Laboratory performance and regulatory requirements.

1987 ◽  
Vol 33 (6) ◽  
pp. 1087-1102 ◽  
Author(s):  
M L Kenney
Keyword(s):  
Linear Regression ◽  
Proficiency Test ◽  
Clinical Laboratory ◽  
Group Practice ◽  
Federal Regulations ◽  
Test Results ◽  
Regulatory Requirements ◽  
Service Levels ◽  
Z Scores ◽  
Log Normal

Abstract We compared performance levels of four clinical laboratory groups defined by federal regulatory characteristics, to assess the appropriateness of selected regulations: laboratories in JCAH-accredited hospitals; non-doctoral-directed independent laboratories; state-regulated but federally exempt group-practice laboratories; and unregulated laboratories in physicians' offices (POLs). Federal regulations evaluated were those dealing with the doctoral directorship requirement and exemption of POLs from regulation. Quantitative analytes were compared by using linear regression on log-normal transformations of mean absolute-z scores of proficiency test results. The scope of services offered by laboratories was statistically related to performance in quantitative analytes. Confounding effects of scope-of-service levels were statistically controlled. Proportions of errors in qualitative analytes were compared. No pattern of statistically discernible differences in performance was found between hospital laboratories and non-doctoral-directed laboratories. Both regulated non-doctoral-directed laboratories and state-regulated but federally exempt group-practice laboratories demonstrated higher levels of performance than unregulated POLs.

Regulation of Laboratory Genetic Testing

2017 ◽  
Author(s):  
Barbara Zehnbauer ◽  
W. Andrew Faucett
Keyword(s):  
Genetic Testing ◽  
Clinical Laboratory ◽  
Genetic Counselor ◽  
Professional Standards ◽  
Test Results ◽  
Regulatory Requirements ◽  
Clinical Genetic ◽  
Regulatory Oversight ◽  
Laboratory Staff ◽  
Phenotypic Information

Laboratory regulations provide rules to establish consistency and to evaluate performance. They also set out the qualifications and experience needed for laboratory staff to fulfill regulatory requirements and meet professional standards. Clinical genetic counselors play a significant role in determining which tests to offer patients, which laboratories to consider for testing, and which phenotypic information to provide to the clinical laboratory to improve the interpretation of test results. This chapter discusses laboratory regulations pertinent to the type of genetic testing offered and specimens received in the laboratory. The goal is to help the laboratory genetic counselor understand the regulatory oversight of genetic testing and the quality management of clinical laboratory operations.

scholarly journals Simultaneous determination of acetaldehyde, ethyl acetate, methanol, iso butanol, and iso almyacol concentrations in white alcol in some areas in Hai Duong province in 2018 - 2019

2020 ◽  
Vol 3 (3) ◽  
pp. 196-203
Author(s):  
Hoang Nguyen Duc ◽  
Canh Tran Quang ◽  
◽  
Keyword(s):  
Ethyl Acetate ◽  
Simultaneous Determination ◽  
Proficiency Test ◽  
Isoamyl Alcohol ◽  
Test Results ◽  
Isobutyl Alcohol ◽  
Methanol Content ◽  
Z Scores ◽  
The Relationship

The research has developed a method for simultaneous determination of acetaldehyde, ethyl acetate, methanol, isobutyl alcohol, isoamyl alcohol in white alcohol. Validation results show that the method has satisfactory accuracy with recovery in the range of 105 - 108%, repeatability RSD < 1.57%, detection limit below 3 mg/L for all compounds. Proficiency test results in 2020 were satisfactory with Z-scores of all substances below 2. The method has been applied to analyze 200 distilled alcohol samples and 50 blended alcohol samples taken in Hai Duong city during the period from 2018 to 2020. Three of 200 distilled alcohol samples have the methanol content higher than the maximum limit. The relationship between methanol content in proportion to content of acetaldehyde, ethyl acetate, isobutyl alcohol, and isoamyl alcohol in the same sample has been evaluated to distinguish between blended alcohol and distilled alcohol.

Review of sodium analysis proficiency test results

2011 ◽  
Vol 28 (2) ◽  
pp. 136-144 ◽  
Author(s):  
M. Sykes ◽  
B. Parmar ◽  
M. Knaggs
Keyword(s):  
Proficiency Test ◽  
Test Results

scholarly journals Does physiological distribution of blood parameters in children depend on socioeconomic status? Results of a German cross-sectional study

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019143 ◽  
Author(s):  
Kristin Rieger ◽  
Mandy Vogel ◽  
Christoph Engel ◽  
Uta Ceglarek ◽  
Kristian Harms ◽  
...  
Keyword(s):  
Physical Activity ◽  
Socioeconomic Status ◽  
Linear Regression ◽  
Family Income ◽  
Blood Parameters ◽  
Research Centre ◽  
Regression Analyses ◽  
Pubertal Stage ◽  
Cross Sectional ◽  
Z Scores

ObjectivesIn the present study, we examined the relation between socioeconomic status (SES) and the physiological distribution of iron-related blood parameters.DesignThis is a cross-sectional analysis of longitudinal population-based cohort study.SettingBased on a sample of healthy participants from a German research centre, various blood parameters and values of clinical examinations and questionnaires were collected.ParticipantsA total of 1206 healthy volunteers aged 2.5 to 19 years, one child per family randomly selected, were included.Primary and secondary outcome measuresAssociations between the SES of children by Winkler-Stolzenberg Index (WSI) and its dimensions (income, education, occupation) and iron-related blood parameters (haemoglobin, ferritin and transferrin) were analysed by linear regression analyses. Gender and pubertal stage were included as covariables. Additionally, associations between SES of children by WSI and physical activity (side-to-side jumps, push-ups) as well as body mass index (BMI) were analysed by linear regression analyses.ResultsChildren with high WSI or family income showed significantly increased z-scores for haemoglobin (P=0.046; P<0.001). Children with increased WSI or family income showed significantly lower z-scores for transferrin (P<0.001). There was a significant correlation between haemoglobin and gender (P<0.001) and between transferrin and pubertal stage (P=0.024). Furthermore, physical activity was positively correlated and BMI was negatively correlated with WSI (P<0.001).DiscussionOur data show an association between SES and the distribution of iron-dependent parameters. Lower SES is correlated with lower values for haemoglobin and higher values for transferrin. Furthermore, we demonstrate that physical activity and BMI are associated with SES. Whereas higher SES is correlated with higher values for physical activity and lower BMI. Our parameters are standardised as z-scores with the advantages that the results are comparable across different age groups and present physiological courses.Trial registration numberNCT02550236; Results.

scholarly journals Pengaruh Likuiditas, Leverage, Aktivitas, dan Profitabilitas terhadap Nilai Perusahaan pada Sektor Barang Konsumsi yang Terdaftar Di Bursa Efek Indonesia Periode 2015-2018

2020 ◽  
Vol 20 (3) ◽  
pp. 919
Author(s):  
Anju Galingging ◽  
Fery Xaverius Aritonang ◽  
Herlina Novita
Keyword(s):  
Linear Regression ◽  
Multiple Linear Regression ◽  
Consumer Goods ◽  
Firm Value ◽  
Research Method ◽  
Quantitative Method ◽  
Stock Exchange ◽  
Test Results ◽  
Activity Variable ◽  
Independent Variable

The purpose of this study is to determine and analyze the effect of Liquidity, Leverage, Activity, and Profitability on Firm Value in the Consumer Goods Sector Listed on the Indonesia Stock Exchange for the period 2015-2018. This study uses a quantitative method with a desciptive type. The population of this study is the Consumer Goods Sector that is listed on the Indonesia Stock Exchange for the 2015-2018 period, as many as 50 companies. Sampling using purposive sampling and obtained a research sample of 60 samples from 15 sectors of consumer goods multiplied by 4 years. This research method uses multiple linear regression. The coefficient test results obtained from the Adjusted R Square value are 3.7%, which means that the variation in the Firm Value variable described by the independent variable is 96.3%. The research results simultaneously show that liquidity, leverage, activity, and profitability have no effect on firm value. Meanwhile, partially it shows that liquidity, leverage, and profitability have no and insignificant effect on firm value, but for the activity variable has a significant effect on firm value.

scholarly journals Peranan Kompetensi Dalam Meningkatkan Kinerja Karyawan PT. Summit Oto Finance

MBIA ◽  
2019 ◽  
Vol 18 (2) ◽  
pp. 43-51
Author(s):  
Shandra Bahasoan
Keyword(s):  
Linear Regression ◽  
Multiple Linear Regression ◽  
Significant Influence ◽  
Employee Performance ◽  
Self Concept ◽  
Research Approach ◽  
Test Results ◽  
Quantitative Descriptive ◽  
Descriptive Method

The study was conducted aimed at knowing the role of competencies, namely knowledge, skills and self-concept in improving the performance of employees of PT. Summit Oto Finance, with a sample of 54 people . The method used in this study using questionnaires, interviews and documentation. Research approach by using quantitative descriptive method by analyzing Multiple Linear Regression to measure the performance of employees of PT. Summit Oto Finance. The results of this study simultaneously independent competency variables consisting of knowledge, skills and self-concept have a positive and significant influence on the dependent variable,namely employee performance. From the test results the correlation of the influence of competencies on employee performance is 94.1 percent while 5.9 percent is influenced by other factors. Dominant competencies affect the performance of employees of PT. Summit Oto Finance is a skill.

scholarly journals ANALISIS FAKTOR-FAKTOR YANG MEMPENGARUHI IMPOR BERAS DI INDONESIA

2019 ◽  
Vol 11 (2) ◽  
pp. 183-201
Author(s):  
Yona Namira ◽  
Iskandar Andi Nuhung ◽  
Mudatsir Najamuddin
Keyword(s):  
Time Series ◽  
Linear Regression ◽  
Multiple Linear Regression ◽  
Time Series Data ◽  
Series Data ◽  
Test Results ◽  
The Us ◽  
Rice Prices ◽  
Us Dollar ◽  
Spss Software

This study aims to 1) identify factors that affect the import of rice in Indonesia 2) analyze the influence of these factors on imports of rice in Indonesia. The data used in this research are time series data from 1994 to 2013 from the Central Statistics Agency (BPS), the Ministry of Agriculture, Ministry of Commerce, National Logistics Agency (Bulog), and Bank Indonesia. Multiple linear regression through SPSS software version 21 was employed to analyze the data. The test results together indicated the variables of productions, consumptions, stocks of rice, domestic rice prices, international rice prices and the rupiah against the US dollar affect the imports of rice in Indonesia.

scholarly journals Case Report: Two Cases of Subacute Thyroiditis Following SARS-CoV-2 Vaccination

2021 ◽  
Vol 8 ◽  
Author(s):  
Catherine Bornemann ◽  
Katharina Woyk ◽  
Caroline Bouter
Keyword(s):  
Viral Infections ◽  
Clinical Laboratory ◽  
Previous History ◽  
Subacute Thyroiditis ◽  
Clinical Test ◽  
Thyroid Disorders ◽  
Thyroid Disorder ◽  
Lateral Neck ◽  
Test Results ◽  
History Of

Subacute thyroiditis is an inflammatory thyroid disorder associated with viral infections. Rare cases of subacute thyroiditis have also been described following vaccination. Recently, a few cases of subacute thyroiditis following SARS-CoV-2 vaccination have also been reported. Here, we present two cases of cytological proven subacute thyroiditis after receiving the first dose of a SARS-CoV-2 vaccination. We describe clinical, laboratory, imaging and cytological findings in two cases of subacute thyroiditis that presented in our department 2 weeks after SARS-CoV-2 vaccination with Spikevax (Moderna Biotech, Spain) and Vaxzevria (AstraZeneca; Sweden). Both cases did not have a previous history of thyroid disorders and presented with anterior and lateral neck pain. Clinical test results as well as cytological findings were consistent with subacute thyroiditis. Subacute thyroiditis may develop following a SARS-CoV-2 vaccination and should be considered as a possible side effect in cases that present with thyroid pain.

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