42 CFR 493.1407 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Laboratory director responsibilities. 493.1407 Section 493.1407 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing Moderate Complexity Testing § 493.1407 Standard; Laboratory director...

42 CFR 493.1359 - Standard; PPM laboratory director responsibilities.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; PPM laboratory director responsibilities... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Provider-Performed Microscopy (ppm) Procedures § 493.1359 Standard...

[Accreditation of clinical laboratories based on ISO standards].

PubMed

Kawai, Tadashi

2004-11-01

International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

Clinical pathology accreditation: standards for the medical laboratory

PubMed Central

Burnett, D; Blair, C; Haeney, M R; Jeffcoate, S L; Scott, K W M; Williams, D L

2002-01-01

This article describes a new set of revised standards for the medical laboratory, which have been produced by Clinical Pathology Accreditation (UK) Ltd (CPA). The original standards have been in use since 1992 and it was recognised that extensive revision was required. A standards revision group was established by CPA and this group used several international standards as source references, so that the resulting new standards are compatible with the most recent international reference sources. The aim is to make the assessment of medical laboratories as objective as possible in the future. CPA plans to introduce these standards in the UK in 2003 following extensive consultation with professional bodies, piloting in selected laboratories, and training of assessors. PMID:12354795

Standardization of Laboratory Methods for the PERCH Study

PubMed Central

Karron, Ruth A.; Morpeth, Susan C.; Bhat, Niranjan; Levine, Orin S.; Baggett, Henry C.; Brooks, W. Abdullah; Feikin, Daniel R.; Hammitt, Laura L.; Howie, Stephen R. C.; Knoll, Maria Deloria; Kotloff, Karen L.; Madhi, Shabir A.; Scott, J. Anthony G.; Thea, Donald M.; Adrian, Peter V.; Ahmed, Dilruba; Alam, Muntasir; Anderson, Trevor P.; Antonio, Martin; Baillie, Vicky L.; Dione, Michel; Endtz, Hubert P.; Gitahi, Caroline; Karani, Angela; Kwenda, Geoffrey; Maiga, Abdoul Aziz; McClellan, Jessica; Mitchell, Joanne L.; Morailane, Palesa; Mugo, Daisy; Mwaba, John; Mwansa, James; Mwarumba, Salim; Nyongesa, Sammy; Panchalingam, Sandra; Rahman, Mustafizur; Sawatwong, Pongpun; Tamboura, Boubou; Toure, Aliou; Whistler, Toni; O’Brien, Katherine L.; Murdoch, David R.

2017-01-01

Abstract The Pneumonia Etiology Research for Child Health study was conducted across 7 diverse research sites and relied on standardized clinical and laboratory methods for the accurate and meaningful interpretation of pneumonia etiology data. Blood, respiratory specimens, and urine were collected from children aged 1–59 months hospitalized with severe or very severe pneumonia and community controls of the same age without severe pneumonia and were tested with an extensive array of laboratory diagnostic tests. A standardized testing algorithm and standard operating procedures were applied across all study sites. Site laboratories received uniform training, equipment, and reagents for core testing methods. Standardization was further assured by routine teleconferences, in-person meetings, site monitoring visits, and internal and external quality assurance testing. Targeted confirmatory testing and testing by specialized assays were done at a central reference laboratory. PMID:28575358

42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: General laboratory systems quality... for Nonwaived Testing General Laboratory Systems § 493.1239 Standard: General laboratory systems... laboratory systems requirements specified at §§ 493.1231 through 493.1236. (b) The general laboratory systems...

Comparison of Spectrophotometric and Visual Readings of NCCLS Method and Evaluation of a Colorimetric Method Based on Reduction of a Soluble Tetrazolium Salt, 2,3-Bis {2-Methoxy-4-Nitro-5-[(Sulfenylamino) Carbonyl]-2H- Tetrazolium-Hydroxide}, for Antifungal Susceptibility Testing of Aspergillus Species

PubMed Central

Meletiadis, Joseph; Mouton, Johan W.; Meis, Jacques F. G. M.; Bouman, Bianca A.; Donnelly, Peter J.; Verweij, Paul E.

2001-01-01

The susceptibilities of 25 clinical isolates of various Aspergillus species (Aspergillus fumigatus, A. flavus, A. terreus, A. ustus, and A. nidulans) to itraconazole (ITC) and amphotericin B (AMB) were determined using the standard proposed by NCCLS for antifungal susceptibility testing of filamentous fungi, a modification of this method using spectrophotometric readings, and a colorimetric method using the tetrazolium salt 2,3-bis {2-methoxy-4-nitro-5-[(sulfenylamino) carbonyl]-2H-tetrazolium-hydroxide} (XTT). Five MIC end points for ITC (MIC-0, no visible growth or ≤5% the growth control value [GC]; MIC-1, slight growth or 6 to 25% the GC; MIC-2, prominent reduction in growth or 26 to 50% the GC; MIC-3, slight reduction in growth or 51 to 75% the GC; and MIC-4, no reduction in growth or 76 to 100% the GC) and one for AMB (MIC-0) were determined visually by four observers and spectrophotometrically. The intraexperimental (between the observers) and interexperimental (between the experiments) levels of agreement of the NCCLS and XTT methods exceeded 95% for MIC-0 of AMB and MIC-0 and MIC-1 of ITC. The MIC-2 of ITC showed lower reproducibility, although spectrophotometric reading and/or incubation for 48 h increased the interexperimental reproducibility from 85 to >93%. Between visual and spectrophotometric readings, high levels of agreement were found for AMB (≈97%) and MIC-1 (≈92%) and MIC-2 (≈88%) of ITC. Poor agreement was found for MIC-0 of ITC (51% after 24 h), since the spectrophotometric readings resulted in higher MIC-0 values than the visual readings. The agreement was increased to 98% by shifting the threshold level of MIC-0 from 5 to 10% relative optical density and by establishing an optical density of greater than 0.1 for the GC as the validation criterion. No statistically significant differences were found between the NCCLS method and the XTT method, with the levels of agreement exceeding 97% for MIC-0 of AMB and 83% for MIC-0, MIC-1, and MIC

Comparison of results of fluconazole disk diffusion testing for Candida species with results from a central reference laboratory in the ARTEMIS global antifungal surveillance program.

PubMed

Pfaller, M A; Hazen, K C; Messer, S A; Boyken, L; Tendolkar, S; Hollis, R J; Diekema, D J

2004-08-01

The accuracy of antifungal susceptibility tests is important for accurate resistance surveillance and for the clinical management of patients with serious infections. Our main objective was to compare the results of fluconazole disk diffusion testing of Candida spp. performed by ARTEMIS participating centers with disk diffusion and MIC results obtained by the central reference laboratory. A total of 2,949 isolates of Candida spp. were tested by NCCLS disk diffusion and reference broth microdilution methods in the central reference laboratory. These results were compared to the results of disk diffusion testing performed in the 54 participating centers. All tests were performed and interpreted following NCCLS recommendations. Overall categorical agreement between participant disk diffusion test results and reference laboratory MIC results was 87.4%, with 0.2% very major errors (VME) and 3.3% major errors (ME). The categorical agreement between the disk diffusion test results obtained in the reference laboratory with the MIC test results was similar: 92.8%. Likewise, good agreement was observed between participant disk diffusion test results and reference laboratory disk diffusion test results: 90.4%, 0.4% VME, and 3.4% ME. The disk diffusion test was especially reliable in detecting those isolates of Candida spp. that were characterized as resistant by reference MIC testing. External quality assurance data obtained by surveillance programs such as the ARTEMIS Global Antifungal Surveillance Program ensure the generation of useful surveillance data and result in the continued improvement of antifungal susceptibility testing practices.

VIEW OF THE INTERIOR OF BUILDING 125, THE STANDARDS LABORATORY. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

VIEW OF THE INTERIOR OF BUILDING 125, THE STANDARDS LABORATORY. THE PRIMARY FUNCTION OF THE STANDARDS LABORATORY WAS TO ENSURE AND IMPLEMENT A SYSTEM OF QUALITY CONTROL FOR INCOMING MATERIALS USED IN MANUFACTURING PROCESSES. SEVERAL ENGINEERING CONTROLS WERE USED TO ASSURE ACCURACY OF THE CALIBRATION PROCESSES INCLUDING: FLEX-FREE GRANITE TABLES, AIR LOCKED DOORS, TEMPERATURE CONTROLS, AND A SUPER-CLEAN ENVIRONMENT - Rocky Flats Plant, Standards Laboratory, Immediately north of 215A water tower & adjacent to Third Street, Golden, Jefferson County, CO

Review and comparison of quality standards, guidelines and regulations for laboratories.

PubMed

Datema, Tjeerd A M; Oskam, Linda; Klatser, Paul R

2012-01-01

The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services . Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2010 CFR

2010-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope of the laboratory environmental management standard? The Laboratory Environmental Management Standard... environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... of general laboratory systems quality assessment reviews with appropriate staff. (c) The laboratory must document all general laboratory systems quality assessment activities. [68 FR 3703, Jan. 24, 2003... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: General laboratory systems quality...

The need for accurate total cholesterol measurement. Recommended analytical goals, current state of reliability, and guidelines for better determinations.

PubMed

Naito, H K

1989-03-01

We have approached a dawn of a new era in detection, evaluation, treatment, and monitoring of individuals with elevated blood cholesterol levels who are at increased risk for CHD. The NHLBI's National Cholesterol Education Program will be the major force underlying this national awareness program, which is dependent on the clinical laboratories providing reliable data. Precision or reproducibility of results is not a problem for most of the laboratories, but accuracy is a major concern. Both the manufacturers and laboratorians need to standardize the measurement for cholesterol so that the accuracy base is traceable to the NCCLS NRS/CHOL. The manufacturers need to adopt a uniform policy that will ensure that the values assigned to calibration, quality control, and quality assurance or survey materials are accurate and traceable to the NCCLS/CHOL. Since, at present, there are some limitations of these materials caused by matrix effects, laboratories are encouraged to use the CDC-NHLBI National Reference Laboratory Network to evaluate and monitor their ability to measure patient blood cholesterol levels accurately. Major areas of analytical problems are identified and general, as well as specific, recommendations are provided to help ensure reliable measurement of cholesterol in patient specimens.

Transfer Standard Uncertainty Can Cause Inconclusive Inter-Laboratory Comparisons

PubMed Central

Wright, John; Toman, Blaza; Mickan, Bodo; Wübbeler, Gerd; Bodnar, Olha; Elster, Clemens

2016-01-01

Inter-laboratory comparisons use the best available transfer standards to check the participants’ uncertainty analyses, identify underestimated uncertainty claims or unknown measurement biases, and improve the global measurement system. For some measurands, instability of the transfer standard can lead to an inconclusive comparison result. If the transfer standard uncertainty is large relative to a participating laboratory’s uncertainty, the commonly used standardized degree of equivalence ≤ 1 criterion does not always correctly assess whether a participant is working within their uncertainty claims. We show comparison results that demonstrate this issue and propose several criteria for assessing a comparison result as passing, failing, or inconclusive. We investigate the behavior of the standardized degree of equivalence and alternative comparison measures for a range of values of the transfer standard uncertainty relative to the individual laboratory uncertainty values. The proposed alternative criteria successfully discerned between passing, failing, and inconclusive comparison results for the cases we examined. PMID:28090123

The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group.

PubMed

Humphries, Romney M; Kircher, Susan; Ferrell, Andrea; Krause, Kevin M; Malherbe, Rianna; Hsiung, Andre; Burnham, C A

2018-05-09

Expedited pathways to antimicrobial agent approval by the United States Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement a disk diffusion method for a variety of reasons, including dwindling proficiency with this method, interruptions to laboratory workflow, uncertainty surrounding the quality and reliability of a disk diffusion test, and perceived need to report an MIC to clinicians. This mini-review provides a report from the Clinical and Laboratory Standards Institute Working Group on Methods Development and Standardization on the current standards and clinical utility of disk diffusion testing. Copyright © 2018 American Society for Microbiology.

DOE standard: The Department of Energy Laboratory Accreditation Program for radiobioassay

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1998-12-01

This technical standard describes the US Department of Energy Laboratory Accreditation Program (DOELAP) for Radiobioassay, for use by the US Department of Energy (DOE) and DOE Contractor radiobioassay programs. This standard is intended to be used in conjunction with the general administrative technical standard that describes the overall DOELAP accreditation process--DOE-STD-1111-98, Department of Energy Laboratory Accreditation Program Administration. This technical standard pertains to radiobioassay service laboratories that provide either direct or indirect (in vivo or in vitro) radiobioassay measurements in support of internal dosimetry programs at DOE facilities or for DOE and DOE contractors. Similar technical standards have been developedmore » for other DOELAP dosimetry programs. This program consists of providing an accreditation to DOE radiobioassay programs based on successful completion of a performance-testing process and an on-site evaluation by technical experts. This standard describes the technical requirements and processes specific to the DOELAP Radiobioassay Accreditation Program as required by 10 CFR 835 and as specified generically in DOE-STD-1111-98.« less

Iodine Standard Materials: Preparation and Inter-Laboratory Comparisons

DOE Office of Scientific and Technical Information (OSTI.GOV)

D D Jenson; M L Adamic; J E Olson

The Idaho National Laboratory is preparing to enter the community of AMS practioners who analyze for 129Iodine. We expect to take delivery of a 0.5 MV compact accelerator mass spectrometry system, built by NEC, in the early summer of 2014. The primary mission for this instrument is iodine; it is designed to analyze iodine in the +3 charge state. As part of the acceptance testing for this instrument, both at NEC and on-site in our laboratory, some sort of standard or reference material is needed to verify performance. Appropriate standard materials are not readily available in the commercial marketplace. Smallmore » quantities can sometimes be acquired from other laboratories already engaged in iodine analyses. In the longer-term, meaningful quantities of standard materials are needed for routine use in analyses, and for quality control functions1. We have prepared some standard materials, starting with elemental Woodward iodine and NIST SRM 3231 [Iodine-129 Isotopic Standard (high level)] 10-6 solution. The goal was to make mixtures at the 5x10-10, 5x10-11, 5x10-12 ratio levels, along with some unmodified Woodward, in the chemical form of silver iodide. Approximately twenty grams of each of these mixtures were prepared. The elemental Woodward iodine was dissolved in chloroform, then reduced to iodide using sodium bisulfite in water. At this point the NIST spike material was added, in the form of sodium iodide. The mixed iodides were oxidized back to iodine in chloroform using hydrogen peroxide. This oxidation step was essential for isotopic equilibration of the 127 and 129 atoms. The iodine was reduced to iodide using sodium bisulfite as before. Excess sulfites and sulfates were precipitated with barium nitrate. After decanting, silver nitrate was used to precipitate the desired silver iodide. Once the silver iodide was produced, the material was kept in darkness as much as possible to minimize photo-oxidation. The various mixtures were synthesized independently

Illinois Occupational Skill Standards: Clinical Laboratory Science/Biotechnology Cluster.

ERIC Educational Resources Information Center

Illinois Occupational Skill Standards and Credentialing Council, Carbondale.

This document, which is intended to serve as a guide for workforce preparation program providers, details the Illinois Occupational Skill Standards for clinical laboratory occupations programs. The document begins with a brief overview of the Illinois perspective on occupational skill standards and credentialing, the process used to develop the…

Correlation between In Vitro and In Vivo Antifungal Activities in Experimental Fluconazole-Resistant Oropharyngeal and Esophageal Candidiasis

PubMed Central

Walsh, Thomas J.; Gonzalez, Corina E.; Piscitelli, Steven; Bacher, John D.; Peter, Joanne; Torres, Richard; Shetti, Daiva; Katsov, Victoria; Kligys, Kristina; Lyman, Caron A.

2000-01-01

Oropharyngeal and esophageal candidiasis (OPEC) is a frequent opportunistic mycosis in immunocompromised patients. Azole-resistant OPEC is a refractory form of this infection occurring particularly in human immunodeficiency virus (HIV)-infected patients. The procedures developed by the Antifungal Subcommittee of the National Committee for Clinical Laboratory Standards (NCCLS) are an important advance in standardization of in vitro antifungal susceptibility methodology. In order to further understand the relationship between NCCLS methodology and antifungal therapeutic response, we studied the potential correlation between in vitro susceptibility to fluconazole and in vivo response in a rabbit model of fluconazole-resistant OPEC. MICs of fluconazole were determined by NCCLS methods. Three fluconazole-susceptible (FS) (MIC, ≤0.125 μg/ml) and three fluconazole-resistant (FR) (MIC, ≥64 μg/ml) isolates of Candida albicans from prospectively monitored HIV-infected children with OPEC were studied. FR isolates were recovered from children with severe OPEC refractory to fluconazole, and FS isolates were recovered from those with mucosal candidiasis responsive to fluconazole. Fluconazole at 2 mg/kg of body weight/day was administered to infected animals for 7 days. The concentrations of fluconazole in plasma were maintained above the MICs for FS isolates throughout the dosing interval. Fluconazole concentrations in the esophagus were greater than or equal to those in plasma. Rabbits infected with FS isolates and treated with fluconazole had significant reductions in oral mucosal quantitative cultures (P < 0.001) and tissue burden of C. albicans in tongue, soft palate, and esophagus (P < 0.001). In comparison, rabbits infected with FR isolates were unresponsive to fluconazole and had no reduction in oral mucosal quantitative cultures or tissue burden of C. albicans versus untreated controls. We conclude that there is a strong correlation between in vitro fluconazole

Correlation between in vitro and in vivo antifungal activities in experimental fluconazole-resistant oropharyngeal and esophageal candidiasis.

PubMed

Walsh, T J; Gonzalez, C E; Piscitelli, S; Bacher, J D; Peter, J; Torres, R; Shetti, D; Katsov, V; Kligys, K; Lyman, C A

2000-06-01

Oropharyngeal and esophageal candidiasis (OPEC) is a frequent opportunistic mycosis in immunocompromised patients. Azole-resistant OPEC is a refractory form of this infection occurring particularly in human immunodeficiency virus (HIV)-infected patients. The procedures developed by the Antifungal Subcommittee of the National Committee for Clinical Laboratory Standards (NCCLS) are an important advance in standardization of in vitro antifungal susceptibility methodology. In order to further understand the relationship between NCCLS methodology and antifungal therapeutic response, we studied the potential correlation between in vitro susceptibility to fluconazole and in vivo response in a rabbit model of fluconazole-resistant OPEC. MICs of fluconazole were determined by NCCLS methods. Three fluconazole-susceptible (FS) (MIC, /=64 microgram/ml) isolates of Candida albicans from prospectively monitored HIV-infected children with OPEC were studied. FR isolates were recovered from children with severe OPEC refractory to fluconazole, and FS isolates were recovered from those with mucosal candidiasis responsive to fluconazole. Fluconazole at 2 mg/kg of body weight/day was administered to infected animals for 7 days. The concentrations of fluconazole in plasma were maintained above the MICs for FS isolates throughout the dosing interval. Fluconazole concentrations in the esophagus were greater than or equal to those in plasma. Rabbits infected with FS isolates and treated with fluconazole had significant reductions in oral mucosal quantitative cultures (P < 0.001) and tissue burden of C. albicans in tongue, soft palate, and esophagus (P < 0.001). In comparison, rabbits infected with FR isolates were unresponsive to fluconazole and had no reduction in oral mucosal quantitative cultures or tissue burden of C. albicans versus untreated controls. We conclude that there is a strong correlation between in vitro

LabRS: A Rosetta stone for retrospective standardization of clinical laboratory test results.

PubMed

Hauser, Ronald George; Quine, Douglas B; Ryder, Alex

2018-02-01

Clinical laboratories in the United States do not have an explicit result standard to report the 7 billion laboratory tests results they produce each year. The absence of standardized test results creates inefficiencies and ambiguities for secondary data users. We developed and tested a tool to standardize the results of laboratory tests in a large, multicenter clinical data warehouse. Laboratory records, each of which consisted of a laboratory result and a test identifier, from 27 diverse facilities were captured from 2000 through 2015. Each record underwent a standardization process to convert the original result into a format amenable to secondary data analysis. The standardization process included the correction of typos, normalization of categorical results, separation of inequalities from numbers, and conversion of numbers represented by words (eg, "million") to numerals. Quality control included expert review. We obtained 1.266 × 109 laboratory records and standardized 1.252 × 109 records (98.9%). Of the unique unstandardized records (78.887 × 103), most appeared <5 times (96%, eg, typos), did not have a test identifier (47%), or belonged to an esoteric test with <100 results (2%). Overall, these 3 reasons accounted for nearly all unstandardized results (98%). Current results suggest that the tool is both scalable and generalizable among diverse clinical laboratories. Based on observed trends, the tool will require ongoing maintenance to stay current with new tests and result formats. Future work to develop and implement an explicit standard for test results would reduce the need to retrospectively standardize test results. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Standardizing clinical laboratory data for secondary use.

PubMed

Abhyankar, Swapna; Demner-Fushman, Dina; McDonald, Clement J

2012-08-01

Clinical databases provide a rich source of data for answering clinical research questions. However, the variables recorded in clinical data systems are often identified by local, idiosyncratic, and sometimes redundant and/or ambiguous names (or codes) rather than unique, well-organized codes from standard code systems. This reality discourages research use of such databases, because researchers must invest considerable time in cleaning up the data before they can ask their first research question. Researchers at MIT developed MIMIC-II, a nearly complete collection of clinical data about intensive care patients. Because its data are drawn from existing clinical systems, it has many of the problems described above. In collaboration with the MIT researchers, we have begun a process of cleaning up the data and mapping the variable names and codes to LOINC codes. Our first step, which we describe here, was to map all of the laboratory test observations to LOINC codes. We were able to map 87% of the unique laboratory tests that cover 94% of the total number of laboratory tests results. Of the 13% of tests that we could not map, nearly 60% were due to test names whose real meaning could not be discerned and 29% represented tests that were not yet included in the LOINC table. These results suggest that LOINC codes cover most of laboratory tests used in critical care. We have delivered this work to the MIMIC-II researchers, who have included it in their standard MIMIC-II database release so that researchers who use this database in the future will not have to do this work. Published by Elsevier Inc.

Report on the Project for Establishment of the Standardized Korean Laboratory Terminology Database, 2015.

PubMed

Jung, Bo Kyeung; Kim, Jeeyong; Cho, Chi Hyun; Kim, Ju Yeon; Nam, Myung Hyun; Shin, Bong Kyung; Rho, Eun Youn; Kim, Sollip; Sung, Heungsup; Kim, Shinyoung; Ki, Chang Seok; Park, Min Jung; Lee, Kap No; Yoon, Soo Young

2017-04-01

The National Health Information Standards Committee was established in 2004 in Korea. The practical subcommittee for laboratory test terminology was placed in charge of standardizing laboratory medicine terminology in Korean. We aimed to establish a standardized Korean laboratory terminology database, Korea-Logical Observation Identifier Names and Codes (K-LOINC) based on former products sponsored by this committee. The primary product was revised based on the opinions of specialists. Next, we mapped the electronic data interchange (EDI) codes that were revised in 2014, to the corresponding K-LOINC. We established a database of synonyms, including the laboratory codes of three reference laboratories and four tertiary hospitals in Korea. Furthermore, we supplemented the clinical microbiology section of K-LOINC using an alternative mapping strategy. We investigated other systems that utilize laboratory codes in order to investigate the compatibility of K-LOINC with statistical standards for a number of tests. A total of 48,990 laboratory codes were adopted (21,539 new and 16,330 revised). All of the LOINC synonyms were translated into Korean, and 39,347 Korean synonyms were added. Moreover, 21,773 synonyms were added from reference laboratories and tertiary hospitals. Alternative strategies were established for mapping within the microbiology domain. When we applied these to a smaller hospital, the mapping rate was successfully increased. Finally, we confirmed K-LOINC compatibility with other statistical standards, including a newly proposed EDI code system. This project successfully established an up-to-date standardized Korean laboratory terminology database, as well as an updated EDI mapping to facilitate the introduction of standard terminology into institutions. © 2017 The Korean Academy of Medical Sciences.

International standards for tuberculosis care: relevance and implications for laboratory professionals.

PubMed

Pai, M; Daley, P; Hopewell, P C

2007-04-01

On World Tuberculosis (TB) Day 2006, the International Standards for Tuberculosis Care (ISTC) was officially released and widely endorsed by several agencies and organizations. The ISTC release was the culmination of a year long global effort to develop and set internationally acceptable, evidence-based standards for tuberculosis care. The ISTC describes a widely endorsed level of care that all practitioners, public and private, should seek to achieve in managing individuals who have or are suspected of having, TB and is intended to facilitate the effective engagement of all healthcare providers in delivering high quality care for patients of all ages, including those with smear-positive, smear-negative and extra-pulmonary TB, TB caused by drug-resistant Mycobacterium tuberculosis and TB/HIV coinfection. In this article, we present the ISTC, with a special focus on the diagnostic standards and describe their implications and relevance for laboratory professionals in India and worldwide. Laboratory professionals play a critical role in ensuring that all the standards are actually met by providing high quality laboratory services for smear microscopy, culture and drug susceptibility testing and other services such as testing for HIV infection. In fact, if the ISTC is widely followed, it can be expected that there will be a greater need and demand for quality assured laboratory services and this will have obvious implications for all laboratories in terms of work load, requirement for resources and trained personnel and organization of quality assurance systems.

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2014 CFR

2014-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope... 40 Protection of Environment 26 2014-07-01 2014-07-01 false What is the scope of the laboratory environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2012 CFR

2012-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope... 40 Protection of Environment 27 2012-07-01 2012-07-01 false What is the scope of the laboratory environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2013 CFR

2013-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope... 40 Protection of Environment 27 2013-07-01 2013-07-01 false What is the scope of the laboratory environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

40 CFR 262.103 - What is the scope of the laboratory environmental management standard?

Code of Federal Regulations, 2011 CFR

2011-07-01

... University Laboratories XL Project-Laboratory Environmental Management Standard § 262.103 What is the scope... 40 Protection of Environment 26 2011-07-01 2011-07-01 false What is the scope of the laboratory environmental management standard? 262.103 Section 262.103 Protection of Environment ENVIRONMENTAL PROTECTION...

The Tanzania experience: clinical laboratory testing harmonization and equipment standardization at different levels of a tiered health laboratory system.

PubMed

Massambu, Charles; Mwangi, Christina

2009-06-01

The rapid scale-up of the care and treatment programs in Tanzania during the preceding 4 years has greatly increased the demand for quality laboratory services for diagnosis of HIV and monitoring patients during antiretroviral therapy. Laboratory services were not in a position to cope with this demand owing to poor infrastructure, lack of human resources, erratic and/or lack of reagent supply and commodities, and slow manual technologies. With the limited human resources in the laboratory and the need for scaling up the care and treatment program, it became necessary to install automated equipment and train personnel for the increased volume of testing and new tests across all laboratory levels. With the numerous partners procuring equipment, the possibility of a multitude of equipment platforms with attendant challenges for procurement of reagents, maintenance of equipment, and quality assurance arose. Tanzania, therefore, had to harmonize laboratory tests and standardize laboratory equipment at different levels of the laboratory network. The process of harmonization of tests and standardization of equipment included assessment of laboratories, review of guidelines, development of a national laboratory operational plan, and stakeholder advocacy. This document outlines this process.

Inter-laboratory comparison study on measuring semi-volatile organic chemicals in standards and air samples.

PubMed

Su, Yushan; Hung, Hayley

2010-11-01

Measurements of semi-volatile organic chemicals (SVOCs) were compared among 21 laboratories from 7 countries through the analysis of standards, a blind sample, an air extract, and an atmospheric dust sample. Measurement accuracy strongly depended on analytes, laboratories, and types of standards and samples. Intra-laboratory precision was generally good with relative standard deviations (RSDs) of triplicate injections <10% and with median differences of duplicate samples between 2.1 and 22%. Inter-laboratory variability, measured by RSDs of all measurements, was in the range of 2.8-58% in analyzing standards, and 6.9-190% in analyzing blind sample and air extract. Inter-laboratory precision was poorer when samples were subject to cleanup processes, or when SVOCs were quantified at low concentrations. In general, inter-laboratory differences up to a factor of 2 can be expected to analyze atmospheric SVOCs. When comparing air measurements from different laboratories, caution should be exercised if the data variability is less than the inter-laboratory differences. 2010. Published by Elsevier Ltd. All rights reserved.

42 CFR 493.1359 - Standard; PPM laboratory director responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for... subparts H, J, K, and M of this part. [57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3713, Jan. 24, 2003...

A report from the AVS Standards Committee - Comparison of ion gauge calibrations by several standards laboratories

NASA Technical Reports Server (NTRS)

Warshawsky, I.

1982-01-01

Calibrations by four U.S. laboratories of four hot-cathode ion gauges, in the range 0.07-13 mPa, showed systematic differences among laboratories that were much larger than the expected error of any one calibration. They also suggested that any of the four gauges tested, if properly packaged and shipped, was able to serve as a transfer standard with probable error of 2%. A second comparison was made of the calibrations by two U.S. laboratories of some other gauges that had also been calibrated by the National Physical Laboratory, England. Results did not permit conclusive determination of whether differences were due to the laboratories or to changes in the gauges.

Productivity standards for histology laboratories.

PubMed

Buesa, René J

2010-04-01

The information from 221 US histology laboratories (histolabs) and 104 from 24 other countries with workloads from 600 to 116 000 cases per year was used to calculate productivity standards for 23 technical and 27 nontechnical tasks and for 4 types of work flow indicators. The sample includes 254 human, 40 forensic, and 31 veterinary pathology services. Statistical analyses demonstrate that most productivity standards are not different between services or worldwide. The total workload for the US human pathology histolabs averaged 26 061 cases per year, with 54% between 10 000 and less than 30 000. The total workload for 70% of the histolabs from other countries was less than 20 000, with an average of 15 226 cases per year. The fundamental manual technical tasks in the histolab and their productivity standards are as follows: grossing (14 cases per hour), cassetting (54 cassettes per hour), embedding (50 blocks per hour), and cutting (24 blocks per hour). All the other tasks, each with their own productivity standards, can be completed by auxiliary staff or using automatic instruments. Depending on the level of automation of the histolab, all the tasks derived from a workload of 25 cases will require 15.8 to 17.7 hours of work completed by 2.4 to 2.7 employees with 18% of their working time not directly dedicated to the production of diagnostic slides. This article explains how to extrapolate this productivity calculation for any workload and different levels of automation. The overall performance standard for all the tasks, including 8 hours for automated tissue processing, is 3.2 to 3.5 blocks per hour; and its best indicator is the value of the gross work flow productivity that is essentially dependent on how the work is organized. This article also includes productivity standards for forensic and veterinary histolabs, but the staffing benchmarks for histolabs will be the subject of a separate article. Copyright 2010 Elsevier Inc. All rights reserved.

Improving Consistency in Large Laboratory Courses: A Design for a Standardized Practical Exam

ERIC Educational Resources Information Center

Chen, Xinnian; Graesser, Donnasue; Sah, Megha

2015-01-01

Laboratory courses serve as important gateways to science, technology, engineering, and mathematics education. One of the challenges in assessing laboratory learning is to conduct meaningful and standardized practical exams, especially for large multisection laboratory courses. Laboratory practical exams in life sciences courses are frequently…

Illinois Occupational Skill Standards: Agricultural Laboratory and Field Technician Cluster.

ERIC Educational Resources Information Center

Illinois Occupational Skill Standards and Credentialing Council, Carbondale.

These Illinois skill standards for the agricultural laboratory and field technician cluster are intended to serve as a guide to workforce preparation program providers as they define content for their programs and to employers as they establish the skills and standards necessary for job acquisition. They could also serve as a mechanism for…

U.S. Geological Survey Standard Reference Sample Project: Performance Evaluation of Analytical Laboratories

USGS Publications Warehouse

Long, H. Keith; Daddow, Richard L.; Farrar, Jerry W.

1998-01-01

Since 1962, the U.S. Geological Survey (USGS) has operated the Standard Reference Sample Project to evaluate the performance of USGS, cooperator, and contractor analytical laboratories that analyze chemical constituents of environmental samples. The laboratories are evaluated by using performance evaluation samples, called Standard Reference Samples (SRSs). SRSs are submitted to laboratories semi-annually for round-robin laboratory performance comparison purposes. Currently, approximately 100 laboratories are evaluated for their analytical performance on six SRSs for inorganic and nutrient constituents. As part of the SRS Project, a surplus of homogeneous, stable SRSs is maintained for purchase by USGS offices and participating laboratories for use in continuing quality-assurance and quality-control activities. Statistical evaluation of the laboratories results provides information to compare the analytical performance of the laboratories and to determine possible analytical deficiences and problems. SRS results also provide information on the bias and variability of different analytical methods used in the SRS analyses.

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 3 2012-01-01 2012-01-01 false Standard hourly fee rate for laboratory testing... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and Charges § 91.37 Standard hourly fee rate for laboratory testing, analysis, and other services. (a) The...

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 3 2014-01-01 2014-01-01 false Standard hourly fee rate for laboratory testing... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and Charges § 91.37 Standard hourly fee rate for laboratory testing, analysis, and other services. (a) The...

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false Standard hourly fee rate for laboratory testing... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and Charges § 91.37 Standard hourly fee rate for laboratory testing, analysis, and other services. (a) The...

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Standard hourly fee rate for laboratory testing... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and Charges § 91.37 Standard hourly fee rate for laboratory testing, analysis, and other services. (a) The...

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population.

PubMed

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-03-26

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients' care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine.

The standardization of urine particle counting in medical laboratories--a Polish experience with the EQA programme.

PubMed

Cwiklińska, Agnieszka; Kąkol, Judyta; Kuchta, Agnieszka; Kortas-Stempak, Barbara; Pacanis, Anastasis; Rogulski, Jerzy; Wróblewska, Małgorzata

2012-02-01

Given the common problems with the standardization of urine particle counting methods and the great variability in the results obtained by Polish laboratories under international Labquality External Quality Assessment (EQA), we initiated educational recovery activities. Detailed instructions on how to perform the standardized examination were sent to EQA participants, as was a questionnaire forms which enabled information to be gathered in respect to the procedures being applied. Laboratory results were grouped according to the method declared on the EQA 'Result' form or according to a manual examination procedure established on the basis of the questionnaire. The between-laboratory CVs for leukocyte and erythrocyte counts were calculated for each group and compared using the Mann-Whitney test. Significantly lower between-laboratory CVs (p = 0.03) were achieved for leukocyte counting among the laboratories that analysed control specimens in accordance with standardized procedures as compared with those which used non-standardized procedures. We also observed a visible lower variability for erythrocyte counting. Unfortunately despite our activities, only a few of the Polish laboratories applied the standardized examination procedures, and only 29% of the results could have been considered to be standardized (16% - manual methods, 13% - automated systems). The standardization of urine particle counting methods continues to be a significant problem in medical laboratories and requires further recovery activities which can be conducted using the EQA scheme.

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

PubMed Central

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-01-01

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients’ care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine. PMID:27019800

76 FR 72216 - Occupational Exposure to Hazardous Chemicals in Laboratories Standard; Extension of the Office of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-22

... by developing a written Chemical Hygiene Plan (CHP) that describes standard operating procedures for...] Occupational Exposure to Hazardous Chemicals in Laboratories Standard; Extension of the Office of Management... requirements specified in the Standard on Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR...

NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE (NELAC): CONSTITUTION, BYLAWS, AND STANDARDS

EPA Science Inventory

The principles and operating procedures for the National Environmental Laboratory Accreditation Conference (NELAC) are contained in the NELAC Constitution and Bylaws. The major portion of this document (standards) contains detailed requirements for accrediting environmental labo...

[Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

PubMed

Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

2013-02-01

The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Quality assurance of reference standards from nine European solar-ultraviolet monitoring laboratories.

PubMed

Gröbner, Julian; Rembges, Diana; Bais, Alkiviadis F; Blumthaler, Mario; Cabot, Thierry; Josefsson, Weine; Koskela, Tapani; Thorseth, Trond M; Webb, Ann R; Wester, Ulf

2002-07-20

A program for quality assurance of reference standards has been initiated among nine solar-UV monitoring laboratories. By means of a traveling lamp package that comprises several 1000-W ANSI code DXW-type quartz-halogen lamps, a 0.1-ohm shunt, and a 6-1/2 digit voltmeter, the irradiance scales used by the nine laboratories were compared with one another; a relative uncertainty of 1.2% was found. The comparison of 15 reference standards yielded differences of as much as 9%; the average difference was less than 3%.

Food intake in laboratory rats provided standard and fenbendazole-supplemented diets.

PubMed

Vento, Peter J; Swartz, Megan E; Martin, Lisa Be; Daniels, Derek

2008-11-01

The benzimidazole anthelmintic fenbendazole (FBZ) is a common and effective treatment for pinworm infestation in laboratory animal colonies. Although many investigators have examined the potential for deleterious biologic effects of FBZ, more subtle aspects of the treatment remain untested. Accordingly, we evaluated differences in food intake when healthy male Sprague-Dawley rats were provided a standard nonmedicated laboratory rodent chow or the same chow supplemented with FBZ. We also tested for a preference for either food type when subjects were provided a choice of the 2 diets. Data from these experiments showed no differences in food intake or body weight when rats were maintained on either standard or FBZ-supplemented chow. When the rats were given access to both the standard and FBZ-supplemented diets, they showed a clear preference for the standard diet. The preference for the standard diet indicates that the rats can discriminate between the 2 foods and may avoid the FBZ-supplemented chow when possible. Investigators conducting experiments during treatment with FBZ in which differences in food preference are relevant should be aware of these data and plan their studies accordingly.

Food Intake in Laboratory Rats Provided Standard and Fenbendazole-supplemented Diets

PubMed Central

Vento, Peter J; Swartz, Meghan E; Martin, Lisa BE; Daniels, Derek

2008-01-01

The benzimidazole anthelmintic fenbendazole (FBZ) is a common and effective treatment for pinworm infestation in laboratory animal colonies. Although many investigators have examined the potential for deleterious biologic effects of FBZ, more subtle aspects of the treatment remain untested. Accordingly, we evaluated differences in food intake when healthy male Sprague–Dawley rats were provided a standard nonmedicated laboratory rodent chow or the same chow supplemented with FBZ. We also tested for a preference for either food type when subjects were provided a choice of the 2 diets. Data from these experiments showed no differences in food intake or body weight when rats were maintained on either standard or FBZ-supplemented chow. When the rats were given access to both the standard and FBZ-supplemented diets, they showed a clear preference for the standard diet. The preference for the standard diet indicates that the rats can discriminate between the 2 foods and may avoid the FBZ-supplemented chow when possible. Investigators conducting experiments during treatment with FBZ in which differences in food preference are relevant should be aware of these data and plan their studies accordingly. PMID:19049253

[The analytical reliability of clinical laboratory information and role of the standards in its support].

PubMed

Men'shikov, V V

2012-12-01

The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

The evaluation of hospital laboratory information management systems based on the standards of the American National Standard Institute

PubMed Central

Isfahani, Sakineh Saghaeiannejad; Khajouei, Reza; Jahanbakhsh, Maryan; Mirmohamadi, Mahboubeh

2014-01-01

Introduction: Nowadays, modern laboratories are faced with a huge volume of information. One of the goals of the Laboratory Information Management System (LIMS) is to assist in the management of the information generated in the laboratory. This study intends to evaluate the LIMS based on the standards of the American National Standard Institute (ANSI). Materials and Methods: This research is a descriptive–analytical study, which had been conducted in 2011, on the LIMSs in use, in the teaching and private hospitals in Isfahan. The data collecting instrument was a checklist, which was made by evaluating three groups of information components namely: ‘System capabilities’, ‘work list functions,’ and ‘reporting’ based on LIS8-A. Data were analyzed using the SPSS 20. Data were analyzed using (relative) frequency, percentage. To compare the data the following statistical tests were used: Leven test, t-test, and Analysis of Variance (ANOVA). Results: The results of the study indicated that the LIMS had a low conformity (30%) with LIS8-A (P = 0.001), with no difference between teaching and private hospitals (P = 0.806). The ANOVA revealed that in terms of conformity with the LIS8-A standard, there was a significant difference between the systems produced by different vendors (P = 0.023). According to the results, a Kowsar system with more than %57 conformity in the three groups of information components had a better conformity to the standard, compared to the other systems. Conclusions: This study indicated that none of the LIMSs had a good conformity to the standard. It seems that system providers did not pay sufficient attention to many of the information components required by the standards when designing and developing their systems. It was suggested that standards from certified organizations and institutions be followed in the design and development process of health information systems. PMID:25077154

The evaluation of hospital laboratory information management systems based on the standards of the American National Standard Institute.

PubMed

Isfahani, Sakineh Saghaeiannejad; Khajouei, Reza; Jahanbakhsh, Maryan; Mirmohamadi, Mahboubeh

2014-01-01

Nowadays, modern laboratories are faced with a huge volume of information. One of the goals of the Laboratory Information Management System (LIMS) is to assist in the management of the information generated in the laboratory. This study intends to evaluate the LIMS based on the standards of the American National Standard Institute (ANSI). This research is a descriptive-analytical study, which had been conducted in 2011, on the LIMSs in use, in the teaching and private hospitals in Isfahan. The data collecting instrument was a checklist, which was made by evaluating three groups of information components namely: 'System capabilities', 'work list functions,' and 'reporting' based on LIS8-A. Data were analyzed using the SPSS 20. Data were analyzed using (relative) frequency, percentage. To compare the data the following statistical tests were used: Leven test, t-test, and Analysis of Variance (ANOVA). The results of the study indicated that the LIMS had a low conformity (30%) with LIS8-A (P = 0.001), with no difference between teaching and private hospitals (P = 0.806). The ANOVA revealed that in terms of conformity with the LIS8-A standard, there was a significant difference between the systems produced by different vendors (P = 0.023). According to the results, a Kowsar system with more than %57 conformity in the three groups of information components had a better conformity to the standard, compared to the other systems. This study indicated that none of the LIMSs had a good conformity to the standard. It seems that system providers did not pay sufficient attention to many of the information components required by the standards when designing and developing their systems. It was suggested that standards from certified organizations and institutions be followed in the design and development process of health information systems.

Standards, Regulation and Registration of Dental Laboratories. An Industry Update.

PubMed

Giovannone, Paul L

2015-01-01

State dental associations are showing increased interest in maintaining current standards and regulations affecting the dental laboratory industry as mandated by the Food and Drug Administration. The domestic dental laboratory industry is being significantly stressed by foreign competition, rapid technology development and unprecedented consolidation, which are changing the way that prosthetic devices and restorations are manufactured and delivered to dentists. Of paramount importance to the prescribing dentist is the accurate documentation of the source and materials being used in prostheses being delivered to patients.

College of American Pathologists' laboratory standards for next-generation sequencing clinical tests.

PubMed

Aziz, Nazneen; Zhao, Qin; Bry, Lynn; Driscoll, Denise K; Funke, Birgit; Gibson, Jane S; Grody, Wayne W; Hegde, Madhuri R; Hoeltge, Gerald A; Leonard, Debra G B; Merker, Jason D; Nagarajan, Rakesh; Palicki, Linda A; Robetorye, Ryan S; Schrijver, Iris; Weck, Karen E; Voelkerding, Karl V

2015-04-01

The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL). This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.

ISO/IEC 17025 laboratory accreditation of NRC Acoustical Standards Program

NASA Astrophysics Data System (ADS)

Wong, George S. K.; Wu, Lixue; Hanes, Peter; Ohm, Won-Suk

2004-05-01

Experience gained during the external accreditation of the Acoustical Standards Program at the Institute for National Measurement Standards of the National Research Council is discussed. Some highlights include the preparation of documents for calibration procedures, control documents with attention to reducing future paper work and the need to maintain documentation or paper trails to satisfy the external assessors. General recommendations will be given for laboratories that are contemplating an external audit in accordance to the requirements of ISO/IEC 17025.

Naval Research Laboratory Industrial Chemical Analysis and Respiratory Filter Standards Development

DTIC Science & Technology

2017-09-29

Filter Standards Development September 29, 2017 Approved for public release; distribution is unlimited. Thomas E. suTTo Materials and Systems Branch...LIMITATION OF ABSTRACT Naval Research Laboratory Industrial Chemical Analysis and Respiratory Filter Standards Development Thomas E. Sutto Naval Research...approach, developed by NRL, is tested by examining the filter behavior against a number of chemicals to determine if the NRL approach resulted in the

Microfluidic cartridges for DNA purification and genotyping processed in standard laboratory instruments

NASA Astrophysics Data System (ADS)

Focke, Maximilian; Mark, Daniel; Stumpf, Fabian; Müller, Martina; Roth, Günter; Zengerle, Roland; von Stetten, Felix

2011-06-01

Two microfluidic cartridges intended for upgrading standard laboratory instruments with automated liquid handling capability by use of centrifugal forces are presented. The first microfluidic cartridge enables purification of DNA from human whole blood and is operated in a standard laboratory centrifuge. The second microfluidic catridge enables genotyping of pathogens by geometrically multiplexed real-time PCR. It is operated in a slightly modified off-the-shelf thermal cycler. Both solutions aim at smart and cost-efficient ways to automate work flows in laboratories. The DNA purification cartridge automates all liquid handling steps starting from a lysed blood sample to PCR ready DNA. The cartridge contains two manually crushable glass ampoules with liquid reagents. The DNA yield extracted from a 32 μl blood sample is 192 +/- 30 ng which corresponds to 53 +/- 8% of a reference extraction. The genotyping cartridge is applied to analyse isolates of the multi-resistant Staphyloccus aureus (MRSA) by real-time PCR. The wells contain pre-stored dry reagents such as primers and probes. Evaluation of the system with 44 genotyping assays showed a 100% specificity and agreement with the reference assays in standard tubes. The lower limit of detection was well below 10 copies of DNA per reaction.

Development of a Fan-Filter Unit Test Standard, LaboratoryValidations, and its Applications across Industries

DOE Office of Scientific and Technical Information (OSTI.GOV)

Xu, Tengfang

2006-10-20

Lawrence Berkeley National Laboratory (LBNL) is now finalizing the Phase 2 Research and Demonstration Project on characterizing 2-foot x 4-foot (61-cm x 122-cm) fan-filter units in the market using the first-ever standard laboratory test method developed at LBNL.[1][2][3] Fan-filter units deliver re-circulated air and provide particle filtration control for clean environments. Much of the energy in cleanrooms (and minienvironments) is consumed by 2-foot x 4-foot (61-cm x 122-cm) or 4-foot x 4-foot (122-cm x 122-cm) fan-filter units that are typically located in the ceiling (25-100% coverage) of cleanroom controlled environments. Thanks to funding support by the California Energy Commission's Industrialmore » Program of the Public Interest Energy Research (PIER) Program, and significant participation from manufacturers and users of fan-filter units from around the world, LBNL has developed and performed a series of standard laboratory tests and reporting on a variety of 2-foot x 4-foot (61-cm x 122-cm) fan-filter units (FFUs). Standard laboratory testing reports have been completed and reported back to anonymous individual participants in this project. To date, such reports on standard testing of FFU performance have provided rigorous and useful data for suppliers and end users to better understand, and more importantly, to quantitatively characterize performance of FFU products under a variety of operating conditions.[1] In the course of the project, the standard laboratory method previously developed at LBNL has been under continuous evaluation and update.[2][3] Based upon the updated standard, it becomes feasible for users and suppliers to characterize and evaluate energy performance of FFUs in a consistent way.« less

Integrating standard operating procedures and industry notebook standards to evaluate students in laboratory courses.

PubMed

Wallert, Mark A; Provost, Joseph J

2014-01-01

To enhance the preparedness of graduates from the Biochemistry and Biotechnology (BCBT) Major at Minnesota State University Moorhead for employment in the bioscience industry we have developed a new Industry certificate program. The BCBT Industry Certificate was developed to address specific skill sets that local, regional, and national industry experts identified as lacking in new B.S. and B.A. biochemistry graduates. The industry certificate addresses concerns related to working in a regulated industry such as Good Laboratory Practices, Good Manufacturing Practices, and working in a Quality System. In this article we specifically describe how we developed a validation course that uses Standard Operating Procedures to describe grading policy and laboratory notebook requirements in an effort to better prepare students to transition into industry careers. © 2013 by The International Union of Biochemistry and Molecular Biology.

Hydrogen Field Test Standard: Laboratory and Field Performance

PubMed Central

Pope, Jodie G.; Wright, John D.

2015-01-01

The National Institute of Standards and Technology (NIST) developed a prototype field test standard (FTS) that incorporates three test methods that could be used by state weights and measures inspectors to periodically verify the accuracy of retail hydrogen dispensers, much as gasoline dispensers are tested today. The three field test methods are: 1) gravimetric, 2) Pressure, Volume, Temperature (PVT), and 3) master meter. The FTS was tested in NIST's Transient Flow Facility with helium gas and in the field at a hydrogen dispenser location. All three methods agree within 0.57 % and 1.53 % for all test drafts of helium gas in the laboratory setting and of hydrogen gas in the field, respectively. The time required to perform six test drafts is similar for all three methods, ranging from 6 h for the gravimetric and master meter methods to 8 h for the PVT method. The laboratory tests show that 1) it is critical to wait for thermal equilibrium to achieve density measurements in the FTS that meet the desired uncertainty requirements for the PVT and master meter methods; in general, we found a wait time of 20 minutes introduces errors < 0.1 % and < 0.04 % in the PVT and master meter methods, respectively and 2) buoyancy corrections are important for the lowest uncertainty gravimetric measurements. The field tests show that sensor drift can become a largest component of uncertainty that is not present in the laboratory setting. The scale was calibrated after it was set up at the field location. Checks of the calibration throughout testing showed drift of 0.031 %. Calibration of the master meter and the pressure sensors prior to travel to the field location and upon return showed significant drifts in their calibrations; 0.14 % and up to 1.7 %, respectively. This highlights the need for better sensor selection and/or more robust sensor testing prior to putting into field service. All three test methods are capable of being successfully performed in the field and give

Validation of Radiometric Standards for the Laboratory Calibration of Reflected-Solar Earth Observing Satellite Instruments

NASA Technical Reports Server (NTRS)

Butler, James J.; Johnson, B. Carol; Rice, Joseph P.; Brown, Steven W.; Barnes, Robert A.

2007-01-01

Historically, the traceability of the laboratory calibration of Earth-observing satellite instruments to a primary radiometric reference scale (SI units) is the responsibility of each instrument builder. For the NASA Earth Observing System (EOS), a program has been developed using laboratory transfer radiometers, each with its own traceability to the primary radiance scale of a national metrology laboratory, to independently validate the radiances assigned to the laboratory sources of the instrument builders. The EOS Project Science Office also developed a validation program for the measurement of onboard diffuse reflecting plaques, which are also used as radiometric standards for Earth-observing satellite instruments. Summarized results of these validation campaigns, with an emphasis on the current state-of-the-art uncertainties in laboratory radiometric standards, will be presented. Future mission uncertainty requirements, and possible enhancements to the EOS validation program to ensure that those uncertainties can be met, will be presented.

Present status and perspective of laboratory hematology in Japan: On the standardization of blood cell morphology including myelodysplasia: On behalf of the Japanese Society for Laboratory Hematology.

PubMed

Tohyama, K

2018-05-01

The Japanese Society for Laboratory Hematology (JSLH) was launched in 2000 and has been developed by a mutual collaboration of hematologists, medical technologists, and the companies involved in hematological laboratory testing. The aim of JSLH is the progress and development of laboratory hematology by academic conferences, periodic publication of academic journal, training and education (in the meeting, the journal, or the website), promotion of the standardization of laboratory hematology, and certification of the laboratory hematology specialists. Among 3 specialized committees organized for the standardization of laboratory hematology, the standardization committee on blood cell morphology has been dealing with the various projects on peripheral/bone marrow blood cells and normal/abnormal morphology. Another independent organization, the Japanese National Research Group on idiopathic bone marrow failure syndromes (BMF), has raised the importance of the dysplasia of myelodysplastic syndromes (MDS) and has been conducting the prospective registration, central review, and follow-up study of MDS. This group recently proposed the grading system for diagnostic accuracy of MDS, and the detailed procedure of morphological diagnosis of MDS is presented in the specialized color atlas with typical photographs of various dysplasia. JSLH has also approved the grading system for diagnostic accuracy of MDS and adopted this standardized diagnostic system to the educational item for certification of the laboratory hematology specialists, aiming at a nationwidely expanding morphological evaluation of myelodysplasia. Further and significant progress in the standardization of blood cell morphology will be expected in Japan through the activity of JSLH. © 2018 John Wiley & Sons Ltd.

Updated standards and processes for accreditation of echocardiographic laboratories from The European Association of Cardiovascular Imaging.

PubMed

Popescu, Bogdan A; Stefanidis, Alexandros; Nihoyannopoulos, Petros; Fox, Kevin F; Ray, Simon; Cardim, Nuno; Rigo, Fausto; Badano, Luigi P; Fraser, Alan G; Pinto, Fausto; Zamorano, Jose Luis; Habib, Gilbert; Maurer, Gerald; Lancellotti, Patrizio; Andrade, Maria Joao; Donal, Erwan; Edvardsen, Thor; Varga, Albert

2014-07-01

Standards for echocardiographic laboratories were proposed by the European Association of Echocardiography (now the European Association of Cardiovascular Imaging) 7 years ago in order to raise standards of practice and improve the quality of care. Criteria and requirements were published at that time for transthoracic, transoesophageal, and stress echocardiography. This paper reassesses and updates the quality standards to take account of experience and the technical developments of modern echocardiographic practice. It also discusses quality control, the incentives for laboratories to apply for accreditation, the reaccreditation criteria, and the current status and future prospects of the laboratory accreditation process. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

76 FR 38550 - Technical Standard DOE-STD-1095-2011, Department of Energy Laboratory Accreditation for External...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

... Laboratory Accreditation for External Dosimetry AGENCY: Office of Health, Safety and Security, Department of... Department) is issuing Technical Standard DOE-STD-1095-2011, Department of Energy Laboratory Accreditation... part, to determine whether to accredit dosimetry programs in accordance with the DOE Laboratory...

Improving consistency in large laboratory courses: a design for a standardized practical exam.

PubMed

Chen, Xinnian; Graesser, Donnasue; Sah, Megha

2015-06-01

Laboratory courses serve as important gateways to science, technology, engineering, and mathematics education. One of the challenges in assessing laboratory learning is to conduct meaningful and standardized practical exams, especially for large multisection laboratory courses. Laboratory practical exams in life sciences courses are frequently administered by asking students to move from station to station to answer questions, apply knowledge gained during laboratory experiments, interpret data, and identify various tissues and organs using various microscopic and gross specimens. This approach puts a stringent time limit on all questions regardless of the level of difficulty and also invariably increases the potential risk of cheating. To avoid potential cheating in laboratory courses with multiple sections, the setup for practical exams is often changed in some way between sections. In laboratory courses with multiple instructors or teaching assistants, practical exams may be handled inconsistently among different laboratory sections, due to differences in background knowledge, perceptions of the laboratory goals, or prior teaching experience. In this article, we describe a design for a laboratory practical exam that aims to align the assessment questions with well-defined laboratory learning objectives and improve the consistency among all laboratory sections. Copyright © 2015 The American Physiological Society.

Differences in Anticipatory Behaviour between Rats (Rattus norvegicus) Housed in Standard versus Semi-Naturalistic Laboratory Environments.

PubMed

Makowska, I Joanna; Weary, Daniel M

2016-01-01

Laboratory rats are usually kept in relatively small cages, but research has shown that they prefer larger and more complex environments. The physiological, neurological and health effects of standard laboratory housing are well established, but fewer studies have addressed the sustained emotional impact of a standard cage environment. One method of assessing affective states in animals is to look at the animals' anticipatory behaviour between the presentation of a cue signalling the arrival of a reward and the arrival of that reward. The primary aim of this study was to use anticipatory behaviour to assess the affective state experienced by female rats a) reared and housed long-term in a standard laboratory cage versus a semi-naturalistic environment, and b) before and after treatment with an antidepressant or an anxiolytic. A secondary aim was to add to the literature on anticipatory behaviour by describing and comparing the frequency and duration of individual elements of anticipatory behaviour displayed by rats reared in these two systems. In all experiments, total behavioural frequency was higher in standard-housed rats compared to rats from the semi-naturalistic condition, suggesting that standard-housed rats were more sensitive to rewards and experiencing poorer welfare than rats reared in the semi-naturalistic environment. What rats did in anticipation of the reward also differed between housing treatments, with standard-housed rats mostly rearing and rats from the semi-naturalistic condition mostly sitting facing the direction of the upcoming treat. Drug interventions had no effect on the quantity or form of anticipatory behaviour, suggesting that the poorer welfare experienced by standard-housed rats was not analogous to depression or anxiety, or alternatively that the drug interventions were ineffective. This study adds to mounting evidence that standard laboratory housing for rats compromises rat welfare, and provides further scientific support for

Creating Cost-Effective DNA Size Standards for Use in Teaching and Research Laboratories

ERIC Educational Resources Information Center

Shultz, Jeff

2011-01-01

I have devised a method with which a molecular size standard can be readily manufactured using Lambda DNA and PCR. This method allows the production of specific sized DNA fragments and is easily performed in a standard molecular biology laboratory. The material required to create these markers can also be used to provide a highly robust and…

75 FR 39023 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-07

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 27348 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-14

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 9229 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 5088 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-01

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 154 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-04

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 32950 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-10

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

75 FR 55795 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-14

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

Proposed quality control guidelines for antimicrobial susceptibility tests using tilmicosin.

PubMed Central

Shryock, T R; White, D W; Werner, C S; Staples, J M

1995-01-01

Quality control guidelines for tilmicosin, a novel veterinary-use-only macrolide, were developed in a multi-laboratory study according to established National Committee for Clinical Laboratory Standards (NCCLS) procedures (M23-T2). Tilmicosin was incorporated into Sensititre plates for broth microdilution endpoint testing and into two lots of 15-micrograms disks for Kirby-Bauer agar disk diffusion testing. One common lot and five unique lots of Mueller-Hinton media were used. (Broth was cation adjusted, and agar was supplemented with 5% defibrinated sheep blood.) Bacteria used for reference strains included Pasteurella haemolytica 128K, Pasteurella multocida ATCC 43137, and Staphylococcus aureus ATCC 29213 (microdilution) and ATCC 25923 (disk). Replicate tests were conducted. Disk diffusion and broth microdilution quality control ranges are proposed. PMID:7714188

International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants.

PubMed

Gosselin, Robert C; Adcock, Dorothy M; Bates, Shannon M; Douxfils, Jonathan; Favaloro, Emmanuel J; Gouin-Thibault, Isabelle; Guillermo, Cecilia; Kawai, Yohko; Lindhoff-Last, Edelgard; Kitchen, Steve

2018-03-01

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of international clinical and laboratory direct acting oral anticoagulant (DOAC) experts. The committee developed consensus recommendations for laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban and edoxaban), which would be germane for laboratories assessing DOAC anticoagulation. This guidance document addresses all phases of laboratory DOAC measurements, including pre-analytical (e.g. preferred time sample collection, preferred sample type, sample stability), analytical (gold standard method, screening and quantifying methods) and post analytical (e.g. reporting units, quality assurance). The committee addressed the use and limitations of screening tests such as prothrombin time, activated partial thromboplastin time as well as viscoelastic measurements of clotting blood and point of care methods. Additionally, the committee provided recommendations for the proper validation or verification of performance of laboratory assays prior to implementation for clinical use, and external quality assurance to provide continuous assessment of testing and reporting method. Schattauer GmbH Stuttgart.

75 FR 45128 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-02

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the..., ``Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

76 FR 25376 - Occupational Exposure to Hazardous Chemicals in Laboratories Standard; Extension of the Office of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

... describes: Standard operating procedures for using hazardous chemicals; hazard-control techniques; equipment...] Occupational Exposure to Hazardous Chemicals in Laboratories Standard; Extension of the Office of Management... collection requirements specified in the Standard on Occupational Exposure to Hazardous Chemicals in...

7 CFR 91.37 - Standard hourly fee rate for laboratory testing, analysis, and other services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Standard hourly fee rate for laboratory testing, analysis, and other services. 91.37 Section 91.37 Agriculture Regulations of the Department of Agriculture... AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Fees and...

NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE: CONSTITUTION, BYLAWS AND STANDARDS; APPROVED JUNE 2000

EPA Science Inventory

As Director of the Environmental Protection Agency's National Environmental
Laboratory Accreditation Program (NELAP), I offer my sincere appreciation to the many individuals who worked on the 2000 revision of the NELAC standards. I would like to give special recognition to th...

Standard Specification for Language Laboratory.

ERIC Educational Resources Information Center

North Carolina State Dept. of Administration, Raleigh.

This specification covers the components of electronic and electromechanical equipment, nonelectronic materials for the teacher-student positions, and other items of a miscellaneous nature to provide for a complete and workable language laboratory facility. Language laboratory facilities covered by this specification are of two types: (1)…

78 FR 63999 - Notice of Vitamin D Standardization Program (VDSP) Symposium: Tools To Improve Laboratory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Vitamin D Standardization Program (VDSP) Symposium: Tools To Improve Laboratory Measurement SUMMARY: The National Institutes of Health, Office of Dietary Supplements (ODS), and the National Institute of Standards and...

NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE; CONSTITUTION, BYLAWS AND STANDARDS: APPROVED MAY 25, 2001

EPA Science Inventory

The principles and operating procedures for the National Environmental Laboratory Accreditation Conference (NELAC) are contained in the NELAC Constitution and Bylaws. The major portion of this document (standards) contains detailed requirements for accrediting environmental labo...

New HPV Serology Laboratory Aims to Standardize Assays and Contribute to Vaccine Implementation and Access | Frederick National Laboratory for Cancer Research

Cancer.gov

A new international initiative, led by scientists at the Frederick National Laboratory for Cancer Research and several other institutions, is being launched to provide expertise and leadership on the development, validation, and standardization of hu

The OSHA Hazardous Chemical Occupational Exposure Standard for Laboratories - A New Management Regulation to Ensure Employee Health

DTIC Science & Technology

1991-04-01

Hazardous Chemical Occupational Exposur PE - 87714F Standard for Laboratories- A New Management Regu- PR - SUPT lation to Ensure Employee Health TA - XX 6...produce acute or chronic adverse health effects in sional visitors such as guests or sales personnel. exposed workers . Health hazards include...standard is to safeguard the health and well- place and increases the likelihood of exposure. being of laboratory workers . The welfare of our person- A

Quantity quotient reporting. A proposal for a standardized presentation of laboratory results.

PubMed

Haeckel, Rainer; Wosniok, Werner

2009-01-01

Laboratory results are reported in different units (despite international recommendations for SI units) together with different reference limits, of which several exist for many quantities. It is proposed to adopt the concept of the intelligence quotient and to report quantitative results as a quantity quotient (QQ) in laboratory medicine. This quotient is essentially the difference (measured result minus mean or mode value of the reference interval) divided by the observed biological variation CV(o). Thus, all quantities are reported in the same unit system with the same reference limits (for convenience shifted to e.g., 80-120). The critical difference can also be included in this standardization concept. In this way the information of reference intervals and the original result are integrated into one combined value, which has the same format for all quantities suited for quotient reporting (QR). The proposal of QR does not interfere with neither the current concepts of traceability, SI units or method standardization. This proposal represents a further step towards harmonization of reporting. It provides simple values which can be interpreted easily by physicians and their patients.

40 CFR 262.206 - Labeling and management standards for containers of unwanted material in the laboratory.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Labeling and management standards for containers of unwanted material in the laboratory. 262.206 Section 262.206 Protection of Environment... the laboratory to assure safe storage of the unwanted material, to prevent leaks, spills, emissions to...

Importance of the Primary Radioactivity Standard Laboratory and Implementation of its Quality Management

NASA Astrophysics Data System (ADS)

Sahagia, Maria; Razdolescu, Anamaria Cristina; Luca, Aurelian; Ivan, Constantin

2007-04-01

The paper presents some specific aspects of the implementation of the quality management in the Radionuclide Metrology Laboratory, from IFIN-HH, the owner of the primary Romanian standard in radioactivity. The description of the accreditation, according to the EN ISO/IEC 17025:2005, is presented.

Assessment of three medical and research laboratories using WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: a long way to go.

PubMed

Taremwa, Ivan Mugisha; Ampaire, Lucas; Iramiot, Jacob; Muhwezi, Obed; Matte, Aloysius; Itabangi, Herbert; Mbabazi, Hope; Atwebembeire, Jeninah; Kamwine, Monicah; Katawera, Victoria; Mbalibulha, Yona; Orikiriza, Patrick; Boum, Yap

2017-01-01

While the laboratory represents more than 70% of clinical diagnosis and patient management, access to reliable and quality laboratory diagnostics in sub-Saharan Africa remains a challenge. To gain knowledge and suggest evidence based interventions towards laboratory improvement in Southwestern Uganda, we assessed the baseline laboratory quality standards in three medical and research laboratories in Southwestern Uganda. We conducted a cross sectional survey from October, 2013 to April, 2014. Selected laboratories, including one private research, one private for profit and one public laboratory, were assessed using the WHO AFRO_SLIPTA checklist and baseline scores were determined. The three laboratories assessed met basic facility requirements, had trained personnel, and safety measures in place. Sample reception was properly designed and executed with a well designated chain of custody. All laboratories had sufficient equipment for the nature of work they were involved in. However, we found that standard operating procedures were incomplete in all three laboratories, lack of quality audit schemes by two laboratories and only one laboratory enrolled into external quality assurance schemes. The SLIPTA scores were one star for the research laboratory and no star for both the public and private-for-profit laboratories. While most of the laboratory systems were in place, the low scores obtained by the assessed laboratories reflect the need for improvement to reach standards of quality assured diagnostics in the region. Therefore, routine mentorship and regional supportive supervision are necessary to increase the quality of laboratory services.

Performance of the RAD-57 pulse CO-oximeter compared with standard laboratory carboxyhemoglobin measurement.

PubMed

Touger, Michael; Birnbaum, Adrienne; Wang, Jessica; Chou, Katherine; Pearson, Darion; Bijur, Polly

2010-10-01

We assess agreement between carboxyhemoglobin levels measured by the Rad-57 signal extraction pulse CO-oximeter (RAD), a Food and Drug Administration-approved device for noninvasive bedside measurement, and standard laboratory arterial or venous measurement in a sample of emergency department (ED) patients with suspected carbon monoxide poisoning. The study was a cross-sectional cohort design using a convenience sample of adult and pediatric ED patients in a Level I trauma, burn, and hyperbaric oxygen referral center. Measurement of RAD carboxyhemoglobin was performed simultaneously with blood sampling for laboratory determination of carboxyhemoglobin level. The difference between the measures for each patient was calculated as laboratory carboxyhemoglobin minus carboxyhemoglobin from the carbon monoxide oximeter. The limits of agreement from a Bland-Altman analysis are calculated as the mean of the differences between methods ±1.96 SDs above and below the mean. Median laboratory percentage carboxyhemoglobin level was 2.3% (interquartile range 1 to 8.5; range 0% to 38%). The mean difference between laboratory carboxyhemoglobin values and RAD values was 1.4% carboxyhemoglobin (95% confidence interval [CI] 0.2% to 2.6%). The limits of agreement of differences of measurement made with the 2 devices were -11.6% and 14.4% carboxyhemoglobin. This range exceeded the value of ±5% carboxyhemoglobin defined a priori as clinically acceptable. RAD correctly identified 11 of 23 patients with laboratory values greater than 15% carboxyhemoglobin (sensitivity 48%; 95% CI 27% to 69%). There was one case of a laboratory carboxyhemoglobin level less than 15%, in which the RAD device gave a result greater than 15% (specificity of RAD 96/97=99%; 95% CI 94% to 100%). In the range of carboxyhemoglobin values measured in this sample, the level of agreement observed suggests RAD measurement may not be used interchangeably with standard laboratory measurement. Copyright © 2010 American

HEW to Set Laboratory Safety Standards.

ERIC Educational Resources Information Center

Chemical and Engineering News, 1978

1978-01-01

Describes Department of Health, Education and Welfare (HEW) proposed guidelines for laboratories using chemical carcinogens. The guidelines are designed to provide protection for laboratory workers and their environment from exposure to all types of carcinogenic agents. (GA)

The effects of calculator-based laboratories on standardized test scores

NASA Astrophysics Data System (ADS)

Stevens, Charlotte Bethany Rains

Nationwide, the goal of providing a productive science and math education to our youth in today's educational institutions is centering itself around the technology being utilized in these classrooms. In this age of digital technology, educational software and calculator-based laboratories (CBL) have become significant devices in the teaching of science and math for many states across the United States. Among the technology, the Texas Instruments graphing calculator and Vernier Labpro interface, are among some of the calculator-based laboratories becoming increasingly popular among middle and high school science and math teachers in many school districts across this country. In Tennessee, however, it is reported that this type of technology is not regularly utilized at the student level in most high school science classrooms, especially in the area of Physical Science (Vernier, 2006). This research explored the effect of calculator based laboratory instruction on standardized test scores. The purpose of this study was to determine the effect of traditional teaching methods versus graphing calculator teaching methods on the state mandated End-of-Course (EOC) Physical Science exam based on ability, gender, and ethnicity. The sample included 187 total tenth and eleventh grade physical science students, 101 of which belonged to a control group and 87 of which belonged to the experimental group. Physical Science End-of-Course scores obtained from the Tennessee Department of Education during the spring of 2005 and the spring of 2006 were used to examine the hypotheses. The findings of this research study suggested the type of teaching method, traditional or calculator based, did not have an effect on standardized test scores. However, the students' ability level, as demonstrated on the End-of-Course test, had a significant effect on End-of-Course test scores. This study focused on a limited population of high school physical science students in the middle Tennessee

Interlaboratory Study of Quality Control Isolates for a Broth Microdilution Method (Modified CLSI M38-A) for Testing Susceptibilities of Dermatophytes to Antifungals▿

PubMed Central

Ghannoum, M. A.; Arthington-Skaggs, B.; Chaturvedi, V.; Espinel-Ingroff, A.; Pfaller, M. A.; Rennie, R.; Rinaldi, M. G.; Walsh, T. J.

2006-01-01

The Clinical and Laboratory Standards Institute (CLSI; formerly National Committee for Clinical Laboratory Standards, or NCCLS) M38-A standard for the susceptibility testing of filamentous fungi does not specifically address the testing of dermatophytes. In 2003, a multicenter study investigated the reproducibility of the microdilution method developed at the Center for Medical Mycology, Cleveland, Ohio, for testing the susceptibility of dermatophytes. Data from that study supported the introduction of this method for testing dermatophytes in the future version of the CLSI M38-A standard. In order for the method to be accepted by CLSI, appropriate quality control isolates needed to be identified. To that end, an interlaboratory study, involving the original six laboratories plus two additional sites, was conducted to evaluate potential candidates for quality control isolates. These candidate strains included five Trichophyton rubrum strains known to have elevated MICs to terbinafine and five Trichophyton mentagrophytes strains. Antifungal agents tested included ciclopirox, fluconazole, griseofulvin, itraconazole, posaconazole, terbinafine, and voriconazole. Based on the data generated, two quality control isolates, one T. rubrum isolate and one T. mentagrophytes isolate, were identified and submitted to the American Type Culture Collection (ATCC) for inclusion as reference strains. Ranges encompassing 95.2 to 97.9% of all data points for all seven drugs were established. PMID:17050812

Services of the CDRH X-ray calibration laboratory and their traceability to National Standards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cerra, F.; Heaton, H.T.

The X-ray Calibration Laboratory (XCL) of the Center for Devices and Radiological Health (CDRH) provides calibration services for the Food and Drug Administration (FDA). The instruments calibrated are used by FDA and contract state inspectors to verify compliance with federal x-ray performance standards and for national surveys of x-ray trends. In order to provide traceability of measurements, the CDRH XCL is accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) for reference, diagnostic, and x-ray survey instrument calibrations. In addition to these accredited services, the CDRH XCL also calibrates non-invasive kVp meters in single- and three-phase x-ray beams, and thermoluminescentmore » dosimeter (TLD) chips used to measure CT beam profiles. The poster illustrates these services and shows the traceability links back to the National Standards.« less

Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard.

PubMed

Lowe, Nancy K; Neal, Jeremy L; Ryan-Wenger, Nancy A

2009-01-01

To estimate the accuracy of the clinical diagnosis of the three most common causes of acute vulvovaginal symptoms (bacterial vaginosis, candidiasis vaginitis, and trichomoniasis vaginalis) using a traditional, standardized clinical diagnostic protocol compared with a DNA probe laboratory standard. This prospective clinical comparative study had a sample of 535 active-duty United States military women presenting with vulvovaginal symptoms. Clinical diagnoses were made by research staff using a standardized protocol of history, physical examination including pelvic examination, determination of vaginal pH, vaginal fluid amines test, and wet-prep microscopy. Vaginal fluid samples were obtained for DNA analysis. The research clinicians were blinded to the DNA results. The participants described a presenting symptom of abnormal discharge (50%), itching/irritation (33%), malodor (10%), burning (4%), or others such as vulvar pain and vaginal discomfort. According to laboratory standard, there were 225 cases (42%) of bacterial vaginosis, 76 cases (14%) of candidiasis vaginitis, 8 cases (1.5%) of trichomoniasis vaginalis, 87 cases of mixed infections (16%), and 139 negative cases (26%). For each single infection, the clinical diagnosis had a sensitivity and specificity of 80.8% and 70.0% for bacterial vaginosis, 83.8% and 84.8% for candidiasis vaginitis, and 84.6% and 99.6% for trichomoniasis vaginalis when compared with the DNA probe standard. Compared with a DNA probe standard, clinical diagnosis is 81-85% sensitive and 70-99% specific for bacterial vaginosis, Candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis and, therefore, subsequent treatment of these common vaginal problems remains difficult. II.

A laboratory comparison of individual Targis/Vectris posts with standard fiberglass posts.

PubMed

Corsalini, Massimo; Genovese, Katia; Lamberti, Luciano; Pappalettere, Carmine; Carella, Mauro; Carossa, Stefano

2007-01-01

This article presents an in vitro analysis of a specific occlusal loading test on endodontically treated teeth restored with 2 different composite post materials. Individual, customized posts (IFPs) were compared to standard fiberglass posts (SFPs). The selected IFPs (standard cylindric Targis/Vectris posts) were compared to SFPs (Conic 6% Post, Ghimas). The posts were first subjected to a 3-point bending test to compare their flexural elastic properties. They were then used to restore 22 endodontically treated artificial maxillary central incisors and subjected to a specific occlusal loading simulation test. The loading test showed that IFP restorations performed better than SFP restorations. A clinical evaluation of this laboratory observation is suggested.

Paving the way for a gold standard of care for infertility treatment: improving outcomes through standardization of laboratory procedures.

PubMed

Schoolcraft, William; Meseguer, Marcos

2017-10-01

Infertility affects over 70 million couples globally. Access to, and interest in, assisted reproductive technologies is growing worldwide, with more couples seeking medical intervention to conceive, in particular by IVF. Despite numerous advances in IVF techniques since its first success in 1978, almost half of the patients treated remain childless. The multifactorial nature of IVF treatment means that success is dependent on many variables. Therefore, it is important to examine how each variable can be optimized to achieve the best possible outcomes for patients. The current approach to IVF is fragmented, with various protocols in use. A systematic approach to establishing optimum best practices may improve IVF success and live birth rates. Our vision of the future is that technological advancements in the laboratory setting are standardized and universally adopted to enable a gold standard of care. Implementation of best practices for laboratory procedures will enable clinicians to generate high-quality gametes, and to produce and identify gametes and embryos of maximum viability and implantation potential, which should contribute to improving take-home healthy baby rates. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard.

PubMed

Feller, Etty

2008-01-01

Laboratories with a quality system accredited to the ISO/IEC 17025 standard have a definite advantage, compared to non-accredited laboratories, when preparing their facilities for the implementation of the principles of good laboratory practice (GLP) of the Organisation for Economic Co-operation and Development (OECD). Accredited laboratories have an established quality system covering the administrative and technical issues specified in the standard. The similarities and differences between the ISO/IEC 17025 standard and the OECD principles of GLP are compared and discussed.

Comparison on the physico-chemical and nutritional qualities of normal and abnormal colored fresh chicken liver.

PubMed

Xiong, Guoyuan; Gao, Xueqin; Zheng, Haibo; Li, Xin; Xu, Xinglian; Zhou, Guanghong

2017-06-01

This study evaluated the differences of physico-chemical and nutritional qualities between abnormal colored chicken livers (ANCCLs) and normal colored chicken livers (NCCLs) and the safety of the both livers. Compared with NCCLs, ANCCLs were lower in protein, water contents (P < 0.01), pH and pigment contents (P < 0.05). NCCLs contained higher polyunsaturated fatty acid (PUFA) and saturated fatty acids (SFA) (P < 0.05). The PUFA/SFA ratio of NCCLs was 0.453, higher (P < 0.05) than that of ANCCLs. The contents of alanine, valine, tyrosine, lysine and histidine in NCCLs were higher (P < 0.05) than in ANCCLs. The contents of K, Na, P, Cu, Fe and Se of NCCLs were higher (P < 0.05), but the Ca content was lower (P < 0.05). The content of the heavy metals (As, Hg, Pb and Cd) of the two types of livers complied with food safety requirements. Although NCCLs had higher nutritional value than ANCCLs, both livers were acceptable for human consumption. © 2016 Japanese Society of Animal Science.

Electronic laboratory quality assurance program: A method of enhancing the prosthodontic curriculum and addressing accreditation standards.

PubMed

Moghadam, Marjan; Jahangiri, Leila

2015-08-01

An electronic quality assurance (eQA) program was developed to replace a paper-based system and to address standards introduced by the Commission on Dental Accreditation (CODA) and to improve educational outcomes. This eQA program provides feedback to predoctoral dental students on prosthodontic laboratory steps at New York University College of Dentistry. The purpose of this study was to compare the eQA program of performing laboratory quality assurance with the former paper-based format. Fourth-year predoctoral dental students (n=334) who experienced both the paper-based and the electronic version of the quality assurance program were surveyed about their experiences. Additionally, data extracted from the eQA program were analyzed to identify areas of weakness in the curriculum. The study findings revealed that 73.8% of the students preferred the eQA program to the paper-based version. The average number of treatments that did not pass quality assurance standards was 119.5 per month. This indicated a 6.34% laboratory failure rate. Further analysis of these data revealed that 62.1% of the errors were related to fixed prosthodontic treatment, 27.9% to partial removable dental prostheses, and 10% to complete removable dental prostheses in the first 18 months of program implementation. The eQA program was favored by dental students who have experienced both electronic and paper-based versions of the system. Error type analysis can yield the ability to create customized faculty standardization sessions and refine the didactic and clinical teaching of the predoctoral students. This program was also able to link patient care activity with the student's laboratory activities, thus addressing the latest requirements of the CODA regarding the competence of graduates in evaluating laboratory work related to their patient care. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Antifungal Susceptibility Testing of Fluconazole by Flow Cytometry Correlates with Clinical Outcome

PubMed Central

Wenisch, Christoph; Moore, Caroline B.; Krause, Robert; Presterl, Elisabeth; Pichna, Peter; Denning, David W.

2001-01-01

Susceptibility testing of fungi by flow cytometry (also called fluorescence-activated cell sorting [FACS]) using vital staining with FUN-1 showed a good correlation with the standard M27-A procedure for assessing MICs. In this study we determined MICs for blood culture isolates from patients with candidemia by NCCLS M27-A and FACS methods and correlated the clinical outcome of these patients with in vitro antifungal resistance test results. A total of 24 patients with candidemia for whom one or more blood cultures were positive for a Candida sp. were included. Susceptibility testing was performed by NCCLS M27-A and FACS methods. The correlation of MICs (NCCLS M27-A and FACS) and clinical outcome was calculated. In 83% of the cases, the MICs of fluconazole determined by FACS were within 1 dilution of the MICs determined by the NCCLS M27-A method. For proposed susceptibility breakpoints, there was 100% agreement between the M27-A and FACS methods. In the FACS assay, a fluconazole MIC of <1 μg/ml was associated with cure (P < 0.001) whereas an MIC of ≥1 μg/ml was associated with death (P < 0.001). The M27-A-derived fluconazole MICs did not correlate with outcome (P = 1 and P = 0.133). PMID:11427554

75 FR 75485 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-03

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were... Laboratories and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen...

Intra-building telecommunications cabling standards for Sandia National Laboratories, New Mexico

DOE Office of Scientific and Technical Information (OSTI.GOV)

Adams, R.L.

1993-08-01

This document establishes a working standard for all telecommunications cable installations at Sandia National Laboratories, New Mexico. It is based on recent national commercial cabling standards. The topics addressed are Secure and Open/Restricted Access telecommunications environments and both twisted-pair and optical-fiber components of communications media. Some of the state-of-the-art technologies that will be supported by the intrabuilding cable infrastructure are Circuit and Packet Switched Networks (PBX/5ESS Voice and Low-Speed Data), Local Area Networks (Ethernet, Token Ring, Fiber and Copper Distributed Data Interface), and Wide Area Networks (Asynchronous Transfer Mode). These technologies can be delivered to every desk and can transportmore » data at rates sufficient to support all existing applications (such as Voice, Text and graphics, Still Images, Full-motion Video), as well as applications to be defined in the future.« less

LOINC, a universal standard for identifying laboratory observations: a 5-year update.

PubMed

McDonald, Clement J; Huff, Stanley M; Suico, Jeffrey G; Hill, Gilbert; Leavelle, Dennis; Aller, Raymond; Forrey, Arden; Mercer, Kathy; DeMoor, Georges; Hook, John; Williams, Warren; Case, James; Maloney, Pat

2003-04-01

The Logical Observation Identifier Names and Codes (LOINC) database provides a universal code system for reporting laboratory and other clinical observations. Its purpose is to identify observations in electronic messages such as Health Level Seven (HL7) observation messages, so that when hospitals, health maintenance organizations, pharmaceutical manufacturers, researchers, and public health departments receive such messages from multiple sources, they can automatically file the results in the right slots of their medical records, research, and/or public health systems. For each observation, the database includes a code (of which 25 000 are laboratory test observations), a long formal name, a "short" 30-character name, and synonyms. The database comes with a mapping program called Regenstrief LOINC Mapping Assistant (RELMA(TM)) to assist the mapping of local test codes to LOINC codes and to facilitate browsing of the LOINC results. Both LOINC and RELMA are available at no cost from http://www.regenstrief.org/loinc/. The LOINC medical database carries records for >30 000 different observations. LOINC codes are being used by large reference laboratories and federal agencies, e.g., the CDC and the Department of Veterans Affairs, and are part of the Health Insurance Portability and Accountability Act (HIPAA) attachment proposal. Internationally, they have been adopted in Switzerland, Hong Kong, Australia, and Canada, and by the German national standards organization, the Deutsches Instituts für Normung. Laboratories should include LOINC codes in their outbound HL7 messages so that clinical and research clients can easily integrate these results into their clinical and research repositories. Laboratories should also encourage instrument vendors to deliver LOINC codes in their instrument outputs and demand LOINC codes in HL7 messages they get from reference laboratories to avoid the need to lump so many referral tests under the "send out lab" code.

Antibiotic resistance among clinical isolates of Haemophilus influenzae in the United States in 1994 and 1995 and detection of beta-lactamase-positive strains resistant to amoxicillin-clavulanate: results of a national multicenter surveillance study.

PubMed

Doern, G V; Brueggemann, A B; Pierce, G; Holley, H P; Rauch, A

1997-02-01

A total of 1,537 clinical isolates of Haemophilus influenzae were recovered in 30 U.S. medical center laboratories between 1 November 1994 and 30 April 1995 and were characterized in a central laboratory with respect to serotype and beta-lactamase production and the in vitro activities of 15 oral antimicrobial agents. Overall, 36.4% of the isolates were found to produce beta-lactamase. The rank order of activity of six cephalosporins on the basis of MICs was cefixime > cefpodoxime > cefuroxime > loracarbef > or = cefaclor > cefprozil. On the basis of current National Committee for Clinical Laboratory Standards (NCCLS) breakpoints ages of isolates found to be resistant or intermediate to these agents were as follows: 0.1, 0.3, 6.4, 16.3, 18.3, and 29.8, respectively (National Committee for Clinical Laboratory Standards. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically, 4th ed. M7-A4, 1995). Azithromycin was, on a weight basis, the most potent of the macrolides tested in this study, followed by erythromycin and then clarithromycin. Azithromycin was typically fourfold more active than erythromycin, which was, in turn, slightly more active than clarithromycin. However, when compared on the basis of the frequency of resistance determined by using current NCCLS breakpoints, there was essentially no difference between azithromycin and clarithromycin, i.e., 0.5 and 1.9%, respectively (P = 0.086). Interpretive breakpoints for erythromycin MIC tests versus H. influenzae have not been developed. Resistance to other non- beta-lactam agents was variable, as follows: trimethoprim-sulfamethoxazole, 9.0%; chloramphenicol, 0.2%; tetracycline, 1.3%; and rifampin, 0.3%. Two conspicuous findings in this study were the identification of 39 strains H. influenzae that were beta-lactamase negative but ampicillin intermediate or resistant (BLNAR) and, even more surprisingly, 17 beta-lactamase-positive isolates that were resistant to amoxicillin

Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

Cancer.gov

The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In

Spectral Irradiance Calibration in the Infrared. 11; Comparison of (alpha) Bootis and 1 Ceres with a Laboratory Standard

NASA Technical Reports Server (NTRS)

Witteborn, Fred C.; Cohen, Martin; Bregman, Jesse D.; Wooden, Diane H.; Heere, Karen; Shirley, Eric L.

1999-01-01

Infrared spectra of two celestial objects frequently used as flux standards are calibrated against an absolute laboratory flux standard at a spectral resolving power of 100 to 200. The spectrum of the KI.5 III star alpha Boo is measured from 3 to 30 microns, and that of the C-type asteroid 1 Ceres from 5 to 30 microns. While these "standard" spectra do not have the apparent precision of those based on calculated models, they do not require the assumptions involved in theoretical models of stars and asteroids. Specifically, they provide a model-independent means of calibrating celestial flux in the spectral range from 12 to 30 microns, where accurate absolute photometry is not available. The agreement found between the spectral shapes of alpha Boo and Ceres based on laboratory standards and those based on observed ratios to alpha CMa (Sirius) and alpha Lyr (Vega), flux-calibrated by theoretical modeling of these hot stars, strengthens our confidence in the applicability of the stellar models as primary irradiance standards.

Spectral Irradiance Calibration in the Infrared 11: Comparison of (alpha) Boo and 1 Ceres with a Laboratory Standard

NASA Technical Reports Server (NTRS)

Witteborn, Fred C.; Cohen, Martin; Bregman, Jess D.; Wooden, Diane; Heere, Karen; Shirley, Eric L.

1998-01-01

Infrared spectra of two celestial objects frequently used as flux standards are calibrated against an absolute laboratory flux standard at a spectral resolving power of 100 to 200. The spectrum of the K1.5III star, alpha Boo, is measured from 3 microns to 30 microns and that of the C-type asteroid, 1 Ceres, from 5 microns to 30 microns. While these 'standard' spectra do not have the apparent precision of those based on calculated models, they do not require the assumptions involved in theoretical models of stars and asteroids. Specifically they provide a model-independent means of calibrating celestial flux in the spectral range from 12 microns to 30 microns where accurate absolute photometry is not available. The agreement found between the spectral shapes of alpha Boo and Ceres based on laboratory standards, and those based on observed ratios to alpha CMa (Sirius) and alpha Lyr (Vega), flux calibrated by theoretical modeling of these hot stars strengthens our confidence in the applicability of the stellar models as primary irradiance standards.

Ethical and methodological standards for laboratory and medical biological rhythm research.

PubMed

Portaluppi, Francesco; Touitou, Yvan; Smolensky, Michael H

2008-11-01

The main objectives of this article are to update the ethical standards for the conduct of human and animal biological rhythm research and recommend essential elements for quality chronobiological research information, which should be especially useful for new investigators of the rhythms of life. A secondary objective is to provide for those with an interest in the results of chronobiology investigations, but who might be unfamiliar with the field, an introduction to the basic methods and standards of biological rhythm research and time series data analysis. The journal and its editors endorse compliance of all investigators to the principles of the Declaration of Helsinki of the World Medical Association, which relate to the conduct of ethical research on human beings, and the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, which relate to the conduct of ethical research on laboratory and other animals. The editors and the readers of the journal expect the authors of submitted manuscripts to have adhered to the ethical standards dictated by local, national, and international laws and regulations in the conduct of investigations and to be unbiased and accurate in reporting never-before-published research findings. Authors of scientific papers are required to disclose all potential conflicts of interest, particularly when the research is funded in part or in full by the medical and pharmaceutical industry, when the authors are stock-holders of the company that manufactures or markets the products under study, or when the authors are a recent or current paid consultant to the involved company. It is the responsibility of the authors of submitted manuscripts to clearly present sufficient detail about the synchronizer schedule of the studied subjects (i.e., the sleep-wake schedule, ambient light-dark cycle, intensity and spectrum of ambient light exposure, seasons when the research was

The gallium melting-point standard: its role in manufacture and quality control of electronic thermometers for the clinical laboratory.

PubMed

Sostman, H E

1977-01-01

I discuss the traceability of calibration of electronic thermometers to thermometric constants of nature or to the National Bureau of Standards, form 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 degrees C) as a thermometer calibration fixed point, and enumerate its advantages in the routine calibration verification of electrical thermometers in the clinical chemistry laboratory.

Laboratory diagnosis of creatine deficiency syndromes: a technical standard and guideline of the American College of Medical Genetics and Genomics.

PubMed

Sharer, J Daniel; Bodamer, Olaf; Longo, Nicola; Tortorelli, Silvia; Wamelink, Mirjam M C; Young, Sarah

2017-02-01

Disclaimer: These ACMG Standards and Guidelines are intended as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines is voluntary and does not necessarily assure a successful medical outcome. These Standards and Guidelines should not be considered inclusive of all proper procedures and tests or exclusive of others that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, clinical laboratory geneticists should apply their professional judgment to the specific circumstances presented by the patient or specimen. Clinical laboratory geneticists are encouraged to document in the patient's record the rationale for the use of a particular procedure or test, whether or not it is in conformance with these Standards and Guidelines. They also are advised to take notice of the date any particular guideline was adopted, and to consider other relevant medical and scientific information that becomes available after that date. It also would be prudent to consider whether intellectual property interests may restrict the performance of certain tests and other procedures.Cerebral creatine deficiency syndromes are neurometabolic conditions characterized by intellectual disability, seizures, speech delay, and behavioral abnormalities. Several laboratory methods are available for preliminary and confirmatory diagnosis of these conditions, including measurement of creatine and related metabolites in biofluids using liquid chromatography-tandem mass spectrometry or gas chromatography-mass spectrometry, enzyme activity assays in cultured cells, and DNA sequence analysis. These guidelines are intended to standardize these procedures to help optimize the diagnosis of creatine deficiency syndromes. While biochemical methods are emphasized, considerations for confirmatory molecular testing are also discussed

Determination of moxifloxacin anaerobic susceptibility breakpoints according to the Clinical and Laboratory Standards Institute guidelines.

PubMed

Ambler, Jane; Rennie, Robert; Poupard, James; Koeth, Laura; Stass, Heino; Endermann, Rainer; Choudhri, Shurjeel

2008-05-01

A summary of the key data presented to Clinical and Laboratory Standards Institute (CLSI, formerly National Committee for Clinical and Laboratory Standards) in determination of moxifloxacin anaerobic breakpoints is presented. The breakpoint analysis required review of a variety of data, including bacteriologic and clinical outcomes by MIC of anaerobic isolates from prospective clinical trials in patients with complicated intra-abdominal infections, human and animal pharmacokinetic/pharmacodynamic (PK/PD) information and in vitro models, MIC distributions of indicated organisms, and animal model efficacy data for strains with MIC values around prospective breakpoints. The compilation of the various components of this breakpoint analysis supports the US Food and Drug Administration (FDA) and CLSI moxifloxacin anaerobic breakpoints of < or =2 mg/L (susceptible), 4 mg/L (intermediate), and > or =8 mg/L (resistant), and provides information to European investigators for interpretation of MICs prior to establishment of the European Committee on Antimicrobial Susceptibility Testing breakpoints.

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution... Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (ii...) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or...

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2012 CFR

2012-10-01

... degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution... Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (ii...) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or...

Standard Specifications for Language Laboratory.

ERIC Educational Resources Information Center

North Carolina State Dept. of Administration, Raleigh.

Specifications are presented covering the components of electronic and electro-mechanical equipment, non-electrical materials for the teacher-student positions, and other items of a miscellaneous nature to provide for a complete, workable language laboratory facility. Instructions for the use of specifications are included for the purchaser,…

42 CFR 493.1407 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... developed and used for each of the tests performed in the laboratory provide quality laboratory services for... results are found to be unacceptable or unsatisfactory; (5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and...

TREAT Asia Quality Assessment Scheme (TAQAS) to standardize the outcome of HIV genotypic resistance testing in a group of Asian laboratories

PubMed Central

Land, Sally; Cunningham, Philip; Zhou, Jialun; Frost, Kevin; Katzenstein, David; Kantor, Rami; Chen, Yi-Ming Arthur; Oka, Shinichi; DeLong, Allison; Sayer, David; Smith, Jeffery; Dax, Elizabeth M.; Law, Matthew

2010-01-01

The TREAT Asia (Therapeutics, Research, Education, and AIDS Training in Asia) Network is building capacity for Human Immunodeficiency Virus Type-1 (HIV-1) drug resistance testing in the region. The objective of the TREAT Asia Quality Assessment Scheme – designated TAQAS – is to standardize HIV-1 genotypic resistance testing (HIV genotyping) among laboratories to permit rigorous comparison of results from different clinics and testing centres. TAQAS has evaluated three panels of HIV-1-positive plasma from clinical material or low-passage, culture supernatant for up to 10 Asian laboratories. Laboratory participants used their standard protocols to perform HIV genotyping. Assessment was in comparison to a target genotype derived from all participants and the reference laboratory’s result. Agreement between most participants at the edited nucleotide sequence level was high (>98%). Most participants performed to the reference laboratory standard in detection of drug resistance mutations (DRMs). However, there was variation in the detection of nucleotide mixtures (0–83%) and a significant correlation with the detection of DRMs (p < 0.01). Interpretation of antiretroviral resistance showed ~70% agreement among participants when different interpretation systems were used but >90% agreement with a common interpretation system, within the Stanford University Drug Resistance Database. Using the principles of external quality assessment and a reference laboratory, TAQAS has demonstrated high quality HIV genotyping results from Asian laboratories. PMID:19490972

Improved compliance with reporting standards: A retrospective analysis of Intersocietal Accreditation Commission Nuclear Cardiology Laboratories.

PubMed

Maddux, P Tim; Farrell, Mary Beth; Ewing, Joseph A; Tilkemeier, Peter L

2018-06-01

In 2011, Tilkemeier et al reported significant nuclear cardiology laboratory noncompliance with reporting standards. The aim of this study was to identify and examine noncompliant reporting elements with the Intersocietal Accreditation Commission Nuclear/PET (IAC) Reporting Standards and to compare compliance between 2008 and 2014. This was a retrospective study of compliance with 18 reporting elements utilizing accreditation findings from all laboratories applying for accreditation in 2008 and 2014. 1816 labs applying for initial or subsequent accreditation were analyzed for compliance. The mean reporting noncompliance per lab decreased from 2008 to 2014 (2.48 ± 2.67 to 1.24 ± 1.79, P < .001). Noncompliance decreased across lab types, labs with Certification Board of Nuclear Cardiology physicians on staff, and by geographic region (P < .001). Overall severity of reporting issues decreased. Facilities with compliant reports increased from 35.0% in 2008 to 57.1% in 2014 (P < .001). Continuing medical education, accreditation, and other instructional activities aimed at improving nuclear cardiology reporting appear to have made a positive impact over time with the number and severity of noncompliance decreased. More labs are now compliant with the IAC Standards and, thus, reporting guidelines. However, the need for continued educational efforts remains.

Prevalence and risk factors of non-carious cervical lesions related to occupational exposure to acid mists.

PubMed

Bomfim, Rafael Aiello; Crosato, Edgard; Mazzilli, Luiz Eugênio Nigro; Frias, Antonio Carlos

2015-01-01

This study evaluates the prevalence and risk factors of non-carious cervical lesions (NCCLs) in a Brazilian population of workers exposed and non-exposed to acid mists and chemical products. One hundred workers (46 exposed and 54 non-exposed) were evaluated in a Centro de Referência em Saúde do Trabalhador - CEREST (Worker's Health Reference Center). The workers responded to questionnaires regarding their personal information and about alcohol consumption and tobacco use. A clinical examination was conducted to evaluate the presence of NCCLs, according to WHO parameters. Statistical analyses were performed by unconditional logistic regression and multiple linear regression, with the critical level of p < 0.05. NCCLs were significantly associated with age groups (18-34, 35-44, 45-68 years). The unconditional logistic regression showed that the presence of NCCLs was better explained by age group (OR = 4.04; CI 95% 1.77-9.22) and occupational exposure to acid mists and chemical products (OR = 3.84; CI 95% 1.10-13.49), whereas the linear multiple regression revealed that NCCLs were better explained by years of smoking (p = 0.01) and age group (p = 0.04). The prevalence of NCCLs in the study population was particularly high (76.84%), and the risk factors for NCCLs were age, exposure to acid mists and smoking habit. Controlling risk factors through preventive and educative measures, allied to the use of personal protective equipment to prevent the occupational exposure to acid mists, may contribute to minimizing the prevalence of NCCLs.

Blood Cholesterol Measurement in Clinical Laboratories in the United States. Current Status. A Report from the Laboratory Standardization Panel of the National Cholesterol Education Program.

ERIC Educational Resources Information Center

National Heart, Lung, and Blood Inst. (DHHS/NIH), Bethesda, MD.

Precise and accurate cholesterol measurements are required to identify and treat individuals with high blood cholesterol levels. However, the current state of reliability of blood cholesterol measurements suggests that considerable inaccuracy in cholesterol testing exists. This report describes the Laboratory Standardization Panel findings on the…

Measurement of Henry's Law Constants Using Internal Standards: A Quantitative GC Experiment for the Instrumental Analysis or Environmental Chemistry Laboratory

ERIC Educational Resources Information Center

Ji, Chang; Boisvert, Susanne M.; Arida, Ann-Marie C.; Day, Shannon E.

2008-01-01

An internal standard method applicable to undergraduate instrumental analysis or environmental chemistry laboratory has been designed and tested to determine the Henry's law constants for a series of alkyl nitriles. In this method, a mixture of the analytes and an internal standard is prepared and used to make a standard solution (organic solvent)…

[Accreditation of medical laboratories].

PubMed

Horváth, Andrea Rita; Ring, Rózsa; Fehér, Miklós; Mikó, Tivadar

2003-07-27

In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the

Synthesis of amino-functionalized silica nanoparticles for preparation of new laboratory standards

NASA Astrophysics Data System (ADS)

Alvarez-Toral, Aitor; Fernández, Beatriz; Malherbe, Julien; Claverie, Fanny; Pecheyran, Christophe; Pereiro, Rosario

2017-12-01

Platinum group elements (PGEs) are particularly interesting analytes in different fields, including environmental samples as well as high cost materials that contain them, such as for example automotive catalysts. This type of solid samples could be analysed by laser ablation (LA) coupled to ICP-MS, which allow to significantly reducing the analysis time since the time-consuming processes for sample preparation are not required. There is a considerable demand of standards with high PGEs concentration for quantification purposes, which cannot be carried out easily using LA-ICP-MS because the available standards (i.e. NIST SRM 61 × series) do not have such analytes in the same concentration range. In this paper, a new strategy is proposed for the synthesis of homogeneous laboratory standards with Pt, Pd and Rh concentrations that range from 77 μg/g of Pd up to 2035 μg/g of Rh. The proposed strategy is based on the synthesis of monodisperse amino-functionalized amorphous silica nanoparticles, which can retain metal ions. In addition to Pt, Pd and Rh, three lanthanides were also added to the nanoparticles (La, Ce, Nd). Sturdy pressed pellets can be made from the resulting nanopowder without the use of any binder. Elemental composition of standards made of nanoparticles was analysed by conventional nebulization ICP-MS and their homogeneity was successfully evaluated by LA-ICP-MS.

75 FR 16813 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of [[Page 16814

Roles of laboratories and laboratory systems in effective tuberculosis programmes.

PubMed

Ridderhof, John C; van Deun, Armand; Kam, Kai Man; Narayanan, P R; Aziz, Mohamed Abdul

2007-05-01

Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB.

42 CFR 493.1445 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic... result is found to be unacceptable or unsatisfactory; (5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and...

77 FR 16551 - Standards for Private Laboratory Analytical Packages and Introduction to Laboratory Related...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-21

... Food Modernization Safety Act for Private Laboratory Managers AGENCY: Food and Drug Administration, HHS... Food Modernization Safety Act for Private Laboratory Managers.'' The topic to be discussed is the...

Minimum inhibitory concentration breakpoints and disk diffusion inhibitory zone interpretive criteria for tilmicosin susceptibility testing against Pasteurella multocida and Actinobacillus pleuropneumoniae associated with porcine respiratory disease.

PubMed

Shryock, Thomas R; Staples, J Mitchell; DeRosa, David C

2002-09-01

Tilmicosin is a novel macrolide antibiotic developed for exclusive use in veterinary medicine. Tilmicosin has been approved as a feed premix to control porcine respiratory disease associated with Pasteurella multocida and Actinobacillus pleuropneumoniae. The development of antimicrobial susceptibility testing guidelines for tilmicosin was predicated on the relationship of clinical efficacy studies that demonstrated a favorable therapeutic outcome, on pharmacokinetic data, and on in vitro test data, as recommended by the National Committee for Clinical Laboratory Standards (NCCLS). The approved breakpoints for the minimum inhibitory concentration dilution testing for both species are resistant, > or = 32 microg/ml, and susceptible, < or = 16 microg/ml. The zone of inhibition interpretive criteria for disk diffusion testing with a 15-microg tilmicosin disk are resistant, < or = 10 mm, and susceptible, > or = 11 mm.

Measurements for 8 common analytes in native sera identify inadequate standardization among 6 routine laboratory assays.

PubMed

Stepman, Hedwig C M; Tiikkainen, Ulla; Stöckl, Dietmar; Vesper, Hubert W; Edwards, Selvin H; Laitinen, Harri; Pelanti, Jonna; Thienpont, Linda M

2014-06-01

External quality assessment (EQA) with commutable samples is essential for assessing the quality of assays performed by laboratories, particularly when the emphasis is on their standardization status and interchangeability of results. We used a panel of 20 fresh-frozen single-donation serum samples to assess assays for the measurement of creatinine, glucose, phosphate, uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. The commercial random access platforms included: Abbott Architect, Beckman Coulter AU, Ortho Vitros, Roche Cobas, Siemens Advia, and Thermo Scientific Konelab. The assessment was done at the peer group level and by comparison against the all-method trimmed mean or reference method values, where available. The considered quality indicators were intraassay imprecision, combined imprecision (including sample-matrix interference), bias, and total error. Fail/pass decisions were based on limits reflecting state-of-the-art performance, but also limits related to biological variation. Most assays showed excellent peer performance attributes, except for HDL- and LDL cholesterol. Cases in which individual assays had biases exceeding the used limits were the Siemens Advia creatinine (-4.2%), Ortho Vitros phosphate (8.9%), Beckman Coulter AU triglycerides (5.4%), and Thermo Scientific Konelab uric acid (6.4%), which lead to considerable interassay discrepancies. Additionally, large laboratory effects were observed that caused interlaboratory differences of >30%. The design of the EQA study was well suited for monitoring different quality attributes of assays performed in daily laboratory practice. There is a need for improvement, even for simple clinical chemistry analytes. In particular, the interchangeability of results remains jeopardized both by assay standardization issues and individual laboratory effects. © 2014 The American Association for Clinical Chemistry.

Inquiry-based laboratory investigations and student performance on standardized tests in biological science

NASA Astrophysics Data System (ADS)

Patke, Usha

Achievement data from the 3rd International Mathematics and Sciences Study and Program for International Student Assessment in science have indicated that Black students from economically disadvantaged families underachieve at alarming rates in comparison to White and economically advantaged peer groups. The study site was a predominately Black, urban school district experiencing underachievement. The purpose of this correlational study was to examine the relationship between students' use of inquiry-based laboratory investigations and their performance on the Biology End of Course Test, as well as to examine the relationship while partialling out the effects of student gender. Constructivist theory formed the theoretical foundation of the study. Students' perceived levels of experience with inquiry-based laboratory investigations were measured using the Laboratory Program Variable Inventory (LPVI) survey. LPVI scores of 256 students were correlated with test scores and were examined by student gender. The Pearson correlation coefficient revealed a small direct correlation between students' experience in inquiry-based laboratory investigation classes and standardized test scores on the Biology EOCT. A partial correlational analysis indicated that the correlation remained after controlling for gender. This study may prompt a change from teacher-centered to student-centered pedagogy at the local site in order to increase academic achievement for all students. The results of this study may also influence administrators and policy makers to initiate local, state, or nationwide curricular development. A change in curriculum may promote social change as students become more competent, and more able, to succeed in life beyond secondary school.

[ISO 15189 accreditation in clinical microbiology laboratory: general concepts and the status in our laboratory].

PubMed

Akyar, Işin

2009-10-01

One important trend in the laboratory profession and quality management is the global convergence of laboratory operations. The goal of an accredited medical laboratory is to continue "offering useful laboratory service for diagnosis and treatment of the patients and also aid to the health of the nation". An accredited clinical laboratory is managed by a quality control system, it is competent technically and the laboratory service meets the needs of all its patients and physicians by taking the responsibility of all the medical tests and therapies. For this purpose, ISO 15189 international standard has been prepared by 2003. ISO 15189 standard is originated from the arrangement of ISO 17025 and ISO 9001:2000 standards. Many countries such as England, Germany, France, Canada and Australia have preferred ISO 15189 as their own laboratory accreditation programme, meeting all the requirements of their medical laboratories. The accreditation performance of a clinical microbiology laboratory is mainly based on five essential points; preanalytical, analytical, postanalytical, quality control programmes (internal, external, interlaboratory) and audits (internal, external). In this review article, general concepts on ISO 15189 accreditation standards for the clinical microbiology laboratories have been summarized and the status of a private laboratory (Acibadem LabMed, Istanbul) in Turkey has been discussed.

Roles of laboratories and laboratory systems in effective tuberculosis programmes

PubMed Central

van Deun, Armand; Kam, Kai Man; Narayanan, PR; Aziz, Mohamed Abdul

2007-01-01

Abstract Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories’ functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB. PMID:17639219

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such... supervising non-waived laboratory testing; or (B) Beginning September 1, 1993, have at least 20 continuing... defined in § 493.1407; or (C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section...

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such... supervising non-waived laboratory testing; or (B) Beginning September 1, 1993, have at least 20 continuing... defined in § 493.1407; or (C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section...

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such... supervising non-waived laboratory testing; or (B) Beginning September 1, 1993, have at least 20 continuing... defined in § 493.1407; or (C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section...

Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

ERIC Educational Resources Information Center

Education Development Center, Inc., Newton, MA.

The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

[Laboratory accreditation and proficiency testing].

PubMed

Kuwa, Katsuhiko

2003-05-01

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

[ISO 15189 medical laboratory accreditation].

PubMed

Aoyagi, Tsutomu

2004-10-01

This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines will also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. The Japan Accreditation Board for Conformity Assessment (AB) and the Japanese Committee for Clinical Laboratory Standards (CCLS) are jointly developing the program of accreditation of medical laboratories. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements. The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. The latter includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories' examination results shall have traceability of measurements and implement uncertainty of measurement. Implementation of ISO 15189 will result in a significant improvement in medical laboratories management system and their technical competence. The accreditation of medical laboratory will improve medical laboratory service and be useful for patients.

Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

Cancer.gov

The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In partnership with NIST and the FDA, NCL has laid a solid, scientific foundation for using the power of nanotechnology to increase the potency and target the delivery

Creep Laboratory manual

NASA Astrophysics Data System (ADS)

Osgerby, S.; Loveday, M. S.

1992-06-01

A manual for the NPL Creep Laboratory, a collective name given to two testing laboratories, the Uniaxial Creep Laboratory and the Advanced High Temperature Mechanical Testing Laboratory, is presented. The first laboratory is devoted to uniaxial creep testing and houses approximately 50 high sensitivity creep machines including 10 constant stress cam lever machines. The second laboratory houses a low cycle fatigue testing machine of 100 kN capacity driven by a servo-electric actuator, five machines for uniaxial tensile creep testing of engineering ceramics at temperatures up to 1600C, and an electronic creep machine. Details of the operational procedures for carrying out uniaxial creep testing are given. Calibration procedures to be followed in order to comply with the specifications laid down by British standards, and to provide traceability back to the primary standards are described.

Standard metabolism and growth dynamics of laboratory-reared larvae of Sardina pilchardus.

PubMed

Moyano, M; Garrido, S; Teodósio, M A; Peck, M A

2014-04-01

This study provides the first measurements of the standard respiration rate (R(S)) and growth dynamics of European sardine Sardina pilchardus larvae reared in the laboratory. At 15° C, the relationship between RS (µl O(2) individual(-1)  h(-1)) and larval dry mass (M(D), µg) was equal to: R(S) = 0·0057(±0·0007, ± s.e.)·M(D) (0·8835(±0·0268)), (8-11% M(D) day(-1)). Interindividual differences in RS were not related to interindividual differences in growth rate or somatic (Fulton's condition factor) or biochemical-based condition (RNA:DNA). © 2014 The Fisheries Society of the British Isles.

42 CFR 493.1355 - Condition: Laboratories performing PPM procedures; laboratory director.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing PPM procedures; laboratory director. 493.1355 Section 493.1355 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS...

42 CFR 493.1355 - Condition: Laboratories performing PPM procedures; laboratory director.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing PPM procedures; laboratory director. 493.1355 Section 493.1355 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS...

75 FR 62842 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-13

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were... and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen...

The role of standards in the development and implementation of clinical laboratory tests: a domestic and global perspective.

PubMed

Michaud, Ginette Y

2005-01-01

In the field of clinical laboratory medicine, standardization is aimed at increasing the trueness and reliability of measured values. Standardization relies on the use of written standards, reference measurement procedures and reference materials. These are important tools for the design and validation of new tests, and for establishing the metrological traceability of diagnostic assays. Their use supports the translation of research technologies into new diagnostic assays and leads to more rapid advances in science and medicine, as well as improvements in the quality of patient care. The various standardization tools are described, as are the procedures by which written standards, reference procedures and reference materials are developed. Recent efforts to develop standards for use in the field of molecular diagnostics are discussed. The recognition of standardization tools by the FDA and other regulatory authorities is noted as evidence of their important role in ensuring the safety and performance of in vitro diagnostic devices.

Clinical laboratory accreditation in India.

PubMed

Handoo, Anil; Sood, Swaroop Krishan

2012-06-01

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

Harmonization of good laboratory practice requirements and laboratory accreditation programs.

PubMed

Royal, P D

1994-09-01

Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Three OECD Consensus Workshops and three inspectors training workshops have been held. In concert with these efforts, several OECD countries have developed GLP accreditation programs, managed by local health and environmental ministries. In addition, Canada and the United States are investigating Laboratory Accreditation programs for environmental monitoring assessment and GLP-regulated studies. In the European Community (EC), the need for quality standards specifying requirements for production and international trade has promoted International Standards Organization (ISO) certification for certain products. ISO-9000 standards identify requirements for certification of quality systems. These certification programs may affect the trade and market of laboratories conducting GLP studies. Two goals identified by these efforts are common to both programs: first, harmonization and recognition of requirements, and second, confidence in the rigor of program components used to assess the integrity of data produced and study activities. This confidence can be promoted, in part, through laboratory inspection and screening processes. However, the question remains, will data produced by sanctioned laboratories be mutually accepted on an international basis?(ABSTRACT TRUNCATED AT 250 WORDS)

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2012 CFR

2012-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2011 CFR

2011-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2014 CFR

2014-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2013 CFR

2013-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

75 FR 22150 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Correction In notice document 2010-7170 beginning on page 16813 in the issue of Friday, April 2...

In Vitro Activities of Terbinafine against Cutaneous Isolates of Candida albicans and Other Pathogenic Yeasts

PubMed Central

Ryder, Neil S.; Wagner, Sonja; Leitner, Ingrid

1998-01-01

Terbinafine is active in vitro against a wide range of pathogenic fungi, including dermatophytes, molds, dimorphic fungi, and some yeasts, but earlier studies indicated that the drug had little activity against Candida albicans. In contrast, clinical studies have shown topical and oral terbinafine to be active in cutaneous candidiasis and Candida nail infections. In order to define the anti-Candida activity of terbinafine, we tested the drug against 350 fresh clinical isolates and additional strains by using a broth dilution assay standardized according to the guidelines of the National Committee for Clinical Laboratory Standards (NCCLS) M27-A assay. Terbinafine was found to have an MIC of 1 μg/ml for reference C. albicans strains. For 259 clinical isolates, the MIC at which 50% of the isolates are inhibited (MIC50) of terbinafine was 1 μg/ml (fluconazole, 0.5 μg/ml), and the MIC90 was 4 μg/ml (fluconazole, 1 μg/ml). Terbinafine was highly active against Candida parapsilosis (MIC90, 0.125 μg/ml) and showed potentially interesting activity against isolates of Candida dubliniensis, Candida guilliermondii, Candida humicola, and Candida lusitaniae. It was not active against the Candida glabrata, Candida krusei, and Candida tropicalis isolates in this assay. Cryptococcus laurentii and Cryptococcus neoformans were highly susceptible to terbinafine, with MICs of 0.06 to 0.25 μg/ml. The NCCLS macrodilution assay provides reproducible in vitro data for terbinafine against Candida and other yeasts. The MICs for C. albicans and C. parapsilosis are compatible with the known clinical efficacy of terbinafine in cutaneous infections, while the clinical relevance of its activities against the other species has yet to be determined. PMID:9593126

From Topos to Oikos: The Standardization of Glass Containers as Epistemic Boundaries in Modern Laboratory Research (1850-1900).

PubMed

Espahangizi, Kijan

2015-09-01

Glass vessels such as flasks and test tubes play an ambiguous role in the historiography of modern laboratory research. In spite of the strong focus on the role of materiality in the last decades, the scientific glass vessel - while being symbolically omnipresent - has remained curiously neglected in regard to its materiality. The popular image or topos of the transparent, neutral, and quasi-immaterial glass container obstructs the view of the physico-chemical functionality of this constitutive inner boundary in modern laboratory environments and its material historicity. In order to understand how glass vessels were able to provide a stable epistemic containment of spatially enclosed experimental phenomena in the new laboratory ecologies emerging in the nineteenth and early twentieth century, I will focus on the history of the material standardization of laboratory glassware. I will follow the rise of a new awareness for measurement errors due to the chemical agency of experimental glass vessels, then I will sketch the emergence of a whole techno-scientific infrastructure for the improvement of glass container quality in late nineteenth-century Germany. In the last part of my argument, I will return to the laboratory by looking at the implementation of this glass reform that created a new oikos for the inner experimental milieus of modern laboratory research.

42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing high complexity testing; laboratory director. 493.1441 Section 493.1441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; laboratory director. 493.1441 Section 493.1441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

Competency assessment in laboratory medicine: Standardization and utility for technical staff assessment and recertification in Saudi Arabia.

PubMed

Nemenqani, Dalal M; Tekian, Ara; Park, Yoon Soo

2017-04-01

licensure in sample laboratories in Saudi Arabia. The program will be monitored and evaluated during and after implementation for processes and outcomes. Conclusions will be utilized for national competency program. This study represents an important step towards the implementation of a standardized laboratory competence assessment program at a national level.

Sweat test for cystic fibrosis: Wearable sweat sensor vs. standard laboratory test.

PubMed

Choi, Dong-Hoon; Thaxton, Abigail; Jeong, In Cheol; Kim, Kain; Sosnay, Patrick R; Cutting, Garry R; Searson, Peter C

2018-03-23

Sweat chloride testing for diagnosis of cystic fibrosis (CF) involves sweat induction, collection and handling, and measurement in an analytical lab. We have developed a wearable sensor with an integrated salt bridge for real-time measurement of sweat chloride concentration. Here, in a proof-of-concept study, we compare the performance of the sensor to current clinical practice in CF patients and healthy subjects. Sweat was induced on both forearms of 10 individuals with CF and 10 healthy subjects using pilocarpine iontophoresis. A Macroduct sweat collection device was attached to one arm and sweat was collected for 30 min and then sent for laboratory analysis. A sensor was attached to the other arm and the chloride ion concentration monitored in real time for 30 min using a Bluetooth transceiver and smart phone app. Stable sweat chloride measurements were obtained within 15 min following sweat induction using the wearable sensor. We define the detection time as the time at which the standard deviation of the real-time chloride ion concentration remained below 2 mEq/L for 5 min. The sweat volume for sensor measurements at the detection time was 13.1 ± 11.4 μL (SD), in many cases lower than the minimum sweat volume of 15 μL for conventional testing. The mean difference between sweat chloride concentrations measured by the sensor and the conventional laboratory practice was 6.2 ± 9.5 mEq/L (SD), close to the arm-to-arm variation of about 3 mEq/L. The Pearson correlation coefficient between the two measurements was 0.97 highlighting the excellent agreement between the two methods. A wearable sensor can be used to make real-time measurements of sweat chloride within 15 min following sweat induction, requiring a small sweat volume, and with excellent agreement to standard methods. Copyright © 2018 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Radiation and Health Technology Laboratory Capabilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bihl, Donald E.; Lynch, Timothy P.; Murphy, Mark K.

2005-07-09

The Radiological Standards and Calibrations Laboratory, a part of Pacific Northwest National Laboratory (PNNL)(a) performs calibrations and upholds reference standards necessary to maintain traceability to national standards. The facility supports U.S. Department of Energy (DOE) programs at the Hanford Site, programs sponsored by DOE Headquarters and other federal agencies, radiological protection programs at other DOE and commercial nuclear sites and research and characterization programs sponsored through the commercial sector. The laboratory is located in the 318 Building of the Hanford Site's 300 Area. The facility contains five major exposure rooms and several laboratories used for exposure work preparation, low-activity instrumentmore » calibrations, instrument performance evaluations, instrument maintenance, instrument design and fabrication work, thermoluminescent and radiochromic Dosimetry, and calibration of measurement and test equipment (M&TE). The major exposure facilities are a low-scatter room used for neutron and photon exposures, a source well room used for high-volume instrument calibration work, an x-ray facility used for energy response studies, a high-exposure facility used for high-rate photon calibration work, a beta standards laboratory used for beta energy response studies and beta reference calibrations and M&TE laboratories. Calibrations are routinely performed for personnel dosimeters, health physics instrumentation, photon and neutron transfer standards alpha, beta, and gamma field sources used throughout the Hanford Site, and a wide variety of M&TE. This report describes the standards and calibrations laboratory.« less

Intercomparison of Laboratory Radiance Calibration Standards

NASA Technical Reports Server (NTRS)

Pavri, Betina; Chrien, Tom; Green, Robert; Williams, Orlesa

2000-01-01

Several standards for radiometric calibration were measured repeatedly with a spectroradiometer in order to understand how they compared in accuracy and stability. The tested radiance standards included a NIST 1000 W bulb and halon panel, two calibrated and stabilized integrating spheres, and a cavity blackbody. Results indicate good agreement between the blackbody and 1000 W bulb/spectralon panel, If these two radiance sources are assumed correct, then the integrating spheres did not conform. to their manufacturer-reported radiances in several regions of the spectrum. More detailed measurements am underway to investigate the discrepancy.

Inter-laboratory trial of a standardized sediment contact test with the aquatic plant Myriophyllum aquaticum (ISO 16191).

PubMed

Feiler, Ute; Ratte, Monika; Arts, Gertie; Bazin, Christine; Brauer, Frank; Casado, Carmen; Dören, Laszlo; Eklund, Britta; Gilberg, Daniel; Grote, Matthias; Gonsior, Guido; Hafner, Christoph; Kopf, Willi; Lemnitzer, Bernd; Liedtke, Anja; Matthias, Uwe; Okos, Ewa; Pandard, Pascal; Scheerbaum, Dirk; Schmitt-Jansen, Mechthild; Stewart, Kathleen; Teodorovic, Ivana; Wenzel, Andrea; Pluta, Hans-Jürgen

2014-03-01

A whole-sediment toxicity test with Myriophyllum aquaticum has been developed by the German Federal Institute of Hydrology and standardized within the International Organization for Standardization (ISO; ISO 16191). An international ring-test was performed to evaluate the precision of the test method. Four sediments (artificial, natural) were tested. Test duration was 10 d, and test endpoint was inhibition of growth rate (r) based on fresh weight data. Eighteen of 21 laboratories met the validity criterion of r ≥ 0.09 d(-1) in the control. Results from 4 tests that did not conform to test-performance criteria were excluded from statistical evaluation. The inter-laboratory variability of growth rates (20.6%-25.0%) and inhibition (26.6%-39.9%) was comparable with the variability of other standardized bioassays. The mean test-internal variability of the controls was low (7% [control], 9.7% [solvent control]), yielding a high discriminatory power of the given test design (median minimum detectable differences [MDD] 13% to 15%). To ensure these MDDs, an additional validity criterion of CV ≤ 15% of the growth rate in the controls was recommended. As a positive control, 90 mg 3,5-dichlorophenol/kg sediment dry mass was tested. The range of the expected growth inhibition was proposed to be 35 ± 15%. The ring test results demonstrated the reliability of the ISO 16191 toxicity test and its suitability as a tool to assess the toxicity of sediment and dredged material. © 2013 SETAC.

Guidelines on Good Clinical Laboratory Practice

PubMed Central

Ezzelle, J.; Rodriguez-Chavez, I. R.; Darden, J. M.; Stirewalt, M.; Kunwar, N.; Hitchcock, R.; Walter, T.; D’Souza, M. P.

2008-01-01

A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. PMID:18037599

42 CFR 493.1234 - Standard: Communications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1234 Standard: Communications. The laboratory must have a system in place to... laboratory and an authorized person who orders or receives test results. [68 FR 3703, Jan. 24, 2003; 68 FR...

A professional development model for medical laboratory scientists working in the microbiology laboratory.

PubMed

Amerson, Megan H; Pulido, Lila; Garza, Melinda N; Ali, Faheem A; Greenhill, Brandy; Einspahr, Christopher L; Yarsa, Joseph; Sood, Pramilla K; Hu, Peter C

2012-01-01

The University of Texas M.D. Anderson Cancer Center, Division of Pathology and Laboratory Medicine is committed to providing the best pathology and medicine through: state-of-the art techniques, progressive ground-breaking research, education and training for the clinical diagnosis and research of cancer and related diseases. After surveying the laboratory staff and other hospital professionals, the Department administrators and Human Resource generalists developed a professional development model for Microbiology to support laboratory skills, behavior, certification, and continual education within its staff. This model sets high standards for the laboratory professionals to allow the labs to work at their fullest potential; it provides organization to training technologists based on complete laboratory needs instead of training technologists in individual areas in which more training is required if the laboratory needs them to work in other areas. This model is a working example for all microbiology based laboratories who want to set high standards and want their staff to be acknowledged for demonstrated excellence and professional development in the laboratory. The PDM model is designed to focus on the needs of the laboratory as well as the laboratory professionals.

Standard terminology in the laboratory and classroom

NASA Technical Reports Server (NTRS)

Strehlow, Richard A.

1992-01-01

Each of the materials produced by modern technologists is associated with a family of immaterials--all the concepts of substance, process, and purpose. It is concepts that are essential to transfer knowledge. It is concepts that are the stuff of terminology. Terminology is standardized today by companies, standards organizations, governments, and other groups. Simply described, it is the pre-negotiation of the meanings of terms. Terminology has become a key issue in businesses, and terminology knowledge is essential in understanding the modern world. The following is a introductory workshop discussing the concepts of terminology and methods of its standardization.

Internal audit in a microbiology laboratory.

PubMed Central

Mifsud, A J; Shafi, M S

1995-01-01

AIM--To set up a programme of internal laboratory audit in a medical microbiology laboratory. METHODS--A model of laboratory based process audit is described. Laboratory activities were examined in turn by specimen type. Standards were set using laboratory standard operating procedures; practice was observed using a purpose designed questionnaire and the data were analysed by computer; performance was assessed at laboratory audit meetings; and the audit circle was closed by re-auditing topics after an interval. RESULTS--Improvements in performance scores (objective measures) and in staff morale (subjective impression) were observed. CONCLUSIONS--This model of process audit could be applied, with amendments to take local practice into account, in any microbiology laboratory. PMID:7665701

External Standards or Standard Addition? Selecting and Validating a Method of Standardization

NASA Astrophysics Data System (ADS)

Harvey, David T.

2002-05-01

A common feature of many problem-based laboratories in analytical chemistry is a lengthy independent project involving the analysis of "real-world" samples. Students research the literature, adapting and developing a method suitable for their analyte, sample matrix, and problem scenario. Because these projects encompass the complete analytical process, students must consider issues such as obtaining a representative sample, selecting a method of analysis, developing a suitable standardization, validating results, and implementing appropriate quality assessment/quality control practices. Most textbooks and monographs suitable for an undergraduate course in analytical chemistry, however, provide only limited coverage of these important topics. The need for short laboratory experiments emphasizing important facets of method development, such as selecting a method of standardization, is evident. The experiment reported here, which is suitable for an introductory course in analytical chemistry, illustrates the importance of matrix effects when selecting a method of standardization. Students also learn how a spike recovery is used to validate an analytical method, and obtain a practical experience in the difference between performing an external standardization and a standard addition.

42 CFR 493.1233 - Standard: Complaint investigations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1233 Standard: Complaint investigations. The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory...

Slime production and proteinase activity of Candida species isolated from blood samples and the comparison of these activities with minimum inhibitory concentration values of antifungal agents.

PubMed

Ozkan, Semiha; Kaynak, Fatma; Kalkanci, Ayse; Abbasoglu, Ufuk; Kustimur, Semra

2005-05-01

Slime and proteinase activity of 54 strains consisting of 19 Candida parapsilosis and 35 C. albicans strains isolated from blood samples were investigated in this study. Ketoconazole, amphothericin B, and fluconazole susceptibility of Candida species were compared with slime production and proteinase activity of these species. For both Candida species, no correlation was detected between the slime activity and minimum inhibitory concentration (MIC) values of the three antifungal agents. For both Candida species no correlation was detected between the proteinase activity and the MIC values of amphothericin B, and fluconazole however, statistically significant difference, was determined between the proteinase activity and MIC values of ketoconazole (p = 0.007). Slime production was determined by using modified Christensen macrotube method and proteinase activity was measured by the method of Staib. Antifungal susceptibility was determined through the guidelines of National Committee for Laboratory Standards (NCCLS M27-A).

Design and verification of the shielding around the new Neutron Standards Laboratory (LPN) at CIEMAT.

PubMed

Méndez-Villafañe, R; Guerrero, J E; Embid, M; Fernández, R; Grandio, R; Pérez-Cejuela, P; Márquez, J L; Alvarez, F; Ortego, P

2014-10-01

The construction of the new Neutron Standards Laboratory at CIEMAT (Laboratorio de Patrones Neutrónicos) has been finalised and is ready to provide service. The facility is an ∼8 m×8 m×8 m irradiation vault, following the International Organization for Standardization 8529 recommendations. It relies on several neutron sources: a 5-GBq (5.8× 10(8) s(-1)) (252)Cf source and two (241)Am-Be neutron sources (185 and 11.1 GBq). The irradiation point is located 4 m over the ground level and in the geometrical centre of the room. Each neutron source can be moved remotely from its storage position inside a water pool to the irradiation point. Prior to this, an important task to design the neutron shielding and to choose the most appropriate materials has been developed by the Radiological Security Unit and the Ionizing Radiations Metrology Laboratory. MCNPX was chosen to simulate the irradiation facility. With this information the walls were built with a thickness of 125 cm. Special attention was put on the weak points (main door, air conditioning system, etc.) so that the ambient dose outside the facility was below the regulatory limits. Finally, the Radiation Protection Unit carried out a set of measurements in specific points around the installation with an LB6411 neutron monitor and a Reuter-Stokes high-pressure ion chamber to verify experimentally the results of the simulation. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

PubMed Central

Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

2012-01-01

Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

42 CFR 493.1850 - Laboratory registry.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Laboratory registry. 493.1850 Section 493.1850... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Enforcement Procedures § 493.1850 Laboratory... laboratories, including the following: (1) A list of laboratories that have been convicted, under Federal or...

42 CFR 493.1850 - Laboratory registry.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Laboratory registry. 493.1850 Section 493.1850... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Enforcement Procedures § 493.1850 Laboratory... laboratories, including the following: (1) A list of laboratories that have been convicted, under Federal or...

42 CFR 493.1403 - Condition: Laboratories performing moderate complexity testing; laboratory director.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1403 Section 493.1403 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

42 CFR 493.1403 - Condition: Laboratories performing moderate complexity testing; laboratory director.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1403 Section 493.1403 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2010 CFR

2010-01-01

... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

Preservice laboratory education strengthening enhances sustainable laboratory workforce in Ethiopia

PubMed Central

2013-01-01

Background There is a severe healthcare workforce shortage in sub Saharan Africa, which threatens achieving the Millennium Development Goals and attaining an AIDS-free generation. The strength of a healthcare system depends on the skills, competencies, values and availability of its workforce. A well-trained and competent laboratory technologist ensures accurate and reliable results for use in prevention, diagnosis, care and treatment of diseases. Methods An assessment of existing preservice education of five medical laboratory schools, followed by remedial intervention and monitoring was conducted. The remedial interventions included 1) standardizing curriculum and implementation; 2) training faculty staff on pedagogical methods and quality management systems; 3) providing teaching materials; and 4) procuring equipment for teaching laboratories to provide practical skills to complement didactic education. Results A total of 2,230 undergraduate students from the five universities benefitted from the standardized curriculum. University of Gondar accounted for 252 of 2,230 (11.3%) of the students, Addis Ababa University for 663 (29.7%), Jimma University for 649 (29.1%), Haramaya University for 429 (19.2%) and Hawassa University for 237 (10.6%) of the students. Together the universities graduated 388 and 312 laboratory technologists in 2010/2011 and 2011/2012 academic year, respectively. Practical hands-on training and experience with well-equipped laboratories enhanced and ensured skilled, confident and competent laboratory technologists upon graduation. Conclusions Strengthening preservice laboratory education is feasible in resource-limited settings, and emphasizing its merits (ample local capacity, country ownership and sustainability) provides a valuable source of competent laboratory technologists to relieve an overstretched healthcare system. PMID:24164781

42 CFR 493.1101 - Standard: Facilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Facilities. 493.1101 Section 493.1101... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Facility Administration for Nonwaived Testing § 493.1101 Standard: Facilities. (a) The laboratory must be constructed, arranged, and maintained to...

Exposure to hazardous substances in a standard molecular biology laboratory environment: evaluation of exposures in IARC laboratories.

PubMed

Chapot, Brigitte; Secretan, Béatrice; Robert, Annie; Hainaut, Pierre

2009-07-01

Working in a molecular biology laboratory environment implies regular exposure to a wide range of hazardous substances. Several recent studies have shown that laboratory workers may have an elevated risk of certain cancers. Data on the nature and frequency of exposures in such settings are scanty. The frequency of use of 163 agents by staff working in molecular biology laboratories was evaluated over a period of 4 years by self-administered questionnaire. Of the agents listed, ethanol was used by the largest proportion of staff (70%), followed by ethidium bromide (55%). Individual patterns of use showed three patterns, namely (i) frequent use of a narrow range of products, (ii) occasional use of a wide range of products, and (iii) frequent and occasional use of an intermediate range of products. Among known or suspected carcinogens (International Agency for Research on Cancer Group 1 and 2A, respectively), those most frequently used included formaldehyde (17%), oncogenic viruses (4%), and acrylamide (32%). The type of exposure encountered in research laboratories is extremely diverse. Few carcinogenic agents are used frequently but many laboratory workers may be exposed occasionally to known human carcinogens. In addition, many of the chemicals handled by staff represent a health hazard. The results enabled the staff physician to develop an individual approach to medical surveillance and to draw a personal history of occupational exposures for laboratory staff.

Procedures of Exercise Physiology Laboratories

NASA Technical Reports Server (NTRS)

Bishop, Phillip A.; Fortney, Suzanne; Greenisen, Michael; Siconolfi, Steven F.; Bamman, Marcas M.; Moore, Alan D., Jr.; Squires, William

1998-01-01

This manual describes the laboratory methods used to collect flight crew physiological performance data at the Johnson Space Center. The Exercise Countermeasures Project Laboratory is a standard physiology laboratory; only the application to the study of human physiological adaptations to spaceflight is unique. In the absence of any other recently published laboratory manual, this manual should be a useful document staffs and students of other laboratories.

Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda.

PubMed

Ssengooba, Willy; Gelderbloem, Sebastian J; Mboowa, Gerald; Wajja, Anne; Namaganda, Carolyn; Musoke, Philippa; Mayanja-Kizza, Harriet; Joloba, Moses Lutaakome

2015-01-15

Despite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility. Between September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode. The laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P <0.01). It started full operations in October 2009 performing smear microscopy, culture, identification, and drug susceptibility testing (DST). The annual culture workload was 7,636, 10,242, and 2,712 inoculations for the years 2010, 2011, and 2012, respectively. Other performance indicators of TB culture laboratories were also monitored. Scores from EQA panels included smear microscopy >80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012. From our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality

42 CFR 493.645 - Additional fee(s) applicable to approved State laboratory programs and laboratories issued a...

Code of Federal Regulations, 2011 CFR

2011-10-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration § 493.645 Additional fee(s) applicable to approved State laboratory programs and... laboratory programs and laboratories issued a certificate of accreditation, certificate of waiver, or...

Proficiency Testing as a tool to monitor consistency of measurements in the IAEA/WHO Network of Secondary Standards Dosimetry Laboratories

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meghzifene, Ahmed; Czap, Ladislav; Shortt, Ken

2008-08-14

The International Atomic Energy Agency (IAEA) and the World Health Organization (WHO) established a Network of Secondary Standards Dosimetry Laboratories (IAEA/WHO SSDL Network) in 1976. Through SSDLs designated by Member States, the Network provides a direct link of national dosimetry standards to the international measurement system of standards traceable to the Bureau International des Poids et Mesures (BIPM). Within this structure and through the proper calibration of field instruments, the SSDLs disseminate S.I. quantities and units.To ensure that the services provided by SSDL members to end-users follow internationally accepted standards, the IAEA has set up two different comparison programmes. Onemore » programme relies on the IAEA/WHO postal TLD service and the other uses comparisons of calibrated ionization chambers to help the SSDLs verify the integrity of their national standards and the procedures used for the transfer of the standards to the end-users. The IAEA comparisons include {sup 60}Co air kerma (N{sub K}) and absorbed dose to water (N{sub D,W}) coefficients. The results of the comparisons are confidential and are communicated only to the participants. This is to encourage participation of the laboratories and their full cooperation in the reconciliation of any discrepancy.This work describes the results of the IAEA programme comparing calibration coefficients for radiotherapy dosimetry, using ionization chambers. In this programme, ionization chambers that belong to the SSDLs are calibrated sequentially at the SSDL, at the IAEA, and again at the SSDL. As part of its own quality assurance programme, the IAEA has participated in several regional comparisons organized by Regional Metrology Organizations.The results of the IAEA comparison programme show that the majority of SSDLs are capable of providing calibrations that fall inside the acceptance level of 1.5% compared to the IAEA.« less

Risk of Fungemia Due to Rhodotorula and Antifungal Susceptibility Testing of Rhodotorula Isolates

PubMed Central

Zaas, Aimee K.; Boyce, Molly; Schell, Wiley; Lodge, Barbara Alexander; Miller, Jackie L.; Perfect, John R.

2003-01-01

Rhodotorula infections occur among patients with immunosuppression and/or central venous catheters. Using standardized methods (NCCLS M27-A), we determined the antifungal susceptibilities of 10 Rhodotorula bloodstream infection isolates. Patient information was collected for clinical correlation. The MICs of amphotericin B and posaconazole were the lowest, and the MICs of triazoles and echinocandins were higher than those of other antifungal agents. PMID:14605170

Comparison of a New Cobinamide-Based Method to a Standard Laboratory Method for Measuring Cyanide in Human Blood

PubMed Central

Swezey, Robert; Shinn, Walter; Green, Carol; Drover, David R.; Hammer, Gregory B.; Schulman, Scott R.; Zajicek, Anne; Jett, David A.; Boss, Gerry R.

2013-01-01

Most hospital laboratories do not measure blood cyanide concentrations, and samples must be sent to reference laboratories. A simple method is needed for measuring cyanide in hospitals. The authors previously developed a method to quantify cyanide based on the high binding affinity of the vitamin B12 analog, cobinamide, for cyanide and a major spectral change observed for cyanide-bound cobinamide. This method is now validated in human blood, and the findings include a mean inter-assay accuracy of 99.1%, precision of 8.75% and a lower limit of quantification of 3.27 µM cyanide. The method was applied to blood samples from children treated with sodium nitroprusside and it yielded measurable results in 88 of 172 samples (51%), whereas the reference laboratory yielded results in only 19 samples (11%). In all 19 samples, the cobinamide-based method also yielded measurable results. The two methods showed reasonable agreement when analyzed by linear regression, but not when analyzed by a standard error of the estimate or paired t-test. Differences in results between the two methods may be because samples were assayed at different times on different sample types. The cobinamide-based method is applicable to human blood, and can be used in hospital laboratories and emergency rooms. PMID:23653045

Preservation Study for Ultra-Dilute VX Standards | Science ...

EPA Pesticide Factsheets

Report Lawrence Livermore National Laboratory (LLNL) supplies ultra-dilute (10 µg/mL) chemical warfare agent (CWA) standards to the Environmental Response Laboratory Network (ERLN) laboratories to allow the use of authentic standards to assist in analyses required for a remediation event involving CWAs. For this reason, it is important to collect data regarding the shelf-lives of these standards. The instability has the potential to impact quality control in regional ERLN laboratories, resulting in data that are difficult to interpret. Thus, this study investigated the use of chemical stabilizers to increase the shelf-life of VX standards. VX standards with long shelf-lives are desirable, as long shelf-life would significantly reduce the costs associated with synthesizing and resupplying the ERLN laboratories with VX.

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false USDA laboratory. 996.21 Section 996.21 Agriculture... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false USDA laboratory. 996.21 Section 996.21 Agriculture... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 8 2014-01-01 2014-01-01 false USDA laboratory. 996.21 Section 996.21 Agriculture... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

7 CFR 996.21 - USDA laboratory.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false USDA laboratory. 996.21 Section 996.21 Agriculture... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.21 USDA laboratory. USDA laboratory means laboratories of the Science and Technology Programs, Agricultural Marketing...

Plasma creatinine in dogs: intra- and inter-laboratory variation in 10 European veterinary laboratories

PubMed Central

2011-01-01

Background There is substantial variation in reported reference intervals for canine plasma creatinine among veterinary laboratories, thereby influencing the clinical assessment of analytical results. The aims of the study was to determine the inter- and intra-laboratory variation in plasma creatinine among 10 veterinary laboratories, and to compare results from each laboratory with the upper limit of its reference interval. Methods Samples were collected from 10 healthy dogs, 10 dogs with expected intermediate plasma creatinine concentrations, and 10 dogs with azotemia. Overlap was observed for the first two groups. The 30 samples were divided into 3 batches and shipped in random order by postal delivery for plasma creatinine determination. Statistical testing was performed in accordance with ISO standard methodology. Results Inter- and intra-laboratory variation was clinically acceptable as plasma creatinine values for most samples were usually of the same magnitude. A few extreme outliers caused three laboratories to fail statistical testing for consistency. Laboratory sample means above or below the overall sample mean, did not unequivocally reflect high or low reference intervals in that laboratory. Conclusions In spite of close analytical results, further standardization among laboratories is warranted. The discrepant reference intervals seem to largely reflect different populations used in establishing the reference intervals, rather than analytical variation due to different laboratory methods. PMID:21477356

Isolation gowns in health care settings: Laboratory studies, regulations and standards, and potential barriers of gown selection and use

PubMed Central

Kilinc Balci, F. Selcen

2016-01-01

Although they play an important role in infection prevention and control, textile materials and personal protective equipment (PPE) used in health care settings are known to be one of the sources of cross-infection. Gowns are recommended to prevent transmission of infectious diseases in certain settings; however, laboratory and field studies have produced mixed results of their efficacy. PPE used in health care is regulated as either class I (low risk) or class II (intermediate risk) devices in the United States. Many organizations have published guidelines for the use of PPE, including isolation gowns, in health care settings. In addition, the Association for the Advancement of Medical Instrumentation published a guidance document on the selection of gowns and a classification standard on liquid barrier performance for both surgical and isolation gowns. However, there is currently no existing standard specific to isolation gowns that considers not only the barrier resistance but also a wide array of end user desired attributes. As a result, infection preventionists and purchasing agents face several difficulties in the selection process, and end users have limited or no information on the levels of protection provided by isolation gowns. Lack of knowledge about the performance of protective clothing used in health care became more apparent during the 2014 Ebola epidemic. This article reviews laboratory studies, regulations, guidelines and standards pertaining to isolation gowns, characterization problems, and other potential barriers of isolation gown selection and use. PMID:26391468

International Organization for Standardization (ISO) 15189.

PubMed

Schneider, Frank; Maurer, Caroline; Friedberg, Richard C

2017-09-01

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189. © The Korean Society for Laboratory Medicine.

42 CFR 493.1425 - Standard; Testing personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratory's quality control policies, document all quality control activities, instrument and procedural... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Moderate Complexity Testing § 493.1425 Standard; Testing personnel...

Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

PubMed

Freeman, Kathleen P; Bauer, Natali; Jensen, Asger L; Thoresen, Stein

2006-06-01

A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2010 CFR

2010-01-01

... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

The prevalence and severity of non-carious cervical lesions in a group of patients attending a university hospital in Trinidad.

PubMed

Smith, W A J; Marchan, S; Rafeek, R N

2008-02-01

Non-carious cervical lesions (NCCLs) are often encountered in clinical practice and their aetiology attributed to toothbrush abrasion, erosion and tooth flexure. This paper aims to determine the prevalence and severity of NCCLs in a sample of patients attending a university clinic in Trinidad and to investigate the relationship with medical and dental histories, oral hygiene practices, dietary habits and occlusion. Data were collected via a questionnaire and clinical examination. Odds ratios were used to determine the association of the presence of lesions and the factors examined. One hundred and fifty-six patients with a mean age of 40.6 years were examined of whom 62.2% had one or more NCCLs. Forty five per cent of the lesions were sensitive to compressed air. Younger age groups had a significantly lower correlation with the presence of NCCLs than older age groups. Other significant factors included patients who reported heartburn, gastric reflux, headaches, bruxism, sensitive teeth and swimming or had a history of broken restorations in the last year. There was also significant correlation of NCCLs in patients who brushed more than once a day or used a medium or hard toothbrush. Patients with vegetarian diets and those who reported consuming citrus fruits, soft drinks, alcohol, yoghurt and vitamin C drinks were associated with the presence of lesions. Significant associations were also found in patients with group function, faceting, clicking joints or those who wore occlusal splints.

Standardization of glycohemoglobin results and reference values in whole blood studied in 103 laboratories using 20 methods.

PubMed

Weykamp, C W; Penders, T J; Miedema, K; Muskiet, F A; van der Slik, W

1995-01-01

We investigated the effect of calibration with lyophilized calibrators on whole-blood glycohemoglobin (glyHb) results. One hundred three laboratories, using 20 different methods, determined glyHb in two lyophilized calibrators and two whole-blood samples. For whole-blood samples with low (5%) and high (9%) glyHb percentages, respectively, calibration decreased overall interlaboratory variation (CV) from 16% to 9% and from 11% to 6% and decreased intermethod variation from 14% to 6% and from 12% to 5%. Forty-seven laboratories, using 14 different methods, determined mean glyHb percentages in self-selected groups of 10 nondiabetic volunteers each. With calibration their overall mean (2SD) was 5.0% (0.5%), very close to the 5.0% (0.3%) derived from the reference method used in the Diabetes Control and Complications Trial. In both experiments the Abbott IMx and Vision showed deviating results. We conclude that, irrespective of the analytical method used, calibration enables standardization of glyHb results, reference values, and interpretation criteria.

[Standardization in laboratory hematology by participating in external quality assurance programs].

PubMed

Nazor, Aida; Siftar, Zoran; Flegar-Mestrić, Zlata

2011-09-01

Since 1985, Department of Clinical Chemistry and Laboratory Medicine, Merkur University Hospital, Zagreb, has been participating in the International External Quality Assessment Scheme for Hematology (IEQAS-H) organized by the World Health Organization (WHO). Owing to very good results, in 1987 the Department received a certificate of participation in this control scheme. Department has been cooperating in the external quality assessment program in laboratory hematology which has been continuously performed in Croatia since 1986 by the Committee for External Quality Assessment Schemes under the auspices of the Croatian Society of Medical Biochemists and School of Pharmacy and Biochemistry, University of Zagreb. Nowadays, 186 medical biochemical laboratories are included in the National External Quality Assessment program, which is performed three times per year. Our Department has participated in the international projects of the European Committee for External Quality Assurance Programs in Laboratory Medicine (EQALM).

40 CFR 160.49 - Laboratory operation areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Laboratory operation areas. 160.49 Section 160.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Facilities § 160.49 Laboratory operation areas. Separate laboratory...

40 CFR 160.49 - Laboratory operation areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Laboratory operation areas. 160.49 Section 160.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Facilities § 160.49 Laboratory operation areas. Separate laboratory...

Development of the Global Measles Laboratory Network.

PubMed

Featherstone, David; Brown, David; Sanders, Ray

2003-05-15

The routine reporting of suspected measles cases and laboratory testing of samples from these cases is the backbone of measles surveillance. The Global Measles Laboratory Network (GMLN) has developed standards for laboratory confirmation of measles and provides training resources for staff of network laboratories, reference materials and expertise for the development and quality control of testing procedures, and accurate information for the Measles Mortality Reduction and Regional Elimination Initiative. The GMLN was developed along the lines of the successful Global Polio Laboratory Network, and much of the polio laboratory infrastructure was utilized for measles. The GMLN has developed as countries focus on measles control activities following successful eradication of polio. Currently more than 100 laboratories are part of the global network and follow standardized testing and reporting procedures. A comprehensive laboratory accreditation process will be introduced in 2002 with six quality assurance and performance indicators.

Components of laboratory accreditation.

PubMed

Royal, P D

1995-12-01

Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. This proposal was the result of the Inspector General Office reports that identified weaknesses in the current operation. Several accreditation programs can be evaluated and common components identified when proposing a structure for accrediting a GLP system. An understanding of these components is useful in building that structure. Internationally accepted accreditation programs provide a template for building a U.S. GLP accreditation program. This presentation will discuss the traditional structure of accreditation as presented in the Organization of Economic Cooperative Development/GLP program, ISO-9000 Accreditation and ISO/IEC Guide 25 Standard, and the Canadian Association for Environmental Analytical Laboratories, which has a biological component. Most accreditation programs are managed by a recognized third party, either privately or with government oversight. Common components often include a formal review of required credentials to evaluate organizational structure, a site visit to evaluate the facility, and a performance evaluation to assess technical competence. Laboratory performance is measured against written standards and scored. A formal report is then sent to the laboratory indicating accreditation status. Usually, there is a scheduled reevaluation built into the program. Fee structures vary considerably and will need to be examined closely when building a GLP program.

Measuring laboratory-based influenza surveillance capacity: development of the 'International Influenza Laboratory Capacity Review' Tool.

PubMed

Muir-Paulik, S A; Johnson, L E A; Kennedy, P; Aden, T; Villanueva, J; Reisdorf, E; Humes, R; Moen, A C

2016-01-01

The 2005 International Health Regulations (IHR 2005) emphasized the importance of laboratory capacity to detect emerging diseases including novel influenza viruses. To support IHR 2005 requirements and the need to enhance influenza laboratory surveillance capacity, the Association of Public Health Laboratories (APHL) and the Centers for Disease Control and Prevention (CDC) Influenza Division developed the International Influenza Laboratory Capacity Review (Tool). Data from 37 assessments were reviewed and analyzed to verify that the quantitative analysis results accurately depicted a laboratory's capacity and capabilities. Subject matter experts in influenza and laboratory practice used an iterative approach to develop the Tool incorporating feedback and lessons learnt through piloting and implementation. To systematically analyze assessment data, a quantitative framework for analysis was added to the Tool. The review indicated that changes in scores consistently reflected enhanced or decreased capacity. The review process also validated the utility of adding a quantitative analysis component to the assessments and the benefit of establishing a baseline from which to compare future assessments in a standardized way. Use of the Tool has provided APHL, CDC and each assessed laboratory with a standardized analysis of the laboratory's capacity. The information generated is used to improve laboratory systems for laboratory testing and enhance influenza surveillance globally. We describe the development of the Tool and lessons learnt. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

A professional development model for medical laboratory scientists working in the immunohematology laboratory.

PubMed

Garza, Melinda N; Pulido, Lila A; Amerson, Megan; Ali, Faheem A; Greenhill, Brandy A; Griffin, Gary; Alvarez, Enrique; Whatley, Marsha; Hu, Peter C

2012-01-01

Transfusion medicine, a section of the Department of Laboratory Medicine at The University of Texas MD Anderson Cancer Center is committed to the education and advancement of its health care professionals. It is our belief that giving medical laboratory professionals a path for advancement leads to excellence and increases overall professionalism in the Immunohematology Laboratory. As a result of this strong commitment to excellence and professionalism, the Immunohematology laboratory has instituted a Professional Development Model (PDM) that aims to create Medical Laboratory Scientists (MLS) that are not only more knowledgeable, but are continually striving for excellence. In addition, these MLS are poised for advancement in their careers. The professional development model consists of four levels: Discovery, Application, Maturation, and Expert. The model was formulated to serve as a detailed path to the mastery of all process and methods in the Immunohematology Laboratory. Each level in the professional development model consists of tasks that optimize the laboratory workflow and allow for concurrent training. Completion of a level in the PDM is rewarded with financial incentive and further advancement in the field. The PDM for Medical Laboratory Scientists in the Immunohematology Laboratory fosters personal development, rewards growth and competency, and sets high standards for all services and skills provided. This model is a vital component of the Immunohematology Laboratory and aims to ensure the highest quality of care and standards in their testing. It is because of the success of this model and the robustness of its content that we hope other medical laboratories aim to reach the same level of excellence and professionalism, and adapt this model into their own environment.

International Organization for Standardization (ISO) 15189

PubMed Central

Schneider, Frank; Friedberg, Richard C.

2017-01-01

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189. PMID:28643484

42 CFR 493.1230 - Condition: General laboratory systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: General laboratory systems. 493.1230... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1230 Condition: General laboratory systems. Each laboratory that...

Protocol standards and implementation within the digital engineering laboratory computer network (DELNET) using the universal network interface device (UNID). Part 2

NASA Astrophysics Data System (ADS)

Phister, P. W., Jr.

1983-12-01

Development of the Air Force Institute of Technology's Digital Engineering Laboratory Network (DELNET) was continued with the development of an initial draft of a protocol standard for all seven layers as specified by the International Standards Organization's (ISO) Reference Model for Open Systems Interconnections. This effort centered on the restructuring of the Network Layer to perform Datagram routing and to conform to the developed protocol standards and actual software module development of the upper four protocol layers residing within the DELNET Monitor (Zilog MCZ 1/25 Computer System). Within the guidelines of the ISO Reference Model the Transport Layer was developed utilizing the Internet Header Format (IHF) combined with the Transport Control Protocol (TCP) to create a 128-byte Datagram. Also a limited Application Layer was created to pass the Gettysburg Address through the DELNET. This study formulated a first draft for the DELNET Protocol Standard and designed, implemented, and tested the Network, Transport, and Application Layers to conform to these protocol standards.

Accuracy investigation of phthalate metabolite standards.

PubMed

Langlois, Éric; Leblanc, Alain; Simard, Yves; Thellen, Claude

2012-05-01

Phthalates are ubiquitous compounds whose metabolites are usually determined in urine for biomonitoring studies. Following suspect and unexplained results from our laboratory in an external quality-assessment scheme, we investigated the accuracy of all phthalate metabolite standards in our possession by comparing them with those of several suppliers. Our findings suggest that commercial phthalate metabolite certified solutions are not always accurate and that lot-to-lot discrepancies significantly affect the accuracy of the results obtained with several of these standards. These observations indicate that the reliability of the results obtained from different lots of standards is not equal, which reduces the possibility of intra-laboratory and inter-laboratory comparisons of results. However, agreements of accuracy have been observed for a majority of neat standards obtained from different suppliers, which indicates that a solution to this issue is available. Data accuracy of phthalate metabolites should be of concern for laboratories performing phthalate metabolite analysis because of the standards used. The results of our investigation are presented from the perspective that laboratories performing phthalate metabolite analysis can obtain accurate and comparable results in the future. Our findings will contribute to improving the quality of future phthalate metabolite analyses and will affect the interpretation of past results.

Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories

PubMed Central

Jang, Mi-Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong-Ho; Min, Won-Ki; Lee, Ji Sung

2017-01-01

Background Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. Methods We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Results Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. Conclusions These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. PMID:28224767

External quality assessment of medical laboratories in Croatia: preliminary evaluation of post-analytical laboratory testing.

PubMed

Krleza, Jasna Lenicek; Dorotic, Adrijana; Grzunov, Ana

2017-02-15

Proper standardization of laboratory testing requires assessment of performance after the tests are performed, known as the post-analytical phase. A nationwide external quality assessment (EQA) scheme implemented in Croatia in 2014 includes a questionnaire on post-analytical practices, and the present study examined laboratory responses in order to identify current post-analytical phase practices and identify areas for improvement. In four EQA exercises between September 2014 and December 2015, 145-174 medical laboratories across Croatia were surveyed using the Module 11 questionnaire on the post-analytical phase of testing. Based on their responses, the laboratories were evaluated on four quality indicators: turnaround time (TAT), critical values, interpretative comments and procedures in the event of abnormal results. Results were presented as absolute numbers and percentages. Just over half of laboratories (56.3%) monitored TAT. Laboratories varied substantially in how they dealt with critical values. Most laboratories (65-97%) issued interpretative comments with test results. One third of medical laboratories (30.6-33.3%) issued abnormal test results without confirming them in additional testing. Our results suggest that the nationwide post-analytical EQA scheme launched in 2014 in Croatia has yet to be implemented to the full. To close the gaps between existing recommendations and laboratory practice, laboratory professionals should focus on ensuring that TAT is monitored and lists of critical values are established within laboratories. Professional bodies/institutions should focus on clarify and harmonized rules to standardized practices and applied for adding interpretative comments to laboratory test results and for dealing with abnormal test results.

AMT's Position on Physician's Office Laboratories.

ERIC Educational Resources Information Center

AMT Events, 1986

1986-01-01

The following standards are affirmed by the American Medical Technologists organization: (1) regardless of the size of the laboratory setting, the patient deserves the highest quality of laboratory service available; (2) certified personnel should be employed by physicians in office laboratories; (3) quality control should be mandatory and…

Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories.

PubMed

Jang, Mi Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong Ho; Min, Won Ki; Lee, Ji Sung; Lee, Yong Wha; Lee, You Kyoung

2017-05-01

Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. © The Korean Society for Laboratory Medicine

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 8 2014-01-01 2014-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

7 CFR 996.22 - USDA-approved laboratory.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false USDA-approved laboratory. 996.22 Section 996.22... STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES Definitions § 996.22 USDA-approved laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology Programs...

40 CFR 792.49 - Laboratory operation areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Laboratory operation areas. 792.49... CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.49 Laboratory operation areas. Separate laboratory space and other space shall be provided, as needed, for the performance of the routine...

42 CFR 493.1234 - Standard: Communications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Communications. 493.1234 Section 493.1234 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Laboratory Systems § 493.1234 Standard: Communications. The laboratory must have a system in place to...

Laboratory issues: use of nutritional biomarkers.

PubMed

Blanck, Heidi Michels; Bowman, Barbara A; Cooper, Gerald R; Myers, Gary L; Miller, Dayton T

2003-03-01

Biomarkers of nutritional status provide alternative measures of dietary intake. Like the error and variation associated with dietary intake measures, the magnitude and impact of both biological (preanalytical) and laboratory (analytical) variability need to be considered when one is using biomarkers. When choosing a biomarker, it is important to understand how it relates to nutritional intake and the specific time frame of exposure it reflects as well as how it is affected by sampling and laboratory procedures. Biological sources of variation that arise from genetic and disease states of an individual affect biomarkers, but they are also affected by nonbiological sources of variation arising from specimen collection and storage, seasonality, time of day, contamination, stability and laboratory quality assurance. When choosing a laboratory for biomarker assessment, researchers should try to make sure random and systematic error is minimized by inclusion of certain techniques such as blinding of laboratory staff to disease status and including external pooled standards to which laboratory staff are blinded. In addition analytic quality control should be ensured by use of internal standards or certified materials over the entire range of possible values to control method accuracy. One must consider the effect of random laboratory error on measurement precision and also understand the method's limit of detection and the laboratory cutpoints. Choosing appropriate cutpoints and reducing error is extremely important in nutritional epidemiology where weak associations are frequent. As part of this review, serum lipids are included as an example of a biomarker whereby collaborative efforts have been put forth to both understand biological sources of variation and standardize laboratory results.

Appliance Standard Testing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hogan, Kathleen; Tiemann, Gregg

2016-08-03

The U.S. Department of Energy’s Appliance Standards and Equipment Program tests, sets and helps enforce efficiency standards on more than 60 U.S. products. A majority of that testing is performed at the Intertek laboratory in Cortland, NY.

Evidence for the occurrence of gingival recession and non-carious cervical lesions as a consequence of traumatic toothbrushing.

PubMed

Heasman, Peter A; Holliday, Richard; Bryant, Andrew; Preshaw, Philip M

2015-04-01

To identify the best available evidence for the effect of toothbrushing on the initiation and progression of gingival recession and non-carious cervical lesions (NCCLs). A protocol was developed for the questions: Does traumatic toothbrushing, compared to normal toothbrushing, lead to an increased prevalence of non-inflammatory gingival recession? [FQ1] and NCCLs? [FQ2]. The search covered four electronic databases. Bibliographies of review articles, relevant texts, World and European Workshops were screened. Hand searches were performed of the Journals of Clinical Periodontology, Periodontology, Periodontal Research and IADR abstracts. A meta-analysis included 159 subjects and showed that subjects who used MTBs (manual toothbrush) had greater gingival recession after 12 months when compared with those using PTBs (powered toothbrush). Thirteen cross-sectional studies identified the most frequent toothbrushing factors associated with gingival recession as being toothbrushing frequency, a horizontal or scrub toothbrushing method, bristle hardness, toothbrushing duration and the frequency of changing a toothbrush. The principal toothbrushing factors associated with NCCLs were toothbrushing method and frequency. The data to support or refute the association between toothbrushing and gingival recession and NCCLs remain largely inconclusive. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

7 CFR 160.17 - Laboratory analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory analysis. 160.17 Section 160.17 Agriculture... STANDARDS FOR NAVAL STORES Methods of Analysis, Inspection, Sampling and Grading § 160.17 Laboratory analysis. The analysis and laboratory testing of naval stores shall be conducted, so far as is practicable...

7 CFR 160.17 - Laboratory analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory analysis. 160.17 Section 160.17 Agriculture... STANDARDS FOR NAVAL STORES Methods of Analysis, Inspection, Sampling and Grading § 160.17 Laboratory analysis. The analysis and laboratory testing of naval stores shall be conducted, so far as is practicable...

Undergraduate Organic Chemistry Laboratory Safety

NASA Astrophysics Data System (ADS)

Luckenbaugh, Raymond W.

1996-11-01

Each organic chemistry student should become familiar with the educational and governmental laboratory safety requirements. One method for teaching laboratory safety is to assign each student to locate safety resources for a specific class laboratory experiment. The student should obtain toxicity and hazardous information for all chemicals used or produced during the assigned experiment. For example, what is the LD50 or LC50 for each chemical? Are there any specific hazards for these chemicals, carcinogen, mutagen, teratogen, neurotixin, chronic toxin, corrosive, flammable, or explosive agent? The school's "Chemical Hygiene Plan", "Prudent Practices for Handling Hazardous Chemicals in the Laboratory" (National Academy Press), and "Laboratory Standards, Part 1910 - Occupational Safety and Health Standards" (Fed. Register 1/31/90, 55, 3227-3335) should be reviewed for laboratory safety requirements for the assigned experiment. For example, what are the procedures for safe handling of vacuum systems, if a vacuum distillation is used in the assigned experiment? The literature survey must be submitted to the laboratory instructor one week prior to the laboratory session for review and approval. The student should then give a short presentation to the class on the chemicals' toxicity and hazards and describe the safety precautions that must be followed. This procedure gives the student first-hand knowledge on how to find and evaluate information to meet laboartory safety requirements.

CTBTO Contractor Laboratory Test Sample Production Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bob Hague; Tracy Houghton; Nick Mann

2013-08-01

In October 2012 scientists from both Idaho National Laboratory (INL) and the CTBTO contact laboratory at Seibersdorf, Austria designed a system and capability test to determine if the INL could produce and deliver a short lived radio xenon standard in time for the standard to be measured at the CTBTO contact laboratory at Seibersdorf, Austria. The test included sample standard transportation duration and potential country entrance delays at customs. On October 23, 2012 scientists at the Idaho National Laboratory (INL) prepared and shipped a Seibersdorf contract laboratory supplied cylinder. The canister contained 1.0 scc of gas that consisted of 70%more » xenon and 30% nitrogen by volume. The t0 was October 24, 2012, 1200 ZULU. The xenon content was 0.70 +/ 0.01 scc at 0 degrees C. The 133mXe content was 4200 +/ 155 dpm per scc of stable xenon on t0 (1 sigma uncertainty). The 133Xe content was 19000 +/ 800 dpm per scc of stable xenon on t0 (1 sigma uncertainty).« less

National Laboratory Planning: Developing Sustainable Biocontainment Laboratories in Limited Resource Areas.

PubMed

Yeh, Kenneth B; Adams, Martin; Stamper, Paul D; Dasgupta, Debanjana; Hewson, Roger; Buck, Charles D; Richards, Allen L; Hay, John

2016-01-01

Strategic laboratory planning in limited resource areas is essential for addressing global health security issues. Establishing a national reference laboratory, especially one with BSL-3 or -4 biocontainment facilities, requires a heavy investment of resources, a multisectoral approach, and commitments from multiple stakeholders. We make the case for donor organizations and recipient partners to develop a comprehensive laboratory operations roadmap that addresses factors such as mission and roles, engaging national and political support, securing financial support, defining stakeholder involvement, fostering partnerships, and building trust. Successful development occurred with projects in African countries and in Azerbaijan, where strong leadership and a clear management framework have been key to success. A clearly identified and agreed management framework facilitate identifying the responsibility for developing laboratory capabilities and support services, including biosafety and biosecurity, quality assurance, equipment maintenance, supply chain establishment, staff certification and training, retention of human resources, and sustainable operating revenue. These capabilities and support services pose rate-limiting yet necessary challenges. Laboratory capabilities depend on mission and role, as determined by all stakeholders, and demonstrate the need for relevant metrics to monitor the success of the laboratory, including support for internal and external audits. Our analysis concludes that alternative frameworks for success exist for developing and implementing capabilities at regional and national levels in limited resource areas. Thus, achieving a balance for standardizing practices between local procedures and accepted international standards is a prerequisite for integrating new facilities into a country's existing public health infrastructure and into the overall international scientific community.

National Laboratory Planning: Developing Sustainable Biocontainment Laboratories in Limited Resource Areas

PubMed Central

Adams, Martin; Stamper, Paul D.; Dasgupta, Debanjana; Hewson, Roger; Buck, Charles D.; Richards, Allen L.; Hay, John

2016-01-01

Strategic laboratory planning in limited resource areas is essential for addressing global health security issues. Establishing a national reference laboratory, especially one with BSL-3 or -4 biocontainment facilities, requires a heavy investment of resources, a multisectoral approach, and commitments from multiple stakeholders. We make the case for donor organizations and recipient partners to develop a comprehensive laboratory operations roadmap that addresses factors such as mission and roles, engaging national and political support, securing financial support, defining stakeholder involvement, fostering partnerships, and building trust. Successful development occurred with projects in African countries and in Azerbaijan, where strong leadership and a clear management framework have been key to success. A clearly identified and agreed management framework facilitate identifying the responsibility for developing laboratory capabilities and support services, including biosafety and biosecurity, quality assurance, equipment maintenance, supply chain establishment, staff certification and training, retention of human resources, and sustainable operating revenue. These capabilities and support services pose rate-limiting yet necessary challenges. Laboratory capabilities depend on mission and role, as determined by all stakeholders, and demonstrate the need for relevant metrics to monitor the success of the laboratory, including support for internal and external audits. Our analysis concludes that alternative frameworks for success exist for developing and implementing capabilities at regional and national levels in limited resource areas. Thus, achieving a balance for standardizing practices between local procedures and accepted international standards is a prerequisite for integrating new facilities into a country's existing public health infrastructure and into the overall international scientific community. PMID:27559843

Laboratory Safety is Everyone's Responsibility.

ERIC Educational Resources Information Center

Brubaker, Inara M.; And Others

1981-01-01

Outlines a survey of laboratory practices and policies for employee protection from exposure to chemicals. Findings support the argument that academic, industrial, and other research laboratories are different from the manufacturing environment and should have a different toxic chemical policy and standards. (Author/SK)

Laboratory automation: total and subtotal.

PubMed

Hawker, Charles D

2007-12-01

Worldwide, perhaps 2000 or more clinical laboratories have implemented some form of laboratory automation, either a modular automation system, such as for front-end processing, or a total laboratory automation system. This article provides descriptions and examples of these various types of automation. It also presents an outline of how a clinical laboratory that is contemplating automation should approach its decision and the steps it should follow to ensure a successful implementation. Finally, the role of standards in automation is reviewed.

Appliance Standard Testing

ScienceCinema

Hogan, Kathleen; Tiemann, Gregg

2018-01-16

The U.S. Department of Energy’s Appliance Standards and Equipment Program tests, sets and helps enforce efficiency standards on more than 60 U.S. products. A majority of that testing is performed at the Intertek laboratory in Cortland, NY.

Inter-Laboratory Comparison for Calibration of Relative Humidity Devices Among Accredited Laboratories in Malaysia

NASA Astrophysics Data System (ADS)

Hussain, F.; Khairuddin, S.; Othman, H.

2017-01-01

An inter-laboratory comparison in relative humidity measurements among accredited laboratories has been coordinated by the National Metrology Institute of Malaysia. It was carried out to determine the performance of the participating laboratories. The objective of the comparison was to acknowledge the participating laboratories competencies and to verify the level of accuracies declared in their scope of accreditation, in accordance with the MS ISO/IEC 17025 accreditation. The measurement parameter involved was relative humidity for the range of 30-90 %rh at a nominal temperature of 50°C. Eight accredited laboratories participated in the inter-laboratory comparison. Two units of artifacts have been circulated among the participants as the transfer standards.

Levels of Non-Polybrominated Diphenyl Ether Brominated Flame Retardants in Residential House Dust Samples and Fire Station Dust Samples in California

PubMed Central

Brown, F Reber; Whitehead, Todd P; Park, June-Soo; Metayer, Catherine; Petreas, Myrto X

2014-01-01

Eleven novel brominated flame retardants (NBFRs) were analyzed in dust samples from California homes as a part of the Northern California Childhood Leukemia Study (NCCLS) and from the living quarters of California fire stations as a part of the Firefighter Occupational Exposure (FOX) study using high resolution gas chromatography/mass spectrometry. The eleven NBFRs, were: α- and β-1,2-dibromo-4-(1,2-dibromoethyl)cyclohexane (α- and β-DBE-DBCH), 2-bromoallyl 2,3,6-tribromophenylether (BATE), pentabromotoluene (PBT), pentabromoethylbenzene (PBEB), 2,3-dibromopropyl 2,4,6-tribromophenyl ether (TBP-DBPE), hexabromobenzene (HBB), 2-ethylhexyl-2,3,4,5-tetrabromobenzoate (EH-TBB), 1,2-bis(2,4,6-tribromophenoxy) ethane (BTBPE), bis(2-ethylhexyl) tetrabromophthalate (BEH-TEBP), and decabromodiphenylethane (DBDPE). Six of the seven NBFRs that are produced in relatively small quantities (i.e., α−, β−DBE-DBCH, BATE, PBEB, PBT, TBP-DBPE) were measured close to or below the limit of quantitation (0.64 ng/g) in both the NCCLS and FOX samples, and the seventh, HBB, was measured at median concentrations of 1.85 ng/g and 9.40 ng/g in the NCCLS and FOX samples, respectively. The remaining four NBFRs, EH-TBB, BEH-TEBP, BTBPE, and DBDPE, are produced in higher quantities, and were detected at median concentrations of 337 ng/g, 186 ng/g, 22.3, ng/g, and 82.8 ng/g, respectively in the NCCLS samples, and at median concentrations of 2687 ng/g, 2076 ng/g, 28.4 ng/g, and 161 ng/g, respectively, in the FOX samples. Concentrations of NBFRs in the NCCLS and FOX dust samples were several times lower than concentrations of PBDEs previously measured in the same samples. Concentrations of NBFRs in the NCCLS and FOX dust samples were generally comparable to concentrations of NBFRs in other studies of house dust from the US and Canada. PMID:25261858

21 CFR 58.81 - Standard operating procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling...

21 CFR 58.81 - Standard operating procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling...

21 CFR 58.81 - Standard operating procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling...

21 CFR 58.81 - Standard operating procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling...

42 CFR 493.1232 - Standard: Specimen identification and integrity.

Code of Federal Regulations, 2011 CFR

2011-10-01

... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1232 Standard: Specimen identification and integrity. The laboratory must establish and follow written policies and procedures that ensure positive identification and...

40 CFR 792.49 - Laboratory operation areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Laboratory operation areas. 792.49 Section 792.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.49 Laboratory operation areas...

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... specific component, drug product container, closure, in-process material, or drug product, and lot tested... product container, closure, in-process material, or drug product tested. (7) The initials or signature of... of any testing and standardization of laboratory reference standards, reagents, and standard...

Dental Laboratory Technology Program Guide.

ERIC Educational Resources Information Center

Georgia Univ., Athens. Dept. of Vocational Education.

This program guide contains the standard dental laboratory technology curriculum for both diploma programs and associate degree programs in technical institutes in Georgia. The curriculum encompasses the minimum competencies required for entry-level workers in the dental laboratory technology field. The general information section contains the…

Differences in serum thyroglobulin measurements by 3 commercial immunoradiometric assay kits and laboratory standardization using Certified Reference Material 457 (CRM-457).

PubMed

Lee, Ji In; Kim, Ji Young; Choi, Joon Young; Kim, Hee Kyung; Jang, Hye Won; Hur, Kyu Yeon; Kim, Jae Hyeon; Kim, Kwang-Won; Chung, Jae Hoon; Kim, Sun Wook

2010-09-01

Serum thyroglobulin (Tg) is essential in the follow-up of patients with differentiated thyroid carcinoma (DTC). However, interchangeability and standardization between Tg assays have not yet been achieved, even with the development of an international Tg standard (Certified Reference Material 457 [CRM-457]). Serum Tg from 30 DTC patients and serially diluted CRM-457 were measured using 3 different immunoradiometric assays (IRMA-1, IRMA-2, IRMA-3). The intraclass correlation coefficient (ICC) method was used to describe the concordance of each IRMA to CRM-457. The serum Tg measured by 3 different IRMAs correlated well (r > .85, p < .0001), but clinically relevant discrepancies were found in 13.3% of patients. IRMA-3, which claims to be standardized to CRM-457, showed the best ICC (p(1) = .98) for the CRM-457. Hospitals caring for patients with DTC should either set their own cutoffs for IRMAs for Tg based on their patient pools, or adopt IRMAs standardized to CRM-457 and calibrate their laboratory using CRM-457.

Performance evaluation of the latest fully automated hematology analyzers in a large, commercial laboratory setting: a 4-way, side-by-side study.

PubMed

Bourner, G; Dhaliwal, J; Sumner, J

2005-01-01

Gamma-Dynacare is a Canadian-based community laboratory partnership formed in the mid-1990s through the merger of 3 prominent Ontario medical diagnostic laboratories. Laboratory Corporation of America acquired an interest in the GD partnership in mid 2002. We service more than 10,000 community-based Canadian clinicians, hospital partners, and private clients with an integrated customer-focused system that includes specimen collection, transportation, and results reporting services. With more than 1,700 highly qualified medical, technical, and support staff and a network of laboratories, Gamma Dynacare aims to be at the forefront of technological innovation to better service the clinician base and ultimately deliver better patient care. We were looking for a hematology analyzer that would allow. (1) standardization throughout Ontario in our 4 largest sites and (2) better performance to effectively handle aged samples and minimize slide review. To select the best, most productive hematology analyzer for our environment, it was decided to perform a side-by-side comparison of the top hematology analyzers from Abbott (Cell-Dyn 3500), Beckman Coulter (LH 750), Bayer (Advia 120), and Sysmex (XE 2100), utilizing the same samples. CBC, differential and reticulocyte parameters were all evaluated according to CLSI (formerly NCCLS) and established hematology analyzer evaluation guidelines. We assessed each analyzer for precision, linearity, carryover, stability, differential capabilities, slide review rates, and throughput (clean bench studies). Two hundred samples were assessed for differential and morphology flagging on each analyzer using the reference 400 cell manual differential for comparison. Throughput was assessed by analyzing 700 consecutive samples representative of our workload mix. Stability studies at 24 hours showed that the Beckman Coulter LH 750 was least affected by EDTA, effect with minimal changes in the mean corpuscular volume (MCV) and hematocrit. Both

Situation analysis of occupational and environmental health laboratory accreditation in Thailand.

PubMed

Sithisarankul, Pornchai; Santiyanont, Rachana; Wongpinairat, Chongdee; Silva, Panadda; Rojanajirapa, Pinnapa; Wangwongwatana, Supat; Srinetr, Vithet; Sriratanaban, Jiruth; Chuntutanon, Swanya

2002-06-01

The objective of this study was to analyze the current situation of laboratory accreditation (LA) in Thailand, especially on occupational and environmental health. The study integrated both quantitative and qualitative approaches. The response rate of the quantitative questionnaires was 54.5% (226/415). The majority of the responders was environmental laboratories located outside hospital and did not have proficiency testing. The majority used ISO 9000, ISO/IEC 17025 or ISO/ EEC Guide 25, and hospital accreditation (HA) as their quality system. However, only 30 laboratories were currently accredited by one of these systems. Qualitative research revealed that international standard for laboratory accreditation for both testing laboratory and calibration laboratory was ISO/IEC Guide 25, which has been currently revised to be ISO/IEC 17025. The National Accreditation Council (NAC) has authorized 2 organizations as Accreditation Bodies (ABs) for LA: Thai Industrial Standards Institute, Ministry of Industry, and Bureau of Laboratory Quality Standards, Department of Medical Sciences, Ministry of Public Health. Regarding LA in HA, HA considered clinical laboratory as only 1 of 31 items for accreditation. Obtaining HA might satisfy the hospital director and his management team, and hence might actually be one of the obstacles for the hospital to further improve their laboratory quality system and apply for ISO/IEC 17025 which was more technically oriented. On the other hand, HA may be viewed as a good start or even a pre-requisite for laboratories in the hospitals to further improve their quality towards ISO/IEC 17025. Interviewing the director of NAC and some key men in some large laboratories revealed several major problems of Thailand's LA. Both Thai Industrial Standards Institute and Bureau of Laboratory Quality Standards did not yet obtain Mutual Recognition Agreement (MRA) with other international ABs. Several governmental bodies had their own standards and

42 CFR 493.1231 - Standard: Confidentiality of patient information.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

42 CFR 493.1231 - Standard: Confidentiality of patient information.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 5 2012-10-01 2012-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

42 CFR 493.1231 - Standard: Confidentiality of patient information.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

42 CFR 493.1231 - Standard: Confidentiality of patient information.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 5 2013-10-01 2013-10-01 false Standard: Confidentiality of patient information... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1231 Standard: Confidentiality of patient information...

Behavioral Health and Performance Laboratory Standard Measures (BHP-SM)

NASA Technical Reports Server (NTRS)

Williams, Thomas J.; Cromwell, Ronita

2017-01-01

The Spaceflight Standard Measures is a NASA Johnson Space Center Human Research Project (HRP) project that proposes to collect a set of core measurements, representative of many of the human spaceflight risks, from astronauts before, during and after long-duration International Space Station (ISS) missions. The term "standard measures" is defined as a set of core measurements, including physiological, biochemical, psychosocial, cognitive, and functional, that are reliable, valid, and accepted in terrestrial science, are associated with a specific and measurable outcome known to occur as a consequence of spaceflight, that will be collected in a standardized fashion from all (or most) crewmembers. While such measures might be used to define standards of health and performance or readiness for flight, the prime intent in their collection is to allow longitudinal analysis of multiple parameters in order to answer a variety of operational, occupational, and research-based questions. These questions are generally at a high level, and the approach for this project is to populate the standard measures database with the smallest set of data necessary to indicate further detailed research is required. Also included as standard measures are parameters that are not outcome-based in and of-themselves, but provide ancillary information that supports interpretation of the outcome measures, e.g., nutritional assessment, vehicle environmental parameters, crew debriefs, etc. The project's main aim is to ensure that an optimized minimal set of measures is consistently captured from all ISS crewmembers until the end of Station in order to characterize the human in space. -This allows the HRP to identify, establish, and evaluate a common set of measures for use in spaceflight and analog research to: develop baselines, systematically characterize risk likelihood and consequences, and assess effectiveness of countermeasures that work for behavioral health and performance risk factors

ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I.

PubMed

Guzel, Omer; Guner, Ebru Ilhan

2009-03-01

Medical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence. International Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation. Accreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet. Preparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has

The quality and scope of information provided by medical laboratories to patients before laboratory testing: Survey of the Working Group for Patient Preparation of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Nikolac, Nora; Simundic, Ana-Maria; Kackov, Sanja; Serdar, Tihana; Dorotic, Adrijana; Fumic, Ksenija; Gudasic-Vrdoljak, Jelena; Klenkar, Kornelija; Sambunjak, Jadranka; Vidranski, Valentina

2015-10-23

The aim of this work was to evaluate to what extent the scope and content of information provided to patients is standardized across medical biochemistry laboratories in Croatia. Two on-line self-report surveys were sent out: Survey A regarding attitudes on importance of patient preparation and Survey B on the contents of patient preparation instructions. 13/118 laboratories (11%) do not provide written instructions to patients on how to prepare for laboratory testing, and 36 (40%) do not include information about water intake in their instructions. Only half of laboratories provide instructions for prostate-specific antigen (53.8%), female sex hormones (53.7%) and therapeutic drug monitoring (TDM) (52.5%). Inadequate information about fasting status (55.0%) and 24 hour urine collection (77.9%) were frequent errors with high severity and were associated with the greatest potential to cause patient harm. Laboratory professionals in Croatia have a positive attitude towards the importance of patient preparation for laboratory testing. However, the information for laboratory testing is not standardized and frequently lacks guidance for tests related to TDM, coagulation and endocrinology. This study highlights the need for standardized, updated and evidence-based recommendations for patient preparation in order to minimize the risk for patients. Copyright © 2015 Elsevier B.V. All rights reserved.

42 CFR 493.1283 - Standard: Test records.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1283 Standard: Test records. (a) The laboratory must maintain an information or record system that includes the following: (1) The positive identification of the specimen. (2) The date and...

Assessment of biosafety precautions in Khartoum state diagnostic laboratories, Sudan

PubMed Central

Elduma, Adel Hussein

2012-01-01

Background This study was conducted to evaluate the biosafety precautions that applied by diagnostic laboratories in Khartoum state, 2009. Methods A total number of 190 laboratories were surveyed about their compliance with standard biosafety precautions. These laboratories included 51 (27%) laboratories from government, 75 (39%) from private sectors and 64 (34%) laboratories belong to organization providing health care services. Results The study found that 32 (16.8%) of laboratories appointed biosafety officers. Only, ten (5.2%) participated in training about response to fire emergency, and 28 (14.7%) reported the laboratory accident occurred during work. 45 (23.7%) laboratories had a written standard operation procedures (SOPs), and 35 (18.4%) had written procedures for the lean-up of spills. Moreover, biosafety cabinet was found in 11 (5.8%) laboratories, autoclave in 28 (14.7%) and incinerator in only two (1.1%) laboratories. Sharp disposable containers were found in 84 (44.2%). Fire alarm system was found in 2 (1.1%) laboratories, fire extinguisher in 39 (20.5%) laboratories, and fire emergency exit found in 14 (7.4%) laboratories. Furthermore, 19 (10%) laboratories had a hepatitis B virus vaccination programme, 5 (6.2%) applied BCG vaccine, and 2 (1.1%0) vaccinated the staff against influenza. Conclusion The study concluded that the standards biosafety precautions adopted by the diagnostic laboratories in Khartoum state was very low. Further, the laboratory personnel awareness towards biosafety principles implementation was very low too. PMID:22514753

Assessment of biosafety precautions in Khartoum state diagnostic laboratories, Sudan.

PubMed

Elduma, Adel Hussein

2012-01-01

This study was conducted to evaluate the biosafety precautions that applied by diagnostic laboratories in Khartoum state, 2009. A total number of 190 laboratories were surveyed about their compliance with standard biosafety precautions. These laboratories included 51 (27%) laboratories from government, 75 (39%) from private sectors and 64 (34%) laboratories belong to organization providing health care services. The study found that 32 (16.8%) of laboratories appointed biosafety officers. Only, ten (5.2%) participated in training about response to fire emergency, and 28 (14.7%) reported the laboratory accident occurred during work. 45 (23.7%) laboratories had a written standard operation procedures (SOPs), and 35 (18.4%) had written procedures for the lean-up of spills. Moreover, biosafety cabinet was found in 11 (5.8%) laboratories, autoclave in 28 (14.7%) and incinerator in only two (1.1%) laboratories. Sharp disposable containers were found in 84 (44.2%). Fire alarm system was found in 2 (1.1%) laboratories, fire extinguisher in 39 (20.5%) laboratories, and fire emergency exit found in 14 (7.4%) laboratories. Furthermore, 19 (10%) laboratories had a hepatitis B virus vaccination programme, 5 (6.2%) applied BCG vaccine, and 2 (1.1%0) vaccinated the staff against influenza. The study concluded that the standards biosafety precautions adopted by the diagnostic laboratories in Khartoum state was very low. Further, the laboratory personnel awareness towards biosafety principles implementation was very low too.

National Vehicle and Fuel Emissions Laboratory (NVFEL)

EPA Pesticide Factsheets

NVFEL is the primary EPA research laboratory used for fuel and emissions testing. The laboratory supports emission standards for motor vehicles, engines, and fuels, as well as the development of automotive technology.

Safety in the Chemical Laboratory: The Selection of Eyewash Stations for Laboratory Use.

ERIC Educational Resources Information Center

Walters, Douglas B.; And Others

1988-01-01

Evaluates and compares common eyewash stations currently being used in laboratories. Discusses types available, installation, water supply needs, and maintenance. Lists current OSHA eyewash station standards. (ML)

10 CFR 431.18 - Testing laboratories.

Code of Federal Regulations, 2010 CFR

2010-01-01

... EQUIPMENT Electric Motors Test Procedures, Materials Incorporated and Methods of Determining Efficiency... Technology/National Voluntary Laboratory Accreditation Program (NIST/NVLAP); or (2) A laboratory... of the National Institute of Standards and Technology (NIST) which is part of the U.S. Department of...

Harmonization in laboratory medicine: Requests, samples, measurements and reports.

PubMed

Plebani, Mario

2016-01-01

In laboratory medicine, the terms "standardization" and "harmonization" are frequently used interchangeably as the final goal is the same: the equivalence of measurement results among different routine measurement procedures over time and space according to defined analytical and clinical quality specifications. However, the terms define two distinct, albeit closely linked, concepts based on traceability principles. The word "standardization" is used when results for a measurement are equivalent and traceable to the International System of Units (SI) through a high-order primary reference material and/or a reference measurement procedure (RMP). "Harmonization" is generally used when results are equivalent, but neither a high-order primary reference material nor a reference measurement procedure is available. Harmonization is a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of accurate and actionable laboratory information. Patients, clinicians and other healthcare professionals assume that clinical laboratory tests performed by different laboratories at different times on the same sample and specimen can be compared, and that results can be reliably and consistently interpreted. Unfortunately, this is not necessarily the case, because many laboratory test results are still highly variable and poorly standardized and harmonized. Although the initial focus was mainly on harmonizing and standardizing analytical processes and methods, the scope of harmonization now also includes all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits as well as tests and test profiles, requests and criteria for interpretation. Several projects and initiatives aiming to improve standardization and harmonization in the testing process are now underway. Laboratory professionals should therefore step up their efforts to provide

The gallium melting-point standard: its application and evaluation for temperature measurements in the clinical laboratory.

PubMed

Bowers, G N; Inman, S R

1977-01-01

We are impressed with the ease and certainty of calibration electronic thermometers with thermistor probes to +/- 0.01 degree C at the gallium melting point, 29.771(4) degrees C. The IFCC reference method for measuring aspartate aminotransferase activity in serum was run at the reaction temperature of 29.771(4) degrees C. By constantly referencing to gallium as an integral part of the assay procedure, we determined the absolute reaction temperature to IPTS-68 (International Practical Temperature Scale of 1968) to +/- 0.02 degrees C. This unique temperature calibration standard near the center of the range of temperatures commonly used in the clinical laboratory is a valuable addition and can be expected to improve the accuracy of measurements, especially in clinical enzymology.

Safety in the Chemical Laboratory

ERIC Educational Resources Information Center

Steere, Norman V., Ed.

1975-01-01

The National Fire Protection Association has proposed national standards dealing with laboratory operations, ventilation, chemical handling and storage, compressed gases, fire prevention, and emergency procedures. The standards are likely to be used as guidelines by insurance companies, and governmental agencies that award grants and contracts for…

A Laboratory Safety Program at Delaware.

ERIC Educational Resources Information Center

Whitmyre, George; Sandler, Stanley I.

1986-01-01

Describes a laboratory safety program at the University of Delaware. Includes a history of the program's development, along with standard safety training and inspections now being implemented. Outlines a two-day laboratory safety course given to all graduate students and staff in chemical engineering. (TW)

7 CFR 75.43 - Laboratory testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... AND CERTIFICATION OF QUALITY OF AGRICULTURAL AND VEGETABLE SEEDS Fees and Charges § 75.43 Laboratory...

7 CFR 75.43 - Laboratory testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... AND CERTIFICATION OF QUALITY OF AGRICULTURAL AND VEGETABLE SEEDS Fees and Charges § 75.43 Laboratory...

Characteristics of The Narrow Spectrum Beams Used in the Secondary Standard Dosimetry Laboratory at the Lebanese Atomic Energy Commission.

PubMed

Melhem, N; El Balaa, H; Younes, G; Al Kattar, Z

2017-06-15

The Secondary Standard Dosimetry Laboratory at the Lebanese Atomic Energy Commission has different calibration methods for various types of dosimeters used in industrial, military and medical fields. The calibration is performed using different beams of X-rays (low and medium energy) and Gamma radiation delivered by a Cesium 137 source. The Secondary Standard Dosimetry laboratory in charge of calibration services uses different protocols for the determination of high and low air kerma rate and for narrow and wide series. In order to perform this calibration work, it is very important to identify all the beam characteristics for the different types of sources and qualities of radiation. The following work describes the methods used for the determination of different beam characteristics and calibration coefficients with their uncertainties in order to enhance the radiation protection of workers and patient applications in the fields of medical diagnosis and industrial X-ray. All the characteristics of the X-ray beams are determined for the narrow spectrum series in the 40 and 200 keV range where the inherent filtration, the current intensity, the high voltage, the beam profile and the total uncertainty are the specific characteristics of these X-ray beams. An X-ray software was developed in order to visualize the reference values according to the characteristics of each beam. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

78 FR 73208 - Underwriters Laboratories, Inc.: Application for Expansion

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-05

... Laboratories, Inc., requests the addition of multiple test standards to its scope of recognition. This... Laboratory (NRTL). UL requests the addition of multiple test standards to their NRTL scope of recognition... recognition has three elements: (1) The type of products the NRTL may test, with each type specified by its...

42 CFR 493.551 - General requirements for laboratories.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false General requirements for laboratories. 493.551... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program § 493.551...

42 CFR 493.551 - General requirements for laboratories.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false General requirements for laboratories. 493.551... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program § 493.551...

[Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

PubMed

Ishibashi, Midori

2015-01-01

The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

[Study of quality of a branch laboratory--an opinion of a laboratory manager].

PubMed

Yazawa, Naoyuki

2006-11-01

At the stage of establishing a branch laboratory, quality evaluation is extremely difficult. Even the results of a control survey by the headquarters of the branch laboratory are unhelpful. For a clinical laboratory, the most important function is to provide reliable data all the time, and to maintain the reliability of clinical doctors with informed responses. We mostly refer to control surveys and daily quality control data to evaluate a clinical laboratory, but we rarely check its fundamental abilities, such as planning events, preserving statistical data about the standard range, using the right method for quality control and others. This is generally disregarded and it is taken for granted that they will be correct the first time. From my six years of experience working with X's branch laboratory, I realized that there might be some relation between the quality of a branch laboratory and the fundamental abilities of the company itself. I would never argue that all branch laboratories are ineffective, but they should be conscious of fundamental activities. The referring laboratory, not the referral laboratory, should be responsible for ensuring that the referral laboratory's examination results and findings are correct.

Laboratories new to the ICRM.

PubMed

Karam, Lisa; Anagnostakis, Marios J; Gudelis, Arunas; Marsoem, Pujadi; Mauring, Alexander; Wurdiyanto, Gatot; Yücel, Ülkü

2012-09-01

The Scientific Committee of the ICRM decided, for the 2011 Conference, to present laboratories that are at a key developmental stage in establishing, expanding or applying radionuclide metrology capabilities. The expansion of radionuclide metrology capabilities is crucial to meet evolving and emerging needs in health care, environmental monitoring, and nuclear energy. Five laboratories (from Greece, Lithuania, Indonesia, Norway and Turkey) agreed to participate. Each laboratory is briefly introduced, and examples of their capabilities and standardization activities are discussed. Published by Elsevier Ltd.

Standardization of collection requirements for fasting samples: for the Working Group on Preanalytical Phase (WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

PubMed

Simundic, A M; Cornes, M; Grankvist, K; Lippi, G; Nybo, M

2014-05-15

Standardized protocols for patient preparation for laboratory testing are currently lacking. Moreover, a great heterogeneity exists in the definitions of "fasting" currently being used among healthcare workers and in the literature. Marked metabolic and hormonal changes occur after food ingestion, mainly due to the absorption of fluids, lipids, proteins, carbohydrates and other food constituents. This postprandial response varies markedly in response to numerous factors, such as eating behavior, food composition, fasting duration, time of the day, chronic and acute smoking, coffee and alcohol consumption. It is therefore crucial to minimize the total variability by controlling as many of these modifying factors as possible. Control of the abovementioned effects on postprandial response can only be achieved by standardizing the way patients are prepared for laboratory testing, i.e. by defining the fasting duration, as well as what is and what is not allowed (e.g., coffee, tea, smoking, water) during the period of fasting prior to sample collection. The aim of this article is to describe the range of effects of different approaches to fasting on laboratory tests, and to provide a framework for the harmonization of definitions for fasting requirements for laboratory tests. Copyright © 2013 Elsevier B.V. All rights reserved.

42 CFR 493.1806 - Available sanctions: All laboratories.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Available sanctions: All laboratories. 493.1806... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Enforcement Procedures § 493.1806 Available sanctions: All laboratories. (a) Applicability. CMS may impose one or more of the sanctions...

42 CFR 493.1806 - Available sanctions: All laboratories.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Available sanctions: All laboratories. 493.1806... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Enforcement Procedures § 493.1806 Available sanctions: All laboratories. (a) Applicability. CMS may impose one or more of the sanctions...

In vitro susceptibility of filamentous fungi to itraconazole, voriconazole and posaconazole by Clinical and Laboratory Standards Institute reference method and E-test.

PubMed

Kondori, N; Svensson, E; Mattsby-Baltzer, I

2011-09-01

The use of anti-fungal agents has increased dramatically in recent years and new drugs have been developed. Several methods are available for determinations of their specific biological activities, i.e. the standard method for minimum inhibitory concentration-determination is described in M-38 [Clinical and Laboratory Standards Institute document M-38 (CLSI M-38)]. However, alternative methods, such as the E-test, are currently available in Mycology laboratories. The susceptibilities of clinical isolates of Aspergillus spp. (n = 29), Fusarium spp. (n = 5), zygomycetes (n = 21) and Schizophyllum (n = 1) were determined for itraconazole, voriconazole and posaconazole, using the CLSI M-38-A broth dilution method and also by the E-test. A good overall agreement (83.7%) between the two methods for all drugs and organisms was observed. Analyses of voriconazole showed a better agreement (93%) between the methods than posaconazole and itraconazole (85% and 74% respectively). Aspergillus spp. were the most susceptible fungi to the anti-fungal agents tested in this study. Posaconazole was the most active drug against filamentous fungi in vitro, followed by itraconazole and voriconazole. The latter (voriconazole) demonstrated no significant in vitro activity against zygomycetes. © 2010 Blackwell Verlag GmbH.

Quality assurance program for molecular medicine laboratories.

PubMed

Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; Nafisi, N; Sohrabi, A; Rafiee, M; Sabzavi, F; Entekhabi, B

2013-01-01

Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level.

Quality in the molecular microbiology laboratory.

PubMed

Wallace, Paul S; MacKay, William G

2013-01-01

In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases. Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program. Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical-from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered. For most European based clinical microbiology laboratories this means following the common International Standard Organization (ISO9001) framework and ISO15189 which sets out the quality management requirements for the medical laboratory (BS EN ISO 15189 (2003) Medical laboratories-particular requirements for quality and competence. British Standards Institute, Bristol, UK). In the United States clinical laboratories performing human diagnostic tests are regulated by the Centers for Medicare and Medicaid Services (CMS) following the requirements within the Clinical Laboratory Improvement Amendments document 1988 (CLIA-88). This chapter focuses on the key quality assurance and quality control requirements within the

Laboratory errors and patient safety.

PubMed

Miligy, Dawlat A

2015-01-01

Laboratory data are extensively used in medical practice; consequently, laboratory errors have a tremendous impact on patient safety. Therefore, programs designed to identify and reduce laboratory errors, as well as, setting specific strategies are required to minimize these errors and improve patient safety. The purpose of this paper is to identify part of the commonly encountered laboratory errors throughout our practice in laboratory work, their hazards on patient health care and some measures and recommendations to minimize or to eliminate these errors. Recording the encountered laboratory errors during May 2008 and their statistical evaluation (using simple percent distribution) have been done in the department of laboratory of one of the private hospitals in Egypt. Errors have been classified according to the laboratory phases and according to their implication on patient health. Data obtained out of 1,600 testing procedure revealed that the total number of encountered errors is 14 tests (0.87 percent of total testing procedures). Most of the encountered errors lay in the pre- and post-analytic phases of testing cycle (representing 35.7 and 50 percent, respectively, of total errors). While the number of test errors encountered in the analytic phase represented only 14.3 percent of total errors. About 85.7 percent of total errors were of non-significant implication on patients health being detected before test reports have been submitted to the patients. On the other hand, the number of test errors that have been already submitted to patients and reach the physician represented 14.3 percent of total errors. Only 7.1 percent of the errors could have an impact on patient diagnosis. The findings of this study were concomitant with those published from the USA and other countries. This proves that laboratory problems are universal and need general standardization and bench marking measures. Original being the first data published from Arabic countries that

Laboratory Safety Guide for Arkansas K-12 Schools.

ERIC Educational Resources Information Center

Arkansas State Dept. of Education, Little Rock.

This document presents laboratory safety rules for Arkansas K-12 schools which were developed by the Arkansas Science Teachers Association (ASTA) and the Arkansas Department of Education (ADE). Contents include: (1) "Laboratory Safety Guide for Arkansas K-12 Schools"; (2) "Safety Considerations"; (3) "Safety Standards for Science Laboratories";…

30 CFR 6.10 - Use of independent laboratories.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Use of independent laboratories. 6.10 Section 6..., AND APPROVAL OF MINING PRODUCTS TESTING AND EVALUATION BY INDEPENDENT LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.10 Use of independent laboratories. (a) MSHA will accept testing and...

Final report on key comparison CCAUV.A-K5: pressure calibration of laboratory standard microphones in the frequency range 2 Hz to 10 kHz

NASA Astrophysics Data System (ADS)

Avison, Janine; Barham, Richard

2014-01-01

This document and the accompanying spreadsheets constitute the final report for key comparison CCAUV.A-K5 on the pressure calibration of laboratory standard microphones in the frequency range from 2 Hz to 10 kHz. Twelve national measurement institutes took part in the key comparison and the National Physical Laboratory piloted the project. Two laboratory standard microphones IEC type LS1P were circulated to the participants and results in the form of regular calibration certificates were collected throughout the project. One of the microphones was subsequently deemed to have compromised stability for the purpose of deriving a reference value. Consequently the key comparison reference value (KCRV) has been made based on the weighted mean results for sensitivity level and for sensitivity phase from just one of the microphones. Corresponding degrees of equivalence (DoEs) have also been calculated and are presented. Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCAUV, according to the provisions of the CIPM Mutual Recognition Arrangement (CIPM MRA).

Development of the Ion Exchange-Gravimetric Method for Sodium in Serum as a Definitive Method

PubMed Central

Moody, John R.; Vetter, Thomas W.

1996-01-01

An ion exchange-gravimetric method, previously developed as a National Committee for Clinical Laboratory Standards (NCCLS) reference method for the determination of sodium in human serum, has been re-evaluated and improved. Sources of analytical error in this method have been examined more critically and the overall uncertainties decreased. Additionally, greater accuracy and repeatability have been achieved by the application of this definitive method to a sodium chloride reference material. In this method sodium in serum is ion-exchanged, selectively eluted and converted to a weighable precipitate as Na2SO4. Traces of sodium eluting before or after the main fraction, and precipitate contaminants are determined instrumentally. Co-precipitating contaminants contribute less than 0.1 % while the analyte lost to other eluted ion-exchange fractions contributes less than 0.02 % to the total precipitate mass. With improvements, the relative expanded uncertainty (k = 2) of the method, as applied to serum, is 0.3 % to 0.4 % and is less than 0.1 % when applied to a sodium chloride reference material. PMID:27805122

Microdilution Susceptibility Testing of Amphotericin B, Itraconazole, and Voriconazole against Clinical Isolates of Aspergillus and Fusarium Species

PubMed Central

Arikan, Sevtap; Lozano-Chiu, Mario; Paetznick, Victor; Nangia, Sunaina; Rex, John H.

1999-01-01

We compared the activities of amphotericin B, itraconazole, and voriconazole against clinical Aspergillus (n = 82) and Fusarium (n = 22) isolates by a microdilution method adopted from the National Committee for Clinical Laboratory Standards (NCCLS-M27A). RPMI 1640 (RPMI), RPMI 1640 supplemented to 2% glucose (RPMI-2), and antibiotic medium 3 supplemented to 2% glucose (AM3) were used as test media. MICs were determined after 24, 48, and 72 h. A narrow range of amphotericin B MICs was observed for Aspergillus isolates, with minor variations among species. MICs for Fusarium isolates were higher than those for Aspergillus isolates. MICs of itraconazole were prominently high for two previously defined itraconazole-resistant Aspergillus fumigatus isolates and Fusarium solani. Voriconazole showed good in vitro activity against itraconazole-resistant isolates, but the MICs of voriconazole for F. solani were high. RPMI was the most efficient medium for detection of itraconazole-resistant isolates, followed by RPMI-2. While the significance remains unclear, AM3 lowered the MICs, particularly those of amphotericin B. PMID:10565912

[Quality Management System in Pathological Laboratory].

PubMed

Koyatsu, Junichi; Ueda, Yoshihiko

2015-07-01

Even compared to other clinical laboratories, the pathological laboratory conducts troublesome work, and many of the work processes are also manual. Therefore, the introduction of the systematic management of administration is necessary. It will be a shortcut to use existing standards such as ISO 15189 for this purpose. There is no standard specialized for the pathological laboratory, but it is considered to be important to a pathological laboratory in particular. 1. Safety nianagement of the personnel and environmental conditions. Comply with laws and regulations concerning the handling of hazardous materials. 2. Pre-examination processes. The laboratory shall have documented procedures for the proper collection and handling of primary samples. Developed and documented criteria for acceptance or rejection of samples are applied. 3. Examination processes. Selection, verification, and validation of the examination procedures. Devise a system that can constantly monitor the traceability of the sample. 4. Post-examination processes. Storage, retention, and disposal of clinical samples. 5. Release of results. When examination results fall within established alert or critical intervals, immediately notify the physicians. The important point is to recognize the needs of the client and be aware that pathological diagnoses are always "the final diagnoses".

Distributed Energy Resource (DER) Cybersecurity Standards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Saleem, Danish; Johnson, Jay

This presentation covers the work that Sandia National Laboratories and National Renewable Energy Laboratory are doing for distributed energy resource cybersecurity standards, prepared for NREL's Annual Cybersecurity & Resilience Workshop on October 9-10, 2017.

Calgary Laboratory Services

PubMed Central

2015-01-01

Calgary Laboratory Services provides global hospital and community laboratory services for Calgary and surrounding areas (population 1.4 million) and global academic support for the University of Calgary Cumming School of Medicine. It developed rapidly after the Alberta Provincial Government implemented an austerity program to address rising health care costs and to address Alberta’s debt and deficit in 1994. Over roughly the next year, all hospital and community laboratory test funding within the province was put into a single budget, fee codes for fee-for-service test billing were closed, roughly 40% of the provincial laboratory budget was cut, and roughly 40% of the pathologists left the province of Alberta. In Calgary, in the face of these abrupt changes in the laboratory environment, private laboratories, publicly funded hospital laboratories and the medical school department precipitously and reluctantly merged in 1996. The origin of Calgary Laboratory Services was likened to an “unhappy shotgun marriage” by all parties. Although such a structure could save money by eliminating duplicated services and excess capacity and could provide excellent city-wide clinical service by increasing standardization, it was less clear whether it could provide strong academic support for a medical school. Over the past decade, iterations of the Calgary Laboratory Services model have been implemented or are being considered in other Canadian jurisdictions. This case study analyzes the evolution of Calgary Laboratory Services, provides a metric-based review of academic performance over time, and demonstrates that this model, essentially arising as an unplanned experiment, has merit within a Canadian health care context. PMID:28725754

Safety in laboratories: Indian scenario.

PubMed

Mustafa, Ajaz; Farooq, A Jan; Qadri, Gj; S A, Tabish

2008-07-01

Health and safety in clinical laboratories is becoming an increasingly important subject as a result of emergence of highly infectious diseases such as Hepatitis and HIV. A cross sectional study was carried out to study the safety measures being adopted in clinical laboratories of India. Heads of laboratories of teaching hospitals of India were subjected to a standardized, pretested questionnaire. Response rate was 44.8%. only 60% of laboratories had person in-charge of safety in laboratory. Seventy three percent of laboratories had safety education program regarding hazards. In 91% of laboratories staff is using protective clothing while working in laboratories. Hazardous material regulations are followed in 78% of laboratories. Regular health check ups are carried among laboratory staff in 43.4% of laboratories.Safety manual is available in 56.5% of laboratories. 73.9% of laboratories are equipped with fire extinguishers. Fume cupboards are provided in 34.7% of laboratories and they are regularly checked in 87.5% of these laboratories. In 78.26% of laboratories suitable measures are taken to minimize formation of aerosols.In 95.6% of laboratories waste is disposed off as per bio-medical waste management handling rules. Laboratory of one private medical college was accredited with NABL and safety parameters were better in that laboratory. Installing safety engineered devices apparently contributes to significant decrease in injuries in laboratories; laboratory safety has to be a part of overall quality assurance programme in hospitals. Accreditation has to be made necessary for all laboratories.

Promoting clinical and laboratory interaction by harmonization.

PubMed

Plebani, Mario; Panteghini, Mauro

2014-05-15

The lack of interchangeable results in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus was mainly on the standardization and harmonization of measurement procedures and their results, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference limits and decision thresholds, as well as test profiles and criteria for the interpretation of results. In particular, as evidence collected in last decades demonstrates that pre-pre- and post-post-analytical steps are more vulnerable to errors, harmonization initiatives should be performed to improve procedures and processes at the laboratory-clinical interface. Managing upstream demand, down-stream interpretation of laboratory results, and subsequent appropriate action through close relationships between laboratorians and clinicians remains a crucial issue of the laboratory testing process. Therefore, initiatives to improve test demand management from one hand and to harmonize procedures to improve physicians' acknowledgment of laboratory data and their interpretation from the other hand are needed in order to assure quality and safety in the total testing process. © 2013.

Design of a medical and laboratory equipment management program for the new standards certification achievement in Mexico.

PubMed

Franco-Clark, D; Pimentel-Aguilar, A B; Rodriguez-Vera, R

2010-01-01

Certification for healthcare institutions in Mexico is ruled by 2009 standards homologated with the Joint Commission International criteria. Nowadays, healthcare requires of medical equipment and devices, so it has become necessary to implement guidelines for its adequate management in order to reach the highest level of quality and safety at the lowest cost. The objective of this work was to develop a Medical and Laboratory Equipment Management Program, oriented to the improvement of quality, effectiveness and efficiency of the technological resources in order to meet the certification requirements. The result of this work allows to have an auto evaluation tool that focuses the efforts of the National Institute for Respiratory Diseases to the achievement of the new requirements established for the certification.

Internal quality control indicators of cervical cytopathology exams performed in laboratories monitored by the External Quality Control Laboratory.

PubMed

Ázara, Cinara Zago Silveira; Manrique, Edna Joana Cláudio; Tavares, Suelene Brito do Nascimento; de Souza, Nadja Lindany Alves; Amaral, Rita Goreti

2014-09-01

To evaluate the impact of continued education provided by an external quality control laboratory on the indicators of internal quality control of cytopathology exams. The internal quality assurance indicators for cytopathology exams from 12 laboratories monitored by the External Quality Control Laboratory were evaluated. Overall, 185,194 exams were included, 98,133 of which referred to the period preceding implementation of a continued education program, while 87,061 referred to the period following this intervention. Data were obtained from the Cervical Cancer Database of the Brazilian National Health Service. Following implementation of the continued education program, the positivity index (PI) remained within recommended limits in four laboratories. In another four laboratories, the PI progressed from below the limits to within the recommended standards. In one laboratory, the PI remained low, in two laboratories, it remained very low, and in one, it increased from very low to low. The percentage of exams compatible with a high-grade squamous intraepithelial lesion (HSIL) remained within the recommended limits in five laboratories, while in three laboratories it progressed from below the recommended levels to >0.4% of the total number of satisfactory exams, and in four laboratories it remained below the standard limit. Both the percentage of atypical squamous cells of undetermined significance (ASC-US) in relation to abnormal exams, and the ratio between ASC-US and intraepithelial lesions remained within recommended levels in all the laboratories investigated. An improvement was found in the indicators represented by the positivity index and the percentage of exams compatible with a high-grade squamous intraepithelial lesion, showing that the role played by the external quality control laboratory in providing continued education contributed towards improving laboratory staff skills in detecting cervical cancer precursor lesions.

The Master level optics laboratory at the Institute of Optics

NASA Astrophysics Data System (ADS)

Adamson, Per

2017-08-01

The master level optics laboratory is a biannual, intensive laboratory course in the fields of geometrical, physical and modern optics. This course is intended for the master level student though Ph.D. advisors which often recommend it to their advisees. The students are required to complete five standard laboratory experiments and an independent project during a semester. The goals of the laboratory experiments are for the students to get hands-on experience setting up optical laboratory equipment, collecting and analyzing data, as well as to communicate key results. The experimental methods, analysis, and results of the standard experiments are submitted in a journal style report, while an oral presentation is given for the independent project.

Quality Assurance Program for Molecular Medicine Laboratories

PubMed Central

Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; Nafisi, N; Sohrabi, A; Rafiee, M; Sabzavi, F; Entekhabi, B

2013-01-01

Background: Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. Methods: We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. Results: Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. Conclusion: Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level. PMID:23865028

42 CFR 493.555 - Federal review of laboratory requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Federal review of laboratory requirements. 493.555... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program § 493.555...

42 CFR 493.555 - Federal review of laboratory requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Federal review of laboratory requirements. 493.555... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program § 493.555...

Errors in clinical laboratories or errors in laboratory medicine?

PubMed

Plebani, Mario

2006-01-01

Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Most errors are due to pre-analytical factors (46-68.2% of total errors), while a high error rate (18.5-47% of total errors) has also been found in the post-analytical phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and post-analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term "laboratory error" and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients' needs and satisfaction, the risk of errors and mistakes

Challenges to laboratory hematology practice: Egypt perspective.

PubMed

Rizk, S H

2018-05-01

Laboratory hematology is an integral part of all clinical laboratories along the extensive healthcare facilities in Egypt. The aim of this review is to portrait the laboratory hematology practice in Egypt including its unique socioeconomic background, blood disease pattern, education and training, regulatory oversight, and the related challenges. Current practice varies widely between different parts of the healthcare system in terms of the range of tests, applied techniques, workforce experience, and quality of service. The national transfusion service (NBTS) in Egypt has been recently upgraded and standardized according to the World Health Organization (WHO) guidelines. Formal postgraduate education roughly follows the British system. Laboratory hematology specialization is achieved through 2-3 years masters' degree followed by 2-4 years doctorate degree in clinical pathology with training and research in hematology. Improvement of laboratory hematology education is recently undergoing a reform as a part of the modernization of higher education policy and following the standards developed by the National Quality Assurance and Accreditation Agency (NQAAA). Accreditation of medical laboratories is recently progressing with the development of the "Egyptian Accreditation Council" (EGAC) as the sole accreditation body system and training of assessors. Current laboratory system has many challenges, some are related to the inadequate system performance, and others are unique to laboratory hematology issues. The rapid technological advances and therapeutic innovations in hematology practice call for an adapting laboratory system with continuous upgrading. © 2018 John Wiley & Sons Ltd.

Microbial ecology laboratory procedures manual NASA/MSFC

NASA Technical Reports Server (NTRS)

Huff, Timothy L.

1990-01-01

An essential part of the efficient operation of any microbiology laboratory involved in sample analysis is a standard procedures manual. The purpose of this manual is to provide concise and well defined instructions on routine technical procedures involving sample analysis and methods for monitoring and maintaining quality control within the laboratory. Of equal importance is the safe operation of the laboratory. This manual outlines detailed procedures to be followed in the microbial ecology laboratory to assure safety, analytical control, and validity of results.

42 CFR 493.1232 - Standard: Specimen identification and integrity.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Specimen identification and integrity... Nonwaived Testing General Laboratory Systems § 493.1232 Standard: Specimen identification and integrity. The laboratory must establish and follow written policies and procedures that ensure positive identification and...

7 CFR 75.43 - Laboratory testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946 AND THE...

40 CFR 160.81 - Standard operating procedures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Standard operating procedures. 160.81... GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting forth study...

40 CFR 160.81 - Standard operating procedures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Standard operating procedures. 160.81... GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting forth study...

40 CFR 160.81 - Standard operating procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Standard operating procedures. 160.81... GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting forth study...

The second international standard for polymyxin B.

PubMed

Lightbown, J W; Thomas, A H; Grab, B; Outschoorn, A S

1973-01-01

Since supplies of the first International Standard for Polymyxin B were exhausted, it was replaced by a second international standard the potency of which was estimated from the results of a collaborative assay carried out by 5 laboratories in 4 countries. The wide variations in the results probably resulted from difficulties experienced in handling the first international standard. The potency finally agreed upon by the collaborating laboratories, on the basis of the overall mean values obtained after rejection of the most discrepant assays, was 8 403 IU/mg. That value was accepted by the WHO Expert Committee on Biological Standardization (1970), which consequently defined the International Unit of polymyxin B as the activity contained in 0.000119 mg of the second international standard.

The second international standard for polymyxin B*

PubMed Central

Lightbown, J. W.; Thomas, A. H.; Grab, B.; Outschoorn, A. S.

1973-01-01

Since supplies of the first International Standard for Polymyxin B were exhausted, it was replaced by a second international standard the potency of which was estimated from the results of a collaborative assay carried out by 5 laboratories in 4 countries. The wide variations in the results probably resulted from difficulties experienced in handling the first international standard. The potency finally agreed upon by the collaborating laboratories, on the basis of the overall mean values obtained after rejection of the most discrepant assays, was 8 403 IU/mg. That value was accepted by the WHO Expert Committee on Biological Standardization (1970), which consequently defined the International Unit of polymyxin B as the activity contained in 0.000119 mg of the second international standard. PMID:4350877

One year comparative clinical evaluation of EQUIA with resin-modified glass ionomer and a nanohybrid composite in noncarious cervical lesions

PubMed Central

Vaid, Deepa Sunil; Shah, Nimisha Chinmay; Bilgi, Priyanka Shripad

2015-01-01

Aims: Comparative evaluation of EQUIA with a resin-modified glass ionomer cement (RMGIC; GC Gold Label glass ionomer light cured universal restorative cement) and a nanohybrid composite (Tetric N-Ceram) in noncarious cervical lesions (NCCLs). Background: To establish the most suitable material for the restoration of NCCLs. Settings and Design: In vivo study. Materials and Methods: Eighty-seven NCCLs were randomly restored with EQUIA, a RMGIC, and a nanohybrid composite. Clinical evaluation of the restorations was done following the Unites States Public Health criteria by a single-blinded investigator. Data were formulated, and statistical analysis was done by Chi-square test. Statistical Analysis Used: Chi-square test. Results: No significant difference was found between EQUIA, RMGIC, and nanohybrid composite at 1-month, at 6 months, and at 1-year (P > 0.05). Conclusions: EQUIA, resin-modified glass ionomer, and nanohybrid composite performed equally at 1-month, 6 months, and 1-year follow-up periods. PMID:26752837

Electromedical devices test laboratories accreditation

NASA Astrophysics Data System (ADS)

Murad, C.; Rubio, D.; Ponce, S.; Álvarez Abri, A.; Terrón, A.; Vicencio, D.; Fascioli, E.

2007-11-01

In the last years, the technology and equipment at hospitals have been increase in a great way as the risks of their implementation. Safety in medical equipment must be considered an important issue to protect patients and their users. For this reason, test and calibrations laboratories must verify the correct performance of this kind of devices under national and international standards. Is an essential mission for laboratories to develop their measurement activities taking into account a quality management system. In this article, we intend to transmit our experience working to achieve an accredited Test Laboratories for medical devices in National technological University.

46 CFR 159.010-3 - Independent laboratory: Standards for acceptance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... engaged, as a regular part of its business, in performing inspections and tests that are the same as or... manufacturer; (4) Not be dependent on Coast Guard acceptance under this subchapter to remain in business; and (5) Not advertise or promote the manufacturer's equipment or material that the laboratory inspects...

42 CFR 493.1264 - Standard: Parasitology.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Systems § 493.1264 Standard: Parasitology. (a) The laboratory must have available a reference collection... these references in the laboratory for appropriate comparison with diagnostic specimens. (b) The...

Progress in Harmonizing Tiered HIV Laboratory Systems: Challenges and Opportunities in 8 African Countries.

PubMed

Williams, Jason; Umaru, Farouk; Edgil, Dianna; Kuritsky, Joel

2016-09-28

In 2014, the Joint United Nations Programme on HIV/AIDS released its 90-90-90 targets, which make laboratory diagnostics a cornerstone for measuring efforts toward the epidemic control of HIV. A data-driven laboratory harmonization and standardization approach is one way to create efficiencies and ensure optimal laboratory procurements. Following the 2008 "Maputo Declaration on Strengthening of Laboratory Systems"-a call for government leadership in harmonizing tiered laboratory networks and standardizing testing services-several national ministries of health requested that the United States Government and in-country partners help implement the recommendations by facilitating laboratory harmonization and standardization workshops, with a primary focus on improving HIV laboratory service delivery. Between 2007 and 2015, harmonization and standardization workshops were held in 8 African countries. This article reviews progress in the harmonization of laboratory systems in these 8 countries. We examined agreed-upon instrument lists established at the workshops and compared them against instrument data from laboratory quantification exercises over time. We used this measure as an indicator of adherence to national procurement policies. We found high levels of diversity across laboratories' diagnostic instruments, equipment, and services. This diversity contributes to different levels of compliance with expected service delivery standards. We believe the following challenges to be the most important to address: (1) lack of adherence to procurement policies, (2) absence or limited influence of a coordinating body to fully implement harmonization proposals, and (3) misalignment of laboratory policies with minimum packages of care and with national HIV care and treatment guidelines. Overall, the effort to implement the recommendations from the Maputo Declaration has had mixed success and is a work in progress. Program managers should continue efforts to advance the

Inter-laboratory validation of bioaccessibility testing for metals.

PubMed

Henderson, Rayetta G; Verougstraete, Violaine; Anderson, Kim; Arbildua, José J; Brock, Thomas O; Brouwers, Tony; Cappellini, Danielle; Delbeke, Katrien; Herting, Gunilla; Hixon, Greg; Odnevall Wallinder, Inger; Rodriguez, Patricio H; Van Assche, Frank; Wilrich, Peter; Oller, Adriana R

2014-10-01

Bioelution assays are fast, simple alternatives to in vivo testing. In this study, the intra- and inter-laboratory variability in bioaccessibility data generated by bioelution tests were evaluated in synthetic fluids relevant to oral, inhalation, and dermal exposure. Using one defined protocol, five laboratories measured metal release from cobalt oxide, cobalt powder, copper concentrate, Inconel alloy, leaded brass alloy, and nickel sulfate hexahydrate. Standard deviations of repeatability (sr) and reproducibility (sR) were used to evaluate the intra- and inter-laboratory variability, respectively. Examination of the sR:sr ratios demonstrated that, while gastric and lysosomal fluids had reasonably good reproducibility, other fluids did not show as good concordance between laboratories. Relative standard deviation (RSD) analysis showed more favorable reproducibility outcomes for some data sets; overall results varied more between- than within-laboratories. RSD analysis of sr showed good within-laboratory variability for all conditions except some metals in interstitial fluid. In general, these findings indicate that absolute bioaccessibility results in some biological fluids may vary between different laboratories. However, for most applications, measures of relative bioaccessibility are needed, diminishing the requirement for high inter-laboratory reproducibility in absolute metal releases. The inter-laboratory exercise suggests that the degrees of freedom within the protocol need to be addressed. Copyright © 2014 Elsevier Inc. All rights reserved.

Laboratory medicine education in Lithuania.

PubMed

Kucinskiene, Zita Ausrele; Bartlingas, Jonas

2011-01-01

In Lithuania there are two types of specialists working in medical laboratories and having a university degree: laboratory medicine physicians and medical biologists. Both types of specialists are officially being recognized and regulated by the Ministry of Health of Lithuania. Laboratory medicine physicians become specialists in laboratory medicine after an accredited 4-year multidisciplinary residency study program in Laboratory Medicine. The residency program curriculum for laboratory medicine physicians is presented. On December 9, 2009 the Equivalence of Standards for medical specialists was accepted and Lithuanian medical specialists in Clinical Chemistry and Laboratory Medicine can now apply for EC4 registration. Medical biologists become specialists in laboratory medicine after an accredited 2-year master degree multidisciplinary study program in Medical Biology, consisting of 80 credits. Various postgraduate advanced training courses for the continuous education of specialists in laboratory medicine were first introduced in 1966. Today it covers 1-2-week courses in different subspecialties of laboratory medicine. They are obligatory for laboratory medicine physicians for the renewal of their license. It is not compulsory for medical biologists to participate in these courses. The Centre of Laboratory Diagnostics represents a place for the synthesis and application of the basic sciences, the performance of research in various fields of laboratory medicine, as well as performance of thousands of procedures daily and provision of specific teaching programs.

42 CFR 493.1281 - Standard: Comparison of test results.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 5 2012-10-01 2012-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

42 CFR 493.1281 - Standard: Comparison of test results.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

42 CFR 493.1281 - Standard: Comparison of test results.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 5 2013-10-01 2013-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

42 CFR 493.1281 - Standard: Comparison of test results.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

42 CFR 493.1281 - Standard: Comparison of test results.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

[How do hospital clinical laboratories and laboratory testing companies cooperate and build reciprocal relations?].

PubMed

Kawano, Seiji

2014-12-01

As the 2nd Joint Symposium of the Japanese Society of Laboratory Medicine and the Japanese Association of Laboratory Pathologists, the symposium on clinical test out-sourcing and branch laboratories was held at the 60th General Meeting of the Japanese Society of Laboratory Medicine on November 2nd, 2013 in Kobe. For the symposium, we conducted a questionnaire survey on the usage of clinical test out-sourcing and the introduction of branch laboratories to clinical laboratories of Japanese university hospitals, both private and public, between July 25th and August 20th, 2013. Seventy-two hospitals responded to the questionnaire survey, consisting of 41 public medical school hospitals and 31 private ones. According to the survey, the selection of each clinical test for out-sourcing was mainly determined by the capacities of hospital clinical laboratories and their equipment, as well as the profitability of each test. The main concerns of clinical laboratory members of university hospitals involved the continuity of measurement principles, traceability, and standardization of reference values for each test. They strongly requested the interchangeability and computerization of test data between laboratory testing companies. A branch laboratory was introduced to six hospitals, all of which were private medical college hospitals, out of 72 university hospitals, and eight of the other hospitals were open to its introduction. The merits and demerits of introducing a branch laboratory were also discussed. (Review).

Cookstove Laboratory Research - Fiscal Year 2016 Report ...

EPA Pesticide Factsheets

This report provides an overview of the work conducted by the EPA cookstove laboratory research team in Fiscal Year 2016. The report describes research and activities including (1) ISO standards development, (2) capacity building for international testing and knowledge centers, (3) laboratory assessments of cookstove systems, (4) journal publications, and (5) cookstove events. The U.S. Environmental Protection Agency’s (EPA’s) cookstove laboratory research program was first developed to assist the EPA-led Partnership for Clean Indoor Air and is now part of the U.S. Government’s commitment to the Global Alliance for Clean Cookstoves (the Alliance). Goals of the program are to: (1) support the development of testing protocols and standards for cookstoves through ISO (International Organization for Standardization) TC (Technical Committee) 285: Clean Cookstoves and Clean Cooking Solutions, (2) support the development of international Regional Testing and Knowledge Centers (many sponsored by the Alliance) for scientifically evaluating and certifying cookstoves to international standards, and (3) provide an independent source of data to Alliance partners. This work supports EPA’s mission to protect human health and the environment. Household air pollution, mainly from solid-fuel cookstoves in the developing world, is estimated to cause approximately 4 million premature deaths per year, and emissions of black carbon and other pollutants from cookstoves aff

Laboratory diagnostics of malaria

NASA Astrophysics Data System (ADS)

Siahaan, L.

2018-03-01

Even now, malaria treatment should only be administered after laboratory confirmation. There are several principal methods for diagnosing malaria. All these methods have their disadvantages.Presumptive treatment of malaria is widely practiced where laboratory tests are not readily available. Microscopy of Giemsa-stained thick and thin blood films remains the gold standard for the diagnosis of malaria infection. The technique of slide preparation, staining and reading are well known and standardized, and so is the estimate of the parasite density and parasite stages. Microscopy is not always available or feasible at primary health services in limited resource settings due to cost, lack of skilled manpower, accessories and reagents required. Rapid diagnostic tests (RDTs) are potential tools for parasite-based diagnosis since the tests are accurate in detecting malaria infections and are easy to use. The test is based on the capture of parasite antigen that released from parasitized red blood cells using monoclonal antibodies prepared against malaria antigen target. Polymerase Chain Reaction (PCR), depend on DNA amplification approaches and have higher sensitivity than microscopy. PCR it is not widely used due to the lack of a standardized methodology, high costs, and the need for highly-trained staff.

Medical Office Laboratory Procedures: Course Proposal. Revised.

ERIC Educational Resources Information Center

Baker, Eleanor

A proposal is presented for a Community College of Philadelphia course, entitled "Medical Office Laboratory Procedures," which provides a laboratory introduction to microscopic and chemical analysis of blood and urine as performed in the physician's office. Following a standard cover form, a statement of the purpose of the course discusses course…

Bio-Oil Analysis Laboratory Procedures | Bioenergy | NREL

Science.gov Websites

Bio-Oil Analysis Laboratory Procedures Bio-Oil Analysis Laboratory Procedures NREL develops standard procedures have been validated and allow for reliable bio-oil analysis. Procedures Determination different hydroxyl groups (-OH) in pyrolysis bio-oil: aliphatic-OH, phenolic-OH, and carboxylic-OH. Download

ISO Standards Update

EPA Science Inventory

This presentation provides a brief update on activities of ISO (International Organization for Standardization) TC (Technical Committee) 285, Clean Cooking Solutions. Slides include information on: (1) Working Group project status updates, (2) background on laboratory and field ...

From Laboratory Research to a Clinical Trial

PubMed Central

Michels, Harold T.; Keevil, C. William; Salgado, Cassandra D.; Schmidt, Michael G.

2015-01-01

Objective: This is a translational science article that discusses copper alloys as antimicrobial environmental surfaces. Bacteria die when they come in contact with copper alloys in laboratory tests. Components made of copper alloys were also found to be efficacious in a clinical trial. Background: There are indications that bacteria found on frequently touched environmental surfaces play a role in infection transmission. Methods: In laboratory testing, copper alloy samples were inoculated with bacteria. In clinical trials, the amount of live bacteria on the surfaces of hospital components made of copper alloys, as well as those made from standard materials, was measured. Finally, infection rates were tracked in the hospital rooms with the copper components and compared to those found in the rooms containing the standard components. Results: Greater than a 99.9% reduction in live bacteria was realized in laboratory tests. In the clinical trials, an 83% reduction in bacteria was seen on the copper alloy components, when compared to the surfaces made from standard materials in the control rooms. Finally, the infection rates were found to be reduced by 58% in patient rooms with components made of copper, when compared to patients' rooms with components made of standard materials. Conclusions: Bacteria die on copper alloy surfaces in both the laboratory and the hospital rooms. Infection rates were lowered in those hospital rooms containing copper components. Thus, based on the presented information, the placement of copper alloy components, in the built environment, may have the potential to reduce not only hospital-acquired infections but also patient treatment costs. PMID:26163568

Standardization of haematology critical results management in adults: an International Council for Standardization in Haematology, ICSH, survey and recommendations.

PubMed

Keng, T B; De La Salle, B; Bourner, G; Merino, A; Han, J-Y; Kawai, Y; Peng, M T; McCafferty, R

2016-10-01

These recommendations are intended to develop a consensus in the previously published papers as to which parameters and what values should be considered critical. A practical guide on the standardization of critical results management in haematology laboratories would be beneficial as part of good laboratory and clinical practice and for use by laboratory-accrediting agencies. A working group with members from Europe, America, Australasia and Asia was formed by International Council for Standardization in Haematology. A pattern of practice survey of 21 questions was distributed in 2014, and the data were collected electronically by Survey Monkey. The mode, or most commonly occurring value, was selected as the threshold for the upper and lower alert limits for critical results reporting. A total of 666 laboratories submitted data to this study and, of these, 499 submitted complete responses. Full blood count critical results alert thresholds, morphology findings that trigger critical result notification, critical results alert list, notification process and maintenance of critical results management protocol are described. This international survey provided a snapshot of the current practice worldwide and has identified the existence of considerable heterogeneity of critical results management. The recommendations in this study represent a consensus of good laboratory practice. They are intended to encourage the implementation of a standardized critical results management protocol in the laboratory. © 2016 John Wiley & Sons Ltd.

Achieving across-laboratory replicability in psychophysical scaling

PubMed Central

Ward, Lawrence M.; Baumann, Michael; Moffat, Graeme; Roberts, Larry E.; Mori, Shuji; Rutledge-Taylor, Matthew; West, Robert L.

2015-01-01

It is well known that, although psychophysical scaling produces good qualitative agreement between experiments, precise quantitative agreement between experimental results, such as that routinely achieved in physics or biology, is rarely or never attained. A particularly galling example of this is the fact that power function exponents for the same psychological continuum, measured in different laboratories but ostensibly using the same scaling method, magnitude estimation, can vary by a factor of three. Constrained scaling (CS), in which observers first learn a standardized meaning for a set of numerical responses relative to a standard sensory continuum and then make magnitude judgments of other sensations using the learned response scale, has produced excellent quantitative agreement between individual observers’ psychophysical functions. Theoretically it could do the same for across-laboratory comparisons, although this needs to be tested directly. We compared nine different experiments from four different laboratories as an example of the level of across experiment and across-laboratory agreement achievable using CS. In general, we found across experiment and across-laboratory agreement using CS to be significantly superior to that typically obtained with conventional magnitude estimation techniques, although some of its potential remains to be realized. PMID:26191019

Sandia National Laboratories Facilities Management and Operations Center Design Standards Manual

DOE Office of Scientific and Technical Information (OSTI.GOV)

Peterson, Timothy L.

2014-09-01

At Sandia National Laboratories in New Mexico (SNL/NM), the design, construction, operation, and maintenance of facilities is guided by industry standards, a graded approach, and the systematic analysis of life cycle benefits received for costs incurred. The design of the physical plant must ensure that the facilities are "fit for use," and provide conditions that effectively, efficiently, and safely support current and future mission needs. In addition, SNL/NM applies sustainable design principles, using an integrated whole-building design approach, from site planning to facility design, construction, and operation to ensure building resource efficiency and the health and productivity of occupants. Themore » safety and health of the workforce and the public, any possible effects on the environment, and compliance with building codes take precedence over project issues, such as performance, cost, and schedule. These design standards generally apply to all disciplines on all SNL/NM projects. Architectural and engineering design must be both functional and cost-effective. Facility design must be tailored to fit its intended function, while emphasizing low-maintenance, energy-efficient, and energy-conscious design. Design facilities that can be maintained easily, with readily accessible equipment areas, low maintenance, and quality systems. To promote an orderly and efficient appearance, architectural features of new facilities must complement and enhance the existing architecture at the site. As an Architectural and Engineering (A/E) professional, you must advise the Project Manager when this approach is prohibitively expensive. You are encouraged to use professional judgment and ingenuity to produce a coordinated interdisciplinary design that is cost-effective, easily contractible or buildable, high-performing, aesthetically pleasing, and compliant with applicable building codes. Close coordination and development of civil, landscape, structural, architectural

Progress in Harmonizing Tiered HIV Laboratory Systems: Challenges and Opportunities in 8 African Countries

PubMed Central

Williams, Jason; Umaru, Farouk; Edgil, Dianna; Kuritsky, Joel

2016-01-01

ABSTRACT In 2014, the Joint United Nations Programme on HIV/AIDS released its 90-90-90 targets, which make laboratory diagnostics a cornerstone for measuring efforts toward the epidemic control of HIV. A data-driven laboratory harmonization and standardization approach is one way to create efficiencies and ensure optimal laboratory procurements. Following the 2008 “Maputo Declaration on Strengthening of Laboratory Systems”—a call for government leadership in harmonizing tiered laboratory networks and standardizing testing services—several national ministries of health requested that the United States Government and in-country partners help implement the recommendations by facilitating laboratory harmonization and standardization workshops, with a primary focus on improving HIV laboratory service delivery. Between 2007 and 2015, harmonization and standardization workshops were held in 8 African countries. This article reviews progress in the harmonization of laboratory systems in these 8 countries. We examined agreed-upon instrument lists established at the workshops and compared them against instrument data from laboratory quantification exercises over time. We used this measure as an indicator of adherence to national procurement policies. We found high levels of diversity across laboratories’ diagnostic instruments, equipment, and services. This diversity contributes to different levels of compliance with expected service delivery standards. We believe the following challenges to be the most important to address: (1) lack of adherence to procurement policies, (2) absence or limited influence of a coordinating body to fully implement harmonization proposals, and (3) misalignment of laboratory policies with minimum packages of care and with national HIV care and treatment guidelines. Overall, the effort to implement the recommendations from the Maputo Declaration has had mixed success and is a work in progress. Program managers should continue efforts to

7 CFR 94.5 - Charges for laboratory service.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Charges for laboratory service. 94.5 Section 94.5 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS...

Assessment and management of chemical exposure in the Mohs laboratory.

PubMed

Gunson, Todd H; Smith, Harvey R; Vinciullo, Carl

2011-01-01

The correct handling, storage, and disposal of chemicals used in the processing of tissue for Mohs micrographic surgery are essential. To identify the chemicals involved in the preparation of Mohs frozen sections and assess the associated occupational health risks. To quantify exposure levels of hazardous chemicals and ensure that they are minimized. A risk assessment form was completed for each chemical. Atmospheric sampling was performed at our previous laboratory for formaldehyde and volatile organic compounds. These data were used in the design of our new facility, where testing was repeated. Twenty-five chemicals were identified. Ten were classified as hazardous substances, 10 were flammable, six had specific disposal requirements, four were potential carcinogens, and three were potential teratogens. Formaldehyde readings at our previous laboratory were up to eight times the national exposure standard. Testing at the new laboratory produced levels well below the exposure standards. Chemical exposure within the Mohs laboratory can present a significant occupational hazard. Acutely toxic and potentially carcinogenic formaldehyde was found at high levels in a relatively standard laboratory configuration. A laboratory can be designed with a combination of physical environment and operational protocols that minimizes hazards and creates a safe working environment. © 2010 by the American Society for Dermatologic Surgery, Inc.

Modular workcells: modern methods for laboratory automation.

PubMed

Felder, R A

1998-12-01

Laboratory automation is beginning to become an indispensable survival tool for laboratories facing difficult market competition. However, estimates suggest that only 8% of laboratories will be able to afford total laboratory automation systems. Therefore, automation vendors have developed alternative hardware configurations called 'modular automation', to fit the smaller laboratory. Modular automation consists of consolidated analyzers, integrated analyzers, modular workcells, and pre- and post-analytical automation. These terms will be defined in this paper. Using a modular automation model, the automated core laboratory will become a site where laboratory data is evaluated by trained professionals to provide diagnostic information to practising physicians. Modem software information management and process control tools will complement modular hardware. Proper standardization that will allow vendor-independent modular configurations will assure success of this revolutionary new technology.

Strengthening laboratory systems in resource-limited settings.

PubMed

Olmsted, Stuart S; Moore, Melinda; Meili, Robin C; Duber, Herbert C; Wasserman, Jeffrey; Sama, Preethi; Mundell, Ben; Hilborne, Lee H

2010-09-01

Considerable resources have been invested in recent years to improve laboratory systems in resource-limited settings. We reviewed published reports, interviewed major donor organizations, and conducted case studies of laboratory systems in 3 countries to assess how countries and donors have worked together to improve laboratory services. While infrastructure and the provision of services have seen improvement, important opportunities remain for further advancement. Implementation of national laboratory plans is inconsistent, human resources are limited, and quality laboratory services rarely extend to lower tier laboratories (eg, health clinics, district hospitals). Coordination within, between, and among governments and donor organizations is also frequently problematic. Laboratory standardization and quality control are improving but remain challenging, making accreditation a difficult goal. Host country governments and their external funding partners should coordinate their efforts effectively around a host country's own national laboratory plan to advance sustainable capacity development throughout a country's laboratory system.

Procedures for establishing and maintaining consistent air-kerma strength standards for low-energy, photon-emitting brachytherapy sources: recommendations of the Calibration Laboratory Accreditation Subcommittee of the American Association of Physicists in Medicine.

PubMed

DeWerd, Larry A; Huq, M Saiful; Das, Indra J; Ibbott, Geoffrey S; Hanson, William F; Slowey, Thomas W; Williamson, Jeffrey F; Coursey, Bert M

2004-03-01

Low dose rate brachytherapy is being used extensively for the treatment of prostate cancer. As of September 2003, there are a total of thirteen 125I and seven 103Pd sources that have calibrations from the National Institute of Standards and Technology (NIST) and the Accredited Dosimetry Calibration Laboratories (ADCLs) of the American Association of Physicists in Medicine (AAPM). The dosimetry standards for these sources are traceable to the NIST wide-angle free-air chamber. Procedures have been developed by the AAPM Calibration Laboratory Accreditation Subcommittee to standardize quality assurance and calibration, and to maintain the dosimetric traceability of these sources to ensure accurate clinical dosimetry. A description of these procedures is provided to the clinical users for traceability purposes as well as to provide guidance to the manufacturers of brachytherapy sources and ADCLs with regard to these procedures.

Good laboratory practices guarantee biosafety in the Sierra Leone-China friendship biosafety laboratory.

PubMed

Wang, Qin; Zhou, Wei-Min; Zhang, Yong; Wang, Huan-Yu; Du, Hai-Jun; Nie, Kai; Song, Jing-Dong; Xiao, Kang; Lei, Wen-Wen; Guo, Jian-Qiang; Wei, He-Jiang; Cai, Kun; Wang, Yan-Hai; Wu, Jiang; Kamara, Gerard; Kamara, Idrissa; Wei, Qiang; Liang, Mi-Fang; Wu, Gui-Zhen; Dong, Xiao-Ping

2016-06-23

The outbreak of Ebola virus disease (EVD) in West Africa between 2014 and 2015 was the largest EDV epidemic since the identification of Ebola virus (EBOV) in 1976, and the countries most strongly affected were Sierra Leone, Guinea, and Liberia. The Sierra Leone-China Friendship Biological Safety Laboratory (SLE-CHN Biosafety Lab), a fixed Biosafety Level 3 laboratory in the capital city of Sierra Leone, was established by the Chinese government and has been active in EBOV detection since 11 March 2015. Complete management and program documents were created for the SLE-CHN Biosafety Lab, and it was divided into four zones (the green, yellow, brown, and red zones) based on the risk assessment. Different types of safe and appropriate personnel protection equipment (PPE) are used in different zones of the laboratory, and it fully meets the Biosafety Level 3 laboratory standards of the World Health Organization. Good preparedness, comprehensive risk assessment and operation documents, appropriate PPE, effective monitoring and intensive training, together with well-designed and reasonable laboratory sectioning are essential for guaranteeing biosafety.

Premise for Standardized Sepsis Models.

PubMed

Remick, Daniel G; Ayala, Alfred; Chaudry, Irshad; Coopersmith, Craig M; Deutschman, Clifford; Hellman, Judith; Moldawer, Lyle; Osuchowski, Marcin

2018-06-05

Sepsis morbidity and mortality exacts a toll on patients and contributes significantly to healthcare costs. Preclinical models of sepsis have been used to study disease pathogenesis and test new therapies, but divergent outcomes have been observed with the same treatment even when using the same sepsis model. Other disorders such as diabetes, cancer, malaria, obesity and cardiovascular diseases have used standardized, preclinical models that allow laboratories to compare results. Standardized models accelerate the pace of research and such models have been used to test new therapies or changes in treatment guidelines. The National Institutes of Health (NIH) mandated that investigators increase data reproducibility and the rigor of scientific experiments and has also issued research funding announcements about the development and refinement of standardized models. Our premise is that refinement and standardization of preclinical sepsis models may accelerate the development and testing of potential therapeutics for human sepsis, as has been the case with preclinical models for other disorders. As a first step towards creating standardized models, we suggest 1) standardizing the technical standards of the widely used cecal ligation and puncture model and 2) creating a list of appropriate organ injury and immune dysfunction parameters. Standardized sepsis models could enhance reproducibility and allow comparison of results between laboratories and may accelerate our understanding of the pathogenesis of sepsis.

Quality systems in veterinary diagnostics laboratories.

PubMed

de Branco, Freitas Maia L M

2007-01-01

Quality assurance of services provided by veterinary diagnostics laboratories is a fundamental element promoted by international animal health organizations to establish trust, confidence and transparency needed for the trade of animals and their products at domestic and international levels. It requires, among other things, trained personnel, consistent and rigorous methodology, choice of suitable methods as well as appropriate calibration and traceability procedures. An important part of laboratory quality management is addressed by ISO/IEC 17025, which aims to facilitate cooperation among laboratories and their associated parties by assuring the generation of credible and consistent information derived from analytical results. Currently, according to OIE recommendation, veterinary diagnostics laboratories are only subject to voluntary compliance with standard ISO/IEC 17025; however, it is proposed here that OIE reference laboratories and collaboration centres strongly consider its adoption.

Residential exposures to pesticides and childhood leukaemia

PubMed Central

Metayer, Catherine; Buffler, Patricia A.

2008-01-01

Like many chemicals, carcinogenicity of pesticides is poorly characterised in humans, especially in children, so that the present knowledge about childhood leukaemia risk derives primarily from epidemiological studies. Overall, case–control studies published in the last decade have reported positive associations with home use of insecticides, mostly before the child's birth, while findings for herbicides are mixed. Previous studies relied solely on self-reports, therefore lacking information on active ingredients and effects of potential recall bias. Few series to date have examined the influence of children's genetic susceptibility related to transport and metabolism of pesticides. To overcome these limitations, investigators of the Northern California Childhood Leukaemia Study (NCCLS) have undertaken, in collaboration with a multidisciplinary team, a comprehensive assessment of residential pesticide exposure, including: (1) quality control of self-reports; (2) home pesticide inventory and linkage to the Environmental Protection Agency to obtain data on active ingredients; (3) collection and laboratory analyses of ∼600 home dust samples for over 60 pesticides and (4) geographic information studies using California environmental databases to assess exposure to agricultural pesticides. The NCCLS is also conducting large-scale genotyping to evaluate the role of genes in xenobiotic pathways relevant to the transport and metabolism of pesticides. A better quantification of children's exposures to pesticides at home is critical to the evaluation of childhood leukaemia risk, especially for future gene–environment interaction studies. PMID:18940823

Effects of cyclic fatigue stress-biocorrosion on noncarious cervical lesions.

PubMed

Grippo, John O; Chaiyabutr, Yada; Kois, John C

2013-08-01

Although there is a high prevalence of noncarious cervical lesions (NCCLs), the etiology of these lesions remains contentious. To evaluate the combined effects of cyclic fatigue stress and biocorrosion activity on NCCLs. Extracted premolar teeth were allocated into four groups (N = 10). Two groups were cyclically fatigue loaded (100 N; 72 cycles per minute; 9,200 cycles) and placed in either hydrochloric acid gel (pH = 0.1) or orange juice (pH = 4). The other two groups were stored in identical chemical solutions without fatigue load. The buccal-lingual width of each tooth was measured before and after testing. The depth of biocorrosion, normalized by the percentage change in buccolingual width, normalized by time (hour) was calculated. The data were analyzed using a two-way analysis of variance and Tukey's HSD multiple comparison test (α = 0.05). Mean (SD) of the depth of biocorrosion values were as follows: teeth receiving fatigue loading with hydrochloric acid gel exposure (1.003%/hour [0.063]) revealed a significantly higher depth of biocorrosion than the fatigue-loaded group with orange juice exposure (0.511%/hour [0.281]) (p < 0.01). For the groups without fatigue loading, those with hydrochloric acid gel (0.022%/hour [0.006]) had a significantly higher depth of biocorrosion than the group with orange juice (0.009%/hour [0.004]) (p < 0.01). The cyclically fatigue-loaded teeth with hydrochloric acid gel had a significantly greater depth of biocorrosion than either group without fatigue loading (p < 0.001). Cyclic fatigue stress-acidic biocorrosion had a significant effect on the depth of the NCCLs. In order to manage the destructive NCCLs lesions properly, it is essential to understand the etiology of these lesions. The present study indicated that the combined mechanisms of cyclic fatigue stress and biocorrosion could contribute to the formation of NCCLs. © 2013 Wiley Periodicals, Inc.

Good Laboratory Practice. Part 1. An Introduction

ERIC Educational Resources Information Center

Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Therrien, Matthew T.

2013-01-01

The Good Laboratory Practice (GLP) regulations were put into place in 1978. They establish a standard of practice to ensure that results from the nonclinical laboratory study reported to the U.S. Food and Drug Administration (FDA) are valid and that the study report accurately reflects the conduct of the study. While the GLP regulations promulgate…

Module Architecture for in Situ Space Laboratories

NASA Technical Reports Server (NTRS)

Sherwood, Brent

2010-01-01

The paper analyzes internal outfitting architectures for space exploration laboratory modules. ISS laboratory architecture is examined as a baseline for comparison; applicable insights are derived. Laboratory functional programs are defined for seven planet-surface knowledge domains. Necessary and value-added departures from the ISS architecture standard are defined, and three sectional interior architecture options are assessed for practicality and potential performance. Contemporary guidelines for terrestrial analytical laboratory design are found to be applicable to the in-space functional program. Densepacked racks of system equipment, and high module volume packing ratios, should not be assumed as the default solution for exploration laboratories whose primary activities include un-scriptable investigations and experimentation on the system equipment itself.

Preparation of high purity plutonium oxide for radiochemistry instrument calibration standards and working standards

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wong, A.S.; Stalnaker, N.D.

1997-04-01

Due to the lack of suitable high level National Institute of Standards and Technology (NIST) traceable plutonium solution standards from the NIST or commercial vendors, the CST-8 Radiochemistry team at Los Alamos National Laboratory (LANL) has prepared instrument calibration standards and working standards from a well-characterized plutonium oxide. All the aliquoting steps were performed gravimetrically. When a {sup 241}Am standardized solution obtained from a commercial vendor was compared to these calibration solutions, the results agreed to within 0.04% for the total alpha activity. The aliquots of the plutonium standard solutions and dilutions were sealed in glass ampules for long termmore » storage.« less

Secondary School Chemistry Teacher's Current Use of Laboratory Activities and the Impact of Expense on Their Laboratory Choices

ERIC Educational Resources Information Center

Boesdorfer, Sarah B.; Livermore, Robin A.

2018-01-01

In the United States with the Next Generation Science Standards (NGSS)'s emphasis on learning science while doing science, laboratory activities in the secondary school chemistry continues to be an important component of a strong curriculum. Laboratory equipment and consumable materials create a unique expense which chemistry teachers and schools…

Fifth International Standard for Gas-Gangrene Antitoxin (Perfringens) (Clostridium welchii Type A Antitoxin)

PubMed Central

Evans, D. G.; Perkins, F. T.

1963-01-01

The Fifth International Standard Gas-Gangrene Antitoxin (Perfringens) (Clostridium welchii Type A Antitoxin) was prepared from serum from immunized horses. It was freeze-dried in ampoules each containing 1 ml. Seven laboratories collaborated in assaying its potency in terms of the Fourth International Standard by the intravenous inoculation of mice. The geometric mean value, taking the results of all the laboratories, was 270 International Units per ampoule and the maximum variation between laboratories was 15%. In vitro (lecithinase) tests were also done by three laboratories, giving an average of 261 International Units per ampoule. The dry weight contents of ampoules, determined in three laboratories, varied by less than 3%, with an average of 90.35 mg per ampoule. The standard was stable for 120 hours at 56°C. Each ampoule of the Fifth International Standard for Gas-Gangrene Antitoxin (Perfringens) contains 270 International Units, and one International Unit is contained in 0.3346 mg of the International Standard. PMID:14107745

National Health Care Skill Standards.

ERIC Educational Resources Information Center

National Consortium on Health Science and Technology Education, Okemos, MI.

This document presents the National Health Care Skill Standards, which were developed by the National Consortium on Health Science and Technology and West Ed Regional Research Laboratory, in partnership with educators and health care employers. The document begins with an overview of the purpose and benefits of skill standards. Presented next are…

Development and operation of a quality assurance system for deviations from standard operating procedures in a clinical cell therapy laboratory.

PubMed

McKenna, D; Kadidlo, D; Sumstad, D; McCullough, J

2003-01-01

Errors and accidents, or deviations from standard operating procedures, other policy, or regulations must be documented and reviewed, with corrective actions taken to assure quality performance in a cellular therapy laboratory. Though expectations and guidance for deviation management exist, a description of the framework for the development of such a program is lacking in the literature. Here we describe our deviation management program, which uses a Microsoft Access database and Microsoft Excel to analyze deviations and notable events, facilitating quality assurance (QA) functions and ongoing process improvement. Data is stored in a Microsoft Access database with an assignment to one of six deviation type categories. Deviation events are evaluated for potential impact on patient and product, and impact scores for each are determined using a 0- 4 grading scale. An immediate investigation occurs, and corrective actions are taken to prevent future similar events from taking place. Additionally, deviation data is collectively analyzed on a quarterly basis using Microsoft Excel, to identify recurring events or developing trends. Between January 1, 2001 and December 31, 2001 over 2500 products were processed at our laboratory. During this time period, 335 deviations and notable events occurred, affecting 385 products and/or patients. Deviations within the 'technical error' category were most common (37%). Thirteen percent of deviations had a patient and/or a product impact score > or = 2, a score indicating, at a minimum, potentially affected patient outcome or moderate effect upon product quality. Real-time analysis and quarterly review of deviations using our deviation management program allows for identification and correction of deviations. Monitoring of deviation trends allows for process improvement and overall successful functioning of the QA program in the cell therapy laboratory. Our deviation management program could serve as a model for other laboratories in

Clinical and Taxonomic Status of Pathogenic Nonpigmented or Late-Pigmenting Rapidly Growing Mycobacteria

PubMed Central

Brown-Elliott, Barbara A.; Wallace, Richard J.

2002-01-01

The history, taxonomy, geographic distribution, clinical disease, and therapy of the pathogenic nonpigmented or late-pigmenting rapidly growing mycobacteria (RGM) are reviewed. Community-acquired disease and health care-associated disease are highlighted for each species. The latter grouping includes health care-associated outbreaks and pseudo-outbreaks as well as sporadic disease cases. Treatment recommendations for each species and type of disease are also described. Special emphasis is on the Mycobacterium fortuitum group, including M. fortuitum, M. peregrinum, and the unnamed third biovariant complex with its recent taxonomic changes and newly recognized species (including M. septicum, M. mageritense, and proposed species M. houstonense and M. bonickei). The clinical and taxonomic status of M. chelonae, M. abscessus, and M. mucogenicum is also detailed, along with that of the closely related new species, M. immunogenum. Additionally, newly recognized species, M. wolinskyi and M. goodii, as well as M. smegmatis sensu stricto, are included in a discussion of the M. smegmatis group. Laboratory diagnosis of RGM using phenotypic methods such as biochemical testing and high-performance liquid chromatography and molecular methods of diagnosis are also discussed. The latter includes PCR-restriction fragment length polymorphism analysis, hybridization, ribotyping, and sequence analysis. Susceptibility testing and antibiotic susceptibility patterns of the RGM are also annotated, along with the current recommendations from the National Committee for Clinical Laboratory Standards (NCCLS) for mycobacterial susceptibility testing. PMID:12364376

Clinical and taxonomic status of pathogenic nonpigmented or late-pigmenting rapidly growing mycobacteria.

PubMed

Brown-Elliott, Barbara A; Wallace, Richard J

2002-10-01

The history, taxonomy, geographic distribution, clinical disease, and therapy of the pathogenic nonpigmented or late-pigmenting rapidly growing mycobacteria (RGM) are reviewed. Community-acquired disease and health care-associated disease are highlighted for each species. The latter grouping includes health care-associated outbreaks and pseudo-outbreaks as well as sporadic disease cases. Treatment recommendations for each species and type of disease are also described. Special emphasis is on the Mycobacterium fortuitum group, including M. fortuitum, M. peregrinum, and the unnamed third biovariant complex with its recent taxonomic changes and newly recognized species (including M. septicum, M. mageritense, and proposed species M. houstonense and M. bonickei). The clinical and taxonomic status of M. chelonae, M. abscessus, and M. mucogenicum is also detailed, along with that of the closely related new species, M. immunogenum. Additionally, newly recognized species, M. wolinskyi and M. goodii, as well as M. smegmatis sensu stricto, are included in a discussion of the M. smegmatis group. Laboratory diagnosis of RGM using phenotypic methods such as biochemical testing and high-performance liquid chromatography and molecular methods of diagnosis are also discussed. The latter includes PCR-restriction fragment length polymorphism analysis, hybridization, ribotyping, and sequence analysis. Susceptibility testing and antibiotic susceptibility patterns of the RGM are also annotated, along with the current recommendations from the National Committee for Clinical Laboratory Standards (NCCLS) for mycobacterial susceptibility testing.

National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China.

PubMed

Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo

2015-01-01

To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479/1307), 38% (228/598), and 36% (449/1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.

National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China

PubMed Central

Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun

2015-01-01

Introduction To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. Materials and methods 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. Results The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Conclusions Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them. PMID:26110033

Fluorescence quantum yield measurements of fluorescent proteins: a laboratory experiment for a biochemistry or molecular biophysics laboratory course.

PubMed

Wall, Kathryn P; Dillon, Rebecca; Knowles, Michelle K

2015-01-01

Fluorescent proteins are commonly used in cell biology to assess where proteins are within a cell as a function of time and provide insight into intracellular protein function. However, the usefulness of a fluorescent protein depends directly on the quantum yield. The quantum yield relates the efficiency at which a fluorescent molecule converts absorbed photons into emitted photons and it is necessary to know for assessing what fluorescent protein is the most appropriate for a particular application. In this work, we have designed an upper-level, biochemistry laboratory experiment where students measure the fluorescence quantum yields of fluorescent proteins relative to a standard organic dye. Four fluorescent protein variants, enhanced cyan fluorescent protein (ECFP), enhanced green fluorescent protein (EGFP), mCitrine, and mCherry, were used, however the methods described are useful for the characterization of any fluorescent protein or could be expanded to fluorescent quantum yield measurements of organic dye molecules. The laboratory is designed as a guided inquiry project and takes two, 4 hr laboratory periods. During the first day students design the experiment by selecting the excitation wavelength, choosing the standard, and determining the concentration needed for the quantum yield experiment that takes place in the second laboratory period. Overall, this laboratory provides students with a guided inquiry learning experience and introduces concepts of fluorescence biophysics into a biochemistry laboratory curriculum. © 2014 The International Union of Biochemistry and Molecular Biology.

30 CFR 6.10 - Use of independent laboratories.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PRODUCT SAFETY STANDARDS § 6.10 Use of independent laboratories. (a) MSHA will accept testing and... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Use of independent laboratories. 6.10 Section 6.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION...

Inter-laboratory Comparison of Three Earplug Fit-test Systems

PubMed Central

Byrne, David C.; Murphy, William J.; Krieg, Edward F.; Ghent, Robert M.; Michael, Kevin L.; Stefanson, Earl W.; Ahroon, William A.

2017-01-01

The National Institute for Occupational Safety and Health (NIOSH) sponsored tests of three earplug fit-test systems (NIOSH HPD Well-Fit™, Michael & Associates FitCheck, and Honeywell Safety Products VeriPRO®). Each system was compared to laboratory-based real-ear attenuation at threshold (REAT) measurements in a sound field according to ANSI/ASA S12.6-2008 at the NIOSH, Honeywell Safety Products, and Michael & Associates testing laboratories. An identical study was conducted independently at the U.S. Army Aeromedical Research Laboratory (USAARL), which provided their data for inclusion in this report. The Howard Leight Airsoft premolded earplug was tested with twenty subjects at each of the four participating laboratories. The occluded fit of the earplug was maintained during testing with a soundfield-based laboratory REAT system as well as all three headphone-based fit-test systems. The Michael & Associates lab had highest average A-weighted attenuations and smallest standard deviations. The NIOSH lab had the lowest average attenuations and the largest standard deviations. Differences in octave-band attenuations between each fit-test system and the American National Standards Institute (ANSI) sound field method were calculated (Attenfit-test - AttenANSI). A-weighted attenuations measured with FitCheck and HPD Well-Fit systems demonstrated approximately ±2 dB agreement with the ANSI sound field method, but A-weighted attenuations measured with the VeriPRO system underestimated the ANSI laboratory attenuations. For each of the fit-test systems, the average A-weighted attenuation across the four laboratories was not significantly greater than the average of the ANSI sound field method. Standard deviations for residual attenuation differences were about ±2 dB for FitCheck and HPD Well-Fit compared to ±4 dB for VeriPRO. Individual labs exhibited a range of agreement from less than a dB to as much as 9.4 dB difference with ANSI and REAT estimates. Factors such as

Cryogenic insulation standard data and methodologies

NASA Astrophysics Data System (ADS)

Demko, J. A.; Fesmire, J. E.; Johnson, W. L.; Swanger, A. M.

2014-01-01

Although some standards exist for thermal insulation, few address the sub-ambient temperature range and cold-side temperatures below 100 K. Standards for cryogenic insulation systems require cryostat testing and data analysis that will allow the development of the tools needed by design engineers and thermal analysts for the design of practical cryogenic systems. Thus, this critically important information can provide reliable data and methodologies for industrial efficiency and energy conservation. Two Task Groups have been established in the area of cryogenic insulation systems Under ASTM International's Committee C16 on Thermal Insulation. These are WK29609 - New Standard for Thermal Performance Testing of Cryogenic Insulation Systems and WK29608 - Standard Practice for Multilayer Insulation in Cryogenic Service. The Cryogenics Test Laboratory of NASA Kennedy Space Center and the Thermal Energy Laboratory of LeTourneau University are conducting Inter-Laboratory Study (ILS) of selected insulation materials. Each lab carries out the measurements of thermal properties of these materials using identical flat-plate boil-off calorimeter instruments. Parallel testing will provide the comparisons necessary to validate the measurements and methodologies. Here we discuss test methods, some initial data in relation to the experimental approach, and the manner reporting the thermal performance data. This initial study of insulation materials for sub-ambient temperature applications is aimed at paving the way for further ILS comparative efforts that will produce standard data sets for several commercial materials. Discrepancies found between measurements will be used to improve the testing and data reduction techniques being developed as part of the future ASTM International standards.

Evaluation of the VITEK 2 System for Identification and Antimicrobial Susceptibility Testing of Medically Relevant Gram-Positive Cocci

PubMed Central

Ligozzi, Marco; Bernini, Cinzia; Bonora, Maria Grazia; de Fatima, Maria; Zuliani, Jessica; Fontana, Roberta

2002-01-01

A study was conducted to evaluate the new VITEK 2 system (bioMérieux) for identification and antibiotic susceptibility testing of gram-positive cocci. Clinical isolates of Staphylococcus aureus (n = 100), coagulase-negative staphylococci (CNS) (n = 100), Enterococcus spp. (n = 89), Streptococcus agalactiae (n = 29), and Streptococcus pneumoniae (n = 66) were examined with the ID-GPC identification card and with the AST-P515 (for staphylococci), AST-P516 (for enterococci and S. agalactiae) and AST-P506 (for pneumococci) susceptibility cards. The identification comparison methods were the API Staph for staphylococci and the API 20 Strep for streptococci and enterococci; for antimicrobial susceptibility testing, the agar dilution method according to the procedure of the National Committee for Clinical Laboratory Standards (NCCLS) was used. The VITEK 2 system correctly identified to the species level (only one choice or after simple supplementary tests) 99% of S. aureus, 96.5% of S. agalactiae, 96.9% of S. pneumoniae, 92.7% of Enterococcus faecalis, 91.3% of Staphylococcus haemolyticus, and 88% of Staphylococcus epidermidis but was least able to identify Enterococcus faecium (71.4% correct). More than 90% of gram-positive cocci were identified within 3 h. According to the NCCLS breakpoints, antimicrobial susceptibility testing with the VITEK 2 system gave 96% correct category agreement, 0.82% very major errors, 0.17% major errors, and 2.7% minor errors. Antimicrobial susceptibility testing showed category agreement from 94 to 100% for S. aureus, from 90 to 100% for CNS, from 91 to 100% for enterococci, from 96 to 100% for S. agalactiae, and from 91 to 100% for S. pneumoniae. Microorganism-antibiotic combinations that gave very major errors were CNS-erythromycin, CNS-oxacillin, enterococci-teicoplanin, and enterococci-high-concentration gentamicin. Major errors were observed for CNS-oxacillin and S. agalactiae-tetracycline combinations. In conclusion the results of

Information Management Systems in the Undergraduate Instrumental Analysis Laboratory.

ERIC Educational Resources Information Center

Merrer, Robert J.

1985-01-01

Discusses two applications of Laboratory Information Management Systems (LIMS) in the undergraduate laboratory. They are the coulometric titration of thiosulfate with electrogenerated triiodide ion and the atomic absorption determination of calcium using both analytical calibration curve and standard addition methods. (JN)

42 CFR 493.25 - Laboratories performing tests of high complexity.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Laboratories performing tests of high complexity. 493.25 Section 493.25 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.25 Laboratories performing tests of high...

42 CFR 493.20 - Laboratories performing tests of moderate complexity.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Laboratories performing tests of moderate complexity. 493.20 Section 493.20 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.20 Laboratories performing tests of...

Reliability on intra-laboratory and inter-laboratory data of hair mineral analysis comparing with blood analysis.

PubMed

Namkoong, Sun; Hong, Seung Phil; Kim, Myung Hwa; Park, Byung Cheol

2013-02-01

Nowadays, although its clinical value remains controversial institutions utilize hair mineral analysis. Arguments about the reliability of hair mineral analysis persist, and there have been evaluations of commercial laboratories performing hair mineral analysis. The objective of this study was to assess the reliability of intra-laboratory and inter-laboratory data at three commercial laboratories conducting hair mineral analysis, compared to serum mineral analysis. Two divided hair samples taken from near the scalp were submitted for analysis at the same time, to all laboratories, from one healthy volunteer. Each laboratory sent a report consisting of quantitative results and their interpretation of health implications. Differences among intra-laboratory and interlaboratory data were analyzed using SPSS version 12.0 (SPSS Inc., USA). All the laboratories used identical methods for quantitative analysis, and they generated consistent numerical results according to Friedman analysis of variance. However, the normal reference ranges of each laboratory varied. As such, each laboratory interpreted the patient's health differently. On intra-laboratory data, Wilcoxon analysis suggested they generated relatively coherent data, but laboratory B could not in one element, so its reliability was doubtful. In comparison with the blood test, laboratory C generated identical results, but not laboratory A and B. Hair mineral analysis has its limitations, considering the reliability of inter and intra laboratory analysis comparing with blood analysis. As such, clinicians should be cautious when applying hair mineral analysis as an ancillary tool. Each laboratory included in this study requires continuous refinement from now on for inducing standardized normal reference levels.

42 CFR 493.1241 - Standard: Test request.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Test request. 493.1241 Section 493.1241 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Preanalytic Systems § 493.1241 Standard: Test request...

42 CFR 493.1283 - Standard: Test records.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Test records. 493.1283 Section 493.1283 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1283 Standard: Test records. (...

42 CFR 493.1291 - Standard: Test report.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Test report. 493.1291 Section 493.1291 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Postanalytic Systems § 493.1291 Standard: Test report....

Standard reference material for Her2 testing: report of a National Institute of Standards and Technology-sponsored Consensus Workshop.

PubMed

Hammond, M Elizabeth H; Barker, Peter; Taube, Sheila; Gutman, Steven

2003-06-01

A workshop was sponsored by the National Institute of Standards and Technology, the Cancer Diagnosis Program of the National Cancer Institute, the Food and Drug Administration, and the College of American Pathologists to address the need for a reference material for Her2 gene protein testing. It was agreed that such a standard was desirable and necessary to ensure the reliability of Her2 testing to qualify patients for trastuzumab therapy. Two standards consisting of well characterized cell lines will be produced, 1 that will be a National Institute of Standards and Technology-certifiable standard, and 1 that will be a commercially developed standard for use in all Her2 testing. It was also agreed that all Her2 testing must be performed on samples fixed only in 10% buffered formalin, as specified in the Food and Drug Administration-approved testing methods. Participants agreed to plan strategies to educate pathologists, clinicians, and laboratories about the need and use of such a standard. A National Committee for Clinical Laboratory Standards guideline for the use of the standard reference material will be created to facilitate this process.

Performance testing of radiobioassay laboratories: In vivo measurements, Final Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

MacLellan, J.A.; Traub, R.J.; Olsen, P.C.

1990-04-01

A study of two rounds of in vivo laboratory performance testing was undertaken by Pacific Northwest Laboratory (PNL) to determine the appropriateness of the in vivo performance criteria of draft American National Standards Institute (ANSI) standard ANSI N13.3, Performance Criteria for Bioassay.'' The draft standard provides guidance to in vivo counting facilities regarding the sensitivity, precision, and accuracy of measurements for certain categories of commonly assayed radionuclides and critical regions of the body. This report concludes the testing program by presenting the results of the Round Two testing. Testing involved two types of measurements: chest counting for radionuclide detection inmore » the lung, and whole body counting for detection of uniformly distributed material. Each type of measurement was further divided into radionuclide categories as defined in the draft standard. The appropriateness of the draft standard criteria by measuring a laboratory's ability to attain them were judged by the results of both round One and Round Two testing. The testing determined that performance criteria are set at attainable levels, and the majority of in vivo monitoring facilities passed the criteria when complete results were submitted. 18 refs., 18 figs., 15 tabs.« less

75 FR 39028 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee (CLIAC) In accordance with section 10(a)(2) of the Federal Advisory... to the standards under which clinical laboratories are regulated; the impact on medical and...

76 FR 5379 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical... for, and the nature of, revisions to the standards under which clinical laboratories are regulated... Coordinating Council on the Clinical Laboratory Workforce; the National Institutes of Health Genetic Test...

Space Food Systems Laboratory

NASA Technical Reports Server (NTRS)

Perchonok, Michele; Russo, Dane M. (Technical Monitor)

2001-01-01

The Space Food Systems Laboratory (SFSL) is a multipurpose laboratory responsible for space food and package research and development. It is located on-site at Johnson Space Center in Building 17. The facility supports the development of flight food, menus, packaging and food related hardware for Shuttle, International Space Station, and Advanced Life Support food systems. All foods used to support NASA ground tests and/or missions must meet the highest standards before they are 'accepted' for use on actual space flights. The foods are evaluated for nutritional content, sensory acceptability, safety, storage and shelf life, and suitability for use in micro-gravity. The food packaging is also tested to determine its functionality and suitability for use in space. Food Scientist, Registered Dieticians, Packaging Engineers, Food Systems Engineers, and Technicians staff the Space Food Systems Laboratory.

Towards a rational antimicrobial testing policy in the laboratory.

PubMed

Banaji, N; Oommen, S

2011-01-01

Antimicrobial policy for prophylactic and therapeutic use of antimicrobials in a tertiary care setting has gained importance. A hospital's antimicrobial policy as laid down by its hospital infection control team needs to include inputs from the microbiology laboratory, besides the pharmacy and therapeutic committee. Therefore, it is of utmost importance that clinical microbiologists across India follow international guidelines and also take into account local settings, especially detection and presence of resistance enzymes. This article draws a framework for rational antimicrobial testing in our laboratories in tertiary care centers, from the Clinical and Laboratory Standards Institute guidelines. It does not address testing methodologies but suggests ways and means by which antimicrobial susceptibility reporting can be rendered meaningful not only to the treating physician but also to the resistance monitoring epidemiologist. It hopes to initiate some standardization in rational choice of antimicrobial testing in laboratories in the country pertaining to nonfastidious bacteria.

Interpretive criteria of antimicrobial disk susceptibility tests with flomoxef.

PubMed

Grimm, H

1991-01-01

320 recently isolated pathogens, 20 strains from each of 16 species, were investigated using Mueller-Hinton agar and DIN as well as NCCLS standards. The geometric mean of the agar dilution MICs of flomoxef were 0.44 mg/l for Staphylococcus aureus, 0.05 mg/l (Klebsiella oxytoca) to 12.6 mg/l (Enterobacter spp.) for enterobacteriaceae, 33.1 mg/l for Acinetobacter anitratus, 64 mg/l for Enterococcus faecalis, and more than 256 mg/l for Pseudomonas aeruginosa. For disk susceptibility testing of flomoxef a 30 micrograms disk loading and the following interpretation of inhibition zones using the DIN method were recommended: resistant-up to 22 mm (corresponding to MICs of 8 mg/l or more), moderately susceptible-23 to 29 mm (corresponding to MICs from 1 to 4 mg/l), and susceptible-30 mm or more (corresponding to MICs of 0.5 mg/l or less). The respective values for the NCCLS method using the American high MIC breakpoints are: resistant--up to 14 mm (corresponding to MICs of 32 mg/l or more), moderately susceptible--15 to 17 mm (corresponding to MICs of 16 mg/l), and susceptible--18 mm or more (corresponding to MICs of 8 mg/l or less).

Selecting clinical quality indicators for laboratory medicine.

PubMed

Barth, Julian H

2012-05-01

Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

Issues concerning international comparison of free-field calibrations of acoustical standards

NASA Astrophysics Data System (ADS)

Nedzelnitsky, Victor

2002-11-01

Primary free-field calibrations of laboratory standard microphones by the reciprocity method establish these microphones as reference standard devices for calibrating working standard microphones, other measuring microphones, and practical instruments such as sound level meters and personal sound exposure meters (noise dosimeters). These primary, secondary, and other calibrations are indispensable to the support of regulatory requirements, standards, and product characterization and quality control procedures important for industry, commerce, health, and safety. International Electrotechnical Commission (IEC) Technical Committee 29 Electroacoustics produces international documentary standards, including standards for primary and secondary free-field calibration and measurement procedures and their critically important application to practical instruments. This paper addresses some issues concerning calibrations, standards activities, and the international key comparison of primary free-field calibrations of IEC-type LS2 laboratory standard microphones that is being planned by the Consultative Committee for Acoustics, Ultrasound, and Vibration (CCAUV) of the International Committee for Weights and Measures (CIPM). This comparison will include free-field calibrations by the reciprocity method at participating major national metrology laboratories throughout the world.

[Tasks and duties of veterinary reference laboratories for food borne zoonoses].

PubMed

Ellerbroek, Lüppo; Alter, T; Johne, R; Nöckler, K; Beutin, L; Helmuth, R

2009-02-01

Reference laboratories are of central importance for consumer protection. Field expertise and high scientific competence are basic requirements for the nomination of a national reference laboratory. To ensure a common approach in the analysis of zoonotic hazards, standards have been developed by the reference laboratories together with national official laboratories on the basis of Art. 33 of Directive (EG) No. 882/2004. Reference laboratories function as arbitrative boards in the case of ambivalent or debatable results. New methods for detection of zoonotic agents are developed and validated to provide tools for analysis, e. g., in legal cases, if results from different parties are disputed. Besides these tasks, national reference laboratories offer capacity building and advanced training courses and control the performance of ring trials to ensure consistency in the quality of analyses in official laboratories. All reference laboratories work according to the ISO standard 17025 which defines the grounds for strict laboratory quality rules and in cooperation with the respective Community Reference Laboratories (CRL). From the group of veterinary reference laboratories for food-borne zoonoses, the national reference laboratories are responsible for Listeria monocytogenes, for Campylobacter, for the surveillance and control of viral and bacterial contamination of bivalve molluscs, for E. coli, for the performance of analysis and tests on zoonoses (Salmonella), and from the group of parasitological zoonotic agents, the national reference laboratory for Trichinella.

Technical standards and guidelines: molecular genetic testing for ultra-rare disorders.

PubMed

Maddalena, Anne; Bale, Sherri; Das, Soma; Grody, Wayne; Richards, Sue

2005-10-01

These standards and guidelines are designed primarily as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines does not necessarily ensure a successful medical outcome. These standards and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the clinical molecular geneticist should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the laboratory record the rationale for any significant deviation from these standards and guidelines.

A Comprehensive Subcellular Proteomic Survey of Salmonella Grown under Phagosome-Mimicking versus Standard Laboratory Conditions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brown, Roslyn N.; Sanford, James A.; Park, Jea H.

Towards developing a systems-level pathobiological understanding of Salmonella enterica, we performed a subcellular proteomic analysis of this pathogen grown under standard laboratory and infection-mimicking conditions in vitro. Analysis of proteins from cytoplasmic, inner membrane, periplasmic, and outer membrane fractions yielded coverage of over 30% of the theoretical proteome. Confident subcellular location could be assigned to over 1000 proteins, with good agreement between experimentally observed location and predicted/known protein properties. Comparison of protein location under the different environmental conditions provided insight into dynamic protein localization and possible moonlighting (multiple function) activities. Notable examples of dynamic localization were the response regulators ofmore » two-component regulatory systems (e.g., ArcB, PhoQ). The DNA-binding protein Dps that is generally regarded as cytoplasmic was significantly enriched in the outer membrane for all growth conditions examined, suggestive of moonlighting activities. These observations imply the existence of unknown transport mechanisms and novel functions for a subset of Salmonella proteins. Overall, this work provides a catalog of experimentally verified subcellular protein location for Salmonella and a framework for further investigations using computational modeling.« less

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

Grid Modernization Laboratory Consortium - Testing and Verification

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kroposki, Benjamin; Skare, Paul; Pratt, Rob

This paper highlights some of the unique testing capabilities and projects being performed at several national laboratories as part of the U. S. Department of Energy Grid Modernization Laboratory Consortium. As part of this effort, the Grid Modernization Laboratory Consortium Testing Network isbeing developed to accelerate grid modernization by enablingaccess to a comprehensive testing infrastructure and creating a repository of validated models and simulation tools that will be publicly available. This work is key to accelerating thedevelopment, validation, standardization, adoption, and deployment of new grid technologies to help meet U. S. energy goals.

76 FR 39879 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee (CLIAC) In accordance with section 10(a)(2) of the Federal Advisory... the nature of, revisions to the standards under which clinical laboratories are regulated; the impact...

Iowa Central Quality Fuel Testing Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Heach, Don; Bidieman, Julaine

2013-09-30

The objective of this project is to finalize the creation of an independent quality fuel testing laboratory on the campus of Iowa Central Community College in Fort Dodge, Iowa that shall provide the exploding biofuels industry a timely and cost-effective centrally located laboratory to complete all state and federal fuel and related tests that are required. The recipient shall work with various state regulatory agencies, biofuel companies and state and national industry associations to ensure that training and testing needs of their members and American consumers are met. The recipient shall work with the Iowa Department of Ag and Landmore » Stewardship on the development of an Iowa Biofuel Quality Standard along with the Development of a standard that can be used throughout industry.« less

Do English NHS Microbiology laboratories offer adequate services for the diagnosis of UTI in children? Healthcare Quality Improvement Partnership (HQIP) Audit of Standard Operational Procedures.

PubMed

McNulty, Cliodna A M; Verlander, Neville Q; Moore, Philippa C L; Larcombe, James; Dudley, Jan; Banerjee, Jaydip; Jadresic, Lyda

2015-09-01

The National Institute of Care Excellence (NICE) 2007 guidance CG54, on urinary tract infection (UTI) in children, states that clinicians should use urgent microscopy and culture as the preferred method for diagnosing UTI in the hospital setting for severe illness in children under 3 years old and from the GP setting in children under 3 years old with intermediate risk of severe illness. NICE also recommends that all 'infants and children with atypical UTI (including non-Escherichia coli infections) should have renal imaging after a first infection'. We surveyed all microbiology laboratories in England with Clinical Pathology Accreditation to determine standard operating procedures (SOPs) for urgent microscopy, culture and reporting of children's urine and to ascertain whether the SOPs facilitate compliance with NICE guidance. We undertook a computer search in six microbiology laboratories in south-west England to determine urine submissions and urine reports in children under 3 years. Seventy-three per cent of laboratories (110/150) participated. Enterobacteriaceae that were not E. coli were reported only as coliforms (rather than non-E. coli coliforms) by 61% (67/110) of laboratories. Eighty-eight per cent of laboratories (97/110) provided urgent microscopy for hospital and 54% for general practice (GP) paediatric urines; 61% of laboratories (confidence interval 52-70%) cultured 1 μl volume of urine, which equates to one colony if the bacterial load is 106 c.f.u. l(-1). Only 22% (24/110) of laboratories reported non-E. coli coliforms and provided urgent microscopy for both hospital and GP childhood urines; only three laboratories also cultured a 5 μl volume of urine. Only one of six laboratories in our submission audit had a significant increase in urine submissions and urines reported from children less than 3 years old between the predicted pre-2007 level in the absence of guidance and the 2008 level following publication of the NICE guidance. Less than a

42 CFR 493.1263 - Standard: Mycology.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Mycology. 493.1263 Section 493.1263 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Systems § 493.1263 Standard: Mycology. (a) The laboratory must check each batch (prepared in-house), lot...

Direct calibration of a reference standard against the air kerma strength primary standard, at 192Ir HDR energy.

PubMed

Rajan, K N Govinda; Selvam, T Palani; Bhatt, B C; Vijayam, M; Patki, V S; Vinatha; Pendse, A M; Kannan, V

2002-04-07

The primary standard of low air kerma rate sources or beams, maintained at the Radiological Standards Laboratory (RSL) of the Bhabha Atomic Research Centre (BARC), is a 60 cm3 spherical graphite ionization chamber. A 192Ir HDR source was standardized at the hospital site in units of air kerma strength (AKS) using this primary standard. A 400 cm3 bakelite chamber, functioning as a reference standard at the RSL for a long period, at low air kerma rates (compared to external beam dose rates), was calibrated against the primary standard. It was seen that the primary standard and the reference standard, both being of low Z, showed roughly the same scatter response and yielded the same calibration factor for the 400 cm3 reference chamber, with or without room scatter. However, any likelihood of change in the reference chamber calibration factor would necessitate the re-transport of the primary standard to the hospital site for re-calibration. Frequent transport of the primary standard can affect the long-term stability of the primary standard, due to its movement or other extraneous causes. The calibration of the reference standard against the primary standard at the RSL, for an industrial type 192Ir source maintained at the laboratory, showed excellent agreement with the hospital calibration, making it possible to check the reference chamber calibration at RSL itself. Further calibration procedures have been developed to offer traceable calibration of the hospital well ionization chambers.

Implementing a Quality Management System in the Medical Microbiology Laboratory.

PubMed

Carey, Roberta B; Bhattacharyya, Sanjib; Kehl, Sue C; Matukas, Larissa M; Pentella, Michael A; Salfinger, Max; Schuetz, Audrey N

2018-07-01

This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages "systems thinking" by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum. Copyright © 2018 American Society for Microbiology.

International Society for the Advancement of Cytometry cell sorter biosafety standards.

PubMed

Holmes, Kevin L; Fontes, Benjamin; Hogarth, Philip; Konz, Richard; Monard, Simon; Pletcher, Charles H; Wadley, Robert B; Schmid, Ingrid; Perfetto, Stephen P

2014-05-01

Flow cytometric cell sorting of biological specimens has become prevalent in basic and clinical research laboratories. These specimens may contain known or unknown infectious agents, necessitating precautions to protect instrument operators and the environment from biohazards arising from the use of sorters. To this end the International Society of Analytical Cytology (ISAC) was proactive in establishing biosafety guidelines in 1997 (Schmid et al., Cytometry 1997;28:99-117) and subsequently published revised biosafety standards for cell sorting of unfixed samples in 2007 (Schmid et al., Cytometry Part A J Int Soc Anal Cytol 2007;71A:414-437). Since their publication, these documents have become recognized worldwide as the standard of practice and safety precautions for laboratories performing cell sorting experiments. However, the field of cytometry has progressed since 2007, and the document requires an update. The new Standards provides guidance: (1) for laboratory design for cell sorter laboratories; (2) for the creation of laboratory or instrument specific Standard Operating Procedures (SOP); and (3) on procedures for the safe operation of cell sorters, including personal protective equipment (PPE) and validation of aerosol containment. Published © 2014 Wiley Periodicals Inc.

International Society for the Advancement of Cytometry Cell Sorter Biosafety Standards

PubMed Central

Holmes, Kevin L.; Fontes, Benjamin; Hogarth, Philip; Konz, Richard; Monard, Simon; Pletcher, Charles H.; Wadley, Robert B.; Schmid, Ingrid; Perfetto, Stephen P.

2014-01-01

Flow cytometric cell sorting of biological specimens has become prevalent in basic and clinical research laboratories. These specimens may contain known or unknown infectious agents, necessitating precautions to protect instrument operators and the environment from biohazards arising from the use of sorters. To this end the International Society of Analytical Cytology (ISAC) was proactive in establishing biosafety guidelines in 1997 (Schmid et al., Cytometry 1997;28:99–117) and subsequently published revised biosafety standards for cell sorting of unfixed samples in 2007 (Schmid et al., Cytometry Part A J Int Soc Anal Cytol 2007;71A:414–437). Since their publication, these documents have become recognized worldwide as the standard of practice and safety precautions for laboratories performing cell sorting experiments. However, the field of cytometry has progressed since 2007, and the document requires an update. The new Standards provides guidance: (1) for laboratory design for cell sorter laboratories; (2) for the creation of laboratory or instrument specific Standard Operating Procedures (SOP); and (3) on procedures for the safe operation of cell sorters, including personal protective equipment (PPE) and validation of aerosol containment. PMID:24634405

Restructuring of international council for standardization in haematology (ICSH) in Asia.

PubMed

Tatsumi, N; Lewis, S M

2002-08-01

Standardization and harmonization in Laboratory testing are a key issue in the midst of globalization era, because most of laboratory testing has been currently achieved with various kinds of automated systems. In the developed countries, automated systems with highly-regulated principles are commonly used in the routine laboratory. However, there are so many undeveloped and developing countries in Asia that diversity of testing levels can be observed in the area. Some laboratories use glass chamber method for blood cell counting, while other laboratory use semi-automated or fully automated analyzers for complete blood count. International standardization on Hematology is focused on the developed system but not for the developing system. Established standardized documents therefore whould not be unsuitable for Asian societies. In the context, International Council for Standardization in Hematology (ICSH) changed its rules to adjust our Asian Societies and ICSH started to restructure the body. International ICSH society is divided into 5 region sub-groups. Asian area is able to possess one new sub-society, ICSH-Asia. Its reconstruction work has been just started with Asain colleagues, and we are now extending the new societies to discuss Asian problems on the quality of hematology testing.

42 CFR 493.1485 - Standard; Cytotechnologist responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Cytotechnologist responsibilities. 493.1485 Section 493.1485 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing High Complexity Testing § 493.1485 Standard; Cytotechnologist...

42 CFR 493.1485 - Standard; Cytotechnologist responsibilities.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Cytotechnologist responsibilities. 493.1485 Section 493.1485 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing High Complexity Testing § 493.1485 Standard; Cytotechnologist...

[Consensus for antimicrobial susceptibility testing for Enterobacteriaceae. Subcommittee on Antimicrobials, SADEBAC (Argentinian Society of Clinical Bacteriology), Argentinian Association of Microbiology].

PubMed

Famiglietti, A; Quinteros, M; Vázquez, M; Marín, M; Nicola, F; Radice, M; Galas, M; Pasterán, F; Bantar, C; Casellas, J M; Kovensky Pupko, J; Couto, E; Goldberg, M; Lopardo, H; Gutkind, G; Soloaga, R

2005-01-01

Taking into account previous recommendations from the National Committee for Clinical Laboratory Standards (NCCLS), the Antimicrobial Committee, Sociedad Argentina de Bacteriología Clínica (SADEBAC), Asociación Argentina de Microbiología (AAM), and the experience from its members and some invited microbiologists, a consensus was obtained for antimicrobial susceptibility testing and interpretation in most frequent enterobacterial species isolated from clinical samples in our region. This document describes the natural antimicrobial resistance of some Enterobacteriaceae family members, including the resistance profiles due to their own chromosomal encoded beta-lactamases. A list of the antimicrobial agents that should be tested, their position on the agar plates, in order to detect the most frequent antimicrobial resistance mechanisms, and considerations on which antimicrobial agents should be reported regarding to the infection site and patient characteristics are included. Also, a description on appropriate phenotypic screening and confirmatory test for detection of prevalent extended spectrum beta-lactamases in our region are presented. Finally, a summary on frequent antimicrobial susceptibility profiles and their probably associated resistance mechanisms, and some infrequent antimicrobial resistance profiles that deserve confirmation are outlined.

Studies on the drug resistance profile of Enterococcus faecium distributed from poultry retailers to hospitals.

PubMed

Limayem, Alya; Donofrio, Robert Scott; Zhang, Chao; Haller, Edward; Johnson, Michael G

2015-01-01

The multidrug resistant Enterococcus faecium (MEF) strains originating from farm animals are proliferating at a substantial pace to impact downstream food chains and could reach hospitals. This study was conducted to elucidate the drug susceptibility profile of MEF strains collected from poultry products in Ann Arbor, MI area and clinical settings from Michigan State Lab and Moffitt Cancer Center (MCC) in Florida. Presumptive positive Enterococcus isolates at species level were identified by Matrix Assisted Laser Desorption/Ionization Time-of-Flight (MALDI-TOF) analysis. The antibiotic susceptibility profile for both poultry and clinical strains was determined by the Thermo Scientific's Sensititre conform to the National Committee for Clinical Laboratory Standards (NCCLS) and validated via quantitative real-time PCR (qPCR) methods. Out of 50 poultry samples (Turkey: n = 30; Chicken: n = 20), 36 samples were positive for Enterococcus species from which 20.83% were identified as E. faecium. All the E. faecium isolates were multidrug resistant and displayed resistance to the last alternative drug, quinupristin/dalfopristin (QD) used to treat vancomycin resistant E. faecium (VRE) in hospitals. Results indicate the presence of MEF strains in food animals and clinical settings that are also resistant to QD.

Comparison of susceptibility test methods to detect penicillin susceptibility in Streptococcus pneumoniae isolates.

PubMed

Mohd Nasir, Mohd Desa; Parasakthi, Navaratnam

2004-06-01

The increasing prevalence of penicillin-resistant Streptococuus pneumoniae urges for fast and accurate susceptibility testing methods. This study evaluated the comparability of three commonly used techniques; disk diffusion, E-test and agar dilution, to detect penicillin susceptibility in clinical isolates of S. pneumoniae. Fifty pneumococcal isolates, obtained from patients at the University of Malaya Medical Centre, were selected to include both penicillin-susceptible strains and those that had decreased susceptibility (resistant and intermediate) to penicillin. The minimum inhibitory concentration (MIC) values of penicillin to serve as the reference was determined by the agar dilution method in which, based on the MIC breakpoints recommended by the National Committee for Clinical Laboratory Standards (NCCLS), 27 strains had decreased susceptibility to penicillin with 17 strains resistant and 10 intermediate. Comparing to the agar dilution method, oxacillin disk diffusion test detected all strains with decreased penicillin susceptibility as such while E-test showed a close agreement of susceptibility (92%) of the isolates to penicillin. This confirmed that oxacillin is a good screening test for S. pneumoniae isolates with decreased susceptibility to penicillin while E-test is very reliable for rapid and accurate detection of penicillin susceptibility.

Open- and closed-formula laboratory animal diets and their importance to research.

PubMed

Barnard, Dennis E; Lewis, Sherry M; Teter, Beverly B; Thigpen, Julius E

2009-11-01

Almost 40 y ago the scientific community was taking actions to control environmental factors that contribute to variation in the responses of laboratory animals to scientific manipulation. Laboratory animal diet was recognized as an important variable. During the 1970s, the American Institute of Nutrition, National Academy of Science, Institute of Laboratory Animal Resources, and Laboratory Animals Centre Diets Advisory Committee supported the use of 'standard reference diets' in biomedical research as a means to improve the ability to replicate research. As a result the AIN76 purified diet was formulated. During this same time, the laboratory animal nutritionist at the NIH was formulating open-formula, natural-ingredient diets to meet the need for standardized laboratory animal diets. Since the development of open-formula diets, fixed-formula and constant-nutrient-concentration closed-formula laboratory animal natural ingredient diets have been introduced to help reduce the potential variation diet can cause in research.

Open- and Closed-Formula Laboratory Animal Diets and Their Importance to Research

PubMed Central

Barnard, Dennis E; Lewis, Sherry M; Teter, Beverly B; Thigpen, Julius E

2009-01-01

Almost 40 y ago the scientific community was taking actions to control environmental factors that contribute to variation in the responses of laboratory animals to scientific manipulation. Laboratory animal diet was recognized as an important variable. During the 1970s, the American Institute of Nutrition, National Academy of Science, Institute of Laboratory Animal Resources, and Laboratory Animals Centre Diets Advisory Committee supported the use of ‘standard reference diets’ in biomedical research as a means to improve the ability to replicate research. As a result the AIN76 purified diet was formulated. During this same time, the laboratory animal nutritionist at the NIH was formulating open-formula, natural-ingredient diets to meet the need for standardized laboratory animal diets. Since the development of open-formula diets, fixed-formula and constant-nutrient–concentration closed-formula laboratory animal natural ingredient diets have been introduced to help reduce the potential variation diet can cause in research. PMID:19930817

Laboratory Integration and Consolidation in a Regional Health System.

PubMed

Cook, Jim

2017-08-01

Health systems face intense pressure to decrease costs and improve services as the health care delivery system in the United States undergoes tremendous change due to health care reform. As health systems grow, like any business, they are forced to explore standardization to realize and maintain efficient practices. Clinical services, such as laboratory medicine, are more difficult to integrate due to wider variation in acceptable practice and culture, compared with other services. However, changes to laboratory service are imperative if health care professionals expect to survive and thrive in the new business environment. In this article, I describe the advocation efforts of the System Laboratory Council group toward implementation of a standardization process that we call integration, to improve the efficiency of the Laboratory Services department of our health system, the University of Maryland Medical System (UMMS). © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group "Laboratory Errors and Patient Safety" project.

PubMed

Sciacovelli, Laura; Lippi, Giuseppe; Sumarac, Zorica; West, Jamie; Garcia Del Pino Castro, Isabel; Furtado Vieira, Keila; Ivanov, Agnes; Plebani, Mario

2017-03-01

The knowledge of error rates is essential in all clinical laboratories as it enables them to accurately identify their risk level, and compare it with those of other laboratories in order to evaluate their performance in relation to the State-of-the-Art (i.e. benchmarking) and define priorities for improvement actions. Although no activity is risk free, it is widely accepted that the risk of error is minimized by the use of Quality Indicators (QIs) managed as a part of laboratory improvement strategy and proven to be suitable monitoring and improvement tools. The purpose of QIs is to keep the error risk at a level that minimizes the likelihood of patients. However, identifying a suitable State-of-the-Art is challenging, because it calls for the knowledge of error rates measured in a variety of laboratories throughout world that differ in their organization and management, context, and the population they serve. Moreover, it also depends on the choice of the events to keep under control and the individual procedure for measurement. Although many laboratory professionals believe that the systemic use of QIs in Laboratory Medicine may be effective in decreasing errors occurring throughout the total testing process (TTP), to improve patient safety as well as to satisfy the requirements of International Standard ISO 15189, they find it difficult to maintain standardized and systematic data collection, and to promote continued high level of interest, commitment and dedication in the entire staff. Although many laboratories worldwide express a willingness to participate to the Model of QIs (MQI) project of IFCC Working Group "Laboratory Errors and Patient Safety", few systematically enter/record their own results and/or use a number of QIs designed to cover all phases of the TTP. Many laboratories justify their inadequate participation in data collection of QIs by claiming that the number of QIs included in the MQI is excessive. However, an analysis of results suggests

The Pathology Laboratory Act 2007 explained.

PubMed

Looi, Lai-Meng

2008-06-01

The past century has seen tremendous changes in the scope and practice of pathology laboratories in tandem with the development of the medical services in Malaysia. Major progress was made in the areas of training and specialization of pathologists and laboratory technical staff. Today the pathology laboratory services have entered the International arena, and are propelled along the wave of globalization. Many new challenges have emerged as have new players in the field. Landmark developments over the past decade include the establishment of national quality assurance programmes, the mushrooming of private pathology laboratories, the establishment of a National Accreditation Standard for medical testing laboratories based on ISO 15189, and the passing of the Pathology Laboratory Act in Parliament in mid-2007. The Pathology Laboratory Act 2007 seeks to ensure that the pathology laboratory is accountable to the public, meets required standards of practice, participates in Quality Assurance programmes, is run by qualified staff, complies with safety requirements and is subject to continuous audit. The Act is applicable to all private laboratories (stand alone or hospital) and laboratories in statutory bodies (Universities, foundations). It is not applicable to public laboratories (established and operated by the government) and side-room laboratories established in clinics of registered medical or dental practitioners for their own patients (tests as in the First and Second Schedules respectively). Tests of the Third Schedule (home test blood glucose, urine glucose, urine pregnancy test) are also exempted. The Act has 13 Parts and provides for control of the pathology laboratory through approval (to establish and maintain) and licensing (to operate or provide). The approval or license may only be issued to a sole proprietor, partnership or body corporate, and then only if the entity includes a registered medical practitioner. Details of personnel qualifications and

Multicenter Evaluation of a Commercial Cytomegalovirus Quantitative Standard: Effects of Commutability on Interlaboratory Concordance

PubMed Central

Shahbazian, M. D.; Valsamakis, A.; Boonyaratanakornkit, J.; Cook, L.; Pang, X. L.; Preiksaitis, J. K.; Schönbrunner, E. R.; Caliendo, A. M.

2013-01-01

Commutability of quantitative reference materials has proven important for reliable and accurate results in clinical chemistry. As international reference standards and commercially produced calibration material have become available to address the variability of viral load assays, the degree to which such materials are commutable and the effect of commutability on assay concordance have been questioned. To investigate this, 60 archived clinical plasma samples, which previously tested positive for cytomegalovirus (CMV), were retested by five different laboratories, each using a different quantitative CMV PCR assay. Results from each laboratory were calibrated both with lab-specific quantitative CMV standards (“lab standards”) and with common, commercially available standards (“CMV panel”). Pairwise analyses among laboratories were performed using mean results from each clinical sample, calibrated first with lab standards and then with the CMV panel. Commutability of the CMV panel was determined based on difference plots for each laboratory pair showing plotted values of standards that were within the 95% prediction intervals for the clinical specimens. Commutability was demonstrated for 6 of 10 laboratory pairs using the CMV panel. In half of these pairs, use of the CMV panel improved quantitative agreement compared to use of lab standards. Two of four laboratory pairs for which the CMV panel was noncommutable showed reduced quantitative agreement when that panel was used as a common calibrator. Commutability of calibration material varies across different quantitative PCR methods. Use of a common, commutable quantitative standard can improve agreement across different assays; use of a noncommutable calibrator can reduce agreement among laboratories. PMID:24025907

Electric Vehicle and Wireless Charging Laboratory

DOT National Transportation Integrated Search

2018-03-23

Wireless charging tests of electric vehicles (EV) have been conducted at the EVTC Wireless Laboratory located at the Florida Solar Energy Center, Cocoa, FL. These tests were performed to document testing protocols, evaluate standards and evaluate ope...

42 CFR 493.1423 - Standard; Testing personnel qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical... stability and storage; (F) The skills required to implement the quality control policies and procedures of... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

42 CFR 493.1495 - Standard; Testing personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... samples are tested in the same manner as patient specimens; (3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

42 CFR 493.1241 - Standard: Test request.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: Test request. 493.1241 Section 493.1241 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing...

42 CFR 493.1241 - Standard: Test request.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Test request. 493.1241 Section 493.1241 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing...

Quality management in European screening laboratories in blood establishments: A view of current approaches and trends.

PubMed

Pereira, Paulo; Westgard, James O; Encarnação, Pedro; Seghatchian, Jerard; de Sousa, Gracinda

2015-04-01

The screening laboratory has a critical role in the post-transfusion safety. The success of its targets and efficiency depends on the management system used. Even though the European Union directive 2002/98/EC requires a quality management system in blood establishments, its requirements for screening laboratories are generic. Complementary approaches are needed to implement a quality management system focused on screening laboratories. This article briefly discusses the current good manufacturing practices and good laboratory practices, as well as the trends in quality management system standards. ISO 9001 is widely accepted in some European Union blood establishments as the quality management standard, however this is not synonymous of its successful application. The ISO "risk-based thinking" is interrelated with the quality risk-management process of the EuBIS "Standards and criteria for the inspection of blood establishments". ISO 15189 should be the next step on the quality assurance of a screening laboratory, since it is focused on medical laboratory. To standardize the quality management systems in blood establishments' screening laboratories, new national and European claims focused on technical requirements following ISO 15189 is needed. Copyright © 2015 Elsevier Ltd. All rights reserved.