In 2017, the Washington State Legislature passed HB 1427, which mandated that boards and commissions for five prescribing professions (dental, medical, nursing, osteopathic, and podiatric) enact comprehensive opioid prescribing rules.  The bill also expanded access to Prescription Monitoring Program (PMP) data to multiple audiences using newly created reporting methods. 

Using best practice guidelines, including the Agency Medical Directors’ Group and CDC guidelines, the professions have recently adopted rules for acute, subacute, and perioperative prescribing and they amended their existing chronic pain rules. The rules also provide direction to practitioners in a variety of other areas of opioid prescribing, including patient notification for opioid risks, storage and disposal; use of alternative therapies for pain; continuing education requirements; co-prescribing of naloxone with high-dose opioid prescriptions; and registration and use of the Prescription Monitoring Program, or PMP.

Find out how what these new regulations say and don’t say and what they mean for opioid prescribing in the future. The session will also talk about education and outreach resources available to prescribers, patients and the public on the opioid rules.

Drug overdose surpassed motor vehicle accidents as the leading cause of accidental death 2006 and has remained the leading cause of accidental death at the state and national level.  Most drug overdose deaths involve at least one prescription drug.  The state of Washington has implemented measures to help in the battel against the prescription drug overdose epidemic including our Prescription Monitoring Program (PMP). Washington’s PMP is designed to help promote patient safety by giving providers the ability to review accurate controlled substance history of patients in their care.  This data is essential for preventing duplicative prescribing; identifying patterns of misuse and, and for care coordination.  This overview will demonstrate ways providers can use data from the PMP to ensure safe prescriptive care for their patients. 

The main problem for insufficient cervical cancer screening globally (less than 20% women at risk) is outreach failure. Enabling POCs with modern IT/mobile technology and connecting them with remote medical centers could solve the problem.

The Global Academy for Women's Health has studied this problem and has proposed one option for its solving this problem and its solution. The optimism for success is coming from the improved Pap test, the new MarkPap(r) test and platform technology offering a composite biomarker which provides instant evaluation of metabolic, cancerogenic and HPV effects on the specimen. It is both cytological and HPV disease testing (dual testing) in one test. It enable IT exchange of files and protocols for global networking via mobile and Internet connection between scattered POC and medical centers and with a protocol for turn-around of data within hours and timely intervention. The specimen is processed in the local POC and Images are transmitted by cell phone camera (Mobile Pap) for evaluation. Further, the presence of this biomarker allows home specimen collection and mailing the specimen to the local POC. This is a dramatic increase in the outreach for screening enabling women living in rural areas, far from medical institutions of any kind, to participate in screening. As announced, this program is aimed to start in parallel with developing local infrastructure enabling sustainability of the new developments. This is exactly according to the recommendation of WHO and dr Tadros Adhanom Ghebreyesus, Director General of WHO, who is acquainted with our work and supports our initiative.

Cervical cancer is the 4th most common cancer worldwide with 528,000 new cases and 266,000 deaths every year. It is also the only cancer 100% preventable. It has been extensively proved, that cervical cancer is caused by persistent infections with the human papilloma virus, termed high-risk HPV. In these persistent infections, there is a characteristic cumulative process called hypermethylation, which can eventually silence some critical tumour suppressor genes of the host cells.

Only around 20% of CIN2/3 lesions will progress to cancer, but still the majority of these are overtreated by ablative therapy leading to comorbidity, especially for women in their child bearing years. 

Hypermethylation of FAM 19A4 and miR124-2 have been shown to be reliable markers of disease progression, and can be used to determine if a CIN2/3 lesion is transforming into carcinoma.

QIAGEN´s QIAsure Methylation Test identifies cervical cancer and the preceding CIN lesion with high short-term progression risk. It has been validated in six different European screening settings as a triage test applicable for both HPV and/or cytology screened populations. It brings valuable benefits for the physician, the patient and has proven to improve cost effectiveness for health care organizations and insurance companies.

Clinical testing with next generation sequencing requires a complex bioinformatics pipeline to process raw DNA sequence into  interpretable variants for medical reporting. With sequencing costs dropping and medical testing trending towards larger targeted panels, exomes, and even genomes, bioinformatics pipelines are under a pressure test to perform at scale. This talk will provide a high level overview of best practice recommendations for leveraging team resources to build scalable bioinformatics solutions that can seamlessly scale from small to large sample volumes. This talk will highlight best practice strategies and automation tools to efficiently build and validate clinical bioinformatics pipelines to handle large sample volumes without sacrificing quality and discuss solutions for monitoring performance of a scalable bioinformatics ecosystem in production.

Point-of-care testing (POCT) allows for prompt clinical interventions by returning fast and reliable results near patients. This important role in patient management has led to the widespread use of POCT across clinical settings. With the increased availability of POCT devices, it is not uncommon to find different device types for the same test within the same institution. This diversity of methods for the same test could confound the quality and efficiency of care delivery, hence standardizing POCT instrumentation would lead to improved patient care. 

This presentation will review the scope and history of the chronic pain and opioid epidemic in the US.  It will then discuss how chronic pain and opioid use is being dealt with in community settings, with a focus on primary care physicians.  The presentation then discusses the application Lipsky's theory of street level bureaucracy to explaining physician and patient behavior related to chronic pain and opioids.  Implications for standard laboratory testing for opioid use and its application to the community is discussed.   

Second and third generations of PTH immunoassays currently available on the market demonstrate significant variability with up to 4.2 fold difference in measurements depending on the method used. Such significant variability is due to differences in antibodies specificity, lack of proper calibration or potential interferences. Pre-analytical conditions, such as sampling and storage, also play significant role in stability of PTH. The measurement inconsistencies between methods, as well as pre-analytical challanges complicate establishment of treatment and prevention cutoff values. The main effort of the PTH IFCC working group is to improve calibration of currently available assays using the available reference material.  

The development of mass spectrometry-based reference measurement procedure is also underway. Ideally, the reference method should allow for differentiation of intact PTH (1-84) and its fragments. Standardization of PTH will provide an opportunity for accurate diagnostic and improved pathophysiologic insight into CKD-MBD, hypo- and hyperparathyrioidism.

As the compendium of putatively disease causing variants expands, gathering the most current and accurate information is critical to computing variant classifications. The QIAGEN knowledgebase includes the most extensively curated database of variant specific publications, including functional studies and clinical cases. QIAGEN Clinical Insight (QCI) leverages this information to invoke all ACMG rules to automatically compute variant classifications. In this webinar, you will see how QCI classifies over 6,000 ClinVar expert panel assessed BRCA1 and BRCA2 variants with incredible accuracy. With respect to clinical actionability, QCI automated ACMG classification was 99.6% concordant with ENIGMA expert panel variant assessments. This level of accuracy speaks to the quality of the clinical, functional, and population level data in the knowledgebase, as well as the robustness of the underlying algorithm used to apply the ACMG guidelines.

Decades of innovation have brought us into a new era of mass spectrometry with the design of Agilent’s revolutionary Triple Quadrupole LC/MS. Ultivo is packed full of the same power and accuracy you’ll find in the big guys but at a fraction of the size.
It’s on a transformative mission to reshape expectations, redefine capabilities, and reassess what’s possible when small meets powerful. 

We will specifically discuss clinical research applications such as quantification of synthetic fentanyls and testosterone using the Ultivo LC/TQ. A new single software interface designed for your entire workflow, from sample submission to reporting, will also be discussed. 

Learning Objectives: 

1. Learn about the instrument innovations that make the new Ultivo Triple Quadrupole possible. 
2. Discover some of the many clinical research applications that the Ultivo LC/TQ can perform.
3. Understand the user experience improvements implemented, including maintenance and software enhancements. 

With significant decrease in the cost of sequencing in numerous commercial as well as cancer center–driven initiatives, genomic profiling is increasingly becoming routine across multiple cancer types. There is a large amount of diverse omic-data that has been generated, which are either publicly accessible through numerous repositories or managed through controlled data archives. However, the sheer volume and diversity of the data presents a significant challenge in data management and analysis. 

OncoLand is an integrated oncology genomics repository and visualization platform. Feature tremendous numbers of consortia data and tens of thousands of processed and carefully curated cancer genomics datasets from public domains. The OncoLand tool enables investigators to easily query and navigate a gene or sets of genes of interest in multiple tumors across data from different platforms, including DNA mutation, gene expression and fusion, copy number, protein, and methylation. The built-in Omicsoft Genome Browser (OGB) allows a detailed view of coverage, gene fusions and alternatively spliced isoforms. OncoLand contains a variety of modules for integrative analysis, comparisons, and clinical associations explorations. OncoLand has become an invaluable platform to accelerate successful cancer research and clinical innovations.

As the diagnostic test menu has increased in size and complexity, healthcare providers are in great need of advice on appropriate test selection and result interpretation. To address this need, diagnostic management teams headed by expert lab leaders have emerged in multiple clinical areas. Despite the great clinical need for such consultative advice for large numbers of patients, diagnostic management teams have been implemented in a limited number of institutions. This presentation will address the details of the 4 main barriers to implementation. The first barrier is the modest or absent payment for this important clinical activity. The second barrier is the limited number of individuals available to provide expert advice on test selection and result interpretation. The third problem relates to the technical issues of connectivity between the laboratory expert and the healthcare provider requesting advice. Finally, the fourth major barrier is the change in culture required within our own discipline to prioritize patient care at or above specimen management. These 4 barriers will be discussed and potential solutions will be offered.

Sepsis is the Achilles’ heel of health care. Despite being relatively unknown to the public, it is a top killer in hospitals and the cost burden is crushing to our healthcare system. More and more, sepsis is keeping hospital CFO’s up at night and is the focus of widespread hospital initiatives. And labs play a critical role in providing a solution that provides return on investment for hospitals and improves patient care.

Hospitals’ top defense against sepsis today is empiric therapy, a probability based approach with broad-spectrum antibiotic care in the absence of species-specific information about the cause of a patient’s infection (if they have an infection at all). Despite the successes of empiric therapy, it is still severely limited by lack of actionable diagnostic information, with studies demonstrating that up to 40% of bloodstream infections receive incorrect treatment.

In this talk, entrepreneur and CEO John McDonough will share how lab implementation of rapid diagnostics can significantly improve empiric therapy, reduce costs, and potentially save lives. New tests now available in over 160 hospitals worldwide allow for more targeted empiric therapy, improving patient outcomes and driving down hospital costs through reduced length of stay and pharmacy costs. Mr. McDonough will present on the breakthrough T2Bacteria and T2Candida Panels, the first FDA-cleared tests to directly provide species-specific results for sepsis-causing pathogens in 3 to 5 hours, without the wait for blood culture. 

 
Learning Objectives: 

1. Review the efficacy of empiric therapy for patients at risk of sepsis and blood stream infections
2. Describe the limitations of current sepsis management
3. Review T2MR technology for rapid identification of bacterial pathogens
4. Describe ability for breakthrough diagnostic technology to improve empiric therapy and provide faster, targeted therapy