Showing papers in "Clinical laboratory science : journal of the American Society for Medical Technology in 2008"

Lower limit of assay sensitivity: an under-recognised and significant problem in von Willebrand disease identification and classification.

Abstract: von Willebrand disease (VWD) is the most common inherited bleeding ailment, and is characterised by low levels of, or abnormal function in, the plasma protein von Willebrand factor (VWF). However, the laboratory testing process is problematic because of both the heterogeneity of VWD and the limitations in the tests used to identify reduced or abnormal VWF. OBJECTIVE: This study reports on the lower levels of sensitivity for the different assays used in the diagnostic process for VWD and their significance in the diagnostic identification and classification of VWD. METHODS: The RCPA Haematology QAP is an international external quality assurance (EQA) program that includes VWF/VWD testing within one of its special haemostasis modules. Over the past 10 years, over 50 samples have been distributed to participants, including five samples devoid of VWF and derived from either true Type 3 VWD patients or else from commercially purchased VWF deficient plasma. Samples were tested blind by study participants, who report back both numerical values (for VWF and Factor VIII:C) and an interpretation regarding whether or not VWD is suggested by laboratory findings, and if so, the probable VWD subtype. RESULTS: Returned data indicates that the lower level of sensitivity (LLS) tends to be around 5-10U/dL for Factor VIII:C, VWF antigen (VWF:Ag), VWF collagen binding (VWF:CB), and VWF ‘activity’ (VWF:Act), but can reach 20U/dL or more for VWF ristocetin cofactor (VWF:RCo). There does not appear to be any improvement over the past decade despite ongoing automation of methodology, and indeed, automation does not seem to provide better LLS performance. CONCLUSIONS: Limitations in the LLS of VWD testing have significant implications in terms of the identification and classification of an individual9s VWD, given that these laboratory assays are used to identify VWD and help characterise functional VWF discordance, and that the majority of severe VWD subtypes have levels of VWF below 20U/dL. Thus, laboratories will sometimes be unable to distinguish whether VWF deficient samples derive from Type 3 VWD or severe Type 1 VWD or even Type 2 VWD. ABBREVIATIONS:ELISA = Enzyme Linked Immuno-sorbent Assay; EQA = external quality assurance; LIA = Latex Immuno-Assay; LLS = Lower limit of sensitivity; QAP = Quality Assurance Program; VWD = von Willebrand disease; VWF = von Willebrand Factor; VWF:Act = von Willebrand Factor ‘Activity’ (assay); VWF:Ag = von Willebrand Factor Antigen (assay); VWF:CB = von Willebrand Factor collagen binding (assay); VWF:RCo = von Willebrand Factor Ristocetin Cofactor (assay).

Rheumatoid factor and anti-CCP autoantibodies in rheumatoid arthritis: a review.

Abstract: For many years, laboratory diagnosis of rheumatoid arthritis has relied on the detection of rheumatoid factor. A new assay that detects antibodies to citrullinated peptides, called the anti-CCP assay, has demonstrated a comparable sensitivity but a much higher specificity than the RF test. This paper reviews RF and anti-CCP in rheumatoid arthritis and examines the usefulness of each autoantibody in RA testing.

Growth inhibition of human colon cancer cells by plant compounds.

Abstract: OBJECTIVE: Evidence is accumulating that compounds of plant origin (phytochemicals) exert anti-cancer effects The purpose of this study was to determine if resveratrol, cinnamaldehyde, and piperine (from red grapes, cinnamon, black pepper respectively) have anti-proliferative effects on colon cancer DESIGN: Quantitative effects of each phytochemical on concentration responses and time courses of proliferation of cultured human colon cancer cells (DLD-1) were assessed SETTING: Research was performed at Saint Louis University MAIN OUTCOMES MEASURES: Responses were measured by spectrophotometry of surviving cells stained by a dye method RESULTS: Phytochemicals displayed anti-proliferative effects on DLD-1 cells in concentration- and kinetic-dependent manners Cinnamaldehyde offered statistically significant effects at 24 hours [200 μM], 48 hours [100 - 200 μM], and 72 hours [200 μM] Piperine displayed a trend towards anti-proliferation at 24 hours and statistically significant inhibition at 48 and 72 hours [100 - 200 μM] Resveratrol displayed significant anti-proliferative effects at 24 hours [50-200 μM], 48 hours [10-200 μM], and 72 hours [10-200 μM] CONCLUSION: Cinnamaldehyde, piperine, and resveratrol offer significant in vitro anti-proliferative effects on cultured human colon cancer cells While each phytochemical exhibited significant anti-proliferative effects, resveratrol results were most impressive in that lower concentrations administered at regular intervals were significantly effective These results taken together with everyday dietary availability of concentrations used in this study strongly suggest that regular intake of low doses of these phytochemicals offer preventive effects against colon cancer ABREVIATIONS: DLD-1 = human colon cancer cells; DMSO = dimethylsulfoxide

Strongyloidiasis: a review and update by case example.

Abstract: A 77-year-old female immigrant from South America presented with epigastric pain, diarrhea, gastrointestinal bleeding, malabsorption, and acid reflux disorder A gastroduodenoscopy, performed to assess for peptic ulcer disease, revealed parasitic larvae in the duodenal mucosa which were subsequently identified as Strongyloides stercoralis rhabditiform larvae Anti-helminthic therapy was initiated to resolve infection OBJECTIVES: Review the pathogenesis, diagnosis and treatment of strongyloidiasis; alert laboratory professionals to the importance of early detection of Strongyloides stercoralis in specimens from immigrants at risk and immunodeficient patients to reduce morbidity and mortality ABBREVIATIONS: AIDS = acquired immunodeficiency syndrome; EIA = enzyme immunoassay; HIV = human immunodeficiency virus; HTLV-1 = human T-cell lymphotropic virus type 1; IgE = immunoglobulin E; IgG = immunoglobulin G

A Quality Improvement Cycle: Hemolyzed Specimens in the Emergency Department

Abstract: OBJECTIVE: To determine the cause of and possible solution for an excessive number of hemolyzed specimens received from the emergency department (ED) of a large medical center. DESIGN: The clinical laboratory staff collected data on hemolyzed specimens for all departments of the medical center. The clinical laboratory management team and ED management team intervened with training and surveillance of the ED staff to heighten the awareness of the problem. SETTING: The clinical chemistry laboratory of a large medical center. MAIN OUTCOME MEASURE: The number of specimens submitted by inpatient departments and the ED was measured in relationship to the number of hemolyzed specimens received from the departments. The clinical laboratory measured specimen processing times and turnaround times to determine their role in possibly contributing to the large number of hemolyzed specimens. Direct observation by a certified phlebotomist documented anecdotal evidence of the ED staff9s phlebotomy practices. ED and clinical laboratory practitioners communicated realistic impressions of the medical centers problem with hemolyzed specimens. RESULTS: The laboratory processing times were not responsible for the hemolyzed specimens. The collection equipment was not responsible for the hemolyzed specimens. The ED had an excessive number of hemolyzed specimens when compared to the rest of the medical center. The collection techniques in the ED appeared to be the origin of the problem. CONCLUSION: The intervention of the laboratory manager with the ED chief and nurse manager abated some of the professional arrogance between the departments. The dialogue educated the staffs about specific data that pointed to a possible origin of the problem. The ED chief placed his department on surveillance against problematic draws. Communication was improved between the two departments. However, only a moderate improvement in the number of hemolyzed specimens was noted. More training of medical center departments in phlebotomy and periodic proficiency evaluation of the all staff was indicated as a possible long-term solution. ABBREVIATIONS:CLT = clinical laboratory technician; CLS = clinical laboratory scientist; ED = emergency department; HIS = hospital information system; LIS = laboratory information system; RBC = red blood cells; SOP = standard operating procedure; TAT = turnaround time.

Occurrence and Detection of Iron-Deficiency Anemia in Infants and Toddlers

Abstract: 1. Richard Bamberg[⇑][1] 1. is professor and chairman of the Department of Clinical Laboratory Science at East Carolina University, Greenville NC 1. Address for correspondence: Richard Bamberg PhD MT(ASCP)SH CLDir CHES, professor and chairman, Department of Clinical Laboratory Science, College of Allied Health Sciences, East Carolina University, Greenville, NC 27858-4353. (252)744-6060, (252)744-6068 (fax). bambergw{at}ecu.edu. 1. Recognize infant and toddler populations vulnerable to developing iron deficiency. 2. Describe characteristic laboratory findings evaluating infant erythropoiesis. 3. Identify variations in iron requirements from birth to age three years. 4. Describe specific laboratory tests and expected results to detect iron deficiency anemia. 5. Distinguish the sensitivity and specificity of the specific tests to detect iron deficiency anemia. 6. Recognize laboratory tests that detect iron deficiency before frank anemia develops. 7. Describe the main limitations of the reticulocyte hemoglobin content assay. Infants and toddlers are particularly vulnerable to developing iron deficiency, which can cause irreversible deficits in neurodevelopment. Children at highest risk include premature and low birth weight infants, those who are fed cow's milk rather than breast milk or formula prior to age one, and those who drink large amounts of cow's milk as toddlers. It is important to detect iron deficiency before it becomes frank anemia through the use of appropriate laboratory tests. Hemoglobin or hematocrit testing, at around age one, has been the usual screening test. These tests, however, do not become abnormally low until frank anemia has developed. Over the past decade, research has shown the assay for reticulocyte hemoglobin content to be a much earlier indicator of iron deficiency. This article provides an overview of the epidemiology, occurrence, and detection of iron deficiency and iron deficiency anemia in young children as well as a comparison of the utility of various laboratory tests. Infants and toddlers are particularly vulnerable to the effects of anemia due to the rapid growth and development of the brain and the rest of the body from birth to age three. Pre-term and/or low birth weight infants are even more vulnerable. Although it is more common in developing countries due to nutritional deficiencies and chronic blood loss from parasitic infections,1 iron-deficiency anemia (IDA) is the most prevalent anemia found in infants, toddlers and child-bearing age females in the United States.2 Therefore, it is important to detect a state of iron deficiency in these… ABBREVIATIONS : CHr = hemoglobin content in reticulocytes; dL = deciliter; FEP/ZPP = free/zinc erythropoietic protoporphyrin; fL = femtoliters; g = gram; ID = iron deficiency; IDA = iron-deficiency anemia; L = liter; MCH = mean cell hemoglobin; MCV = mean corpuscular volume; mg = milligrams; ng = nanograms; NRBC = nucleated red blood cells; oz = ounces; pg = picograms; RDW = red blood cell distribution width; Ret He = reticulocyte hemoglobin; SF = serum ferritin; sTfR = serum transferrin receptor; TIBC = total iron binding capacity; TS = transferrin saturation; ug = micrograms. 1. Recognize infant and toddler populations vulnerable to developing iron deficiency. 2. Describe characteristic laboratory findings evaluating infant erythropoiesis. 3. Identify variations in iron requirements from birth to age three years. 4. Describe specific laboratory tests and expected results to detect iron deficiency anemia. 5. Distinguish the sensitivity and specificity of the specific tests to detect iron deficiency anemia. 6. Recognize laboratory tests that detect iron deficiency before frank anemia develops. 7. Describe the main limitations of the reticulocyte hemoglobin content assay. [1]: #corresp-1

The effect of ozone on common environmental fungi.

Abstract: OBJECTIVE To determine if gaseous ozone can effectively kill common environmental fungi. DESIGN This study was designed to test the null hypothesis that there is no significant difference in viability between fungal conidia treated with ozone and fungal conidia not treated with ozone. A single control group design was utilized. SETTING Academic research laboratory. INTERVENTIONS Freshly prepared suspensions of Cladosporium spp., Stachybotrys spp., and Aspergillus niger conidia were diluted and plated onto the surface of solid agar plates. The plates were exposed to room air or to different concentrations of ozone for up to four hours, as were uninoculated plates. All plates were then incubated at 25 degrees C until quantitative colony counts could be performed. MAIN OUTCOME MEASURE The effect of ozone on fungal conidia viability was assessed by comparing quantitative colony counts from conidia exposed to ozone to quantitative colony counts from conidia exposed only to room air. RESULTS There was a significant (p < 0.05) decrease in viable conidia of all three fungi, at ozone concentrations of 5.0-12.8 parts per million, by four hours of exposure. However, in every case, some conidia remained viable even at the highest level of exposure. CONCLUSIONS These data suggest that ozone must be used in conjunction with other methods of remediation or for more prolonged exposure times in order to eliminate fungal contamination of buildings.

Inherited bleeding disorders: a 14-year retrospective study

Abstract: Congenital bleeding disorders comprise a heterogeneous group of diseases that reflect abnormalities of blood vessels, coagulation proteins, and platelets. A 14-year retrospective study (1991-2005) was conducted for patients referred to the coagulation section of the Hematology Department (King Hussein Medical Center, Amman, Jordan), who had suffered from bleeding tendencies to assess the prevalence of bleeding disorders among Jordanians and to describe their clinical manifestations. Four hundred and three patients matched our criteria. All patients were screened with routine coagulation assays and a complete blood cell count; a factor assay was performed if indicated by the results of the screening assays. A total of 168 patients (41.6%) were diagnosed with a bleeding disorder caused by a factor deficiency, of which 17.1% were described as hemophilia A (n=69), 6.2% were described as vWD (n=25), and 4.2% were described as hemophilia B (n=17). A subset of the total patient population comprising 14.1% of the patients were diagnosed with a Rare Inherited Coagulation Deficiency (RICD), where 4.0% were FX deficient (n=16), 3.7% were FVII deficient (n=15), 3.7% were FV deficient (n=15), 2.5% were FXI deficient (n=10), and 0.2% were diagnosed with afibrinogenemia (n=1).

Searching the biomedical literature: research study designs and critical appraisal

Abstract: Two essential issues to consider when assessing the validity of research studies are the strengths and weaknesses of the study design and quality of methodology. This paper reviews study designs commonly used in clinical research, including case reports, cross-sectional studies, case-control studies, cohort studies, randomized controlled trials, reviews, and meta-analyses. It concludes with an outline for assessing study quality.

Practice levels and educational needs for clinical laboratory personnel.

Abstract: 1. Susan J Beck, PhD CLS (NCA)[⇑][1] 1. is professor and director, Division of Clinical Laboratory Science, University of North Carolina at Chapel Hill, Chapel Hill NC 2. Mary F Briden, MA CLS (NCA) 1. is director, Educational Programs and Partnerships, Rio Salado College, Tempe AZ 3. Paul L Epner, MEd MBA 1. is director, Healthcare Improvement Initiatives, Abbott, Abbott Park IL 1. Address for correspondence: Susan Beck PhD CLS (NCA), professor and director, Division of Clinical Laboratory Science, CB #7145, Bondurant Hall Suite 4100, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7145. (919) 966-3033, (919) 966-5200 (fax). sbeck{at}med.unc.edu. The following white paper was presented to the ASCLS House of Delegates on July 21, 2007. The white paper represents the work of an inter-agency task force commissioned by ASCLS to address issues related to the education and practice roles of clinical laboratory professionals. A white paper is an expository paper to initiate an awareness of an issue and/or to educate regarding the elements of an issue or problem. It does not include a statement of policy or infer action taken by the Society. The task force was chaired by Mary Briden, a past president of ASCLS. Other task force members were: Susan Beck, ASCLS (CLS educator); Bernie Bekken, ASCLS (immediate past president – ex-officio); Dana Duzan, ASCLS (manager); Paul Epner, industry (Abbott Diagnostics); Linda Fell, ASCP (educator); Frankie Harris-Lyne, ASCLS (CLT educator); Shirlyn McKenzie, ASCLS president (ex-officio); Susan Morris, ASCLS (manager); Bob Newberry, AMT (manager); Rick Panning, ASCLS (facilitator, manager); Elissa Passiment, ASCLS executive vice president (task force staff support); Dana Procsal, CLMA (CEO); Deb Rodahl, ASCLS (manager); and Randy Vandevander, ASCLS (manager). In July 2005, the American Society for Clinical Laboratory Science (ASCLS) Board of Directors commissioned a task force entitled “Practice Levels and Educational Needs for Clinical Laboratory Personnel”. This task force was asked to address issues raised in ongoing, unresolved discussions among laboratory professionals concerning the preparation of students for the current clinical laboratory environment. Laboratory managers expressed frustration with the discrepancy between the skills possessed by graduates of laboratory educational programs and the needs in… ABBREVIATIONS: AMT = American Medical Technologists; ASCLS = American Society for Clinical Laboratory Science; ASCP = American Society for Clinical Pathology; CLMA = Clinical Laboratory Management Association; DMAIC = Define, Measure, Analyze, Implement, and Control. [1]: #corresp-1

Telomerase and other novel approaches to bladder cancer detection.

Abstract: 1. Alexis Bennett, MS MT (ASCP)[⇑][1] 1. is medical technologist–specialist in hematology, University of Alabama at Birmingham Hospital, Birmingham AL 1. Address for correspondence: Alexis Bennett, 475 Summit Way, Fultondale AL 35068. awbennett{at}uabmc.edu. 1. List laboratory methods for bladder cancer diagnosis. 2. Describe the function of telomerase in chromosomal replication. 3. Describe the pathologic action of telomerase in tumors. 4. Describe laboratory methods for monitoring telomerase activity. Over 68,000 new cases of urinary bladder cancer are expected in the United States in 2008. Of these, an estimated 13,000 people will die of this disease. Urinary bladder cancer is the fourth most common new cancer in men and the ninth most common in women, with incidence rates of 30.0 and 7.1 per 100,000, respectively.1 Bladder cancer can be divided into two broad categories relating to the severity of disease. The first affects 70% of the patients and is characterized by low-grade tumors with frequent subsequent recurrence. Patients with low-grade malignancies have a good prognosis and low mortality rate. The remaining 30% of patients have high-grade tumor lesions. While both categories are associated with frequent recurrences, patients with high-grade lesions are at high risk for metastasis to other organs and tissues. Patients in this category have particular need for accurate diagnosis and staging in order to improve survival rates.2 The greatest utility for a bladder cancer-screening program is in high-risk populations, i.e., those who have previously had urological cancer. The relatively low incidence rate (44 patients per 100,000 population) makes a general screening program unlikely due to the risks and costs associated with cystoscopy and cytology, the current screening methods.3 However, screening individuals at high risk is beneficial for early bladder cancer detection. Thus, there is a real need for an accurate and non-invasive screening assay with high sensitivity and specificity to be used in these populations. Urine tumor markers are a promising area of oncologic medicine with the… ABBREVIATIONS: hTERT = human telomerase reverse transcriptase; hTR or hTERC = human telomerase RNA component; PCR = polymerase chain reaction; RUO = research use only; TRAP = telomeric repeat amplification protocol. 1. List laboratory methods for bladder cancer diagnosis. 2. Describe the function of telomerase in chromosomal replication. 3. Describe the pathologic action of telomerase in tumors. 4. Describe laboratory methods for monitoring telomerase activity. [1]: #corresp-1

Factors that impact clinical laboratory scientists' commitment to their work organizations.

Abstract: OBJECTIVE: To assess the predictive ability of various aspects of the work environment for organizational commitment. METHODS: A questionnaire measuring three dimensions of organizational commitment along with five aspects of work environment and 10 demographic and work setting characteristics was sent to a national, convenience sample of clinical laboratory professionals. SETTING AND PARTICIPANTS: All persons obtaining the CLS certification by NCA from January 1, 1997 to December 31, 2006. Only respondents who worked full-time in a clinical laboratory setting were included in the database. MAIN OUTCOME MEASURES: Levels of affective, normative, and continuance organizational commitment, organizational support, role clarity, role conflict, transformational leadership behavior of supervisor, and organizational type, total years work experience in clinical laboratories, and educational level of respondents. Questionnaire items used either a 7-point or 5-point Likert response scale. RESULTS: Based on multiple regression analysis for the 427 respondents, organizational support and transformational leadership behavior were found to be significant positive predictors of affective and normative organizational commitment. Work setting (non-hospital laboratory) and total years of work experience in clinical laboratories were found to be significant positive predictors of continuance organizational commitment. Overall the organizational commitment levels for all three dimensions were at the neutral rating or below in the slightly disagree range. CONCLUSIONS: The results indicate a less than optimal level of organizational commitment to employers, which were predominantly hospitals, by CLS practitioners. This may result in continuing retention problems for hospital laboratories. The results offer strategies for improving organizational commitment via the significant predictors. ABBREVIATIONS: ASCP = American Society for Clinical Pathology; CLS= clinical laboratory scientist as certified by NCA; MT = medical technologist as certified by ASCP; NCA=National Credentialing Agency for Laboratory Personnel; RT(R) = registered radiologic technologist as certified by the American Registry of Radiologic Technologists.

Searching MEDLINE via PubMed.

Abstract: As the volume of biomedical literature has increased, so have the number and complexity of databases that index it. Learning to conduct an efficient literature search in an online database is an essential skill for today's clinical laboratory scientist. This article describes basic and advanced strategies for searching PubMed and the use of specialized features including MyNCBI.

A survey of quality indicator use in the clinical laboratory.

Abstract: OBJECTIVE: A survey of clinical laboratories was conducted to capture information about quality indicators in use within the state of Arizona. This information was then used to determine which quality indicators are applicable across the spectrum of clinical laboratories making them suitable for benchmarking laboratory performance. The objectives of this study were also to heighten awareness of benchmarking practices for clinical laboratory managers and laboratory quality assurance personnel, to develop objective methods of quality monitoring for performance improvement, and to encourage collaboration between laboratories and accreditation agencies. METHODS: A review of the current literature was conducted to assess the status of benchmarking within the clinical laboratory. Data were also obtained from the Centers for Medicare & Medicaid Services (CMS) about all licensed clinical laboratories in Arizona. A mail survey was then created and conducted to investigate the use of clinical laboratory quality indicators in Arizona. SETTING AND PARTICIPANTS: A paper survey was mailed to a representative sample of clinical laboratory managers included in the CMS licensed laboratories listing for the state of Arizona. MAIN OUTCOME MEASURES: The selected sample was surveyed by mail and validation testing of the survey was conducted using the t-test. The compiled survey data is also presented in the form of histograms. RESULTS: Applying the t-test to the sample vs. population data proved that the sample was not a very good representation of the population and a better selection method should be used in future studies. Of the 319 of 3198 clinical laboratories randomly selected to receive the survey, 21 (6.58% of the sample or 0.66% of the population) responded with completed surveys. The information received from the respondents revealed a relationship between test volume and the number of indicators being monitored by clinical laboratories, the preference of indicators being monitored by those laboratories, the size of the laboratories where the majority of benchmarking is occurring, and a link between accrediting agencies and benchmarking activities. CONCLUSION: The survey proved that quality indicators are used for quality improvement purposes within the clinical laboratory; although it also showed that the industry still does not have a standardized approach to the use of quality indicators for benchmarking performance against other laboratories. ABBREVIATIONS:CAP = College of American Pathologists; CDC = US Centers for Disease Control and Prevention; CLIA = Clinical Laboratory Improvement Act of 1988; CMS = Centers for Medicare & Medicaid Services; JCAHO = Joint Commission on Accreditation of Healthcare Organizations; NQF = National Quality Forum; PPM = provider performed microscopy; TAT = turnaround time.

Validation study: clarity multistrip urocheck.

Abstract: OBJECTIVE: To test the interchangeability of a previously untested urine reagent strip, Clarity (RAC Medical), with the gold standard, Multistix (Bayer). DESIGN: Seventy-six urine samples were tested with both the comparator and the gold standard urine reagent strips. Pairs of reagent strips were analyzed in the Clinitek Analyzer, recording the following: leukocytes, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketone, bilirubin, glucose, and color. Data was assessed using statistical comparison of ordinal data (chi-square, Fisher9s Exact, kappa, and weighted kappa). This study was approved by the Indiana University-Purdue University at Indianapolis Institutional Review Board. SETTING: The study took place at Wishard Health Services, Indianapolis IN. PATIENTS OR OTHER PARTICIPANTS: All urine tested was obtained from patients of the primary care clinic at Wishard Health Services. INTERVENTIONS: n/a. PRIMARY OUTCOME MEASURE: The ability for both reagent strips to generate (statistically significant) identical readings across all 11 measurements for each sample. RESULT: Kappa values were deemed the best indicator to consistently examine the reproducibility of all 11 measurements of the Clarity versus the Multistix. Ten of eleven measurements were concluded to be non-reproducible by the Clarity strips; nitrite readings achieved a kappa value above 0.85, whereas all other readings achieved kappa values well below the acceptable limits of this investigation (ranging from 0.00 to 0.65). CONCLUSION: There was a lack of statistically significant agreement between the results of both products and therefore it was concluded that both products cannot be used interchangeably.

The doctorate in clinical laboratory science: a view of clinical practice development.

Abstract: 1. Elizabeth Kenimer Leibach[⇑][1] 1. is professor and chair in the Department of Biomedical and Radiological Technologies, Medical College of Georgia, Augusta GA 1. Address for correspondence: Elizabeth Kenimer Leibach EdD MS CLS MT(SBB), professor and chair, Department of Biomedical and Radiological Technologies, EC 2437 Medical College of Georgia, Augusta GA 30912-0500. (706) 721-3046, (706) 721-7631 (fax). ekenimer{at}mcg.edu Seminal reports refocusing the operational definition of quality in clinical laboratory services delivery have drawn attention to the need for a clinical laboratory science (CLS) practitioner of a new ilk.1,2 The doctorate in CLS (DCLS) is the unique and clinically-based degree defining this new healthcare practitioner that will afford an unprecedented opportunity to coordinate laboratory information among all providers to better organize patient care and case management efforts for the entire interdisciplinary healthcare delivery team. Since utilization of laboratory information is foundational to the practice of all other healthcare providers, the DCLS will coordinate the integration of laboratory services as needed into the practices of other healthcare professionals and for the direct management of patients. Postgraduate degrees are valued in the clinical laboratory industry from masters degrees in basic science, health education, and clinical laboratory management to doctorates (PhD) in specialty areas within the clinical laboratory such as immunology, biochemistry, and microbiology.3,4 Missing from these specialty degrees is the doctoral-level CLS generalist who is prepared by a clinical laboratory-focused, patient-centered, and clinically-oriented curriculum to func tion in leadership roles in all aspects of the clinical laboratory industry. The ASCLS, through the DCLS Committee, continues to develop and implement educational programs for the DCLS accessible nationally and for the entire international community. The DCLS practitioner will be credentialed for practice at the doctoral level after graduating from an accredited program and successfully completing a certification examination. Summarizing progress toward the goals of development and implementation, task forces of the American Society… ABBREVIATIONS: ASCLS = American Society for Clinical Laboratory Science; CLS = clinical laboratory science; DCLS = doctorate in clinical laboratory science; NAACLS = National Accrediting Agency for Clinical Laboratory Sciences. [1]: #corresp-1

Transfusion therapy for autoimmune hemolytic anemia patients: a laboratory perspective.

Abstract: 1. Darrell D Drouillard, MS MT(ASCP)[⇑][1] 1. is medical technologist, North Central Federal Clinic, San Antonio TX 1. Address for correspondence: Darrell D. Drouillard, MS, MT(ASCP), Medical Technologist, North Central Federal Clinic, 17440 Henderson Pass, San Antonio TX 78232. (210) 483-2903, (210) 483-2943 (fax). darrell.drouillard{at}va.gov. Patients presenting with autoimmune hemolytic anemias create inherent challenges to those tasked with providing compatible blood for transfusion therapy. These patients have developed autoantibodies against their own red cell surface antigens. Because these antigens are usually high-incidence, these patients will typically demonstrate panagglutination when their serum is exposed to most commercially procured screening red blood cells. This makes the identification of clinically significant alloantibodies difficult for laboratory personnel. Transfusion history, patient phenotype availability, and previous antibody records all impact the testing methods. The end goal is to identify clinically significant alloantibodies in order to provide antigen negative, compatible red blood cells, which reduces the risk of transfusion related reactions. It is imperative to understand the laboratory results and the techniques available that guide the investigative process. Immune hemolytic anemia (IHA) results from an immune mediated response to red blood cell (RBC) surface antigens. Based on the class of antibody, predominantly immunoglobulin G (IgG) and immunoglobulin M (IgM), patients may experience varying degrees of hemolyis. The immunological response may result in complement fixation or subsequent RBC destruction by the splenic macrophages. Though various classifications and sub-classifications exist, the AABB has divided IHAs into three main classes: autoimmune hemolytic anemias (AIHA), drug-induced hemolytic anemias, and alloimmune hemolytic anemias.1 Regardless of the type of anemia, most patients present with diverse, non-specific symptoms that may include dyspnea, pallor, weakness, fatigue, dizziness, abdominal pain, weight loss, and jaundice.2,3 In order to effectively manage the technological methodologies employed in the attainment of compatible RBCs for these… ABBREVIATIONS: AHG = anti-human globulin; AIHA = autoimmune hemolytic anemia; CAS = cold agglutinin syndrome; DAT = direct antiglobulin test; HDN = hemolytic disease of the newborn; IAT = indirect antiglobulin test; IHA = immune hemolytic anemia; LISS = low ionic strength solution; PAM = prophylactic antigen-matched; PCH = paroxysmal cold hemoglobinuria; PEG = polyethylene glycol; RBC = red blood cell; WAIHA = warm autoimmune hemolytic anemia. [1]: #corresp-1

Evaluation of lancets for pain perception and capillary blood volume for glucose monitoring.

Abstract: Objective The purpose of this study was to assess patient pain perception and capillary blood volume of four currently marketed lancets [BD Microtainer Contact-Activated Lancet, Low Flow (Contact-Activated Lancet); LifeScan OneTouch SureSoft Gentle (OneTouch SureSoft Gentle); BD Genie Blue; SurgiLance Safety] in a diabetic population following routine finger-puncture procedures and glucose monitoring. Methods Data were collected from adult subjects diagnosed with type I or type II diabetes mellitus at a 300-bed US hospital following finger-puncture procedures for glucose monitoring. Based on quantitative and qualitative measurements, each blood collection device was evaluated for pain perception and calculated total capillary blood volume. Results A total of 80 subjects received four skin punctures in an alternating finger and hand sequence using each lancet. The ten clinicians (nurses and phlebotomists) conducted the study, collected and then calculated total capillary blood volume. It was determined that the Contact-Activated Lancet produced less perceived pain and bleeding, while obtaining an adequate capillary blood volume for glucose monitoring. Conclusion This study demonstrated that the Contact-Activated Lancet provided an adequate sample volume required for blood glucose monitoring. In addition, less perceived pain was elicited with this lancet when compared with the other lancets evaluated in the study.

Pathophysiology of compound heterozygotes involving hemoglobinopathies and thalassemias.

Abstract: 1. Tim R Randolph, PhD MT(ASCP) CLS(NCA)[⇑][1] 1. is associate professor, Department of Clinical Laboratory Science, Doisy College of Health Sciences, Saint Louis University, St. Louis MO 1. Address for Correspondence: Tim R Randolph MS MT(ASCP) CLS(NCA), associate professor, Department of Clinical Laboratory Science, Doisy College of Health Sciences, Saint Louis University Allied Health Professions Building, 3437 Caroline Street, St. Louis MO 63104-1111. (314) 977-8688. randoltr{at}slu.edu. 1. Compare and contrast hemoglobinopathies and thalassemias. 2. Describe the most common type of mutation found in the majority of hemoglobinopathies and α-thalassemias. 3. List the five categories of mutations common in β-thalassemia. 4. Discuss why compound heterozygotes involving HbS and either a β-chain hemoglobinopathy or β+-thalassemia are less severe than sickle cell disease but more severe than sickle cell trait. 5. Discuss why an α-thalassemia mutation occurring in a HbSS patient lessens the severity of the existing sickle cell disease. 6. List two compound heterozygotes that mimic other hemoglobinopathy and/or thalassemia conditions. Hemoglobinopathies and thalassemias are both hematologic diseases involving mutations in the genes that control the synthesis of globin chains that compose hemoglobin. Some hematologists use the term hemoglobinopathy to describe any hemoglobin disorder to include the hemoglobin variants (e.g., sickle cell) and thalassemia. Other hematologists use the term hemoglobinopathy to describe only the qualitative hemoglobin variants and the term thalassemia to describe disorders producing a quantitative reduction in hemoglobin synthesis. The latter approach will be used in this review. GENETIC MUTATIONS Single nucleotide substitutions (point mutations) are the most common types of lesions occurring in the hemoglobinopathies. To date over 900 distinct mutations have been identified that are known to cause a hemoglobinopathy.1 In most cases the nucleotide alteration found in the hemoglobinopathies is a simple substitution causing the nucleotide sequence to remain “in frame” resulting in a single amino acid substitution that will not change the overall size of the globin protein product. Thus the defect in the globin molecule is ordinarily an amino acid substitution that changes the amino acid sequence affecting protein structure and function rather than quantity. Typical alterations in hemoglobin function include changes in oxygen binding affinity, molecular solubility, and the manner in which the individual hemoglobin molecules interact within the red blood cell (RBC). See Table 1. In contrast, the types of mutations encountered in the thalassemias are broad and diverse and ultimately affect the quantity of protein manufactured inside the developing RBC. Although over 300 different mutations have been identified as the cause… ABBREVIATIONS: Ala = alanine; Arg = arginine; Asn = asparagine; DNA = deoxyribonucleic acid; Gln = glutamine; Glu = glutamic acid (glutamate); Gly = glycine; Hb = hemoglobin; HPLC = high performance liquid chromatography; IVSII-745 = intervening sequence at codon 745; Leu = leucine; Lys = lysine; MCH = mean corpuscular hemoglobin; MCV = mean corpuscular volume; RBC = red blood cell; Term = termination codon; Thr = threonine; Val = valine. 1. Compare and contrast hemoglobinopathies and thalassemias. 2. Describe the most common type of mutation found in the majority of hemoglobinopathies and α-thalassemias. 3. List the five categories of mutations common in β-thalassemia. 4. Discuss why compound heterozygotes involving HbS and either a β-chain hemoglobinopathy or β+-thalassemia are less severe than sickle cell disease but more severe than sickle cell trait. 5. Discuss why an α-thalassemia mutation occurring in a HbSS patient lessens the severity of the existing sickle cell disease. 6. List two compound heterozygotes that mimic other hemoglobinopathy and/or thalassemia conditions. [1]: #corresp-1

Antimicrobial resistance of uncomplicated urinary tract infections in northern Utah.

Abstract: OBJECTIVE To evaluate antimicrobial resistance in uropathogenic bacteria in northern Utah. DESIGN One hundred twenty bacterial isolates from community-acquired UTI in the northern Utah area (Davis and Weber Counties) were tested. Samples were taken from otherwise healthy women, ages 18 to 50. Antimicrobial susceptibility testing for sulfamethoxazole/trimethoprim (SXT/TMP), ciprofloxacin, and nitrofurantoin comprised the process. SETTING The Clinical Laboratory Science Department at Weber State University, with samples coming from clinics in the northern Utah area (Davis and Weber Counties). PARTICIPANTS Urine samples were taken from otherwise healthy women, ages 18 to 50, who suffered from uncomplicated urinary tract infections. MAIN OUTCOME MEASURE Antimicrobial resistance was measured using antimicrobial susceptibility testing and shown with other national resistance rates. RESULTS Of bacterial isolates, 21.3% were resistant to SXT/TMP, 14.4% were resistant to ciprofloxacin, and 13.9% were resistant to nitrofurantoin. The resistance rates for ciprofloxacin and nitrofurantoin were acceptable for empirical UTI treatment (< 20% resistance), but local bacterial populations were found to demonstrate an increase in resistance to these two drugs as compared to previously observed national data. SXT/TMP resistance was above the recommended resistance threshold of 20% for effective empirical treatment, as advised by the IDSA. CONCLUSION Results suggest that uncomplicated community-acquired UTI be treated with nitrofurantoin. Other recommendations include continued monitoring of local uropathogenic antimicrobial resistance.

The doctorate in clinical laboratory science: enhanced quality for healthcare.

Abstract: 1. Elizabeth Kenimer Leibach[⇑][1] 1. is chair and associate professor in the Department of Biomedical and Radiological Technologies, Medical College of Georgia, Augusta GA 1. Address for correspondence: Elizabeth Kenimer Leibach EdD MS CLS MT(SBB), chair and associate professor, Department of Biomedical and Radiological Technologies, EC 2437 Medical College of Georgia, Augusta GA 30912-0500. (706) 721-3046, (706) 721-7631 (fax).ekenimer{at}mcg.edu. The position statement of the American Society for Clinical Laboratory Science (ASCLS) regarding the doctorate in clinical laboratory science (DCLS) begins: Missing within the continuity of healthcare are enough scientists and physicians within the clinical laboratory or elsewhere on the healthcare team who are totally dedicated to and who have the breadth of knowledge and assigned authority essential to the ordering of appropriate laboratory tests, the effective use of laboratory test information, effective consultation with other healthcare team members, direct communication with patients, review of patient records, and interpretation/application of laboratory-generated information in reference to clinical signs and symptoms. A clinical laboratory science professional holding a doctoral degree (DCLS) is needed to provide the critical interface across the healthcare system in order to assure improved patient outcomes and cost effective patient care.1 This succinct introduction defines the practitioner needed to provide the knowledge required “to assure improved patient outcomes and cost effective patient care.” To identify, describe, measure, provide for, and improve the ordering, dissemination, and utilization of medically effective and cost-efficient clinical laboratory information defines the objectives of quality in clinical laboratory science as well as the focus of clinical laboratory science (CLS) evidence-based practice. The Institute of Medicine (Crossing the Quality Chasm, ) has challenged the healthcare delivery system to refocus on appropriate use of healthcare services. The clinical laboratory by every cost, revenue, and quality measure is foundational to any consideration of this directive given that as much as 93% of the objective data in the clinical… ABBREVIATIONS: ASCLS = American Society for Clinical Laboratory Science; CLS = clinical laboratory science; DCLS = doctorate in clinical laboratory science. [1]: #corresp-1

Anemia in an aging population.

Abstract: 1. Rebecca J Laudicina, PhD[⇑][1] 1. is professor, Clinical Laboratory Science, Department of Allied Health Sciences, The University of North Carolina at Chapel Hill, Chapel Hill NC 1. Address for Correspondence: Rebecca J Laudicina PhD, Division of Clinical Laboratory Science, 4110 Bondurant Hall, CB#7145, The University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7145. (919) 843-4350. Rebecca_Laudicina{at}med.unc.edu 1. State the World Health Organization criteria for defining anemia and discuss issues related to this definition. 2. Compare the prevalence of anemia in a variety of subgroups in persons over age 65. 3. Discuss the physical, cognitive, and economic impact of anemia in the elderly. 4. Characterize the major causes of anemia in the geriatric population. 5. Explain laboratory tests and results useful in identifying the cause of anemia in the elderly. Demographic data combined with the results of recent studies indicate that anemia is a significant health concern for our aging population. As of 2006, more than 37 million people in the United States are over age 65 with that number expected to reach 80 million by the year 2050.1,2 More than 10% of all individuals above age 65 have anemia. Furthermore, the prevalence of anemia increases with age, making our oldest seniors even more likely to develop anemia during their lifetimes.3 The significance of these facts led to a special symposium, “Anemia and the Elderly: A Public Health Crisis in Hematology”, conducted at the 2005 meeting of the American Society of Hematology.4 Although the presence of anemia may reflect an underlying or undetected medical condition, anemia is also an independent risk factor for morbidity and mortality in an array of disorders common to seniors, including cancer, renal disease, and heart disease.5 Furthermore, anemia affects physical and mental functioning and interferes with the ability to conduct activities of daily living, thus affecting quality of life. Because the elderly, defined by the US Census Bureau as persons over age 65, is the fastest growing segment of the US population, anemia may be projected to have an increasing impact on our healthcare system.2 In spite of these facts, anemia in elderly patients may be overlooked in medical evaluations due to similarity of symptoms with other disorders and lack of awareness of its prevalence. Diagnosis of anemia and determination of its cause are highly… ABBREVIATIONS: ACD = anemia of chronic disease; CBC = complete blood count; CHr = reticulocyte hemoglobin; EPO = erythropoietin; HGB = hemoglobin; HCT = hematocrit; IDA = iron deficiency anemia; MA = megaloblastic anemia; MCV = mean cell volume; MCH = mean cell hemoglobin; MCHC = mean cell hemoglobin concentration; RDW = red cell distribution width; RET = reticulocyte count; SI = serum iron; sTR = serum transferrin receptor;TIBC = total iron binding capacity; TS = transferrin saturation. 1. State the World Health Organization criteria for defining anemia and discuss issues related to this definition. 2. Compare the prevalence of anemia in a variety of subgroups in persons over age 65. 3. Discuss the physical, cognitive, and economic impact of anemia in the elderly. 4. Characterize the major causes of anemia in the geriatric population. 5. Explain laboratory tests and results useful in identifying the cause of anemia in the elderly. [1]: #corresp-1

The doctorate in clinical laboratory science: CLS education beyond the baccalaureate.

Abstract: 1. Elizabeth Kenimer Leibach[⇑][1] 1. is chair and associate professor in the Department of Biomedical and Radiological Technologies, Medical College of Georgia, Augusta GA 1. Address for correspondence: Elizabeth Kenimer Leibach EdD MS CLS MT(SBB), chair and associate professor, Department of Biomedical and Radiological Technologies, EC 2437 Medical College of Georgia, Augusta GA 30912-0500. (706) 721-3046, (706) 721-7631 (fax). ekenimer{at}mcg.edu. The American Society for Clinical Laboratory Science (ASCLS) has clearly articulated the responsibilities of the Doctorate in Clinical Laboratory Science (DCLS): “Missing within the continuity of healthcare are enough scientists and physicians within the clinical laboratory or elsewhere on the healthcare team, who are totally dedicated to and who have the breadth of knowledge and assigned authority essential to the ordering of appropriate laboratory tests, the effective use of laboratory test information, effective consultation with other healthcare team members, direct communication with patients, review of patient records, and interpretation/application of laboratory generated information in reference to clinical signs and symptoms. A clinical laboratory science professional holding a doctoral degree (DCLS) is needed to provide the critical interface across the healthcare system in order to assure improved patient outcomes and cost effective patient care.”1 At some level, all who have needed healthcare recognize the need for an individual to function in our healthcare system as described above.2 In fact, the need for interpretation of laboratory information related to appropriate patient assessment is a growing need worldwide. In a recent publication in an online global news service, the point was made and supported with survey data that confusion over test-ordering practices in Great Britain places patients at risk.3 Blame for the confusion was attributed to lack of clinical pathology education in the medical curriculum. With the design and implementation of the DCLS, the clinical laboratory science profession has claimed and accepted responsibility for the quality of the information provided by the clinical… ABBREVIATIONS: ASCLS = American Society for Clinical Laboratory Science; CLS = clinical laboratory science; DCLS = doctorate in clinical laboratory science; NAACLS = National Accrediting Agency for Clinical Laboratory Sciences. [1]: #corresp-1

Consumer satisfaction to laboratory test interpretation by the ASCLS response team.

Abstract: OBJECTIVE: To assess consumer satisfaction to responses to laboratory test interpretations as provided by the American Society for Clinical Laboratory Science (ASCLS) Consumer Response Team. Additional information studied included demographics, whether a response to the question was received, and the respective discipline related to the question. DESIGN: A computerized questionnaire was sent to 339 participants who had sent questions concerning laboratory test results to the ASCLS consumer website (www.ascls.org) in May 2007. A total of 99 completed questionnaires (29.3%) provided usable data for analysis. SETTING: Participants answered the questionnaire via electronic mail and results were summarized in Zoomerang. PARTICIPANTS: Participants were national and international consumers who had sent a question regarding their laboratory results to the ASCLS website. Individuals were 18 years of age or older. Participation was voluntary and anonymous. MAIN OUTCOME MEASURES: Consumer satisfaction, measured by eleven satisfaction statements, with laboratory interpretations by the ASCLS Response Team averaged 4.0 on the five-point Likert scale: 1 = Strongly disagree to 5 = Strongly agree. Overall satisfaction of the website itself was 4.2 on the five-point Likert scale 1 = Poor to 5 = Excellent. RESULTS: The majority of respondents were female (71.1%) and ranged in age from 36-64 years (71.7%). Seventy-six percent of respondents reported they had received an answer to their laboratory test question. The most frequent disciplines for questions received were in chemistry, immunology, and hematology, respectively. CONCLUSIONS: This study indicates consumers of the ASCLS website were very satisfied with the clinical laboratory scientist volunteers9 responses. The ASCLS Consumer Response Team model is contributing to the advancement of healthcare by providing this important service to the public. ABBREVIATIONS:ASCLS = American Society for Clinical Laboratory Science.

Clinical laboratory practitioners speak out on Capitol Hill.

Abstract: 1. Paula Garrott Clinical laboratory professionals representing many levels of practice and a variety of institutions and organizations converged on Washington DC March 17-18, 2008 to attend the 20th Annual ASCLS Legislative Symposium. The symposium, which was co-sponsored by ASCP and CLMA, provides an opportunity for clinical laboratory professionals to review legislative and regulatory issues affecting the clinical laboratory and to meet with members of Congress and their staffs to share the concerns and positions of the laboratory community. A show of hands determined that about half of the “Leg Day” attendees were first-timers, including a number of students. Also participating this year were the members of the inaugural class of the ASCLS Leadership Academy. The group of individuals that had previously attended included a handful that had attended all twenty Legislative Symposia! The first day activities were designed to assure that even the “rookies” would be comfortable with the issues and the process of lobbying. The morning session included an overview and impact of legislative and regulatory issues. ASCLS, ASCP, and CLMA staff and legislative liaisons, as well as members of the ASCLS Government Affairs Committee, discussed the federal budget proposals, competitive bidding for clinical laboratory services, potential legislation to modernize the clinical laboratory fee schedule, and the laboratory personnel shortage. Judy Yost from the Centers for Medicare and Medicaid Services (CMS) provided a CLIA update. The update on the Competitive Bidding Demonstration Project included an overview of the legislative background for the project, a review of bidding requirements, the current status,…

Teaching method validation in the clinical laboratory science curriculum.

Abstract: 1. Tara C Moon, MS CLS(NCA)[⇑][1] 1. is assistant professor, Division of Clinical Laboratory Science, The University of North Carolina at Chapel Hill, Chapel Hill NC 2. Vicky A LeGrys, DA CLS(NCA) 1. is professor, Division of Clinical Laboratory Science, The University of North Carolina at Chapel Hill, Chapel Hill NC 1. Address for Correspondence: Tara C Moon MS CLS(NCA), Suite 4100 Bondurant Hall, Campus Box 7145, Division of Clinical Laboratory Science, The University of North Carolina at Chapel Hill, Chapel Hill NC 27599-7145. (919) 843-4353, (919) 966-5200 (fax). tmoon{at}med.unc.edu. With the Clinical Laboratory Improvement Amendment's (CLIA) final rule, the ability of the Clinical Laboratory Scientist (CLS) to perform method validation has become increasingly important. Knowledge of the statistical methods and procedures used in method validation is imperative for clinical laboratory scientists. However, incorporating these concepts in a CLS curriculum can be challenging, especially at a time of limited resources. This paper provides an outline of one approach to addressing these topics in lecture courses and integrating them in the student laboratory and the clinical practicum for direct application. Central to the role of any clinical laboratory scientist is the desire to report accurate patient results. Method validation is an imperative part of that process. There are many occasions when practitioners use the concepts of method validation such as establishing new methods, implementing commercial tests, or performing periodic assessments of established methods. The American Society for Clinical Laboratory Science (ASCLS) includes these skills in its definition of the CLS profession and scope of practice.1 Additionally, method validation is a requirement of laboratory regulations which state that performance of new methods be verified prior to reporting patient test results and periodic assessment of accuracy and precision must occur.2 Despite the attention that quality in the laboratory has received as of late and the new regulations and policies that have resulted, it remains an area that can be improved. Many method validation procedures are still carried out inappropriately or are interpreted incorrectly.3 In the past, when the Joint Commission on Accreditation of… ABBREVIATIONS: ASCLS = American Society for Clinical Laboratory Science; CLIA = Clinical Laboratory Improvement Amendment; CLS = Clinical Laboratory Science; JCAHO = Joint Commission on Accreditation of Healthcare Organizations; NAACLS = National Accrediting Agency for Clinical Laboratory Science. [1]: #corresp-1

Functional assessment of hospital laboratory packaging and shipping preparedness in New York State.

Abstract: 1. Paula A Pennell, MPH[⇑][1] 2. Alan J Antenucci 1. are laboratory preparedness coordinators, Wadsworth Center Laboratory Response Network, New York State Department of Health, Albany NY 1. Address for correspondence: Paula A Pennell, MPH, Laboratory Response Network, NYS Department of Health, Wadsworth Center, PO Box 22002, 120 New Scotland Avenue, Albany, NY 12201. (518) 457-9795, (518) 473-1326 (fax). pap04{at}health.state.ny.us. 1. Lynn E Brennan 1. is project aide, Wadsworth Center Laboratory Response Network, New York State Department of Health, Albany NY 2. Robert L Burhans 1. is director, Office of Health Emergency Preparedness, New York State Department of Health, Albany NY 3. Stephanie E Ostrowski, PhD 1. is coordinator, Wadsworth Center Laboratory Response Network, New York State Department of Health, Albany NY 4. NYS DOH Drill Development Team The 2006-2007 New York State (NYS) Hospital Laboratory Drill Series was implemented in order to test notification, referral and packaging and shipping (P&S) procedures at acute care hospital facilities (statewide, excluding New York City) that submit suspect bioterrorism (BT), chemical terrorism (CT), and/or pandemic influenza (Pan Flu) clinical specimens to the NYS Department of Health (DOH) Wadsworth Center for confirmatory testing. Results showed that 97% and 84% of hospital facilities had the ability to directly access the notification network and retrieve drill guidance, respectively. Most hospital laboratories (92%) demonstrated the ability to refer specimens to the Wadsworth Center laboratory. Evaluation of specimen submissions found that 68% of BT packages, 27% of Pan Flu packages, and 20% of CT packages arrived to the laboratory with no P&S deficiencies. It can be concluded that acute care hospital facilities in NYS are more prepared to refer and submit clinical specimens during a BT public health emergency than during a Pan Flu or CT emergency event. During times of public health emergency, the clinical laboratory has often been regarded as a first responder.1-3 As a sentinel facility, the clinical laboratory must be prepared to provide rapid analysis of specimens for patient diagnosis. If a laboratory is unable to perform testing, then it must have both appropriately trained personnel and access to protocols for the collection, packaging, shipping, and referral of specimens, in accordance with submission guidelines, to a state or federal facility that can perform the confirmatory testing.3-5 Ensuring that protocols are in place… ABBREVIATIONS: AAR = after action report; ASCP = American Society for Clinical Pathology; BT = bioterrorism; CDC = Centers for Disease Control and Prevention; CT = chemical terrorism; DOH = Department of Health; DOT = Department of Transportation; HAN = Health Alert Network; HEPP = Health Emergency Preparedness Program; HHS = Health and Human Services; HPN = Heath Provider Network; IATA = International Air Transport Authority; JCAHO = Joint Commission on Accreditation of Healthcare Organization; LRN = Laboratory Response Network; NYC = New York City; NYS = New York State; PS Pan Flu = pandemic influenza; RRC = Regional Resource Center. [1]: #corresp-1

The effects of over-anticoagulated blood on hematocrit values by the microcentrifuge method.

Abstract: OBJECTIVE: To determine equivalency of hematocrit results by three methods. DESIGN: A total of 101 whole blood samples in EDTA tubes were analyzed in this repeated measures study. SETTING: East Carolina University9s clinical laboratory science program, Greenville NC. PARTICIPANTS: The blood specimens were from adult patients at Nash General Hospital in Rocky Mount NC who had a CBC performed. MAIN OUTCOME MEASURE: Hematocrit values from a whole blood sample with EDTA anticoagulant performed by a Sysmex XE-2100 and by microcentrifuge with two different types of capillary tubes (i.e., heparinized and non-heparinized) filled from the EDTA tubes. RESULTS: The hematocrit means of the total sample for the three methods were 36.2%, 35.4%, and 35.6% for the Sysmex XE-2100, non-heparinized capillary tubes, and heparinized capillary tubes, respectively. Pearson correlation coefficient (pairwise) analyses produced significant r-values at an alpha of .01 for all three method comparisons. CONCLUSIONS: Based on statistically significant Pearson (pairwise) correlation coefficients, the hematocrit values by all three methods can be considered relatively equivalent. The differences between methods are quite small and would be clinically insignificant, thus likely not altering clinical decisions. Though this study was conducted under somewhat ideal conditions relative to the blood specimens selected, the results indicate that the additional dilution produced in a heparinized capillary tube when being filled from an EDTA-anticoagulated tube is not sufficient to produce clinically different microhematocrit results as compared to using the recommended non-heparinized capillary tube. ABBREVIATIONS:Aut = automated; CBC = complete blood count; CT = capillary tube; EDTA = ethylenediaminetetraacetic acid; Hct = hematocrit; Hep = heparinized capillary tube; NonHep = non-heparinized (i.e., no anticoagulant) capillary tube; RBC = red blood cell; RPM = revolutions per minute; WBC = white blood cell.

A survey of scholarly literature databases for clinical laboratory science.

Abstract: 1. Donna L O'Malley, MLS[⇑][1] 1. is library associate professor at the Dana Medical Library at the University of Vermont, Burlington VT 1. Address for correspondence: Donna L O'Malley MLS, library associate professor, Dana Medical Library, University of Vermont, Medical Education Center, Burlington VT 05405. (802) 656-4415, (802) 656-0762 (fax). donna.omalley{at}uvm.edu. 1. Describe what is meant by “primary literature” in the health sciences. 2. Discuss the characteristics of the major primary and summarizing databases used by health professionals. 3. Discuss the advantages and disadvantages of searching the Internet for professional health information. 4. Illustrate how popular Internet search engines can be used to find unique information in the health sciences. This article reviews the use of journal literature databases including CINAHL, EMBASE, and Web of Science; summarizing databases including Cochrane Database of Systematic Reviews, online textbooks, and clinical decision-support tools; and the Internet search engines Google and Google Scholar. The series closes with a practical example employing a cross-section of the knowledge and skills gained from all three articles. The primary literature in the health sciences consists of reports of original research generally published in the form of articles in scholarly/academic journals. The articles in these journals are indexed by searchable databases such as MEDLINE, CINAHL, and EMBASE, which function as an aid to finding articles on a desired topic. The primary literature has the advantage of being a direct communication from the researchers who performed the investigations. By studying the methodology used, the results of the research, and the investigators’ reasoning, readers are able to reach their own conclusions regarding the validity of the research findings. However, until they have stood the test of time, the findings of original research must be interpreted with caution. Since the primary literature is such an enormous body of work, much of which will later be disproved or substantially revised, many scientists and health professionals rely on secondary and tertiary forms of literature to summarize original research. These forms of literature provide the essential background knowledge required to understand and interpret the primary literature and for making professional and clinical decisions. Examples of such literature include review articles, yearbooks, print and online textbooks,… ABBREVIATIONS: CDSR = Cochrane Database of Systematic Reviews; CINAHL = Cumulative Index to Nursing and Allied Health Literature; GDM = gestational diabetes; SCI = Science Citation Index. 1. Describe what is meant by “primary literature” in the health sciences. 2. Discuss the characteristics of the major primary and summarizing databases used by health professionals. 3. Discuss the advantages and disadvantages of searching the Internet for professional health information. 4. Illustrate how popular Internet search engines can be used to find unique information in the health sciences. [1]: #corresp-1

The doctorate in clinical laboratory science: an executive summary.

Abstract: This article describes, in informational bullets, the concept of the doctorate in clinical laboratory science. The intent of the article is to support the marketing of these new practitioners and to provide the conceptual frame and links to data for proposals required to implement educational programs for them.