Point-of-care glucose testing: on-site competency assessment.

PURPOSE: The purpose of this pilot paper is to use on-site assessment to determine common non-compliance in point-of-care (POC) glucose testing, deficiencies that should be improved by the POC team or emphasized in further training. DESIGN/METHODOLOGY/APPROACH: Assessment forms for POC site and staff competency were developed and used for direct observation in four POC sites. Nurses were sampled in these sites. FINDINGS: The on-site assessment demonstrated that initial operator training was insufficient. Only three of 15 nurses achieved a satisfactory score on the first assessment. In all nine participants who had been assessed at least twice improved their performance. In total, 16 (30 percent) of 53 competency items were not achieved, so these should be addressed during refresher training. Improved compliance with the checklist was observed in two of four POC sites. RESEARCH LIMITATIONS/IMPLICATIONS: Medical students and residents also perform the test, so more representative samples are needed. PRACTICAL IMPLICATIONS: The assessment of staff performance in the workplace with constructive input and POC site inspections to identify common deficiencies are recommended. Refresher trainings should be focussed on the deficiencies identified. SOCIAL IMPLICATIONS: Assessing staff performance in the workplace with constructive input and POC site inspections to identify common deficiencies are recommended. Refresher trainings should focus on deficiencies. ORIGINALITY/VALUE: This study involved directly observing POC site staff during glucose testing. The assessment forms were based on ISO 22870:2006 technical requirements.

Accuracy and precision evaluation of Thai plastic microhematocrit tubes: the first product from Thailand.

BACKGROUND: In Thailand, the spun microhematocrit method is usually performed using glass microhematocrit tubes even though broken glass tube during use may result in a risk of injury and blood-borne infection. The main reason is that the safer product alternatives such as plastic microhematocrit tubes are more expensive. Now, plastic tubes for hematocrit determination can be produced in Thailand at a much cheaper price. However precision and accuracy studies are necessary before being able to use them. OBJECTIVE: To compare the accuracy and precision of Thai plastic microhematocrit tubes against the routinely used glass microhematocrit tubes and imported plastic microhematocrit tubes using spun microhematocrit method. MATERIALS AND METHOD: One hundred residual EDTA blood samples from the Department of Clinical Pathology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand along with the three level hematology control materials were measured with spun microhematocrit values using three different types of plastic microhematocrit tubes. This was compared to the routinely used glass microhematocrit tubes as a gold standard. RESULTS: The repeated measures one-way ANOVA found no significant difference between the hematocrit values from each type of tubes with an F(1,99) = 0.667 and p-value = 0.574. Intraclass correlation coefficient (ICC) between four types of microhematocrit tubes ranged from 0.996-0.998 (p-value < 0.001). Correlation coefficients (r) between four types of microhematocrit tubes ranged from 0.996-0.998 (p-value < 0.05). Coefficient of variation (CV) for precision of both within run and between run of Thai plastic microhematocrit tubes ranged from 1.44 to 2.17% compared to 1.39 to 4.01% of the imported plastic microhematocrit tubes. CONCLUSION: The hematocrit values determined by all plastic microhematocrit tubes can be considered relatively equivalent to those of glass microhematocrit tubes in terms of accuracy and precision. The Thai plastic microhematocrit tubes are economical and with the cost-benefit over other plastic tubes of about 12 to 16 times. Therefore, the Thai plastic microhematocrit tubes should be the choice for glass tube replacement.

Activation of the coagulation cascade in patients with leptospirosis.

BACKGROUND: Disseminated intravascular coagulation (DIC) is common among patients with sepsis. Leptospirosis is an important cause of sepsis in tropical areas, and pulmonary hemorrhage associated with thrombocytopenia is the major cause of death, but the coagulopathy in severe leptospirosis has not been further characterized. The aim of this study was to evaluate coagulation factors and the presence of DIC in patients with leptospirosis in northeast Thailand. METHODS: We measured plasma concentrations of fibrinogen, D-dimer, thrombin-antithrombin III complexes, and prothrombin fragment 1,2 and evaluated the DIC score in 79 patients with culture-confirmed and/or serologically confirmed leptospirosis and in 33 healthy Thai control subjects. RESULTS: The median concentrations of fibrinogen, D-dimer, thrombin-antithrombin III complexes, and prothrombin fragment 1,2 were significantly elevated in a cohort of 79 patients with leptospirosis, compared with healthy control subjects (P

A survey of coagulation laboratory practice in Thailand: the first step to establish a National External Quality Assessment Scheme (NEQAS) for blood coagulation.

BACKGROUND: External quality assessment (EQA) is an essential component of laboratory quality assurance. In Thailand, there is no EQA program for coagulation tests at the national level. OBJECTIVE: To collect the necessary data in the first step to set up a National External Quality Assessment Scheme (NEQAS) and to assess the status of coagulation laboratory practice in Thailand. MATERIAL AND METHOD: Questionnaires were sent to hospitals to obtain information about the hospitals, their coagulation laboratory practice and EQA. RESULTS: From a dispatch of 220 questionnaires, 124 (56.4%) were returned. Of the 112 hospitals that had coagulation tests, all of them performed prothrombin time (PT), and 110 laboratories performed activated partial thromboplastin time (APTT) as well. Thirty eight percent of laboratories still used 3.8% sodium citrate as the anticoagulant for coagulation tests. The majority of laboratories (65%) reported normal control value with the patient results. Only 42% of coagulation laboratories established their own reference range. The denominators of PT ratio and APTT ratio calculations were derived from several sources apart from the mean of normal subjects. Seven of 112 (6%) laboratories participated in an EQA program. CONCLUSION: The present survey represents an overview of the current laboratory practice for coagulation tests in Thailand Improvement is necessary, and the survey results emphasize the need for establishing an EQA program in Thailand

Prevalence of 60 kda and 52 kda Ro/SS-A autoantibodies in anti-Ro positive Thai sera in Siriraj Hospital.

BACKGROUND: Anti-Ro antibody may directly react against either Ro60 or Ro52 or both antigens. To be more applicable for routine laboratory practice, the specific antigen type for antibody detection should be identified before test application. OBJECTIVE: Investigate the prevalence of 60 kDa and 52 kDa Ro/SS-A antibodies in Thai patients' sera in Siriraj Hospital. MATERIAL AND METHOD: Specimens for anti-Ro were requested between June and December 2005. They were tested with EUROLINE test kit for prevalence determination. The principle of the test is a qualitative in-vitro-assay that contains test strips coated with parallel lines of 14 highly purified antigens. Of 84 specimens requested for anti-Ro antibody, 76 were collected and tested with the EUROLINE test kits and eight were excluded due to inadequacy. RESULTS: The prevalence of anti-Ro60 and anti-Ro52 of all sera tested for anti-Ro by EUROLINE test kit were 30% (95% CI: 20-40%) and 26% (95% CI: 16-36%), respectively; and, those in anti-Ro positive Thai sera were 82% (95% CI: 68-96%) and 71% (95% CI: 54-88%), respectively. The prevalence of anti-Ro52 alone in anti-Ro positive Thai sera and all specimens requested for anti-Ro was about 18% (95% CI: 4-32%) and 7% (95% CI: 1-13%), respectively. The agreement and Kappa value between the two methods were 0.9 and 0.77, respectively. The study suggests that the test for anti-Ro detection should provide both Ro 60 and Ro 52 antigens. CONCLUSION: The prevalence of both anti-Ro 60 and anti-Ro 52 were quite common, therefore, the test for this specific antibody should provide both antigens for antibody detection.

Utilization of calculated low density lipoprotein cholesterol and measured low density lipoprotein cholesterol in Siriraj Hospital.

A study to determine the utilization of calculated low density lipoprotein (c-LDL) cholesterol and measured low density lipoprotein (m-LDL) cholesterol was conducted. The test results of total cholesterol, triglyceride, HDL-cholesterol and m-LDL-cholesterol from the same individuals aged > or = 18 years who had the tests done at the Department of Clinical Pathology, Faculty of Medicine Siriraj Hospital during January to December 2004 were retrieved. The c-LDL-cholesterol level was computed using Friedewald formula. There were two data sets i.e. the m-LDL-cholesterol cut-off level derivation data set (784 subjects) and the m-LDL-cholesterol cut-off level validation data set (800 subjects). The study results revealed: 1) 2.6% of the subjects had blood triglyceride > 400 mg/dl hence c-LDL-cholesterol could not be computed, 2) the correlation between c-LDL-cholesterol levels and m-LDL-cholesterol levels from both data sets was very good (r > 0. 95, p < 0. 001), 3) the m-LDL-cholesterol levels were usually higher than c-LDL-cholesterol levels, 4) the m-LDL-cholesterol cut-off level derivation data set showed that m-LDL-cholesterol < 87, > 143, > 188, > 233 and > 254 mg/dl were highly correlated with c-LDL-cholesterol < 100, > or = 100, > or = 130, > or = 160 and > or = 190 mg/dl respectively, 5) an application of m-LDL-cholesterol cut-off levels derived from the m-LDL-cholesterol cut-off level derivation data set to the m-LDL-cholesterol cut-off level validation data set showed that m-LDL-cholesterol < 87, > 143, > 188, > 233 and > 254 mg/dl had accuracy in predicting c-LDL-cholesterol < 100, > or = 100, > or = 130, > or = 160 and > or = 190 mg/dl of 100%, 99. 7%, 100%, 100% and 100% respectively, 6) the use of m-LDL-cholesterol levels as a guide for initiating lipid-lowering agents based on cut-off values of c-LDL-cholesterol levels led to an overuse of lipid-lowering agents in 3.6% to 42.9% of the patients and 7) Nomogram for transforming m-LDL-cholesterol to c-LDL-cholesterol was developed as well as a formula for transforming m-LDL-cholesterol to c-LDL-cholesterol (c-LDL-cholesterol = 0.89 x m-LDL-cholesterol). Therefore, m-LDL-cholesterol assay has a very limited use in managing individuals with suspected or known dyslipidemia. The use of m-LDL-cholesterol level as a guide for management of abnormal LDL-cholesterol conditions leads to an overuse of lipid lowering medications and an enormous expense of m-LDL-cholesterol assay.

Short-course therapy with zidovudine plus lamivudine for prevention of mother-to-child transmission of human immunodeficiency virus type 1 in Thailand.

To evaluate the efficacy and safety of short-course therapy with zidovudine plus lamivudine for reduction of perinatal transmission of human immunodeficiency virus type 1 (HIV-1), a single-arm, open-label, prospective, nonrandomized study was conducted. One hundred six treatment-naive pregnant women received zidovudine (300 mg) plus lamivudine (150 mg) twice daily from week 34 of gestation until the onset of labor. During labor, zidovudine and lamivudine were given every 3 h. Neonates received zidovudine syrup for 4 weeks and were bottle fed. The median maternal virus load and CD4+ cell count at weeks 32-34 of gestation were 4.33 log10 copies/mL and 274 cells/mm3, respectively. At delivery, the mothers' mean decrease in virus load was 1.55 log10 copies/mL and the mean increase in CD4+ cell count was 93 cells/mm3, compared with enrollment levels. Three neonates were HIV-1 infected, for a transmission rate of 2.83% (95% confidence interval, 1%-8%). There were no serious adverse events in the mothers. Adverse events noted in neonates were anemia (in 6 neonates), elevated transaminase levels (in 1), and thrombocytopenia (in 3). Short-course therapy with zidovudine plus lamivudine appeared to be safe and effective for prevention of perinatal transmission of HIV-1.

An abnormal systemic and regional hypercoagulable state in patients with mitral stenosis.

Mitral stenosis still remains a major problem in Southeast Asia including Thailand. It contributes to the morbidity and mortality related to thromboembolism which was associated with the left atrial thrombus. However, the pathogenesis of left atrial thrombus in these patients is not completely understood. Therefore, the objective of this study was to investigate the coagulation and platelet activity including the function of the endocardium in the left atrium and peripheral circulation in patients with mitral stenosis who were free of left atrial thrombus and to compare those hematologic markers activity in the peripheral venous blood between the patients with mitral stenosis and the control. Thirty-six patients with moderate to severe mitral stenosis were included in the study. Most of the patients were in functional class II and 50 per cent had atrial fibrillation. Blood was obtained from the femoral vein, femoral artery, pulmonary artery and left atrium of these patients before heparin was administered to determine the value of various hematologic markers. In the control group, blood for determining the hematologic markers was collected only from the antecubital vein. The results of this study demonstrated that the levels of prothrombin activation fragment 1+2 (F1+2), thrombin-antithrombin III complex (TAT) and Beta-thromboglobulin (beta-TG) in the left atrium of the patients with mitral stenosis were significantly higher than those in the femoral vein and femoral artery, whereas the level of thrombomodulin was significantly lower in the left atrium compared with the femoral artery and vein. When comparing with the control group, the levels of TAT, plasminogen activator inhibitors-1 (PAI-1) from the peripheral vein were significantly higher and the level of thrombomodulin was also significantly lower in the patients with mitral stenosis. In conclusion, the present study demonstrated an abnormal hypercoagulable state of the left atrium and systemic circulation related to the abnormalities of coagulation, platelets and the endocardium which may cause the formation of left atrial thrombus in patients with mitral stenosis.

The external quality assessment schemes in Thailand.

In Thailand, the external quality assessment schemes have been organized by 2 main institutions:--The Department of Medical Science, Ministry of Public Health and The Faculty of Medical Technology, Mahidol University. Both schemes were initiated simultaneously by WHO experts in 1973. The Department of Medical Science, Ministry of Public Health established a Unit of Laboratory Quality Standards to be responsible for external quality control for clinical laboratory services. In 1996 the unit was upgraded to become The Bureau of Laboratory Quality Standards and is responsible for The National Proficiency Testing Scheme (NPTS). This includes hematology, clinical chemistry, clinical immunology, clinical microscopy, clinical microbiology and blood banking. Every laboratory is invited to be a member, free of charge. Now there are almost 800 out of 1300 laboratories all over Thailand participating in this NPTS. The proficiency testing samples are sent to the participants 3-4 times/year. The results of laboratory tests performed by participants are evaluated by using target values for every scheme, except clinical chemistry, which use participants' consensus. The control materials used in the clinical chemistry, hematology and immunology schemes are imported from aboard. The remaining control materials are prepared in house. The Faculty of Medical Technology, Mahidol University has organized 4 programs in The External Quality Assurance Scheme (EQAS):--clinical chemistry, clinical hormone, clinical microscopy and clinical immunology and serology. The first scheme was established in 1986 and the remaining schemes were established in 1999. All the control materials used are prepared in house. The members of this EQAS have to pay a membership fee. The control samples are sent to the participants 4-12 times/year. The results of laboratory tests are evaluated by using participants' consensus. There are 150-460 laboratories enrolled in this EQAS. At this time, Thailand is very conscious of quality in every field, including hospitals, and internal and external quality controls are one of the recommendations of the quality standard. So both The NPTS and The EQAS mentioned above are very important for each laboratory at the moment. The author sent questionnaires to 200 laboratories asking whether they were enrolled in an external quality assessment scheme. Fifty-seven laboratories responded and over 70% of them had joined either The NPTS or The EQAS and some of them had joined both. In addition, there are 2 new programs of external quality control:--the external quality control in red cell serology and the external quality assessment of hematology laboratory which have been established recently. However, there are still some types of laboratory that have no external quality assessment programs e.g. coagulation, serology for autoimmune disease and hemoglobin typing. External quality assessment programs for these laboratories are urgently needed.

Improvement of coagulation laboratory practice in Thailand: the first-year experience of the national external quality assessment scheme for blood coagulation.

CONTEXT: In Thailand until 2005 there had been no external quality assessment scheme at the national level for blood coagulation tests. Only a few laboratories had an external quality assessment for these tests. In the year 2005, the Thailand National External Quality Assessment Scheme for Blood Coagulation was founded. OBJECTIVES: To describe the establishment of the Thailand National External Quality Assessment Scheme for Blood Coagulation (including problems encountered and solutions), its progression and expansion, and the improvement of coagulation laboratory practice in Thailand during 2 trial surveys and 4 formal surveys conducted in the first 1 1/2 years. DESIGN: Between 2005 and 2006, the external quality assessment samples for prothrombin time/international normalized ratio and activated partial thromboplastin time were distributed to the participants as well as the instructions and suggestions for the improvement of laboratory practice. From the data collected, the all-method coefficient of variation of the international normalized ratio and activated partial thromboplastin time was calculated for each survey. RESULTS: The number of participants increased during the first 1 1/2 years that the surveys were conducted, from 109 to 127. Survey data demonstrate an improvement in response rate and an increase in the number of laboratories that determine their own reference ranges and repeat this for every change of reagent lot, using the appropriate anticoagulant. The increased precision of tests is indicated by the decrease of the all-method coefficient of variation of the international normalized ratio and activated partial thromboplastin time. Examples of individual laboratory improvement through feedback are also described. CONCLUSIONS: The improvement of coagulation laboratory practice both through the instructions provided and liaison with participants was observed during the course of this scheme.