. The benefits of industry and government partnerships become evident along with having a dedicated supply chain to feed the reagent and consumable needs for high-throughput testing as well as a highly accurate test with a fast turnaround time. Experts from multiple divisions, including R&D, Genomics, Enterprise, and regional centres were bought into the project, resulting in the establishment of SARS-CoV-2 testing within the three facilities in approximately eight weeks. Clinical testing experts in high-throughput, newborn screening, and rare disease testing, built molecular testing pipelines for the facilities based around the use of real-time polymerase chain reaction (RT-PCR) assays and sequencing. Laboratories were setup to meet the requirements set by various regulatory and accreditation agencies such as Clinical Laboratory Improvement Amendments, College of American Pathologies, the UK National Health Service validation group and ISO15189. Methods: Underpinning the testing was the massive IT and bioinformatics effort to enable reporting of the testing outcomes to the relevant authorities. We were able to deploy a novel LIMS system that is used throughout the laboratories to maintain sample chain of custody from arrival at the facility to reporting of results and incorporating interpretive software to support clinical interpretation of the resulting RT-PCR data. The LIMS systems are constantly undergoing improvement to support interpretation and troubleshooting. Local experts in clinical interpretation and reporting were onboarded to augment data analysis and ensure high-quality and reliable reporting whilst ensuring that clinical governance remains at the centre of all activities. Results: Before any SARS-CoV-2 testing was able to commence, several significant challenges were overcome by combining the expertise of our global teams with the local knowledge and support of the respective Governments. Experts in logistics and program management were able to convert three empty facilities with no pre-existing laboratory infrastructure into fully functional clinical testing laboratories within eight weeks. Our assay manufacturing capacity was majorly expanded to accommodate the requirements of SARS-CoV-2 testing, with all three facilities operating on automated platforms and utilizing chemistry with a dedicated secure supply chain. The final major challenge was rapid onboarding and training of staff for the facilities, and a year out, the two active facilities are currently employing over 600 individuals. Conclusion: To date the three facilities have performed over 12 million SARS-CoV-2 RT-PCR assays and SARS-CoV-2 testing will continue into 2022. The number of cases is again growing globally, and with the emergence of new variants and continual uncertainty about the impact on existing vaccines, there is an ongoing requirement for this scale of testing. From the experience of the SARS-CoV-2 global pandemic, the benefits of industry and government collaboration or the public has become much clearer, including greater access to large-scale testing options, significant reductions in time-to-testing and reporting and the rapid deployment of modern, cutting edge technology in diagnostic and monitoring programmes and eventually reduced costs to health services from mass-production. Ultimately the longevity of the individual testing facilities is unclear, but the future of large-scale clinical testing has changed forever and the legacy of this is the clear benefit to everybody when industry and governments work together to provide the public high quality and reliable testing operations.
ABSTRACT
Clinical molecular genetics laboratories have expanded rapidly in the last 15 years, incorporating new technologists at an astounding rate that has brought rare disease testing out of research labs and into standard of care medical practice. These laboratories have had to adapt a succession of new technologies and methods of data analysis while building in-house expertise. When the SARS-CoV-2 virus, the cause of COVID-19, emerged in early 2020 and quickly spread across the globe, many areas of the United States (U.S.) when into lockdown. Noncritical healthcare appointments were postponed resulting in a dramatic drop in the number of samples being referred for genetic testing for rare diseases. As large genetics laboratory experienced the resulting drop in volume, the demand for SARS-CoV-2 testing soared. Equipped with expertise in high throughput testing, as well as clinical technologists trained in high-complexity testing, large genetics laboratories stepped in the fill the gap, a measure that kept laboratories running and staff employed. Our expertise in highthroughput high-complexity led from requests to perform testing in in our genomics laboratory to building new laboratories in both the U.S. and the United Kingdom (U.K.). These efforts resulted in building three laboratories from an empty space to a functioning, staffed clinical laboratory in approximately eight weeks. These laboratories employ over 1200 individuals (∼550 U.S. and ∼700 U.K.) with plans to expand to over 2000. To date, these laboratories have performed ∼2.5 million SARS-CoV-2 assays. Challenges included navigating state, federal, and country regulations and rapidly training a large clinical staff while ensuring optimal assay performance. Clinical testing in the U.S. is governed by the Clinical Laboratory Improvement Amendments (CLIA), which provide very specific requirements for personnel, training, proficiency testing and the quality management system. However, high complexity molecular testing for a viral target could fall into the CLIA category of general chemistry (as does molecular genetic testing) or microbiology, subcategory virology. The category chosen has dramatic effects on the specific experience required for technologists, supervisors and the laboratory director. Outside the U.S., laboratory requirements are dictated by accepted best practices and accrediting agencies, rather than specific laws, sometimes making it difficult to know what requirements need to be met. Various assays with slightly different designs are available, and the assay used must be best suited to the testing workflow. In the U.S., samples collection is supervised by a healthcare provider. A higher sensitivity assay that does not include an internal human control genewas chosen. In the U. K., home collection is allowed, therefore, an assay that includes a human RNAseP gene control but with lower sensitivity for SARS-CoV- 2 was chosen. Given the current global awareness of respiratory virus activity and spread, there is a growing demand for newand expanded testing. Combining SARS-CoV-2 testing with influenza, RSV and potentially other viruses is clinically desirable. Pooling of samples will allow for even greater throughput while reducing the demand for increasingly scarce consumables. Finally, our experience with highthroughput sequencing is allowing us to pivot quickly to viral genome sequencing, which is proving critical to understanding and combating this pandemic. Rare metabolic diseases, intellectual disabilities and hereditary cancer syndromes will always still need attention and continuous innovation. We will need to learn to balance these activities and continue to support testing needs for these in addition to emerging diseases.