The Gallium Melting-Point Standard: Its Role in Manufacture and Quality Control of Electronic Thermometers for the Clinical Laboratory

1977 ◽  
Vol 23 (4) ◽  
pp. 725-732 ◽  
Author(s):  
Henry E Sostman

Abstract I discuss the traceability of calibration of electronic ther-mometers to thermometric constants of nature or to the National Bureau of Standards, from a manufacturer's basic standards through the manufacturing process to the user's laboratory. Useful electrical temperature sensors, their advantages, and means for resolving their disadvantages are described. I summarize our development of a cell for realizing the melting phase equilibrium of pure gallium (at 29.770 °C) as a thermometer calibration fixed point, and enumerate its advantages in the routine calibration veri-fication of electrical thermometers in the clinical chemistry laboratory.

1977 ◽  
Vol 23 (4) ◽  
pp. 733-737 ◽  
Author(s):  
George N Bowers ◽  
Stanford R Inman

Abstract I discuss the traceability of calibration of electronic ther-mometers to thermometric constants of nature or to the National Bureau of Standards, from a manufacturer's basic standards through the manufacturing process to the user's laboratory. Useful electrical temperature sensors, their advantages, and means for resolving their disadvantages are described. I summarize our development of a cell for realizing the melting phase equilibrium of pure gallium (at 29.770 °C) as a thermometer calibration fixed point, and enumerate its advantages in the routine calibration veri-fication of electrical thermometers in the clinical chemistry laboratory.


1976 ◽  
Vol 22 (3) ◽  
pp. 346-349 ◽  
Author(s):  
E J Sampson ◽  
D D Derck ◽  
L M Demers

Abstract We evaluated the Abbott Bichromatic Analyzer-100 (ABA-100) for use in the routine clinical chemistry laboratory by examining 13 different determinations that can be performed on the instrument. Results with the Du Pont "aca" and Technicon continuous-flow systems were compared to the ABA-100 in terms of upper limits of linearity, inter-run coefficient of variation, and results for samples from patients. The upper limits of linearity for the methods on the ABA-100 exceeded all of those for the continuous-flow systems, except for urea nitrogen. Precision of the ABA-100 was as good as or better than that of the aca for all determinations, except for glucose in a normal control serum and creatine kinase and creatinine in an above-normal control serum.


1969 ◽  
Vol 15 (7) ◽  
pp. 600-610 ◽  
Author(s):  
George Westlake ◽  
Donald K McKay ◽  
Philip Surh ◽  
David Seligson

Abstract It is our belief that a general-purpose digital computer that receives and processes the electrical signal from an analytic instrument to its final step, and then processes the latter to produce a patient report, is an essential tool of the clinical laboratory. The present report concerns the development of a discrete-sample-handling analytic instrument that was designed to interface with a computer. A description is given of the entire system that includes the interface, multiplexing, sample identification, and operational characteristics of the instrument. Some advantages of discrete sample handling in analytic chemistry are accuracy, speed, ease of adaptation to computers, use of small amounts of sample, stepwise analysis of analytic method, and ease of trouble-shooting.


2005 ◽  
Vol 2005 (1) ◽  
pp. 8-25 ◽  
Author(s):  
Gary L. Horowitz ◽  
Zahur Zaman ◽  
Norbert J. C. Blanckaert ◽  
Daniel W. Chan ◽  
Jeffrey A. Dubois ◽  
...  

MODULARANALYTICS(Roche Diagnostics) (MODULARANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULARANALYTICSallows customised configurations for various laboratory workloads. The performance and practicability of MODULARANALYTICSwere evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULARANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULARANALYTICSwas less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULARANALYTICSmet diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.


1977 ◽  
Vol 23 (6) ◽  
pp. 929-937 ◽  
Author(s):  
K Levin

Abstract Different types of calorimeters are briefly reviewed, stressing those instruments likely to be of interest in the clinical chemistry laboratory. The unspecific nature of the measuring procedure is emphasized and various pitfalls likely to cause analytical errors are pointed out. Recent work is reviewed where calorimeters have been used as analytical tools for the determination of glucose, protein, enzymes, and other substances. The results generally compared favorably with those obtained by conventional analytical procedures. In recent reports the time per analysis has been brought down to 2 min, with sample volumes in the micro range. Valuable information on the coagulation process has been obtained by use of calorimetry. I also review studies showing that intact cellular elements such as human blood cells, bacteria, and spermatozoa can successfully be investigated with calorimetric techniques. In particular, studies on human blood cells stimulated with various agents appear to be able to give valuable diagnostic information. I believe that new designs of microcalorimeters have placed an easily handled tool at the disposal of the worker in a clinical laboratory and that use of this tool can contribute to the development of our discipline.


1989 ◽  
Vol 11 (4) ◽  
pp. 174-178
Author(s):  
F. R. Hindriks ◽  
A. Bosman ◽  
P. F. Rademaker

The significance of indirect costs in the cost price calculation of clinical chemistry laboratory tests by way of the production centres method has been investigated. A cost structure model based on the ‘production centres’ method, the Academisch Ziekenhuis Groningen (AZG) 1-2-3 model, is used for the calculation of cost and cost prices as an add-in tool to the spreadsheet program Lotus 1-2-3. The system specifications of the AZG 1-2-3 cost structure model have been extended with facilities to impute all relevant indirect costs to cost centres by aid of allocation rules, which can be chosen freely. The inference is made that as indirect costs play a more important part in decision-making processes concerning planning and control, the specification of the relation to the cost centres should be determined in a more detailed way. The AZG 1-2-3 cost structure model has therefore been extended in order to increase the significance as a management tool for laboratory management.


1975 ◽  
Vol 21 (11) ◽  
pp. 1648-1653 ◽  
Author(s):  
Jack H Ladenson

Abstract I describe a system of quality control based on computer detection of changes in individual patient test results. This system, called "delta check," was used to follow all the tests performed by the clinical chemistry laboratory in a 1200-bed hospital. Analysis of 22 months’ experience indicates that specimen misidentification is a serious problem in the clinical chemistry laboratory. Over a nine-month period, errors were most frequent in the results for total thyroxine, total calcium, and total protein. Instances of laboratory error detectable by the delta check system are not detected by other currently used methods of quality control. This system therefore appears to be a valuable asset to the clinical laboratory


2021 ◽  
Author(s):  
Monika Garg ◽  
Neera Sharma ◽  
Saswati Das

Background:The concept of sigma metrics & lean six sigma is well known in the field of healthcare. However not many labs utilize the six sigma metrics for maintenance of high quality laboratory performance. A minimum value of 3 σ is desired in any clinical laboratory & values of σ≥6 are regarded as gold standard for obtaining high quality lab reports. Aims &Objectives: To calculate bias, cv & sigma metrics from the IQC & EQC data in order to ascertain extent of quality management in our lab. Materials &Methods:An extensive study of sample processing and quality practices was carried out in the Central Laboratory of Department of Biochemistry; PGIMER &Dr. RML Hospital, New Delhi; from Feb 2020 to July 2020. The IQC used(both level I & level II) were from Biorad Laboratories India (lyphochek assayed chemistry control) & the EQC used was from Randox Laboratories, UK. All the controls were run on Beckman Coulter clinical chemistry analyser AU 680. Total 14 clinical parameters were analysed & subsequently; Mean, S.D., CV, bias & σ were calculated through their respective formulas. Results:Sigma level was more than 6 for both levels of IQC was observed for Amylase. It indicates world class performance. Total bilirubin, AST, Triglyceride & HDL depicted σ values between 3.1 to 6 for both L1 & L2. Iron showed σ value of 5.5 in L1 whereas it was 3.78 in L2. Conclusion:-:- Sigma metrics in clinical laboratory is an essential technique to ascertain poor assay performance, along with assessment of the efficiency of existing laboratory process.


Author(s):  
Mohit Mehndiratta ◽  
Eram Hussain Pasha ◽  
Nilesh Chandra ◽  
Edelbert Anthonio Almeida

Abstract Objective The aim of this study was to study the incidence of preanalytical errors in the clinical chemistry laboratory attached to a tertiary care hospital. Design and Methods The study was conducted in a clinical chemistry laboratory using the samples and forms received for analysis. Five hundred random samples were analyzed using a predefined set of quality indicators (QIs) over a period of 3 months. The incidence of each preanalytical error was described as a percentage of the total samples analyzed in the study. Statistical Analysis Individual QIs were assigned values as 0 and 1 and were used to assess each sample; 0 if the error was present, and 1 if absent. The incidence of each preanalytical error was described as a percentage of the total samples analyzed in the study. Result Out of the 500 samples observed, 138 samples were error free, while 21 samples had the maximum number of errors, that is, 6. The error committed most often was the omission of provisional diagnosis being mentioned on the requisition form. No preanalytical error was observed for QIs: selecting the appropriate blood collection vial or storage of sample. Conclusion This study confirms that error rate in the preanalytical phase is high and vastly ignored. Errors committed here may be overlooked, given the large number of samples received in the clinical laboratory of a tertiary center. To reduce these errors, the laboratory should provide training to all workers involved in the preanalytical phase. Daily or weekly QI scores should be recorded to assess and rectify shortcomings, thereby improving patient care.


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