We stand by our results because we know you depend on them. Crestar Labs, LLC We stand by our results because we know you depend on them. Crestar Labs is an accredited high-complexity clinical reference laboratory concentrating on esoteric toxicology and genetic analysis. We provide services to physician offices, substance abuse clinics, mental health facilities, rehabilitation programs, and much more. Our goal is to offer the provider tools for improving patient care while maximizing cost savings. Our Focus Crestar Labs recognizes its role within the drug abuse epidemic. We are here to provide healthcare professionals with dependable results when making important decisions regarding the treatment and wellness of their patients. About Crestar Labs
Accreditations & Licensure Crestar Labs is accredited through the Center for Medicare and Medicaid Services, as required by the Clinical Laboratory Improvement Amendment (CLIA), and the College of American Pathologists (CAP). Our accreditation standards and proficiency testing requirements ensure procedural uniformity, testing integrity and reporting accuracy. We have confidence that our reports, in the hands of the provider, contribute to optimized patient care. Crestar Labs licensure covers testing in 49 states (currently seeking New York licensure) Toxicology Why test for drugs? o o o o
Identify use of undisclosed substances Uncover diversion/trafficking Demonstrate abstinence and long-term sobriety Verify compliance with prescription medication Urine Analysis (pros) o o o o o Easy to collect, and plenty of it! Many inexpensive testing options available Window of detection reasonable to identify regular users Federal standardization of cutoffs and drugs detected Considered specimen of choice for drug testing
6 Urine (cons) Actual concentrations are of limited clinical value o Do not correlate with impairments o May or may not identify new use o Will not identify amount of drug taken Easy to adulterate or substitute when collections are not observed. 7 What Laboratory Tests Dont Reveal Time of drug use Amount of drug use Frequency of drug use But concentration, metabolite ratios together with toxicological info
Helps to establish boundaries - Days, weeks, months - 1 mg, 10 mg, 100 mg, 1000 mg Some specimen types provide more information than others; depends upon the question! 8 What Laboratory Tests Reveal Drug or drug class But not always what was administered (Drug source) Sometimes easy Sometimes difficult/impossible Metabolite(s) Parent/metabolite ratio Concentration/quantity Isomeric ratio Requires a special test
Important for amphetamines Specimen information, e.g., creatinine content, specific gravity 9 Our Services Why Choose Crestar Labs? We know you have other choices in the laboratory industry. Crestar focuses on quality analysis and customer support. We offer these competitive advantages over other service providers: Clinically actionable cutoff concentrations Sophisticated confirmation methodology Prompt and friendly laboratory and technical support 24hr-48hr reporting from date of receipt Easy EMR integrations
Web-based ordering and reporting Testing Options Toxicology Urine Genetics Oral Fluid Toxicology Testing Menu Getting Started New Account Enrollment Packet Practice Profile Data Initial Supply Order Patient Risk Panels Urine Patient Risk Panels Oral Fluid Patient Risk Panels Pharmacogenomics
Provider Notice Additional Steps Collector Training (if necessary) Web ordering/reporting Training UPS Shipping Training *Send all completed forms to our Sales Team Email: [email protected] Fax: 615-302-8553 Workflow Overview Post-Analytical Pre-Analytical Collection & Requisition Accessioning
Sample Processing and Testing Analysis Reporting Urine Sample Collection Overview Verify container is sterile Label the specimen cup (NOT lid) with at minimum (2) identifiers Patient name DOB Requisition Number Include date & time of collection
Include collector's initials Verify the lid is securely fastened! Refrigerate if not shipped immediately Ordering Options Screening/Qualitative Options Clinic Point-Of-Care Testing Laboratory Screening (not available if Clinic performs and bills for POCT)
Oxycodone Illicits Other Psychotics Sedatives Requisitions Web Portal-COMING SOON Order Tests Eliminates the need for paper
requisitions View Patient Results View Pending Specimens *Does your office use Practice Fusion? - Crestar Labs has the capability to interface with Practice Fusion. Sending Specimens UPS Options Standard Choice Smart Pickup 2-Click Pickup Request via custom desktop icon Automatically Prints Label Schedule same-day or next-day Pickup Allows Crestar to track packages sent Unlimited Pickups per week Options requiring Crestar approval
High Volume Clinics Custom Shipping Labels & Daily Pickups Mid Volume Clinics Custom Shipping Labels & 2-3 Pickups per Week Low Volume Clinics Smart Pickup or Custom Shipping Labels & UPS Drop Box Reporting Reports may include the following: Qualitative and quantitative results Adjusted urine drug concentrations relative to patient hydration Urine validity specifications (indicating adulteration, diversion or dilution) Outcome based associations indicating consistent or not with a drug regimen Detection window estimates based on current research and available literature Brand and generic names for easy interpretation
Reasons for Delay Missing/Inadequate Information Testing will not begin if requisition: Does not contain provider signature Ordered tests not indicated Testing will begin but Results will not be released if missing: ICD-10 diagnosis codes Payor name, contact information, & policy number
Patient address Patient phone number Patient DOB Specimen collection date Clinic will receive Missing Information Request within 24hrs of specimen receipt Rejections Mislabeled specimen cup (labelling lid is not acceptable) Missing (2) matching identifiers on cup Conflicting cup and requisition information Leaked in transit or insufficient volume Clinic will receive Rejection Notice detailing situation with 24hrs of specimen receipt
Empowering Providers Through Simplified Genomics Pharmacogenomics Testing Pharmacogenetic testing (a.k.a. PGx Testing) is a diagnostic tool that tests specific DNA sequence variations in patients. This testing then uses the latest clinical research to make predictions about how a patient is likely to respond to specific drugs. Addressing The Polypharmacy Dilemma PGx testing provides HERES THE PROBLEM... clinically relevant guidance Which drugs will likely prove effective?
of Americans take least one What dosages might be best to try at first? medication Which drugs will likely have reduced efficacy? Which drugs put the patient at risk for an of the medications ADR? patients Are there any drug-drug interactionstake to are ineffective be aware of? of Americans take five or more medications2
1 Leading cause of death in the US Adverse Drug are Reactions.3 1 THE SOLUTION Pharmacogenetic Testing (PGx) Pharmacogenetics GeneDose - The Next Level of PGx Testing Traditional (Static) Reporting
Patients genetics used to offer guidance on medications with nationally approved pharmacogenetic associations at the time of testing. Guidance is based on scientific research at the time of testing. Drug-Drug Interactions not always incorporated. Report cannot capture interpretation changes that may occur in the future. Results shared with ordering provider via fax or web portal. Pharmacogenetics GeneDose Reporting Patients genetics, lifestyle, demographics, medical conditions, & current medications used to
assess various risks of current regimen (including DDI & ADR) and to offer guidance aimed at reducing unnecessary side effects and risks. Medications can be changed or removed to produce an up-to-date report at any time. Model the use of alternative medications in silico without subjecting patients to ineffective, costly prescriptions. Format allows analysis to be updated as the clinical knowledge & applications evolve. Results shared with ordering provider & patient via separate web portals. Easily & securely share the report with additional providers. TM GeneDose Reporting Package Pharmacogenetics
GeneDoseTM Reports GeneDoseTM LIVE SafeTRx Printable pdf Report Patient Takeaway Provider Summary Provider Access Medication & Risk Modeling Update Report Any Time Invite New Providers Patient Access Update Health Survey
Update Report Any Time Immediate GeneDose Benefits TM Pharmacogenetics Patient Engaged in provider plan via consumer-centered SafeTRx Quickly identify the most effective medication(s) on an individual patient basis Reduction in medications, side effects, ADRs, and healthcare costs Share updated report electronically with any provider at no additional cost
Provider Increased patient compliance Report designed for the average clinician, not a geneticist Designed around the most actionable and reliable pharmacogenetics data Alternative medication modeling using genetics, risk factors, drugdrug interactions, side effects, and Rx cost Pharmacogenomic (PGx) Equipment Pharmacogenetics MagMAX Express-96 Deep Well Magnetic Particle Processor Automated isolation of genomic DNA utilizing magnetic bead-based technology.
Rapid, reliable isolation and sample preparation AccuFill OpenArray Microfluidics Loader Automated transfer of isolated DNA to OpenArray format Precise, reliable transfer for optimal success and consistent turnaround-time QuantStudio 12K Flex Real-Time PCR Analyzer Enhanced fluorescence detection for accurate and sensitive data analysis Accommodates a variety of formats for increased flexibility and scalability from 1 to 12,000 data points in a single run Laboratory Capabilities GeneDose Processing A Single QuantStudio 12K Flex instrument set processes 88 specimens per day Turn Around Time 3-7 Business days (negotiable)
Access Order via secure, online web portal or clients existing platform via a custom interface Advanced report options accessed via GeneDose Live web portal & SafeTRx web portal using embedded links within the pdf report Expansion Implementation of additional QuantStudios can be completed within 2-3 weeks Expansive, Reliable Test Menu GeneDose ABCB1 ABCG2 ADRA2A ADRB2 ANKK1 APOE
OPRM1 SCN1A SLC6A2 SLCO1B1 TPMT VKORC1 Platform includes the most well-characterized and the most promising pharmacogenetic sites NOTE: Governed by guidelines set by Clinical Pharmacogenetics Implementation Consortium (CPIC) SNP sites already approved by CPIC = 81 assays (targeting 23 genes) SNP sites awaiting approval of CPIC = 41 assays (targeting an additional 23 genes) Womens Health Womens Health
Infectious Disease Testing Womens Health Infectious Disease Testing Womens Health Primary Goals Accurately ID pathogenic organism as quickly as possible. Prescribe most appropriate therapy from outset. Identify drug-resistant species (e.g., C. krusei) that may require special treatment. Identify co-infections (e.g., N. gonorrhoeae and T. vaginalis) requiring multiple drugs. Identify precise cause(s) of non-specific symptoms. Conventional Testing Options Womens Health Culture
Benefits: Inexpensive, well-established. Drawbacks: Slow: days to weeks for results. Many pathogenic organisms are not culturable. Special media is required for certain organisms. Antibiotic treatment may mask growth/detection. Doesnt identify species in many cases. Source: Merck Manual, Introduction to Laboratory Diagnosis of Infectious Disease, Oct. 2016 Conventional Testing Options contd Womens Health Microscopy-based ID Benefits: typically inexpensive, can be point-of-care. Drawbacks:
Requires cell staining in many instances. Typically only indicates morphotypes, not species. Demands a skilled microscopist be available. Can only definitively pinpoint a few conditions. Source: Merck Manual, Introduction to Laboratory Diagnosis of Infectious Disease, Oct. 2016 Conventional Testing Options contd Womens Health Non-PCR-Based Nucleic Acid Testing Benefits: often point-of-care (quick answers), species-specific. Drawbacks: Limited coverage: tests identify a narrow range of microorganisms (e.g., STIs only). When test is negative, more testing often must be
undertaken to ID symptom-causing microorganism. delays, need for additional sample collection. Source: Merck Manual, Introduction to Laboratory Diagnosis of Infectious Disease, Oct. 2016 Yesterdays Options Womens Health Microscopy-based Non-PCR-Based Microbial Culture Identification Nucleic Acid Testing Typically inexpensive
Species-Specific Inexpensive Point-of-care Often point-of-care Well-established Requires cell staining Limited coverage Days to detection Requires skilled microscopist
Additional testing with negatives AB treatment may mask growth/detection May not identify species Not Species-Specific Definitive for a few conditions Need A Better Approach Sensitive Broad coverage Single collection Crestars Womens Health Solution Womens Health
Panel Testing Using Real-Time PCR Many Benefits: Specificity Real-time PCR allows Crestar to report precisely which microorganism(s) are present. Sensitivity Numerous CDC-acknowledged studies have demonstrated the improved detection rates of PCR-based methodologies over more traditional tests, especially for STIs.* *Source: Morbidity and Mortality Weekly Report, Centers for Disease Control; March 14, 2014 / 63(RR02); 1-19. Crestars Womens Health Solution Womens Health Panel Testing Using Real-Time PCR Many Benefits: Broad coverage
Comprehensive test covers 27 microorganisms from four major areas: Sexually-transmitted infections (STIs) Chlamydia trachomatis Nesseria gonorrhoeae Vaginitis Aerobic vaginitis (AV), including GroupTrichomonas B Strep Aerobic vaginalis Streptococcus Mycoplasma genitalium agalactiae Candidiasis Candida glabrata Staphylococcus aureus Candida albicans Escherichia coli
Proprietary molecular test based on the Bacterial vaginosis Candida tropicalis Enterococcus faecalis specific detection of 13 BV-associated Candida parapsilosis Candida microorganisms krusei
Crestars Womens Health Solution Womens Health Panel Testing Using Real-Time PCR Many Benefits: Flexibility Physicians can choose which individual panel(s) to run, or perform a comprehensive screen in cases where either (a) symptom profile is vague or ambiguous, or (b) multiple infections are suspected. Single sample collection Crestar can perform a fully comprehensive screen across all 27 organisms using a single vaginal swab. Rapid turnaround Crestar Labs can report full-panel results within 24 hours of sample receipt. Crestars Womens Health Solution The Better Approach Crestars Real-Time PCR Method Achieves
High level of specificity (preferably species-level information) and sensitivity. Broad coverage of the various microorganisms that can cause similar symptoms. A single, minimally invasive sample collection. Rapid turnaround times. Womens Health restar: The Differentiators Womens Health Other labs provide PCR-based screening; what sets these panels apart from others? In 2016, these methods and panels were part of a 400-patient clinical trial for diagnosing bacterial vaginosis using real-time PCR. What resulted was an interpretive algorithm which calls patients as either High (likely BV) or Low (unlikely BV).
Removes ambiguity for physician. restar: The Differentiators Womens Health I can send samples to any of dozens of clinical labs. What sets Crestar apart? We have a strong relationship with the method manufacturer that allows us to receive and share information to constantly improve our methods and implement cutting edge testing As a result, we understand the science behind everything we do. This allows us to actively improve on process and procedures, and to constantly deliver superior results. We stand by our results because we know you depend on them. Womens Health
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