Services
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Laboratory services
Expertise in chemistry, toxicology, LC-MS/MS-based testing, automation, instrument selection, regulatory compliance, and unmet needs of the clinical lab.
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Scientific communication
Communication and education through lectures, seminars, slide decks, scientific writing, and publications on laboratory medicine topics.
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Expert testimony
Expert opinion in clinical toxicology including drugs of abuse result interpretation, accuracy of methodologies, and cannabis use.
Laboratory services: clinical chemistry and toxicology
Laboratory medicine plays a crucial role in healthcare by providing vital information for the prevention, diagnosis, and treatment of disease. Ongoing initiatives, such as technological advances and a shift towards personalized medicine, contribute to the continuous evolution of the field. The emergence of infectious diseases and novel drugs of abuse reminds us of the critical nature of the clinical lab and the importance of staying updated on the latest testing methodologies and surveillance techniques.
Hubbard Lab Consulting (HLC) stays at the forefront of advancement in laboratory medicine to provide tailored solutions. From implementing the latest diagnostic technologies to optimizing workflow efficiencies, HLC strives to help laboratories operate at their highest potential for superior patient care. HLC services can be conducted virtually or in person, depending on your needs and timeline.
LC-MS/MS method development and validation
Liquid chromatography tandem mass spectrometry (LC-MS/MS) is an extremely sensitive and specific technique that can identify and quantify small molecules. It is used extensively in toxicology, therapeutic drug monitoring, endocrinology, tumor biomarker monitoring, and more. Its unparalleled analytical performance makes LC-MS/MS essential to clinical labs. As a laboratory developed test (LDT), LC-MS/MS requires specialized expertise and extensive validation. While this may seem challenging, HLC can advise on analyte selection, facility requirements, laboratory workflows, method development, staff training, and LDT validation. HLC can offer educational sessions to teach technical staff on the basic concepts that must be understood to develop and maintain a robust LC-MS/MS method. We offer customized maintenance forms, validation checklists, and SOP writing assistance. Consulting packages are customized to meet your needs!
The FDA is currently revisiting their oversight discretion on LDTs. This has the potential to impact clinical laboratories and patient access to essential testing. HLC stays apprised of changes in the regulatory landscape and can offer Q&A sessions or high-level overviews of changes as they progress.
Automated chemistry testing and instrument selection
Automated testing is essential to any clinical laboratory. Whether you are considering standalone instruments or full automation, HLC can work with you to plan your laboratory space layout, aid in instrument choice, offer guidance on test menu selection, and suggest testing algorithms according to current expert guidelines. HLC has expertise in immunoassays, spectrophotometric-based tests, ion selective electrodes, ELISAs, SPEPs, blood gas analyzers, and more. HLC assists with writing maintenance and instrument use SOPs (manufacturer user guide must be provided), creating CAP-compliant training and competency assessment worksheets, as well as suggesting quality assurance practices to maintain reliable result output. Individual sessions or start-to-finish consulting are available to help you build your lab!
CAP compliance
The College of American Pathologists (CAP) sets minimum quality standards for clinical laboratories. CAP inspections can be overwhelming for both labs seeking CAP accreditation and established labs. This stress can be ameliorated with preparation and standardized practices. While not affiliated with CAP in any way, HLC can offer CAP checklist reviews, mock inspections, and advice on how to meet specific checklist items.
Pre-market direction for unmet clinical lab needs
Clinical laboratories are constantly being asked to do more with less. Initiatives aimed at reducing manual manipulation of samples, increasing automation, integrating data, and advancing technologies to provide rapid and accurate patient results are imperative. HLC recognizes these diagnostic challenges and can offer invaluable expertise to manufacturers and vendors seeking to address unmet needs in the clinical laboratory space. With a deep understanding of laboratory workflows and a pulse on emerging trends, HLC can provide a key opinion leader (KOL) to advise companies on developing solutions that effectively meet the evolving demands of the modern clinical laboratory. HLC offers a comprehensive assessment of current market needs, identification of gaps in diagnostic capabilities, and strategic guidance on product development and innovation in the fields of clinical chemistry, toxicology, mass spectrometry-based testing, and automation.
Scientific communication: laboratory medicine
With more than 15 years of experience, HLC offers expert slide content, message delivery, scientific writing, and educational services. Whether you need slide decks created, white papers written, or staff education, HLC can help!
Education
HLC is passionate about advancing knowledge and expertise in the field of laboratory medicine. We offer a range of educational services to support learning and professional development for individuals at all experience levels. HLC can develop tailored training or educational programs ranging from introductory courses to advanced workshops designed to meet your needs. This can include written content, lectures, seminars, or small interactive sessions on topics ranging from basic diagnostic testing to emerging trends in the field. Virtual and on-site lectures on topics surrounding clinical laboratory medicine are available. Educational services can include a single seminar, a lecture series, hands-on sessions, reading material, questions to assess understanding and more!
Target audiences for educational services include:
Graduate and undergraduate students
Medical students, residents, and fellows
Vendor manufacturers
Sales staff
Clinicians and healthcare professionals
Laboratorians and technical staff
Researchers
Lay audiences
Inquire today to see if HLC can offer educational services on the topics of your choice!
Presentations and slide decks
Engaging and impactful presentations are critical to effectively communicate scientific content. HLC offers presentations, seminars, or webinars on laboratory medicine topics such as toxicology result interpretation, analytical techniques, serology testing, cardiac biomarkers, and more! These lectures can be tailored to the audience and can range from small internal meetings of manufacturers and sales staff to large conference presentations for scientists and experts in the field.
If you need to present yourself, HLC offers training and coaching services that provide personalized guidance and feedback to help you deliver confident and compelling scientific presentations. Whether you’re delivering a presentation to colleagues, clients, or stakeholders, we offer professional services to help you create compelling slide decks or posters that captivate your audience and convey your message with clarity. HLC assists with PowerPoint design, animation, and content delivery for both oral and poster presentations. Let HLC help you create visually appealing posters or slides that effectively showcase your research and capture the attention of attendees. HLC will work closely with you to create professionally crafted content that aligns with your branding and effectively communicates your key messages.
Scientific writing
Effectively communicate with your clients or intended audience through professionally written reports, newsletters, or articles. HLC specializes in clear and concise scientific communication. Whether you’re an educational institution, laboratory staff member, clinician, or sales representative, we offer a range of scientific writing services tailored to meet your needs.
HLC offers writing assistance for:
Articles and editorials
Textbooks and chapters
Curriculum and education material
Standard operating procedures and laboratory policies
Training manuals
Reports, internal communications, and newsletters
For students working on a research paper, thesis, dissertation, or presentation, HLC offers personalized tutoring and editing services.
Expert testimony: toxicology and clinical laboratory results
HLC offers expert witness reports, position statements, and testimony backed by unparalleled expertise and unwavering credibility. Specializing in clinical toxicology, HLC supports legal cases that require scientific insight and analysis. HLC offers comprehensive explanations of laboratory practices, methodologies, regulations, toxicological result interpretation, and cannabis use. Contact us today to see if HLC can offer expertise to support your legal strategy.
Toxicology
HLC brings a wealth of expertise encompassing various methodologies crucial for accurate analysis and interpretation of toxicological results. HLC’s proficiency spans from the initial screening phase to the confirmatory testing process, and HLC is well versed in intricacies of different methods, including immunoassay techniques, specialized point-of-care testing cups, and the gold standard analysis of liquid chromatography-tandem mass spectrometry (LC-MS/MS). Each method has its strengths and limitations, and the ability to navigate these nuances allows for reliable evaluation of results.
HLC possesses a keen understanding of over the counter and prescribed medications that may lead to unexpected results. Conscience resources to help to identify incidental exposure are limited, and only a seasoned toxicologist can offer insight into individual cases. HLC will meticulously evaluate and contextualize test findings and comment on the certainty of genuine substance use versus incidental exposure.
When it comes to result interpretation, HLC employs a detailed approach that considers various confounding factors, including the sensitivity and specificity of the testing method, potential cross-reactivity with other substances, and the pharmacokinetics of the compounds involved. This comprehensive analysis ensures that expert testimony is grounded in scientific rigor and lends invaluable clarity to legal proceedings.
Laboratory quality
CAP-accredited laboratories document daily quality assurance practices and undergo regular inspections to ensure compliance with regulatory guidelines. Prior to using a test on patients, it must undergo rigorous validation to demonstrate the robustness and reliability of the assay’s performance. HLC offers a meticulous review of method validation data to assess the quality and reliability of testing methodologies. By scrutinizing validation parameters such as accuracy, precision, specificity, sensitivity, matrix effect, reportable ranges, detection limits, and interferences, HLC can comment on the reliability and reproducibility of the assay used. In addition, HLC can review any provided laboratory documentation to assess overall quality of patient testing. This rigorous quality assessment enhances the credibility of expert witness reports and testimony, providing legal professionals with the assurance of scientifically robust analyses for any laboratory testing.
Cannabis use
As states continue to legalize cannabis, there has been a significant increase in its accessibility, leading to a surge in cannabis consumption among individuals. This trend underscores the importance of understanding the complex interplay between cannabis use and its potential legal implications. As a seasoned expert in cannabis toxicology, HLC offers specialized insights into expected concentrations of cannabinoids in various biological fluids over time, windows of detection, and the acute impact of cannabis on driving performance. HLC can relate complicated concepts such as self-titration, interindividual variation, smoking topography, and frequency of use to the (un)certainty of results in a given case. HLC’s commitment to delivering thorough, accurate, and scientifically sound reports ensures that attorneys have the necessary support to navigate complex cases involving cannabis-related issues with confidence and clarity.
