Medical Laboratory Observer articles from June 2009

Medical Laboratory Observer archives from June 2009

QM: 40 years of rules & regs, training & education.(From the guest editor)(medical laboratories training and quality services)(Guest editorial)
June 1, 2009... My career has been closely aligned with the lifetime of MLO. I count it as an achievement that we both have survived so long! Much has changed during these years, but the principles and values that should guide a lab to provide quality services...

AIDS experts urge routine HIV testing.(HIV/AIDS)(University of Alabama-Birmingham recommends testing of human immunodeficiency virus )(Brief article)
June 1, 2009... AIDS experts urge routine HIV testing. Two medical organizations, along with researchers at the University of Alabama-Birmingham, have announced they strongly recommend universal and routine testing for human immunodeficiency virus (HIV) to...

Quest Diagnostics to pay $302M for misbranded test kits.(News)(Nichols Institute Laboratories and Quest Diagnostics Inc. into cases)(Brief article)
June 1, 2009... Quest Diagnostics to pay $302M for misbranded test kits. Quest Diagnostics has agreed to pay $302 million to settle criminal and civil claims that its subsidiary Nichols Institute Diagnostics (NID) knowingly sold a misbranded diagnostic test...

College launches program for clinical laboratory scientists.(Education)(Brief article)
June 1, 2009... College launches program for clinical laboratory scientists. As reported by Inside Tucson Business, in response to the nationwide shortage of qualified clinical laboratory scientists (CLS), the Department of Biochemistry and Molecular...

Many patients in ICU are deficient in vitamin D.(New studies)(Garvan Institute of Medical Research )(Brief article)
June 1, 2009... Many patients in ICU are deficient in vitamin D. Researchers at the Garvan Institute of Medical Research in Sydney, Australia, found that as many as 45% of patients in an intensive care unit (ICU) were vitamin D deficient. In the study,...

Study: Prostate cancer screenings do not reduce deaths.(Testing)(Brief article)
June 1, 2009... Study: Prostate cancer screenings do not reduce deaths The Washington Post reports that two large studies--published in the New England Journal of Medicine--failed to produce convincing evidence that routine testing for prostate cancer...

Conferences.(Conference news)(Calendar)
June 1, 2009... June 15-19, July 20-24. Noblitt & Rueland training seminars are being held at the Disneyland Resort, Anaheim, CA, on FDA and international regulatory compliance, and implementations. Visit www.fdaconsulting.com/reginfo.shtml. July 19-23....

Pieces of the POCT puzzle: point-of-care testing: changing the way patient care is delivered.(Cover story)
June 1, 2009... Point-of-care testing (POCT) is defined as testing at or near the site of patient care. (1), (2) The goal of POCT is to facilitate rapid diagnosis and faster treatment decisions to improve patient care and reduce morbidity and mortality. (1)...

Point-of-care testing: changing the way patient care is delivered.(CONTINUING EDUCATION)
June 1, 2009... MLO and Northern lllinois University (NIU), DeKalb, IL, are co-sponsors in offering continuing education units (CEUs) for this issue's article on POINT-OF-CARE TESTING: CHANGING THE WAY PATIENT CARE IS DELIVERED. CEUs or contact hours are...

A few remarks on analyzers: which end is up?(CLINICAL ISSUES)(Interview)
June 1, 2009... Troy Galloway, senior director of marketing, Automated Systems, and Eric Olson, vice president, Informatics & eBusiness, of Siemens Healthcare Diagnostics volunteered to respond to several questions about effective and efficient use of...

Lightweight compact hemostasis analyzer.(CLINICAL ISSUES)
June 1, 2009... The STart 4 semi-automated hemostasis analyzer features a patented method of electro-mechanical clot detection (viscosity-based). This method eliminates interference from lipemic, icteric, or other optically turbid samples or reagents. The...

Hepatitis B added to test menu.
June 1, 2009... The ARCHITECT CORE automated hepatitis B test for use on the ARCHITECT 1 2000 and I 2000SR immunoassay testing instruments is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG and IgM antibodies to...

Low-maintenance compact analyzer.(CLINICAL ISSUES)
June 1, 2009... The compact ACE Alera clinical chemistry system's patented closed-tube sampling ensures safety by minimizing the risk of bloodborne pathogens. The refrigerated compartment maintains specimen and reagent integrity and eliminates overnight...

Hand-held analyzer with no sample prep.
June 1, 2009... This Claros System immunoassay analyzer--similar in size to an OTC glucose meter--performs quantitative immunoassay blood tests. Due to the complexity of immunoassays, the majority of these tests can only be performed in large laboratories with...

CLIA-waived POC blood-lead analyzer.(CLINICAL ISSUES)
June 1, 2009... The new CLIA-waived point-of-care blood-lead analyzer LeadCare II system is an improved, waived version of the original LeadCare, used for physicians' office lead testing. LeadCare is part of many Childhood Lead Poisoning Prevention Programs....

Easy-to-use analyzer with RFID technology.(CLINICAL ISSUES)
June 1, 2009... The EasyRA is a fully automated, random-access clinical chemistry analyzer that accommodates the diverse needs of a small laboratory. This product offers access to all replaceable components. Its unique slide-out drawer makes maintenance a...

Random-access multiplex testing.
June 1, 2009... The BioPlex 2200 System is a fully automated, random-access multiplex testing platform. The BioPlex 2200 improves workflow with random-access sampling and priority processing. Performing multiplex analysis on the BioPlex 2200 is easy: load a...

Random access and closed tube testing.(CLINICAL ISSUES)
June 1, 2009... The Excyte Mini combines all the features a lab could want in an automated ESR analyzer, with the ease-of-use and reliability techs need. With 10 positions and half-hour test time, the Excyte Mini performs up to 20 sedrate tests per hour. Plus,...

Full automation for the hemostasis lab.
June 1, 2009... The ACL AcuStar is a specialty-test analyzer that offers full automation of highly sensitive immunoassays for the hemostasis lab. Labor-intensive specialty tests that previously required specialized training and up to two hours to perform can...

Auto analysis of principal body fluids.
June 1, 2009... COULTER LH 780 hematology analyzers deliver a full complement of automated capabilities. Corrected RBC count with high WBC interference correction automatically ensures accuracy in the presence of interfering substances. Enumeration of NRBCs...

Wide offering of testing technologies.
June 1, 2009... A broad range of ELISA tests is available along with the DSX (4-plate), and/or DS2 (2-plate) processing systems and newly added menu of automated enteric testing. Also offered by this company is the state-of-the-art AtheNA Multi-Lyte and AIMS...

Measure blood glucose and lactate.
June 1, 2009... The 2300 STAT Plus is a glucose and lactate analyzer is designed to measure whole blood or plasma simultaneously. The analyzer can also be configured to measure glucose or lactate only. Testing requires only the sensor and reagents for the...

Vitamin D: bringing light to the issue.
June 1, 2009... In recent years, a combination of widely publicized epidemiological studies. clinical trials, and impassioned written and verbal exchanges among researchers have contributed to the growing awareness of health professionals and the general...

A2LA's unger reaches warp factor nine.(Editorial)
June 1, 2009... Tool of trade. As a non-profit, membership society established in 1978, A2LA was the first comprehensive multidiscipline laboratory-accreditation system in the United States to offer accreditation for all types of testing. We now have 2,000...

Addressing management issues.(Interview)
June 1, 2009... Lab workers concerned for safety Q We work in a small community, and our doctors' office laboratory sits alone in a new construction area in a rather desolate part of town. Two of us who work after hours -- sometimes until after dark --...

Answering your questions.(complete blood count)
June 1, 2009... Quality of skin puncture CBC Q We have clinics where nurses are collecting and running CBCs on a Coulter using fingersticks only, which can result in a less than optimal sample. Even though the nurses have been trained on collection and...

Confirmatory testing reduces risk.
June 1, 2009... Q We recently had a physician tell us that we need to do a confirmatory culture on all negative rapid strep tests. Do we put the lab at risk if we do not? A The risk here is more likely to fall on the physician who chooses not to follow up...

Emerging technologies push data integration.
June 1, 2009... In an ideal world, patient data, reference intervals, and test results from both anatomic pathology and clinical laboratories flow seamlessly between systems, then into an electronic medical record where a physician can access all the...

Changes in test values crucial to quality lab reports.
June 1, 2009... As modern day labs struggle to stand out from the crowd, a proven ability to provide a more dependable and understandable result report to clients is a major goal. Physicians are monitoring patients more closely than ever and need to know what...

Transitioning medical laboratories demand flexibility.(Interview)
June 1, 2009... With the retirement of an estimated 13,000+ medical lab scientists each year for the past nine years, we have witnessed a "brain drain" of sorts in the medical laboratory. The impetus behind automating the lab is partly based on the loss and...

Insight into patient immune system.
June 1, 2009... The Pneumococcal Antibody Avidity Test builds on the company's suite of assays evaluating immune function, and is designed to help physicians better understand and manage patients who have recurrent infections. The test--along with the...

Highly sensitive H1N1 flu test with 24-hour TAT.
June 1, 2009... A well known national reference lab has introduced the first real-time polymerase chain reaction (PCR) test to aid in identifying Influenza A HIN1, the virus also known as swine flu, and differentiate patients infected with other seasonal...

Proficiency-testing programs enhanced.
June 1, 2009... The Proficiency Testing Programs from this organization are accepted by CAP, CMS, COLA, The Joint Commission, and state regulatory agencies. New and enhanced 2009 programs deal with amniotic fluid; glyco-hemoglobin for Abbott Afinion;...

Verify a range of diarrhea-causing pathogens.
June 1, 2009... The Diarrhea ACE Detection Test has a fast-acting multiplex PCR diagnostic technique to verify, simultaneously, a complex range of pathogens that cause diarrhea, including 10 bacteria {Salmonella spp., Shigella spp., Campylobacter spp., Vibrio...

Detect antiviral-resistant virus strands.
June 1, 2009... A new Cytomegalovirus (CMV) Antiviral Resistance Test accurately detects in three days or less key genetic mutations associated with antiviral resistance to CMV; most other tests' TAT is up to two weeks. The molecular test accurately detects...

Test combines risk factors and molecular markers.
June 1, 2009... The Insight Dx Breast Cancer Profile helps physicians identify the probability of a patient's cancer recurring and assess the need for chemotherapy. The new test has been clinically validated for women with early-stage hormone receptor-positive...

ELISA-based screening for HIT.
June 1, 2009... Testing for Heparin-Induced Thrombocytopenia (HIT) is now available from a national reference laboratory specializing in pediatric testing. The assay is an ELISA-based screening test that addresses heparin-induced thrombocytopenia, an...

Diagnose in utero drug exposure.
June 1, 2009... CordStat is a new alternative to testing a newborn's meconium for the presence of drugs. The test format utilizes umbilical-cord tissue as the sample matrix and has many advantages over meconium testing, which is difficult to collect. In 8% to...

From manual to auto processes.
June 1, 2009... "Over the next decade, microbiology labs will see a significant transformation from discrete manual processes to fully automated systems, allowing labs to increase throughput, enhance traceability, reduce costs, and, ultimately, improve patient...

Solving two micro problems.
June 1, 2009... "Cost saving is the No. 1 issue facing microbiology laboratories today. Our country's laboratories are under increasing pressure to save money, resulting in the need for inexpensive, yet effective, rapid manual microbiology tests. Automated...

Automation in specimen processing.(Brief article)
June 1, 2009... "A key trend in microbiology is in automation of the pre-analytical phase of the clinical laboratory path of workflow. Traditionally, automation in specimen setup of microbiology, unlike chemistry and hematology, has not been fully explored,...

Detection is key.
June 1, 2009... "With microbial resistance to antibiotics on the rise, laboratories are faced with new challenges. Rapid detection of resistance is critical to the proper treatment of patients. I think we will continue seeing medical-device manufacturers...

The modernized petri plate.(Brief article)
June 1, 2009... "Rather than reflect on futuristic musings to discern trends in microbiology, my task falls in the 'can you teach an old dog new tricks' category. In this case, the 'old dog' is the ubiquitous petri plate. It has been around for more than 100...

Today's susceptibility test needs.(Brief article)
June 1, 2009... "Growing antimicrobial-resistance concerns dictate the increased need to test isolates against antimicrobics that were previously assumed effective agents. As international travel and immigration spreads disease, it is imperative that global...

Benchtop microcentrifuges.
June 1, 2009... The Mikro 120, Mikro 200, and Mikro 220 range in capacity from 12 to 48 microtubes. Multiple rotor options are available for all three, and the Mikro 120 offers a compact footprint as well. These microcentrifuges provide powerful performance,...

Open system for nucleic-acid testing.
June 1, 2009... Jaguar offers laboratories a cost-effective, rapid solution for nucleic-acid testing. It is an open system, enabling automation of manual laboratory-developed tests resulting in a virtually unlimited menu. This flexibility will help prevent...

Breath test for SIBO.
June 1, 2009... This simple and accurate Breath Test identifies small-intestinal bacterial overgrowth (SIBO) by testing a patient's breath samples for levels of hydrogen, methane, or both. After ingesting lactulose solution, the patient produces breath samples...

Visual reference for sample volume.
June 1, 2009... Vacuette Coagulation Blood Collection Tube Labels give a visual reference to ensure sample volume is within the fill range. By having a visual reference on every tube, labs can eliminate quality-not-sufficient (QNS) samples and the need to...

Compact POCT chemistry analyzer.
June 1, 2009... The Piccolo Xpress portable point-of-care chemistry analyzer brings CLIA-waived diagnostic-testing capabilities to physician offices, clinics, and healthcare facilities. With an easy three-step operation, this analyzer delivers lab-accurate...

Scanner for immunofluorescense samples.
June 1, 2009... The ScanScope FL acquires high-resolution multicolor digital images that can be archived permanently, eliminating concerns about fading of the fluorochromes on the glass slides over time. Image acquisition is optimized by using a monochrome...

Road to denial: patient safety and quality healthcare.
June 1, 2009... The Deficit Reduction Act of 2005 reduced Medicare overpayments due to medical errors. In October 2008, the Centers for Medicare and Medicaid Services (CMS) began denying or reducing payment for specific healthcare-associated infections(HAIs):...