History of NIST's contributions to development of standard reference materials and reference and definitive methods for clinical chemistry

1995 ◽  
Vol 41 (9) ◽  
pp. 1306-1312 ◽  
Author(s):  
R Schaffer ◽  
G N Bowers ◽  
R S Melville
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Standard Reference Materials ◽  
National Bureau ◽  
Serum Samples ◽  
Clinical Laboratories ◽  
History Of ◽  
Primary Standards ◽  
Definitive Methods

Abstract The issuance of cholesterol as a Standard Reference Material (SRM) in 1967 started the National Institute of Standards and Technology (NIST; then named the National Bureau of Standards) on a major effort to help clinical laboratories establish and improve the quality of measurements they make. NIST now issues three kinds of SRMs for that purpose: analyte samples of certified purity as primary standards, serum samples having certified analyte concentrations as accuracy controls, and materials certified for calibrating instruments. In working with clinical laboratory scientists to establish Reference Methods (RMs) for measuring the analytes, NIST developed Definitive Methods (DMs) to use for evaluating RM accuracy and then used the DMs for assigning analyte values to its SRMs. The development of SRMs and DMs is discussed.

Measurement and Standard Reference Materials in Clinical Chemistry

1968 ◽  
Vol 14 (10) ◽  
pp. 929-943 ◽  
Author(s):  
Donald S Young ◽  
Thomas W Mears
Keyword(s):  
Uric Acid ◽  
Reference Materials ◽  
Measurement System ◽  
High Purity ◽  
Clinical Chemistry ◽  
Standard Reference Materials ◽  
National Bureau ◽  
Additional Component ◽  
Clinical Laboratories ◽  
Chemical Measurements

Abstract The concepts of the measurement system based upon four parameters—length (meter), mass (kilogram), time (second), and temperature (kelvin)—are developed. The proper daily operation of an analytic laboratory depends upon these basic measurements and others derived from them, e.g., the liter. An additional component of chemical measurement which directly influences accuracy is the purity of the standards and reagents employed. The standard reference materials program of the National Bureau of Standards provides a central source of guaranteed high-purity reference materials which are available to all. The reliability of chemical measurements should increase as new standard reference materials such as cholesterol, uric acid, urea, and creatinine are utilized to standardize methods and to calibrate instruments in the clinical laboratories of this country.

Document Control Practices in 120 Clinical Laboratories

2009 ◽  
Vol 133 (6) ◽  
pp. 942-949
Author(s):  
Paul N. Valenstein ◽  
Ana K. Stankovic ◽  
Rhona J. Souers ◽  
Frank Schneider ◽  
Elizabeth A. Wagar
Keyword(s):  
Patient Outcomes ◽  
Clinical Laboratory ◽  
Standard Setting ◽  
Clinical Laboratory Improvement Amendment ◽  
Clinical Laboratories ◽  
Policies And Procedures ◽  
Laboratory Results ◽  
Control Failures

Abstract Context.—A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations. Objective.—To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance. Design.—Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived. Results.—Of the 8814 documents, 3113 (35%) fulfilled all 6 document control requirements. The requirement fulfilled most frequently was availability of the document at all shifts and locations (8564 documents; 97%). Only 4407 (50%) of documents fulfilled Clinical Laboratory Improvement Amendment requirements for being properly archived after updating or discontinuation. Policies and procedures were more likely to fulfill document control requirements than forms and work aids. Documents tended to be better controlled in some laboratory sections (eg, transfusion service) than in others (eg, microbiology and client services). We could not identify document control practices significantly associated with higher compliance rates. Conclusions.—Most laboratories are not meeting regulatory and accreditation requirements related to control of documents. It is not clear whether control failures have any impact on the quality of laboratory results or patient outcomes.

Accuracy in clinical chemistry--does anybody care?

1994 ◽  
Vol 40 (6) ◽  
pp. 859-861 ◽  
Author(s):  
N W Tietz
Keyword(s):  
Laboratory Tests ◽  
Serum Iron ◽  
Clinical Chemistry ◽  
Analytical Techniques ◽  
Optimal Performance ◽  
Diagnostic Process ◽  
Serum Lipase ◽  
Clinical Laboratories

Abstract The role of clinical chemistry in the diagnostic process has been enhanced by the evolution of better instrumentation and analytical techniques. The quality of some laboratory tests, however, has not kept pace with these advances. I present three examples--serum iron, serum lipase, and nonisotopic immunoassays--assays where some currently used methodologies are highly flawed. Causes for the less than optimal performance of some clinical laboratories are discussed.

scholarly journals Challenges of Laboratory Medicine: European Answers

2011 ◽  
Vol 30 (4) ◽  
pp. 273-278 ◽  
Author(s):  
Irena Korita ◽  
Victor Blaton
Keyword(s):  
Strategic Alliances ◽  
Business Models ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biomedical Sciences ◽  
Clinical Laboratories ◽  
Laboratory Services ◽  
Enhance Efficiency

Challenges of Laboratory Medicine: European Answers Medical laboratories play a vital role in modern healthcare, and qualified specialists in Clinical Chemistry and Laboratory Medicine are essential for the provision of high-quality preanalytical, analytical and consultative services. Laboratory medicine has undergone major transformations during the last decade. Ongoing technological developments have considerably improved the productivity of clinical laboratories. Information on laboratory services is globally available, and clinical laboratories worldwide face international competition and there is a huge pressure to reduce costs. To be prepared for the future, clinical laboratories should enhance efficiency and reduce the cost increases by forming alliances and networks, consolidating, integrating or outsourcing, and more importantly create additional value by providing knowledge services related to in vitro diagnostics. Therefore, business models that increase efficiency such as horizontal and vertical integration are proposed, based on collaborative networks for the delivery of clinical laboratory services. Laboratories should cooperate, consolidate and form strategic alliances to enhance efficiency and reduce costs. There is a growing conflict between the science and the art of clinical practice and on the role of the biomedical sciences in medical practice. We have a dehumanizing effect on medical care. Disease is defined at the level of sick molecules and cells and curative medicine is being replaced by the preventive care of the disease. Undoubtedly all those questions will raise considerable problems and challenges for the medical educators.

scholarly journals Determination of errors that compromise the quality of laboratory service in a tertiary hospital

2017 ◽  
Vol 8 (1) ◽  
pp. 64-70
Author(s):  
Kenneth Kipruto Kimengech ◽  
Stanley Kinge Waithaka ◽  
Jackson Onyuka ◽  
Christine Sekadde Kigondu
Keyword(s):  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Common Knowledge ◽  
Tertiary Hospital ◽  
Chemistry Laboratory ◽  
Laboratory Service ◽  
Laboratory Errors ◽  
Analytical Errors

Background: Clinical Laboratory testing is a highly complex process that entails numerous procedures. Although it has been known that laboratory testing services are safe, it is increasingly becoming a common knowledge that they are not that safe. Studies have indicated that there are a number of errors that occur due to laboratory testing processes. These errors may not be realized easily during the testing process, but they make significant impact on the results given.Aims and Objective: To determine the levels of pre-analytical, analytical, and post analytical errors found in the analysis of Clinical Laboratory specimen at Kenyatta National Hospital.Materials and Methods: A prospective and descriptive study was carried out at Clinical Chemistry Laboratory, Department of Laboratory Medicine, Kenyatta National Hospital. A total of 346 request forms, specimens/samples and dispatched results were scrutinized and errors documented as per the different variables in the different phases, over a period of three months and the findings were analyzed.Results: Results of the study showed that Preanalytical errors were most common with a frequency of 148(42.8%), followed by analytical errors 114 (32.9%) and post analytical errors 84 (24.3%), respectively.Conclusions: The study concludes that pre-analytical, analytical, and post analytical errors are errors that compromise the quality of laboratory service delivery, which impacts on the patient management and diagnosis. Clinical laboratory errors can be minimized if due diligence and professionalism is adhered in the laboratory.Asian Journal of Medical Sciences Vol.8(1) 2017 64-70

Assuring the quality of interpretative comments in clinical chemistry

2016 ◽  
Vol 54 (12) ◽  
Author(s):  
Samuel Vasikaran ◽  
Kenneth Sikaris ◽  
Eric Kilpatrick ◽  
Jane French ◽  
Tony Badrick ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Continuing Professional Development ◽  
Laboratory Staff ◽  
Laboratory Services ◽  
Method Of Assessment ◽  
The Impact ◽  
Eqa Schemes ◽  
Interpretative Comments

AbstractThe provision of interpretative advice on laboratory results is a post-analytic activity and an integral part of clinical laboratory services. It is valued by healthcare workers and has the potential to prevent or reduce errors and improve patient outcomes. It is important to ensure that interpretative comments provided by laboratory personnel are of high quality: comments should be patient-focused and answer the implicit or explicit question raised by the requesting clinician. Comment providers need to be adequately trained and qualified and be able to demonstrate their proficiency to provide advice on laboratory reports. External quality assessment (EQA) schemes can play a part in assessing and demonstrating the competence of such laboratory staff and have an important role in their education and continuing professional development. A standard structure is proposed for EQA schemes for interpretative comments in clinical chemistry, which addresses the scope and method of assessment including nomenclature and marking scales. There is a need for evidence that participation in an EQA program for interpretative commenting facilitates improved quality of comments. It is proposed that standardizing goals and methods of assessment as well as nomenclature and marking scales may help accumulate evidence to demonstrate the impact of participation in EQA for interpretative commenting on patient outcome.

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
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Temperature Sensors ◽  
Chemistry Laboratory ◽  
National Bureau ◽  
Clinical Chemistry Laboratory ◽  
A Cell ◽  
Basic Standards ◽  
Constants Of Nature ◽  
Gallium Melting Point

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.

The use of six sigma methodology to evaluate the analytical performances of clinical chemistry analyzers

2016 ◽  
Vol 43 (1) ◽  
pp. 1-8
Author(s):  
Özlem Gülbahar ◽  
Murat Kocabıyık ◽  
Mehmed Zahid Çıracı ◽  
Canan Demirtaş ◽  
Fatma Uçar ◽  
...  
Keyword(s):  
Six Sigma ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Total Quality ◽  
Biochemical Tests ◽  
Analytical Process ◽  
World Class ◽  
Six Sigma Methodology ◽  
Analytical Platforms

AbstractIntroduction:In our study, we aimed to evaluate the analytical process performances of the biochemistry tests in the analysis systems that were widely used in the clinical laboratories by using the six-sigma methodology.Methods:The analytical performances of four different analytical platforms (Beckman Coulter-Olympus AU2700, Abbott-Architect C8000, Roche-Cobas 8000, and Siemens-ADVIA 2400) running 18 biochemical tests (urea, creatinine, uric acid, total bilirubin, AST, ALT, ALP, LDH, HDL-C, CaResults:The parameters that have σ≥6 which means in world class are HDL-C and ALP in all four systems, while only NaDiscussion and conclusion:To improvement and monitoring of the analytical process performance as a part of total quality of a clinical laboratory to provide continuous improving, sigma levels can be used as it is a reliable method.

Evaluation of the ABX Pentra 400: a newly available clinical chemistry analyser

2005 ◽  
Vol 43 (7) ◽  
Author(s):  
Pascal Coudène ◽  
Benjamin Marson ◽  
Stéphanie Badiou ◽  
Sébastien Flavier ◽  
Sébastien Anelli ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Specific Protein ◽  
National Committee ◽  
Ion Selective Electrodes ◽  
Spectrophotometric Measurement ◽  
Good Reliability ◽  
Expected Values ◽  
Substrate Concentrations

AbstractThe performance of the ABX Pentra 400, a new multiparametric analyser available for routine and specialised clinical chemistry analyses, was evaluated according to the National Committee for Clinical Laboratory Standards (NCCLS) and Valtec protocols. Substrate concentrations and enzyme activities were determined by spectrophotometric measurement after coloured reaction or UV detection-based reactions; electrolyte concentrations were determined with ion-selective electrodes, and specific protein concentrations were assayed by immunoturbidimetry. In total, 32 of the most common clinical chemistry parameters were evaluated under simulated routine conditions. The analytical performance of the system and the quality of the ABX Pentra reagent line were both examined in a single-site study. The ABX Pentra 400 was compared with the Olympus AU640, Konelab-Konepro, Beckman Coulter-Immage and Beckman Coulter-Access 2, depending on the tests available on these analysers. The coefficient of variation (CV) values were within expected values. Coefficients of correlation showed high correlation between the analysers compared. The influence of interfering substances was moderate. The practicability of the system was good. We conclude that good reliability and practicability make the ABX Pentra 400 system suitable for laboratories with various needs.

scholarly journals Analisis Penerapan Keselamatan Kerja Pada Petugas Laboratorium Klinik di Kota Pekanbaru

2016 ◽  
Vol 3 (1) ◽  
pp. 33
Author(s):  
Ismulyati Ismulyati ◽  
Rahman Karnila ◽  
Elda Nazriati
Keyword(s):  
Clinical Laboratory ◽  
Behavioral Assessment ◽  
Design Data ◽  
Clinical Laboratories ◽  
Measurement Results ◽  
Laboratory Workers ◽  
Potential Risks ◽  
Observational Design ◽  
Knowledge Attitude And Practice

Abstrak: The workers in clinical laboratories were suspected to always threatened a number of risks and potential accidents due to the interaction between the labor, equipment, materials and labor and environmental situation in it. In addition, the lack of understanding and awareness of companies/agencies and workers to anticipated and managed the potential risks in the laboratory in accordance with established standards. Research has been conducted in nine private clinical laboratories from February to December 2014 with 39 respondents of laboratory workers. This research was a quantitative study which using observational design. Data collection techniques in this research was using interviews, direct observation and questionnaires which distributed to the management of clinical laboratory and clinical laboratory workers. The quality of the clinical laboratory in Pekanbaru city of fair quality were three of eight laboratories. The results of clinical laboratory management signified the majority of fair quality that five of the eight laboratories in Pekanbaru city. The results of behavioral assessment of clinical laboratory workers were not well behaved. Measurement of behavior consists of knowledge attitude and practice of clinical laboratory workers. The measurement results of clinical laboratory workers were moderate categorized, nice attitudes, but the practice was not well categorized.

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