Publications by authors named "Corinne R Fantz"

33 Publications

A Multicenter Evaluation of a Point-of-Care Blood Glucose Meter System in Critically Ill Patients.

J Appl Lab Med 2021 Apr 10. Epub 2021 Apr 10.

UC Davis Health, Sacramento, CA, USA.

Background: Our purpose was to evaluate the performance of the ACCU-CHEK® Inform II blood glucose monitoring system (Roche Diagnostics GmbH) compared with the perchloric acid hexokinase (PCA-HK) comparator method on the cobas® 6000 analyzer (Roche Diagnostics International Ltd) in critically ill patients.

Methods: Overall, 476 arterial (376 pediatric/adult, 100 neonate), 375 venous, and 100 neonatal heel-stick whole-blood samples were collected and evaluated from critical care settings at 10 US hospitals, including the emergency department, medical and surgical intensive care units (ICUs), and neonatal and pediatric ICUs. The ACCU-CHEK Inform II system was evaluated at 2 cutoff boundaries: boundary 1 was ≥95% of results within ±12 mg/dL of the reference (samples with blood glucose <75 mg/dL) or ±12% of the reference (glucose ≥75 mg/dL), and boundary 2 was ≥98% of results within ±15 mg/dL or ±15% of the reference. Clinical performance was assessed by evaluating sample data using Parkes error grid, Monte Carlo simulation, and sensitivity and specificity analyses to estimate clinical accuracy and implications for insulin dosing when using the ACCU-CHEK Inform II system.

Results: Proportions of results within evaluation boundaries 1 and 2, respectively, were 96% and 98% for venous samples, 94% and 97% for pediatric and adult arterial samples, 84% and 98% for neonatal arterial samples, and 96% and 100% for neonatal heel-stick samples. Clinical evaluation demonstrated high specificity and sensitivity, with low risk of potential insulin-dosing errors.

Conclusions: The ACCU-CHEK Inform II system demonstrated clinically acceptable performance against the PCA-HK reference method for blood glucose monitoring in a diverse population of critically ill patients in US care settings.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/jalm/jfab005DOI Listing
April 2021

Implementation of High-Sensitivity and Point-of-Care Cardiac Troponin Assays into Practice: Some Different Thoughts.

Clin Chem 2021 01;67(1):70-78

Department of Clinical Blood Sciences and Cardiology, St George's University Hospitals NHS Foundation Trust and St George's University of London, London, UK.

Background: The primary role of the International Federation of Clinical Chemistry (IFCC) Committee on Clinical Application of Cardiac Bio-Markers (C-CB) is to provide educational materials about cardiac biomarker use, emphasizing high-sensitivity cardiac troponin assays.

Content: This mini-review, regarding high-sensitivity cardiac and point-of-care troponin assays, addresses 1) new IFCC C-CB/AACC Academy laboratory practice recommendations; 2) new and updated concepts from the Fourth Universal Definition of Myocardial Infarction; 3) the role of point-of-care assays in practice and research; 4) regulatory challenges concerning point-of-care assays; e) testing in the COVID-19 world.

Summary: Implementation of high-sensitivity cardiac troponin assays makes a difference now and into the future in clinical practice and research. Providing point-of-care high-sensitivity cardiac troponin assays and optimizing studies to allow clearance of these assays by regulatory agencies, in a timely fashion, may provide improved patient management and outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/clinchem/hvaa264DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7799201PMC
January 2021

COVID-19 Awakens a New Focus on Surge Capacity Blood Glucose Testing and the Critical Role of Telehealth in Self-Management.

J Diabetes Sci Technol 2020 Jul 2;14(4):733-734. Epub 2020 Jun 2.

Global Medical and Scientific Affairs, Roche Diabetes Care, Inc., Indianapolis, IN, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1932296820930035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673152PMC
July 2020

Confirming Point-of-Care INR Test Results.

Authors:
Corinne R Fantz

JAMA 2020 03;323(12):1190-1191

US Medical and Scientific Affairs, Roche Diagnostics Corporation, Indianapolis, Indiana.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jama.2020.0945DOI Listing
March 2020

Assay Integrity of a PCR Influenza Point-of-Care Test Remains Following Artificial System Contamination.

J Appl Lab Med 2019 11 1;4(3):422-426. Epub 2019 Jul 1.

Roche Diagnostics Corporation, Indianapolis, IN.

Background: Healthcare providers who have access to tests at the point of care (POC) are increasingly requesting the same performance from the POC test as they expect from the laboratory. With the introduction of the cobas Liat instrument, highly sensitive molecular diagnostic testing can be performed closer to the patient in CLIA-waived, POC settings. As more sensitive tests become available, there is concern regarding contamination of instrumentation owing to improper handling, mistakes made when processing, or environmental contamination. Recent concerns were raised when a nurse performed environmental surveillance for flu A/B by inserting a dry swab into the cobas Liat instrument and then ran it as a sample on the instrument, generating a positive result. This finding stimulated questions about the possibility of system contamination contributing to false-positive results, ultimately leading to the possibility of providing incorrect treatment to patients.

Methods: To assess the likelihood of system contamination contributing to the generation of false-positive results, in this study we contaminated a cobas Liat System with flu A/B-positive control material. The system contamination was then assessed by swabbing exposed surfaces. Following confirmed system contamination, negative control samples were processed to determine whether system contamination had an impact on the expected negative results.

Results: Instrument contamination was confirmed, and no detectable flu A/B signal was observed for any of the negative control tubes run immediately following confirmation of system contamination.

Conclusion: Environmental contamination of the Liat instrument does not have an impact on the integrity of the result.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/jalm.2018.028639DOI Listing
November 2019

Where Are the Preanalytical Stability Standards?

J Appl Lab Med 2018 May;2(6):830-832

Department of Laboratory Medicine, University of Washington, Seattle, WA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/jalm.2018.026062DOI Listing
May 2018

The Value of Partnerships: Patient Care Isn't Something We Should Leave to Chance.

J Appl Lab Med 2017 May;1(6):771-772

Roche Diagnostics Corporation, US Medical and Scientific Affairs, Decatur, GA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/jalm.2016.022285DOI Listing
May 2017

Current evidence and future perspectives on the effective practice of patient-centered laboratory medicine.

Clin Chem 2015 Apr 2;61(4):589-99. Epub 2015 Feb 2.

University Hospitals Leuven-Gasthuisberg, Leuven, Belgium.

Background: Systematic evidence of the contribution made by laboratory medicine to patient outcomes and the overall process of healthcare is difficult to find. An understanding of the value of laboratory medicine, how it can be determined, and the various factors that influence it is vital to ensuring that the service is provided and used optimally.

Content: This review summarizes existing evidence supporting the impact of laboratory medicine in healthcare and indicates the gaps in our understanding. It also identifies deficiencies in current utilization, suggests potential solutions, and offers a vision of a future in which laboratory medicine is used optimally to support patient care.

Summary: To maximize the value of laboratory medicine, work is required in 5 areas: (a) improved utilization of existing and new tests; (b) definition of new roles for laboratory professionals that are focused on optimizing patient outcomes by adding value at all points of the diagnostic brain-to-brain cycle; (c) development of standardized protocols for prospective patient-centered studies of biomarker clinical effectiveness or extraanalytical process effectiveness; (d) benchmarking of existing and new tests in specified situations with commonly accepted measures of effectiveness; (e) agreed definition and validation of effectiveness measures and use of checklists for articles submitted for publication. Progress in these areas is essential if we are to demonstrate and enhance the value of laboratory medicine and prevent valuable information being lost in meaningless data. This requires effective collaboration with clinicians, and a determination to accept patient outcome and patient experience as the primary measure of laboratory effectiveness.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/clinchem.2014.232629DOI Listing
April 2015

Easy bruising in a patient with secondary amenorrhea.

Clin Chem 2014 Aug;60(8):1047-50

Department of Pathology and Laboratory Medicine, Emory University, Atlanta, GA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/clinchem.2013.207746DOI Listing
August 2014

Pathology consultation on prostate-specific antigen testing.

Am J Clin Pathol 2014 Jul;142(1):7-15

From the Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA.

Objectives: To provide clarity on the pros and cons of using prostate-specific antigen (PSA) as a screening tool for prostate cancer.

Methods: Case scenarios and a literature review of recently published clinical trial data are presented to provide evidence of the controversy.

Results: PSA is a sensitive biomarker for detecting diseases of the prostate, but it is limited in its ability to distinguish cancerous from noncancerous conditions or aggressive from indolent cancers and has resulted in a considerable amount of overdiagnosis and overtreatment.

Conclusions: The analytical methodology for total PSA testing is both reliable and cost-effective, but patients should be encouraged to talk to their providers to understand the benefits and harms associated with this testing.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1309/AJCPU6OOKL9JHEURDOI Listing
July 2014

A prospective tool for risk assessment of sendout testing.

Clin Chim Acta 2014 Jul 29;434:1-5. Epub 2014 Mar 29.

Paul Epner LLC, Evanston, IL, United States.

Objective: Errors associated with laboratory testing can cause significant patient harm. Sendout testing refers to tests sent by a primary lab to a reference lab when testing is unavailable at the primary lab. Sendout testing is particularly high risk for patient harm, due to many factors including increased hand-offs, manual processes, and complexity associated with rare, low-volume tests. No published prospective tools exist for sendout risk assessment.

Methods: A novel prospective tool was developed to assess risk of diagnostic errors involving laboratory sendout testing. This tool was successfully piloted at nine sites.

Results: Marked diversity was noted among survey respondents, particularly in the sections on quality metrics and utilization management. Of note, most sites had committees who managed rules for test ordering, but few places reported enforcing these rules. Only one site claimed to routinely measure the frequency clinicians failed to retrieve test results. An evaluation of the tool indicated that it was both useful and easy to use.

Conclusions: This tool could be used by other laboratories to identify the areas of highest risk to patients, which in turn may guide them in focusing their quality improvement efforts and resources.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cca.2014.03.028DOI Listing
July 2014

Barriers to quality health care for the transgender population.

Clin Biochem 2014 Jul 19;47(10-11):983-7. Epub 2014 Feb 19.

Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA.

The transgender community is arguably the most marginalized and underserved population in medicine. A special issue focusing on men's health would be incomplete without mention of this vulnerable population, which includes those transitioning to and from the male gender. Transgender patients face many barriers in their access to healthcare including historical stigmatization, both structural and financial barriers, and even a lack of healthcare provider experience in treating this unique population. Historical stigmatization fosters a reluctance to disclose gender identity, which can have dire consequences for long-term outcomes due to a lack of appropriate medical history including transition-related care. Even if a patient is willing to disclose their gender identity and transition history, structural barriers in current healthcare settings lack the mechanisms necessary to collect and track this information. Moreover, healthcare providers acknowledge that information is lacking regarding the unique needs and long-term outcomes for transgender patients, which contributes to the inability to provide appropriate care. All of these barriers must be recognized and addressed in order to elevate the quality of healthcare delivered to the transgender community to a level commensurate with the general population. Overcoming these barriers will require redefinition of our current system such that the care a patient receives is not exclusively linked to their sex but also considers gender identity.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.clinbiochem.2014.02.009DOI Listing
July 2014

Interpreting laboratory results in transgender patients on hormone therapy.

Am J Med 2014 Feb 19;127(2):159-62. Epub 2013 Oct 19.

Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Ga.

Background: Clinical guidelines recommend laboratory monitoring of transgender persons on cross-sex hormone therapy, but gender-specific reference intervals leave clinicians with the dilemma of deciding what is "normal" for each patient. The goal of this study was to identify consistent changes in measurands with hormone therapy and determine which reference interval is appropriate.

Methods: Laboratory data were abstracted from the medical records of 55 male-to-female patients on hormone therapy and compared with 20 male and 20 female nontransgender subjects.

Results: Hemoglobin, hematocrit, and low-density lipoprotein resembled female values (P < .005), while alkaline phosphatase, potassium, and creatinine resembled male values (P < .05). Triglycerides were higher (P < .005) than either the male or female groups. The remainder of the measurands showed no differences.

Conclusions: Use of correct reference intervals in interpreting laboratory results reduces the risk of testing-related diagnostic error. Preliminary data suggest that new reference intervals need to be established for transgender patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.amjmed.2013.10.009DOI Listing
February 2014

Dermal exposure to a compounded pain cream resulting in severely elevated clonidine concentration.

J Med Toxicol 2014 Mar;10(1):61-4

Georgia Poison Center, Atlanta, GA, USA,

Introduction: Clonidine is an imidazoline derivative antihypertensive medication that is also used as adjunctive therapy for neuropathic pain disorders via topical administration. Clonidine overdose can manifest both central and peripheral alpha-adrenergic agonist effects.

Case Report: A 23-year-old man presented to an emergency department with altered mental status, bradycardia, and hypertension after suspected overdose. He had rubbed a specially compounded medicinal cream over his entire body containing clonidine 0.2 % (w/w), gabapentin 6 %, imipramine 3 %, ketamine 10 %, lidocaine 2 %, and mefenamic acid 1 %. The patient presented with severe hypertension, bradycardia, and altered mental status. He was found to have a subarachnoid hemorrhage and was treated for hypertensive emergency. Toxicological analysis of initial blood samples revealed a serum clonidine concentration of 5,200 ng/ml. At 6-month follow-up, the patient had made a full recovery.

Discussion: There are limited reports of topical clonidine toxicity, and to our knowledge, this case involves the highest concentration yet reported following clonidine overdose by any route of exposure. The severely elevated serum clonidine concentration found in our patient demonstrates the possibility of toxicity resulting from inappropriate use of such a product. At high serum concentrations, the pharmacodynamic effects of clonidine appear to cause significant peripheral alpha-1 adrenergic stimulation. Toxicologists should be aware of the increasing use of topical clonidine preparations for the treatment of neuropathic pain and the potential for toxicity.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s13181-013-0331-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3951633PMC
March 2014

Using an algorithmic approach to secondary amenorrhea: Avoiding diagnostic error.

Clin Chim Acta 2013 Aug 12;423:56-61. Epub 2013 Apr 12.

Department of Pathology and Laboratory Medicine, Emory University, Atlanta, GA, United States.

Secondary amenorrhea in women of reproductive age may be an indication of an undiagnosed, chronic condition and appropriate treatment is dependent upon accurate diagnosis of the underlying etiology. A thorough clinical assessment and a few common laboratory tests can easily identify the most frequent causes of secondary amenorrhea. However, once these have been ruled out, the more uncommon pathophysiologies can be difficult to diagnose due to similarities in presentation and appropriate laboratory testing and interpretation become critical. In these cases, misdiagnosis is unfortunately common and often the result of poor laboratory utilization in the form of a failure to employ indicated tests, the use of obsolete tests, or erroneous interpretation in the face of interfering factors or co-morbidities. Consequently, the algorithmic approach to laboratory evaluation in the context of secondary amenorrhea described in this review can minimize the risk of diagnostic error as well was decrease test volume, cost, and time to diagnosis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cca.2013.04.007DOI Listing
August 2013

Disparate hemoglobin results.

Clin Chem 2013 Mar;59(3):578-9

Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA 30322, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/clinchem.2012.195586DOI Listing
March 2013

Teaching laboratory medicine to medical students: implementation and evaluation.

Arch Pathol Lab Med 2012 Nov;136(11):1423-9

Department of Pathology and Laboratory Medicine, Emory University, 1364 Clifton Rd, Atlanta, GA 30322, USA.

Context: Laboratory medicine is an integral component of patient care. Approximately 60% to 70% of medical decisions are based on laboratory results. Physicians in specialties that order the tests are teaching medical students laboratory medicine and test use with minimal input from laboratory scientists who implement and maintain the quality control for those tests.

Objective: To develop, implement, and evaluate a 1.5-day medical student clinical laboratory experience for fourth-year medical students in their last month of training.

Design: The experience was devised and directed by laboratory scientists and included a panel discussion, laboratory tours, case studies that focused on the goals and objectives recently published by the Academy of Clinical Laboratory Physicians and Scientists, and medical-student presentations highlighting salient points of the experience. The same knowledge quiz was administered at the beginning and end of the experience and 84 students took both quizzes.

Results: A score of 7 or more was obtained by 16 students (19%) on the initial quiz, whereas 34 (40%) obtained the same score on the final quiz; the improvement was found to be statistically significant (P  =  .002; t  =  3.215), particularly in 3 out of the 10 questions administered.

Conclusions: Although the assessment can only measure a small amount of knowledge recently acquired, the improvement observed by fourth-year medical students devoting a short period to learning laboratory medicine principles was encouraging. This medical student clinical laboratory experience format allowed teaching of a select group of laboratory medicine principles in 1.5 days to an entire medical school class.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.5858/arpa.2011-0537-EPDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3767850PMC
November 2012

Effectiveness of barcoding for reducing patient specimen and laboratory testing identification errors: a Laboratory Medicine Best Practices systematic review and meta-analysis.

Clin Biochem 2012 Sep 28;45(13-14):988-98. Epub 2012 Jun 28.

Battelle Centers for Public Health Research and Evaluation, Century Plaza 1, 2987 Clairmont Road, NE - Suite 450, Atlanta, GA 30329‐4448, USA.

Objectives: This is the first systematic review of the effectiveness of barcoding practices for reducing patient specimen and laboratory testing identification errors.

Design And Methods: The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used.

Results: A total of 17 observational studies reporting on barcoding systems are included in the body of evidence; 10 for patient specimens and 7 for point-of-care testing. All 17 studies favored barcoding, with meta-analysis mean odds ratios for barcoding systems of 4.39 (95% CI: 3.05-6.32) and for point-of-care testing of 5.93 (95% CI: 5.28-6.67).

Conclusions: Barcoding is effective for reducing patient specimen and laboratory testing identification errors in diverse hospital settings and is recommended as an evidence-based "best practice." The overall strength of evidence rating is high and the effect size rating is substantial. Unpublished studies made an important contribution comprising almost half of the body of evidence.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.clinbiochem.2012.06.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4518452PMC
September 2012

Altering the landscape for women in clinical chemistry: perspectives from multigenerational leaders.

Clin Chem 2012 Jul 23;58(7):1082-5. Epub 2012 May 23.

Department of Pathology and Laboratory Medicine, Children's Memorial Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL 60614, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/clinchem.2011.174284DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3703202PMC
July 2012

Development of a fast and simple liquid chromatography-tandem mass spectrometry method for the quantitation of argatroban in patient plasma samples.

J Chromatogr B Analyt Technol Biomed Life Sci 2012 Apr 3;893-894:168-72. Epub 2012 Mar 3.

Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA 30308, USA.

An ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the direct measurement of argatroban in human plasma was developed and compared with the activity-based Hemoclot Thrombin Inhibitors assay. UPLC-MS/MS was performed using diclofenac as an internal standard. In summary, argatroban and diclofenac were extracted from 100 μL of plasma using a methanol precipitation protocol, and chromatographic separation was performed on an ACQUITY TQD mass spectrometer using a UPLC C18 BEH 1.7 μm column with a water and methanol gradient containing 0.1% formic acid. The detection and quantitation were performed using positive ion electrospray ionization and multiple reaction monitoring (MRM) mode. The UPLC-MS/MS method was linear over the concentration range of 0.003-3.0 μg/mL, with a lower limit of quantitation for argatroban of 0.003 μg/mL. The intra- and inter-assay imprecision was less than 12% at the plasma argatroban concentrations tested. Good correlation was demonstrated between the UPLC-MS/MS method and the indirect activity-based assay for determination of argatroban. However, increased plasma fibrinogen levels caused underestimation of argatroban levels using the indirect activity-based assay, whereas the UPLC-MS/MS method was unaffected. UPLC-MS/MS provides a relatively simple, sensitive, and rapid means of argatroban monitoring. It has successfully been applied to assess plasma argatroban concentrations in hospitalized patients and may provide a more accurate determination of argatroban concentrations than an activity-based assay in certain clinical conditions.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jchromb.2012.02.041DOI Listing
April 2012

Falsely decreased human chorionic gonadotropin (hCG) results due to increased concentrations of the free beta subunit and the beta core fragment in quantitative hCG assays.

Clin Chem 2010 Dec 7;56(12):1839-44. Epub 2010 Oct 7.

University of Utah Health Sciences Center, Department of Pathology, Salt Lake City, UT, USA.

Background: Earlier studies have shown that increased concentrations of certain human chorionic gonadotropin (hCG) variants can cause false-negative results in some qualitative hCG devices. The objective of this study was to determine if increased concentrations of hCGβ and hCGβ core fragment (hCGβcf) cause falsely decreased results on 9 commercially available quantitative hCG assays.

Methods: Several concentrations of purified hCGβ and hCGβcf were added to 2 sets of 6 serum samples with and without a fixed concentration of intact hCG. We examined 9 widely used immunoassays to measure immunoreactive hCG. Falsely decreased results were defined as those in which the measured hCG concentration was ≤50% of expected.

Results: High concentrations of hCGβ (≥240 000 pmol/L) produced falsely decreased hCG measurements in 2 assays known to detect this variant. Similarly, high concentrations of hCGβcf (≥63 000 pmol/L) produced falsely decreased hCG measurements in 3 assays that do not detect purified hCGβcf. Two assays were identified that detected both hCGβ and hCGβcf, and neither produced falsely decreased results in the presence of high concentrations of these variants.

Conclusions: Extremely high concentrations of hCG variants can cause falsely decreased results in certain quantitative hCG assays. Of the 9 assays examined, none exhibited falsely decreased results in the presence of hCGβ concentrations typically associated with hCGβ-producing malignancies. Two assays exhibited decreased (>50%) hCG results in the presence of hCGβcf concentrations found during normal pregnancy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/clinchem.2010.143479DOI Listing
December 2010

Patient misidentifications caused by errors in standard bar code technology.

Clin Chem 2010 Oct 11;56(10):1554-60. Epub 2010 Aug 11.

Department of Pathology and Laboratory Medicine, Emory University, Atlanta, GA 30322, USA.

Background: Bar code technology has decreased transcription errors in many healthcare applications. However, we have found that linear bar code identification methods are not failsafe. In this study, we sought to identify the sources of bar code decoding errors that generated incorrect patient identifiers when bar codes were scanned for point-of-care glucose testing and to develop solutions to prevent their occurrence.

Methods: We identified misread wristband bar codes, removed them from service, and rescanned them by using 5 different scanner models. Bar codes were reprinted in pristine condition for use as controls. We determined error rates for each bar code-scanner pair and manually calculated internal bar code data integrity checks.

Results: As many as 3 incorrect patient identifiers were generated from a single bar code. Minor bar code imperfections, failure to control for bar code scanner resolution requirements, and less than optimal printed bar code orientation were confirmed as sources of these errors. Of the scanner models tested, the Roche ACCU-CHEK® glucometer had the highest error rate. The internal data integrity check system did not detect these errors.

Conclusions: Bar code-related patient misidentifications can occur. In the worst case, misidentified patient results could have been transmitted to the incorrect patient medical record. This report has profound implications not only for point-of-care testing but also for bar coded medication administration, transfusion recipient certification systems, and other areas where patient misidentifications can be life-threatening. Careful control of bar code scanning and printing equipment specifications will minimize this threat to patient safety. Ultimately, healthcare device manufacturers should adopt more robust and higher fidelity alternatives to linear bar code symbologies.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/clinchem.2010.150094DOI Listing
October 2010

The analytical specificity of human chorionic gonadotropin assays determined using WHO International Reference Reagents.

Clin Chim Acta 2010 Jan 17;411(1-2):81-5. Epub 2009 Oct 17.

University of Utah Health Sciences Center, Department of Pathology, Salt Lake City, UT 84108, USA.

Background: Human chorionic gonadotropin (hCG) is a heterodimeric glycoprotein hormone with considerable molecular heterogeneity. There is uncertainty regarding which hCG variants are detected by different hCG assays. The analytical specificity of 8 hCG assays was investigated.

Methods: WHO International Reference Reagents for hCG, nicked hCG (hCGn), beta subunit (hCGbeta), nicked beta subunit (hCGbetan), and beta core fragment (hCGbetacf) were individually added to hCG-free human serum. Specimens were analyzed with 8 commercially available hCG assays. Equimolar detection of hCG variants was defined as a recovery of 90-110%.

Results: All assays detected hCG and hCGn with mean recoveries of 98.3 and 94.6%, respectively. Seven assays detected hCGbeta (mean recovery 103.8%) but with high variation, and equimolar detection was observed only in four. The mean recovery of hCGbetan was 85.5% but was highly variable with only two assays showing equimolar detection. With a mean recovery of 53.4%, two assays detected hCGbetacf and both underestimated it considerably. Information provided by the assay manufacturer regarding hCG variant analytical specificity was inadequate or unclear in 75% of the assays.

Conclusions: hCG assays vary considerably in their ability to detect different hCG variants. Manufacturers of hCG assays should clearly indicate the hCG variant specificity of their reagent systems.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cca.2009.10.009DOI Listing
January 2010

Diffusion tensor imaging detects axonal injury and demyelination in the spinal cord and cranial nerves of a murine model of globoid cell leukodystrophy.

NMR Biomed 2009 Dec;22(10):1100-6

Department of Radiology, Washington University School of Medicine, St. Louis, MO 63110, USA.

Globoid cell leukodystrophy is an inherited neurodegenerative disorder caused by a deficiency of the lysosomal enzyme galactosylceramidase. In both human patients and the authentic murine Twitcher model, pathological findings include demyelination as well as axonal damage in both the central and peripheral nervous system. Diffusion tensor imaging (DTI) has emerged as a powerful noninvasive technique that is sensitive to these white matter disease processes. Increases in radial diffusivity (lambda perpendicular) and decreases in axial diffusivity (lambda parallel) correlate with histopathological evidence of demyelination and axonal damage, respectively. Compared to age-matched, normal littermates, DTI of optic nerve and trigeminal nerve in end-stage Twitcher mice displayed a statistically significant increase in lambda perpendicular and decrease in lambda parallel, consistent with previously characterized demyelination and axonal damage in these regions. In the Twitcher spinal cord, a statistically significant decrease in lambda parallel was identified in both the dorsal and ventrolateral white matter, relative to normal controls. These results were consistent with immunofluorescence evidence of axonal damage in these areas as detected by staining for nonphosphorylated neurofilaments (SMI32). Increase in lambda perpendicular in Twitcher spinal cord white matter relative to normal controls reached statistical significance in the dorsal columns and approached statistical significance in the ventrolateral region. Correlative reduced levels of myelin basic protein were detected by immunofluorescent staining in both these white matter regions in the Twitcher spinal cord. Fractional anisotropy, a nonspecific but sensitive indicator of white matter disease, was significantly reduced in the optic nerve, trigeminal nerve, and throughout the spinal cord white matter of Twitcher mice, relative to normal controls. This first reported application of spinal cord DTI in the setting of GLD holds potential as a noninvasive, quantitative assay of therapeutic efficacy in future treatment studies.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/nbm.1420DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2910583PMC
December 2009

Cirrhosis originally diagnosed as nonalcoholic steatohepatitis.

Clin Chem 2008 Aug;54(8):1395-8; discussion 1398-9

Department of Pathology and Laboratory Medicine, Emory University Hospital, Atlanta, GA 30322, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/clinchem.2008.105106DOI Listing
August 2008

Use of serum FSH to identify perimenopausal women with pituitary hCG.

Clin Chem 2008 Apr 7;54(4):652-6. Epub 2008 Feb 7.

Division of Laboratory and Genomic Medicine, Washington University School of Medicine, St. Louis, MO 63110, USA.

Background: Human chorionic gonadotropin (hCG) tests are performed on many female patients before performing medical procedures or administering medications that may harm a fetus. hCG of pituitary origin has been shown to increase with age. Therefore, mild increases in serum hCG in an older patient can be of pituitary origin and does not necessarily indicate pregnancy. The inability to rule out pregnancy in perimenopausal women can create clinical confusion and may delay needed therapies. Our objective was to determine the diagnostic utility of serum follicle-stimulating hormone (FSH) concentrations to rule out hCG of placental origin in perimenopausal women with a low concentration of serum hCG (5.0-14.0 IU/L).

Methods: Seven testing centers performed 39 742 physician-ordered serum quantitative hCG tests over a 15-month period. From these, 100 samples from women 41-55 years of age with serum hCG concentrations 5-14 IU/L were identified. We performed FSH testing and patient chart review for each sample.

Results: Twenty-three patients were found to have hCG of placental origin (pregnancy, resolving abortion, or gestational trophoblastic disease), and in those cases serum FSH was 0.4-43.8 IU/L. An FSH cutoff of 45.0 IU/L identified hCG of placental origin with 100% sensitivity and 75% specificity. FSH >45 IU/L was never observed when hCG was of placental origin (negative predictive value).

Conclusions: These data indicate that quantitative serum FSH can be used to rule out pregnancy and hCG of placental origin in women 41-55 years of age with mild increase in serum hCG concentrations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1373/clinchem.2007.100305DOI Listing
April 2008

AAV2/5 vector expressing galactocerebrosidase ameliorates CNS disease in the murine model of globoid-cell leukodystrophy more efficiently than AAV2.

Mol Ther 2005 Sep;12(3):422-30

Department of Internal Medicine, Washington University School of Medicine, Box 8007, 660 South Euclid Avenue, St. Louis, MO 63110, USA.

Globoid-cell leukodystrophy (GLD) is an autosomal recessive lysosomal storage disorder caused by mutations in the galactosylceramidase (GALC) gene. Infantile GLD has a lethal course with severe cerebral demyelination that progresses to death by 2 years of age. In the current study twitcher mice, an authentic murine model of infantile GLD, were given intracranial injections of either recombinant adeno-associated virus serotype 2 encoding the murine Galc cDNA (AAV2-GALC) or the same genome pseudotyped with AAV5 capsid proteins (AAV2/5-GALC) on day 3 of age. The group injected intracranially with AAV2/5-GALC had approximately 25-fold greater than normal Galc levels in the brain, while AAV2-GALC-injected animals had 28% normal levels. The average life expectancy of twitcher mice ( approximately 38 days) was significantly (P < 0.0001) increased to 48 and 52 days for the AAV2-GALC- and AAV2/5-GALC-treated groups, respectively. The AAV2/5-GALC group performed significantly better in a battery of behavioral tests compared to untreated, AAV2-GFP-treated, or AAV2-treated twitcher animals. This longitudinal study demonstrated that AAV2/5-GALC-mediated gene therapy resulted in higher levels of Galc expression and slowed the neurologic deterioration more completely than AAV2-GALC in the murine model of globoid-cell leukodystrophy. However, the clinical improvements, as assessed by behavioral tests and life span, were only modest.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ymthe.2005.04.019DOI Listing
September 2005