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Sample records for good laboratory practices

Good Laboratory Practice. Part 3. Implementing Good Laboratory Practice in the Analytical Lab

ERIC Educational Resources Information Center

Wedlich, Richard C.; Pires, Amanda; Fazzino, Lisa; Fransen, Joseph M.

2013-01-01

Laboratories submitting experimental results to the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA) in support of Good Laboratory Practice (GLP) nonclinical laboratory studies must conduct such work in compliance with the GLP regulations. To consistently meet these requirements, lab managers employ a "divide…
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…
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
Good Laboratory Practice. Part 2. Recording and Retaining Raw Data

ERIC Educational Resources Information Center

Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Tellarini, Cassandra

2013-01-01

A clear understanding of how "raw data" is defined, recorded, and retained in the laboratory record is essential to the chemist employed in the laboratory compliant with the Good Laboratory Practices regulations. This article is intended to provide an understanding by drawing upon examples taken from the modern pharmaceutical analysis…
Going GLP: Conducting Toxicology Studies in Compliance with Good Laboratory Practices.

PubMed

Carroll, Erica Eggers

2016-01-01

Good laboratory practice standards are US federal regulations enacted as part of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR Part 160), the Toxic Substance Control Act (40 CFR Part 792), and the Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) to support protection of public health in the areas of pesticides, chemicals, and drug investigations in response to allegations of inaccurate data acquisition. Essentially, good laboratory practices (GLPs) are a system of management controls for nonclinical research studies involving animals to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of data collected as part of chemical (including pharmaceuticals) tests, from in vitro through acute to chronic toxicity tests. The GLPs were established in the United States in 1978 as a result of the Industrial Bio-Test Laboratory scandal which led to congressional hearings and actions to prevent fraudulent data reporting and collection. Although the establishment of infrastructure for GLPs compliance is labor-intensive and time-consuming, achievement and maintenance of GLP compliance ensures the accuracy of the data collected from each study, which is critical for defending results, advancing science, and protecting human and animal health. This article describes how and why those in the US Army Medical Department responsible for protecting the public health of US Army and other military personnel made the policy decision to have its toxicology laboratory achieve complete compliance with GLP standards, the first such among US Army laboratories. The challenges faced and how they were overcome are detailed.
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)
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
Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.

PubMed

2012-04-06

Biochemical genetic testing and newborn screening are essential laboratory services for the screening, detection, diagnosis, and monitoring of inborn errors of metabolism or inherited metabolic disorders. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized on the basis of the level of testing complexity as either waived (i.e., from routine regulatory oversight) or nonwaived testing (which includes tests of moderate and high complexity). Laboratories that perform biochemical genetic testing are required by CLIA regulations to meet the general quality systems requirements for nonwaived testing and the personnel requirements for high-complexity testing. Laboratories that perform public health newborn screening are subject to the same CLIA regulations and applicable state requirements. As the number of inherited metabolic diseases that are included in state-based newborn screening programs continues to increase, ensuring the quality of performance and delivery of testing services remains a continuous challenge not only for public health laboratories and other newborn screening facilities but also for biochemical genetic testing laboratories. To help ensure the quality of laboratory testing, CDC collaborated with the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health to develop guidelines for laboratories to meet CLIA requirements and apply additional quality assurance measures for these areas of genetic testing. This report provides recommendations for good laboratory practices that were developed based on recommendations from the Clinical Laboratory Improvement Advisory Committee, with additional input from the Secretary's Advisory Committee on Genetics, Health, and Society; the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and representatives of newborn
Revised guidelines for good practice in IVF laboratories (2015).

PubMed

De los Santos, Maria José; Apter, Susanna; Coticchio, Giovanni; Debrock, Sophie; Lundin, Kersti; Plancha, Carlos E; Prados, Fernando; Rienzi, Laura; Verheyen, Greta; Woodward, Bryan; Vermeulen, Nathalie

2016-04-01

Which recommendations can be provided by the European Society of Human Reproduction and Embryology Special Interest Group (ESHRE SIG) Embryology to support laboratory specialists in the organization and management of IVF laboratories and the optimization of IVF patient care? Structured in 13 sections, the guideline development group formulated recommendations for good practice in the organization and management of IVF laboratories, and for good practice of the specific procedures performed within the IVF laboratory. NA. The guideline was produced by a group of 10 embryologists representing different European countries, settings and levels of expertise. The group evaluated the document of 2008, and based on this assessment, each group member rewrote one or more sections. Two 2-day meetings were organized during which each of the recommendations was discussed and rewritten until consensus within the guideline group was reached. After finalizing the draft, the members of the ESHRE SIG embryology were invited to review the guideline. NA. The guideline provides recommendations on the general organization of an IVF laboratory (staffing and direction, quality management, laboratory safety), and on the specific aspects of the procedures performed in IVF laboratories (Identification of patients and traceability of their reproductive cells, consumables, handling of biological material, oocyte retrieval, sperm preparation, insemination of oocytes, scoring for fertilization, embryo culture and transfer, and cryopreservation). A last section provides recommendations regarding an Emergency plan for IVF laboratories. Evidence on most of the issues described is scarce, and therefore it was decided not to perform a formal search for and assessment of scientific evidence. However, recommendations published in the EUTCD and relevant and recent documents, manuals and consensus papers were taken into account when formulating the recommendations. Despite the limitations, the guideline
Good Laboratory Practices of Materials Testing at NASA White Sands Test Facility

NASA Technical Reports Server (NTRS)

Hirsch, David; Williams, James H.

2005-01-01

An approach to good laboratory practices of materials testing at NASA White Sands Test Facility is presented. The contents include: 1) Current approach; 2) Data analysis; and 3) Improvements sought by WSTF to enhance the diagnostic capability of existing methods.
Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) Review and Applicability for Chemical Security Enhancements

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

Iveson, Steven W.

Global chemical security has been enhanced through the determined use and integration of both voluntary and legislated standards. Many popular standards contain components that specifically detail requirements for the security of materials, facilities and other vital assets. In this document we examine the roll of quality management standards and how they affect the security culture within the institutions that adopt these standards in order to conduct business within the international market place. Good manufacturing practices and good laboratory practices are two of a number of quality management systems that have been adopted as law in many nations. These standards aremore » designed to protect the quality of drugs, medicines, foods and analytical test results in order to provide the world-wide consumer with safe and affective products for consumption. These standards provide no established security protocols and yet manage to increase the security of chemicals, materials, facilities and the supply chain via the effective and complete control over the manufacturing, the global supply chains and testing processes. We discuss the means through which these systems enhance security and how nations can further improve these systems with additional regulations that deal specifically with security in the realm of these management systems. We conclude with a discussion of new technologies that may cause disruption within the industries covered by these standards and how these issues might be addressed in order to maintain or increase the level of security within the industries and nations that have adopted these standards.« less
Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

PubMed

Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

2014-07-01

The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.
College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization.

PubMed

Tworek, Joseph A; Henry, Michael R; Blond, Barbara; Jones, Bruce Allen

2013-02-01

Gynecologic cytopathology is a heavily regulated field, with Clinical Laboratory Improvement Amendments of 1988 mandating the collection of many quality metrics. There is a lack of consensus regarding methods to collect, monitor, and benchmark these data and how these data should be used in a quality assurance program. Furthermore, the introduction of human papilloma virus testing and proficiency testing has provided more data to monitor. To determine good laboratory practices in quality assurance of gynecologic cytopathology. Data were collected through a written survey consisting of 98 questions submitted to 1245 Clinical Laboratory Improvement Amendments-licensed or Department of Defense laboratories. There were 541 usable responses. Additional input was sought through a Web posting of results and questions on the College of American Pathologists Web site. Four senior authors who authored the survey and 28 cytopathologists and cytotechnologists were assigned to 5 working groups to analyze data and present statements on good laboratory practices in gynecologic cytopathology at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference. Ninety-eight attendees at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference discussed and voted on good laboratory practice statements to obtain consensus. This paper describes the rationale, background, process, and strengths and limitations of a series of papers that summarize good laboratory practice statements in quality assurance in gynecologic cytopathology.
Good Practice and Recommendations for Research Team Leadership

DTIC Science & Technology

2017-05-01

ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for Research Team Leadership by Mark L...Do not return it to the originator. ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for...information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services , Directorate for Information
Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.

PubMed

Brodish, D L

1998-01-01

The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.
77 FR 36277 - Academic Development of a Training Program for Good Laboratory Practices in High Containment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-18

... requirements in high and maximum biocontainment, scientists working in this environment and FDA staff who will...] Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments... Containment Environments (U24).'' In this FOA, FDA announces its intention to accept and consider a single...
A Lesson Plan for the Enhancement of Training and Research in Academia by the Adaptation and Adoption of Good Laboratory Practice Guidelines

ERIC Educational Resources Information Center

Sitaraman, Ramakrishnan

2010-01-01

The implementation of good laboratory practices (GLPs) is recognized by the biotechnology and pharmaceutical industries as being critical for ensuring the international acceptability of products. However, as universities and colleges (and research organizations) do not necessarily work under similar constraints, actual laboratory practices vary…
Microscopic or occult hematuria, when reflex testing is not good laboratory practice.

PubMed

Froom, Paul; Barak, Mira

2010-01-01

Consensus opinion suggests that hematuria found by dipstick and not confirmed on microscopic examination (<2 erythrocytes per high power field) signifies a false-positive reagent strip test result. Standard practice is to repeat the dipstick test several days later and if still positive to confirm by microscopic examination. If discordant results are obtained, experts recommend reflex testing for urinary myoglobin and hemoglobin concentrations. The question is whether or not this approach represents good laboratory practice. These recommendations are not evidence based. We conclude that the reference range for red blood cells on the reagent strip should be increased to 25x10(6) cells/L for young men, and 50x10(6) cells/L for the rest of the adult population, ranges consistent with flow cytometry reports. Confirmation reflex testing using tests that have inferior sensitivity, precision and probably accuracy is not recommended.
To Group or Not to Group? Good Practice for Housing Male Laboratory Mice

PubMed Central

Kappel, Sarah; Hawkins, Penny; Mendl, Michael T.

2017-01-01

Simple Summary Wild mice live in territories inhabited by one adult male, several females, and their offspring. This cannot be replicated in the laboratory, so male mice are usually housed in single-sex groups or individually. However, there can be serious animal welfare problems associated with both these approaches, such as lack of social contact when housed individually or aggression between males when kept in groups. Group housing is widely recommended to give male laboratory mice the opportunity to behave as ‘social animals’, but social stress can be detrimental to the welfare of these animals, even without injurious fighting. All of this can also affect the quality of the science, giving rise to ethical concerns. This review discusses whether it is in the best welfare interests of male mice to be housed in groups, or alone. We conclude that it is not possible to give general recommendations for good practice for housing male laboratory mice, as responses to single- and group-housing can be highly context-dependent. The welfare implications of housing protocols should be researched and considered in each case. Abstract It is widely recommended to group-house male laboratory mice because they are ‘social animals’, but male mice do not naturally share territories and aggression can be a serious welfare problem. Even without aggression, not all animals within a group will be in a state of positive welfare. Rather, many male mice may be negatively affected by the stress of repeated social defeat and subordination, raising concerns about welfare and also research validity. However, individual housing may not be an appropriate solution, given the welfare implications associated with no social contact. An essential question is whether it is in the best welfare interests of male mice to be group- or singly housed. This review explores the likely impacts—positive and negative—of both housing conditions, presents results of a survey of current practice and
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.

Implementation of Good Laboratory Practices (GLP) in basic scientific research: Translating the concept beyond regulatory compliance.

PubMed

Jena, G B; Chavan, Sapana

2017-10-01

The principles of Good Laboratory Practices (GLPs) are mainly intended for the laboratories performing studies for regulatory compliances. However, today GLP can be applied to broad disciplines of science to cater to the needs of the experimental objectives, generation of quality data and assay reproducibility. Considering its significance, it can now be applied in academics; industries as well as government set ups throughout the world. GLP is the best way to promote the reliability, reproducibility of the test data and hence facilitates the international acceptability. Now it is high time to translate and implement the concept of GLP beyond regulatory studies. Thus, it can pave the way for better understanding of scientific problems and help to maintain a good human and environmental health. Through this review, we have made an attempt to explore the uses of GLP principles in different fields of science and its acceptability as well as looking for its future perspectives. Copyright © 2017 Elsevier Inc. All rights reserved.
Good practice statements on safe laboratory testing: A mixed methods study by the LINNEAUS collaboration on patient safety in primary care.

PubMed

Bowie, Paul; Forrest, Eleanor; Price, Julie; Verstappen, Wim; Cunningham, David; Halley, Lyn; Grant, Suzanne; Kelly, Moya; Mckay, John

2015-09-01

The systems-based management of laboratory test ordering and results handling is a known source of error in primary care settings worldwide. The consequences are wide-ranging for patients (e.g. avoidable harm or poor care experience), general practitioners (e.g. delayed clinical decision making and potential medico-legal implications) and the primary care organization (e.g. increased allocation of resources to problem-solve and dealing with complaints). Guidance is required to assist care teams to minimize associated risks and improve patient safety. To identify, develop and build expert consensus on 'good practice' guidance statements to inform the implementation of safe systems for ordering laboratory tests and managing results in European primary care settings. Mixed methods studies were undertaken in the UK and Ireland, and the findings were triangulated to develop 'good practice' statements. Expert consensus was then sought on the findings at the wider European level via a Delphi group meeting during 2013. We based consensus on 10 safety domains and developed 77 related 'good practice' statements (≥ 80% agreement levels) judged to be essential to creating safety and minimizing risks in laboratory test ordering and subsequent results handling systems in international primary care. Guidance was developed for improving patient safety in this important area of primary care practice. We need to consider how this guidance can be made accessible to frontline care teams, utilized by clinical educators and improvement advisers, implemented by decision makers and evaluated to determine acceptability, feasibility and impacts on patient safety.
Good cell culture practices &in vitro toxicology.

PubMed

Eskes, Chantra; Boström, Ann-Charlotte; Bowe, Gerhard; Coecke, Sandra; Hartung, Thomas; Hendriks, Giel; Pamies, David; Piton, Alain; Rovida, Costanza

2017-12-01

Good Cell Culture Practices (GCCP) is of high relevance to in vitro toxicology. The European Society of Toxicology In Vitro (ESTIV), the Center for Alternatives for Animal Testing (CAAT) and the In Vitro Toxicology Industrial Platform (IVTIP) joined forces to address by means of an ESTIV 2016 pre-congress session the different aspects and applications of GCCP. The covered aspects comprised the current status of the OECD guidance document on Good In Vitro Method Practices, the importance of quality assurance for new technological advances in in vitro toxicology including stem cells, and the optimized implementation of Good Manufacturing Practices and Good Laboratory Practices for regulatory testing purposes. General discussions raised the duality related to the difficulties in implementing GCCP in an academic innovative research framework on one hand, and on the other hand, the need for such GCCP principles in order to ensure reproducibility and robustness of in vitro test methods for toxicity testing. Indeed, if good cell culture principles are critical to take into consideration for all uses of in vitro test methods for toxicity testing, the level of application of such principles may depend on the stage of development of the test method as well as on the applications of the test methods, i.e., academic innovative research vs. regulatory standardized test method. Copyright © 2017 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.
Volatile organic compounds and good laboratory practices in the in vitro fertilization laboratory: the important parameters for successful outcome in extended culture.

PubMed

Agarwal, Nupur; Chattopadhyay, Ratna; Ghosh, Sanghamitra; Bhoumik, Arpita; Goswami, S K; Chakravarty, Baidyanath

2017-08-01

This study aims to describe the role of implementing good laboratory practices to improve in vitro fertilization (IVF) outcomes which are of great interest for practitioners dealing with infertility. Certain modifications were introduced in May 2015 in our IVF laboratory like high-efficiency particulate air CODA system, steel furniture instead of wooden, use of new disinfectants like oosafe, and restriction of personnel entry along with avoidance of cosmetics like perfume to improve pregnancy rates. Volatile organic compound (VOC) meter reading was monitored at two time points and five different places in the laboratory to compare the embryonic development parameters before (group A: July 2014-April 2015) and after (group B: July 2015-April 2016) remodeling. The IVF outcomes from 1036 cycles were associated in this study. Reduction in VOC meter readings, enhanced air quality, improvement in blastocyst formation rate, implantation, and clinical pregnancy rate were observed in the laboratory after implementation of new facilities. Results illustrated that the attention must be focused on potential hazards which expose laboratories to elevated VOC levels. Blastocyst formation rate increased around 18%. Implantation rate, clinical pregnancy rate, and live birth rate increased by around 11, 10, and 8%, respectively. In conclusion, with proper engineering and material selection, we have been able to reduce chemical contamination and adverse effects on culture with optimized IVF results. None.
Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers.

PubMed

Tembuyser, Lien; Dequeker, Elisabeth M C

2016-01-01

Quality assurance is an indispensable element in a molecular diagnostic laboratory. The ultimate goal is to warrant patient safety. Several risks that can compromise high quality procedures are at stake, from sample collection to the test performed by the laboratory, the reporting of test results to clinicians, and the organization of effective external quality assessment schemes. Quality assurance should therefore be safeguarded at each level and should imply a holistic multidisciplinary approach. This review aims to provide an overview of good quality assurance practices and discusses certain risks and recommendations to promote and improve quality assurance for both diagnostic laboratories and for external quality assessment providers. The number of molecular targets is continuously rising, and new technologies are evolving. As this poses challenges for clinical implementation and increases the demand for external quality assessment, the formation of an international association for improving quality assurance in molecular pathology is called for.
Biosafety principles and practices for the veterinary diagnostic laboratory.

PubMed

Kozlovac, Joseph; Schmitt, Beverly

2015-01-01

Good biosafety and biocontainment programs and practices are critical components of the successful operation of any veterinary diagnostic laboratory. In this chapter we provide information and guidance on critical biosafety management program elements, facility requirements, protective equipment, and procedures necessary to ensure that the laboratory worker and the environment are adequately protected in the challenging work environment of the veterinary diagnostic laboratory in general and provide specific guidance for those laboratories employing molecular diagnostic techniques.
[Useful web sites for information about the recommendations of good practices in laboratory medicine].

PubMed

Szymanowicz, A; Watine, J

2010-12-01

In this paper are presented some useful web sites to find updated reference tables concerning the recommendations of professional practices in laboratory medicine. The knowledge of these reference tables can allow the biologist to develop its role of advice to the clinicians. It can also help him to assure a relevant interpretation of the laboratory results and to value the interest for the patient.
Rules of good practice in the care of laboratory animals used in biomedical research.

PubMed

Valanzano, Angelina

2004-01-01

In recent years, the use of laboratory animals has decreased as a result of the adoption of alternative methods such as in vitro experiments and simulation studies. Nonetheless, animal models continue to be necessary in many fields of biomedical research, giving rise to ethical issues regarding the treatment of these animals. In the present work, a general overview of the rules of good practise in caring for laboratory animals is provided, focussing on housing conditions and the proper means of handling animals, including the importance of the relationship or "bond" between the researcher and the animal.
The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research.

PubMed

De Vos, Filip J; De Decker, Mario; Dierckx, Rudi A

2005-07-01

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GMP) conditions. This review aims to give an overview of the basic principles and guidelines for the preparation of radiopharmaceuticals. Special attention is given to the production area environment and personnel, the two basic requirements for GMP productions. Especially for the production area, two philosophies have to be combined: the cascade system of over-pressure for the production of pharmaceuticals and the under pressure system for the manufacturing of radioisotopes. Personnel should be selected based on education and regularly given special training for the handling of radioactive material. Compared to pharmaceuticals, radiopharmaceuticals have their own labels, taking into account their specific nature. Besides the standard quality control, other items for quality control of radiopharmaceuticals are also discussed in this article.
A Roadmap for Academic Health Centers to Establish Good Laboratory Practice-Compliant Infrastructure

PubMed Central

Adamo, Joan E.; Bauer, Gerhard; Berro, Marlene; Burnett, Bruce K.; Hartman, Karen A.; Masiello, Lisa M.; Moorman-White, Diane; Rubinstein, Eric P.; Schuff, Kathryn G.

2012-01-01

Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration (FDA) regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take prior to the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials. PMID:22373618
Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

PubMed

McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

2012-07-01

There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.
A Good Death? Report of the Second Newcastle Meeting on Laboratory Animal Euthanasia

PubMed Central

Hawkins, Penny; Prescott, Mark J.; Carbone, Larry; Dennison, Ngaire; Johnson, Craig; Makowska, I. Joanna; Marquardt, Nicole; Readman, Gareth; Weary, Daniel M.; Golledge, Huw D. R.

2016-01-01

Simple Summary Millions of laboratory animals are killed each year worldwide. However, there is a lack of consensus regarding what methods of killing are humane for many species and stages of development. This report summarises research findings and discussions from an international meeting of experts and stakeholders, with recommendations to inform good practice for humane killing of mice, rats and zebrafish. It provides additional guidance and perspectives for researchers designing projects that involve euthanasing animals, researchers studying aspects of humane killing, euthanasia device manufacturers, regulators, and institutional ethics or animal care and use committees that wish to review local practice. Abstract Millions of laboratory animals are killed each year worldwide. There is an ethical, and in many countries also a legal, imperative to ensure those deaths cause minimal suffering. However, there is a lack of consensus regarding what methods of killing are humane for many species and stages of development. In 2013, an international group of researchers and stakeholders met at Newcastle University, United Kingdom to discuss the latest research and which methods could currently be considered most humane for the most commonly used laboratory species (mice, rats and zebrafish). They also discussed factors to consider when making decisions about appropriate techniques for particular species and projects, and priorities for further research. This report summarises the research findings and discussions, with recommendations to help inform good practice for humane killing. PMID:27563926
Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings: A Health Program Evaluation Framework Case Study From East Africa.

PubMed

Zhang, Helen L; Omondi, Michael W; Musyoka, Augustine M; Afwamba, Isaac A; Swai, Remigi P; Karia, Francis P; Muiruri, Charles; Reddy, Elizabeth A; Crump, John A; Rubach, Matthew P

2016-08-01

Using a clinical research laboratory as a case study, we sought to characterize barriers to maintaining Good Clinical Laboratory Practice (GCLP) services in a developing world setting. Using a US Centers for Disease Control and Prevention framework for program evaluation in public health, we performed an evaluation of the Kilimanjaro Christian Medical Centre-Duke University Health Collaboration clinical research laboratory sections of the Kilimanjaro Clinical Research Institute in Moshi, Tanzania. Laboratory records from November 2012 through October 2014 were reviewed for this analysis. During the 2-year period of study, seven instrument malfunctions suspended testing required for open clinical trials. A median (range) of 9 (1-55) days elapsed between instrument malfunction and biomedical engineer service. Sixteen (76.1%) of 21 suppliers of reagents, controls, and consumables were based outside Tanzania. Test throughput among laboratory sections used a median (range) of 0.6% (0.2%-2.7%) of instrument capacity. Five (55.6%) of nine laboratory technologists left their posts over 2 years. These findings demonstrate that GCLP laboratory service provision in this setting is hampered by delays in biomedical engineer support, delays and extra costs in commodity procurement, low testing throughput, and high personnel turnover. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Good Practices for Transforming Education

ERIC Educational Resources Information Center

Benavente, Ana; Panchaud, Christine

2008-01-01

This text is a guide to the reading and interpretation of the "good practices" that are developing in the countries participating in this project and elsewhere. A systematic approach to the factors making up a "good practice" has enabled us to share our analyses in a more structured manner and to reflect on their potential for…
75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... for research or marketing permits for products regulated by FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and... requested the ability to cite compliance with the applicable good manufacturing requirements (i.e, parts 210...
[Software for illustrating a cost-quality balance carried out by clinical laboratory practice].

PubMed

Nishibori, Masahiro; Asayama, Hitoshi; Kimura, Satoshi; Takagi, Yasushi; Hagihara, Michio; Fujiwara, Mutsunori; Yoneyama, Akiko; Watanabe, Takashi

2010-09-01

We have no proper reference indicating the quality of clinical laboratory practice, which should clearly illustrates that better medical tests require more expenses. Japanese Society of Laboratory Medicine was concerned about recent difficult medical economy and issued a committee report proposing a guideline to evaluate the good laboratory practice. According to the guideline, we developed software that illustrate a cost-quality balance carried out by clinical laboratory practice. We encountered a number of controversial problems, for example, how to measure and weight each quality-related factor, how to calculate costs of a laboratory test and how to consider characteristics of a clinical laboratory. Consequently we finished only prototype software within the given period and the budget. In this paper, software implementation of the guideline and the above-mentioned problems are summarized. Aiming to stimulate these discussions, the operative software will be put on the Society's homepage for trial
21 CFR 110.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria and...
21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act...
21 CFR 226.1 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115, inclusive...

Good pharmacovigilance practices: technology enabled.

PubMed

Nelson, Robert C; Palsulich, Bruce; Gogolak, Victor

2002-01-01

The assessment of spontaneous reports is most effective it is conducted within a defined and rigorous process. The framework for good pharmacovigilance process (GPVP) is proposed as a subset of good postmarketing surveillance process (GPMSP), a functional structure for both a public health and corporate risk management strategy. GPVP has good practices that implement each step within a defined process. These practices are designed to efficiently and effectively detect and alert the drug safety professional to new and potentially important information on drug-associated adverse reactions. These practices are enabled by applied technology designed specifically for the review and assessment of spontaneous reports. Specific practices include rules-based triage, active query prompts for severe organ insults, contextual single case evaluation, statistical proportionality and correlational checks, case-series analyses, and templates for signal work-up and interpretation. These practices and the overall GPVP are supported by state-of-the-art web-based systems with powerful analytical engines, workflow and audit trials to allow validated systems support for valid drug safety signalling efforts. It is also important to understand that a process has a defined set of steps and any one cannot stand independently. Specifically, advanced use of technical alerting methods in isolation can mislead and allow one to misunderstand priorities and relative value. In the end, pharmacovigilance is a clinical art and a component process to the science of pharmacoepidemiology and risk management.
Critical appraisal in the practice of laboratory medicine.

PubMed

Price, Christopher P; Christenson, Robert H

2016-03-01

Critical appraisal is a key skill employed across the spectrum of laboratory medicine practice. It underpins the use of information that is relevant, of good quality and is meaningful. Relevance is answering the right question for the right patient at the right time, with quality ensuring provision of the right information. Meaningful is making the right decisions in order to deliver the right outcomes. Critical appraisal is about minimizing the risk of bias or 'departures from trueness' in all of the facets of laboratory medicine practice. It can be summarized in four steps: (i) a clear understanding and articulation of the problem being addressed - whether it be an analytical challenge, individual patient care or policymaking; (ii) verifying the methodological approach employed; (iii) assuring the reliability of the results and (iv) ensuring the applicability and implications of the results. Reference is made to a number of checklists that can be used to assist in the process of critical appraisal. © The Author(s) 2015.
Good documentation practice in clinical research.

PubMed

Bargaje, Chitra

2011-04-01

One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement.
Integrating Education: Parekhian Multiculturalism and Good Practice

ERIC Educational Resources Information Center

McGlynn, Claire

2009-01-01

This paper explores the concept of good practice in integrating education in divided societies. Using Northern Ireland as a case study, the paper draws on data from eight schools (both integrated Catholic and Protestant, and separate) that are identified as exemplifying good practice in response to cultural diversity. Analysis is provided through…
Good documentation practice in clinical research

PubMed Central

Bargaje, Chitra

2011-01-01

One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement. PMID:21731856
21 CFR 129.1 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the..., methods, practices, and controls used in the processing, bottling, holding, and shipping of bottled...
Teleworking: Guidelines for Good Practice. IES Report 329.

ERIC Educational Resources Information Center

Huws, Ursula; And Others

Because teleworking presents major new challenges to human resource managers, trade unions, and others involved in the development of good employment practices, this book provides practical guidelines for good practice in regard to teleworkers that recognize that teleworking is not a single category, but covers at least five distinct groups with…
21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part set...
21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 113.5 Section... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10, 113.40..., methods, practices, and controls used by the commercial processor in the manufacture, processing, or...
Good Cell Culture Practice for stem cells and stem-cell-derived models.

PubMed

Pamies, David; Bal-Price, Anna; Simeonov, Anton; Tagle, Danilo; Allen, Dave; Gerhold, David; Yin, Dezhong; Pistollato, Francesca; Inutsuka, Takashi; Sullivan, Kristie; Stacey, Glyn; Salem, Harry; Leist, Marcel; Daneshian, Mardas; Vemuri, Mohan C; McFarland, Richard; Coecke, Sandra; Fitzpatrick, Suzanne C; Lakshmipathy, Uma; Mack, Amanda; Wang, Wen Bo; Yamazaki, Daiju; Sekino, Yuko; Kanda, Yasunari; Smirnova, Lena; Hartung, Thomas

2017-01-01

The first guidance on Good Cell Culture Practice (GCCP) dates back to 2005. This document expands this to include aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice that can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times. This includes recommendations for the documentation and reporting of culture conditions. It is intended as guidance to facilitate the generation of reliable data from cell culture systems, and is not intended to conflict with local or higher level legislation or regulatory requirements. It may not be possible to meet all recommendations in this guidance for practical, legal or other reasons. However, when it is necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and the safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. This workshop report is considered a first step toward a revised GCCP 2.0.
Good Practices in Forensic Toxicology.

PubMed

Drummer, Olaf H

2017-01-01

This manuscript provides an overview for analysts, medical and scientific investigators, and laboratory administrators, the range of factors that should be considered to implement best practice forensic toxicology. These include laboratory influence over the collection of specimens, their proper transport and chain-of-custody before arrival in the laboratory. In addition, the laboratory needs to ensure properly trained staff use suitably validated and documented analytical procedures that meet the intended purpose and type of case in an accredited or suitably quality oriented management system. To assist the investigating officers laboratory results require an interpretation over their possible significance when sufficient details are available over the circumstances of the case. This requires a thorough understanding of the various factors that influence concentrations of substances and ultimately their likely physiological effect. These include consideration of the route of ingestion, influence over chronicity of usage on tissue concentrations and tolerance, possible combined drug effects or likely adverse reactions and consideration of relevant genetic factors that may have influenced pharmacokinetic or pharmacodynamic response. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.
Top 10 metrics for life science software good practices.

PubMed

Artaza, Haydee; Chue Hong, Neil; Corpas, Manuel; Corpuz, Angel; Hooft, Rob; Jimenez, Rafael C; Leskošek, Brane; Olivier, Brett G; Stourac, Jan; Svobodová Vařeková, Radka; Van Parys, Thomas; Vaughan, Daniel

2016-01-01

Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here.
Top 10 metrics for life science software good practices

PubMed Central

2016-01-01

Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here. PMID:27635232
21 CFR 123.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 123.5 Section...) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current good manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities, methods...
[What everybody should know about good clinical practices].

PubMed

Osorio, Lyda

2015-01-01

An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.
21 CFR 114.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 114.5 Section...) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good manufacturing practice. The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in part...
21 CFR 210.1 - Status of current good manufacturing practice regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice regulations...
Good practices in Local Government - A first overview of Portuguese reality

NASA Astrophysics Data System (ADS)

Carvalhosa, P.; Portela, F.; Machado, J.; Santos, M. F.; Abelha, A.

2017-03-01

Good practices in eGov are being increasingly used by Local Governments being that it is considered by them as an advantage. The main goal is providing to the town hall a differentiation point and approximate their services to the citizens. For this, it is necessary to define and apply innovative strategies in order to increase the use of services by the citizens. This paper is framed in a research work and it presents a first overview of the existing good practices in eGov, taking in consideration the Portuguese’s reality. The good practices identified were distinguished with many awards and with a positive response from the target audience. The use of digital marketing strategies aims to increase their membership and coming closer the municipalities of its citizens through the dissemination of the good practices. At this moment the data collected are almost exclusively of good practice in Portugal, however some international practices were also identified. As a result of this study the community has a list of good practices that can be applied in their municipalities.
Emerging Good Practices for Transforming Value Assessment: Patients' Voices, Patients' Values.

PubMed

Perfetto, Eleanor M; Harris, Jason; Mullins, C Daniel; dosReis, Susan

2018-04-01

Patient engagement is a transformative strategy for improving value assessment. US value framework developers have increased engagement activities, but more needs to be learned about how to best achieve meaningful patient engagement in value assessment. The objective was to glean good practices in patient engagement emerging from patient community experiences, to be used in value assessment. The National Health Council Value Workgroup conducted a survey and held a focus group with its member advocacy organizations to gather experiences with value framework developers and views on emerging good practices. Ten of 13 organizations completed the survey; reporting 13 interactions with four framework developers. Most rated experiences as "good" to "very good." Emerging good practices included (1) engage early; (2) engage a range of patients; (3) leverage patient-provided information, data resources, and outreach mechanisms; (4) be transparent; and (5) appreciate and accommodate resource constraints. Twelve of 13 organizations participated in the focus group, and this produced 30 emerging good practices in four areas: (1) timing; (2) methodology and data; (3) partnering; and (4) characterizing engagement. Patient engagement was limited in early development of value frameworks but has increased in the past few years. Patient groups report positive experiences that can serve as emerging good practices. These groups also reported experienced challenges in their interactions and recommended good practices to mitigate those challenges. The growing pool of patient engagement experiences can be translated into good practices to advance a patient-centered, value-driven health care ecosystem. Lessons learned from these early experiences can help establish recommend emerging good practices that can eventually result in best practices and standards in the field. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc
75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-01

.... FDA-1999-N-3539] (formerly Docket No. 1999N-4783) Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... Subjects in 21 CFR Part 10 Administrative practice and procedure, News media. 0 Therefore, under the...

The vendor/laboratory manager relationship: some practical negotiation tips.

PubMed

Bickford, G R

1993-01-01

We negotiate practically every minute of the day with ourselves, as well as with spouses or loved ones, family members, friends, bosses, and coworkers. Skilled negotiators search for the common good, present accurate information, create alternatives, and strive for agreements that are fair to all concerned. Those who use misinformation and manipulation to win their short-term positions fail to build long-term relationships. Developing a positive attitude toward negotiating involves experience, recognizing the negotiating mechanism, evaluating decisions, and correctly determining when to stop negotiating and move on. Negotiations between suppliers and laboratory managers are used in this article to illustrate these processes.
[Good drug distribution practice and its implementation in drug distribution companies].

PubMed

Draksiene, Gailute

2002-01-01

Good Distribution Practice is based on the Directive of the Board of the European Community 92/25/EEC regarding the wholesale distribution of drugs for human consumption. It is stated in the Directive that the whole drug distribution channel is to be controlled from the point of drug production or import down to the supplies to the end user. In order to reach the goal, the drug distribution company must create the quality assurance system and facilitate its correct functioning. This aim requires development of the rules of the Good Distribution Practice. Those rules set the general requirements of the Good Distribution Practice for distribution companies that they must conduct. The article explains main requirements postulated in the rules of the Good Distribution Practice and implementation of the Good Distribution Practice requirements in drug distribution companies.
Good practices in free-energy calculations.

PubMed

Pohorille, Andrew; Jarzynski, Christopher; Chipot, Christophe

2010-08-19

As access to computational resources continues to increase, free-energy calculations have emerged as a powerful tool that can play a predictive role in a wide range of research areas. Yet, the reliability of these calculations can often be improved significantly if a number of precepts, or good practices, are followed. Although the theory upon which these good practices rely has largely been known for many years, it is often overlooked or simply ignored. In other cases, the theoretical developments are too recent for their potential to be fully grasped and merged into popular platforms for the computation of free-energy differences. In this contribution, the current best practices for carrying out free-energy calculations using free energy perturbation and nonequilibrium work methods are discussed, demonstrating that at little to no additional cost, free-energy estimates could be markedly improved and bounded by meaningful error estimates. Monitoring the probability distributions that underlie the transformation between the states of interest, performing the calculation bidirectionally, stratifying the reaction pathway, and choosing the most appropriate paradigms and algorithms for transforming between states offer significant gains in both accuracy and precision.
Recommended practices for the management of embryology, andrology, and endocrinology laboratories: a committee opinion.

PubMed

2014-10-01

This document provides a general overview for physicians of the qualities and conditions necessary for good management practices within the endocrinology, andrology, and embryology laboratories in the United States. It is intended as an addendum to previously published guidelines that further detail these responsibilities. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
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.
Laboratory-supported influenza surveillance in Victorian sentinel general practices.

PubMed

Kelly, H; Murphy, A; Leong, W; Leydon, J; Tresise, P; Gerrard, M; Chibo, D; Birch, C; Andrews, R; Catton, M

2000-12-01

Laboratory-supported influenza surveillance is important as part of pandemic preparedness, for identifying and isolating candidate vaccine strains, for supporting trials of anti-influenza drugs and for refining the influenza surveillance case definition in practice. This study describes the implementation of laboratory-supported influenza surveillance in Victorian sentinel general practices and provides an estimate of the proportion of patients with an influenza-like illness proven to have influenza. During 1998 and 1999, 25 sentinel general practices contributed clinical surveillance data and 16 metropolitan practices participated in laboratory surveillance. Serological, virus-antigen detection, virus culture and multiplex polymerase chain reaction procedures were used to establish the diagnosis of influenza. Two laboratories at major teaching hospitals in Melbourne provided additional data on influenza virus identification. General practice sentinel surveillance and laboratory identification of influenza provided similar data on the pattern of influenza in the community between May and September. The clinical suspicion of influenza was confirmed in 49 to 54 per cent of cases seen in general practice.
Protection of people and environment from radiation risk through good regulatory practice

NASA Astrophysics Data System (ADS)

Jais, Azlina Mohammad; Hassan, Najwa

2017-01-01

The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be
Do quality indicators for general practice teaching practices predict good outcomes for students?

PubMed

Bartlett, Maggie; Potts, Jessica; McKinley, Bob

2016-07-01

Keele medical students spend 113 days in general practices over our five-year programme. We collect practice data thought to indicate good quality teaching. We explored the relationships between these data and two outcomes for students; Objective Structured Clinical Examination (OSCE) scores and feedback regarding the placements. Though both are surrogate markers of good teaching, they are widely used. We collated practice and outcome data for one academic year. Two separate statistical analyses were carried out: (1) to determine how much of the variation seen in the OSCE scores was due to the effect of the practice and how much to the individual student. (2) to identify practice characteristics with a relationship to student feedback scores. (1) OSCE performance: 268 students in 90 practices: six quality indicators independently influenced the OSCE score, though without linear relationships and not to statistical significance. (2) Student satisfaction: 144 students in 69 practices: student feedback scores are not influenced by practice characteristics. The relationships between the quality indicators we collect for practices and outcomes for students are not clear. It may be that neither the quality indicators nor the outcome measures are reliable enough to inform decisions about practices' suitability for teaching.
Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

ERIC Educational Resources Information Center

Hanson, Jana M.; Paulsen, Michael B.; Pascarella, Ernest T.

2016-01-01

This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at 4-year colleges and universities in the USA. We examined whether eight good teaching practices (non-classroom interactions with faculty, prompt…
Evaluation Instruments and Good Practices in Online Education

ERIC Educational Resources Information Center

Baldwin, Sally J.; Trespalacios, Jesús

2017-01-01

Chickering and Gamson's (1987) "Seven Principles for Good Practice in Undergraduate Education" offers extensively researched and validated tenets for best practices in higher education. After a review of the literature, twenty-eight evaluation instruments currently used to design and review online courses in higher education institutions…
Behavioral Patterns in Special Education. Good Teaching Practices.

PubMed

Rodríguez-Dorta, Manuela; Borges, África

2017-01-01

Providing quality education means to respond to the diversity in the classroom. The teacher is a key figure in responding to the various educational needs presented by students. Specifically, special education professionals are of great importance as they are the ones who lend their support to regular classroom teachers and offer specialized educational assistance to students who require it. Therefore, special education is different from what takes place in the regular classroom, demanding greater commitment by the teacher. There are certain behaviors, considered good teaching practices, which teachers have always been connected with to achieve good teaching and good learning. To ensure that these teachers are carrying out their educational work properly it is necessary to evaluate. This means having appropriate instruments. The Observational Protocol for Teaching Functions in Primary School and Special Education (PROFUNDO-EPE, v.3., in Spanish) allows to capture behaviors from these professionals and behavioral patterns that correspond to good teaching practices. This study evaluates the behavior of two special education teachers who work with students from different educational stages and educational needs. It reveals that the analyzed teachers adapt their behavior according the needs and characteristics of their students to the students responding more adequately to the needs presented by the students and showing good teaching practices. The patterns obtained indicate that they offer support, help and clear guidelines to perform the tasks. They motivate them toward learning by providing positive feedback and they check that students have properly assimilated the contents through questions or non-verbal supervision. Also, they provide a safe and reliable climate for learning.
Good Practices in Free-energy Calculations

NASA Technical Reports Server (NTRS)

Pohorille, Andrew; Jarzynski, Christopher; Chipot, Christopher

2013-01-01

As access to computational resources continues to increase, free-energy calculations have emerged as a powerful tool that can play a predictive role in drug design. Yet, in a number of instances, the reliability of these calculations can be improved significantly if a number of precepts, or good practices are followed. For the most part, the theory upon which these good practices rely has been known for many years, but often overlooked, or simply ignored. In other cases, the theoretical developments are too recent for their potential to be fully grasped and merged into popular platforms for the computation of free-energy differences. The current best practices for carrying out free-energy calculations will be reviewed demonstrating that, at little to no additional cost, free-energy estimates could be markedly improved and bounded by meaningful error estimates. In energy perturbation and nonequilibrium work methods, monitoring the probability distributions that underlie the transformation between the states of interest, performing the calculation bidirectionally, stratifying the reaction pathway and choosing the most appropriate paradigms and algorithms for transforming between states offer significant gains in both accuracy and precision. In thermodynamic integration and probability distribution (histogramming) methods, properly designed adaptive techniques yield nearly uniform sampling of the relevant degrees of freedom and, by doing so, could markedly improve efficiency and accuracy of free energy calculations without incurring any additional computational expense.
Editorial: A Note on Good Research Practice

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

Dooley, James J.

Good scientific practice and research misconduct have been concerns of mine for more than a decade (Dooley and Kerch, 2000) and in my role as an editor of the International Journal of Greenhouse Gas Control, I feel it is time to speak up and at the very least share my concerns and suggestions as they relate to the integrity of the research published in this journal. Rather than wait to write an editorial on good research practices in response to a major incident, I thought it might be best to be proactive and address some of the trends we seemore » in submissions to this peer reviewed journal and to offer some suggestions for improvement improving the level of scholarship in some – but by no means all – of the papers submitted.« less
Behavioral Patterns in Special Education. Good Teaching Practices

PubMed Central

Rodríguez-Dorta, Manuela; Borges, África

2017-01-01

Providing quality education means to respond to the diversity in the classroom. The teacher is a key figure in responding to the various educational needs presented by students. Specifically, special education professionals are of great importance as they are the ones who lend their support to regular classroom teachers and offer specialized educational assistance to students who require it. Therefore, special education is different from what takes place in the regular classroom, demanding greater commitment by the teacher. There are certain behaviors, considered good teaching practices, which teachers have always been connected with to achieve good teaching and good learning. To ensure that these teachers are carrying out their educational work properly it is necessary to evaluate. This means having appropriate instruments. The Observational Protocol for Teaching Functions in Primary School and Special Education (PROFUNDO-EPE, v.3., in Spanish) allows to capture behaviors from these professionals and behavioral patterns that correspond to good teaching practices. This study evaluates the behavior of two special education teachers who work with students from different educational stages and educational needs. It reveals that the analyzed teachers adapt their behavior according the needs and characteristics of their students to the students responding more adequately to the needs presented by the students and showing good teaching practices. The patterns obtained indicate that they offer support, help and clear guidelines to perform the tasks. They motivate them toward learning by providing positive feedback and they check that students have properly assimilated the contents through questions or non-verbal supervision. Also, they provide a safe and reliable climate for learning. PMID:28512437
Robust data enables managers to promote good practice.

PubMed

Bassett, Sally; Westmore, Kathryn

2012-11-01

This is the third in a series of articles examining the components of good corporate governance. The effective and efficient use of information and sources of information is crucial for good governance. This article explores the ways in which boards and management can obtain and use information to monitor performance and promote good practice, and how boards can be assured about the quality of information on which they rely. The final article in this series will look at the role of accountability in corporate governance.
21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) General Provisions § 212.2 What is current good manufacturing practice for...
21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Applicability of current good manufacturing practice regulations. 210.2 Section 210.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...
Alternative Pathways to Apprenticeships. Good Practice Guide

ERIC Educational Resources Information Center

National Centre for Vocational Education Research (NCVER), 2015

2015-01-01

Apprenticeships are changing. The increasing proportions of people entering apprenticeships at various levels of ability and backgrounds are stimulating demand for alternative pathways to completions. This good practice guide assembles the key findings for education practitioners and workplace supervisors from three related research reports on…
47 CFR 73.508 - Standards of good engineering practice.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 4 2010-10-01 2010-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...
47 CFR 73.508 - Standards of good engineering practice.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 4 2014-10-01 2014-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

47 CFR 73.508 - Standards of good engineering practice.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 4 2012-10-01 2012-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...
47 CFR 73.508 - Standards of good engineering practice.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 4 2013-10-01 2013-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...
47 CFR 73.508 - Standards of good engineering practice.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 4 2011-10-01 2011-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...
Quality assurance of laboratory work and clinical use of laboratory tests in general practice in norway: a survey.

PubMed

Thue, Geir; Jevnaker, Marianne; Gulstad, Guri Andersen; Sandberg, Sverre

2011-09-01

Virtually all the general practices in Norway participate in the Norwegian Quality Improvement of Laboratory Services in Primary Care, NOKLUS. In order to assess and develop NOKLUS's services, it was decided to carry out an investigation in the largest participating group, general practices. In autumn 2008 a questionnaire was sent to all Norwegian general practices asking for feedback on different aspects of NOKLUS's main services: contact with medical laboratory technologists, sending of control materials, use and maintenance of practice-specific laboratory binders, courses, and testing of laboratory equipment. In addition, attitudes were elicited towards possible new services directed at assessing other technical equipment and clinical use of tests. Responses were received from 1290 of 1552 practices (83%). The great majority thought that the frequency of sending out control material should continue as at present, and they were pleased with the feedback reports and follow-up by the laboratory technologists in the counties. Even after many years of practical experience, there is still a need to update laboratory knowledge through visits to practices, courses, and written information. Practices also wanted quality assurance of blood pressure meters and spirometers, and many doctors wanted feedback on their use of laboratory tests. Services regarding quality assurance of point-of-care tests, guidance, and courses should be continued. Quality assurance of other technical equipment and of the doctor's clinical use of laboratory tests should be established as part of comprehensive quality assurance.
Improving nutritional care: innovation and good practice.

PubMed

Chapman, Carol; Barker, Mary; Lawrence, Wendy

2015-04-01

This paper presents examples of good practice in nutritional screening and care and identifies methods used to overcome contextual constraints and discusses the implications for nursing practice in hospitals. Nutritional screening is an important step in identifying those at risk of malnutrition, but does not produce improved nutritional care unless it results in a care plan that is acted on. The importance of nutrition and implications for clinical care make it imperative to improve practice. Qualitative investigation. Between January 2011-February 2012, focus groups were held using a semi-structured discussion guide with nine groups of health professionals (n = 80) from one hospital: four with nurses, three with doctors and two with dietitians. Discussions were audio-recorded, transcribed and coded into themes and sub-themes, which were then depicted in a thematic map and illustrated with verbatim quotes. Three strategies for sustaining effective nutritional practice emerged: establishing routines to ensure screening was undertaken; re-organizing aspects of care to promote good practice; developing innovative approaches. Issues to be addressed were the perceived disconnection between mandatory screening and the delivery of effective care, a requirement for nutrition education, organizational constraints of a large university hospital and the complexities of multidisciplinary working. Professionals seeking to improve nutritional care in hospitals need to understand the interaction of system and person to facilitate change. Nursing staff need to be able to exercise autonomy and the hospital system must offer enough flexibility to allow wards to organize nutritional screening and care in a way that meets the needs of individual patients. © 2014 John Wiley & Sons Ltd.
21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...
21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...
21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...
21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...
Good enough practices in scientific computing.

PubMed

Wilson, Greg; Bryan, Jennifer; Cranston, Karen; Kitzes, Justin; Nederbragt, Lex; Teal, Tracy K

2017-06-01

Computers are now essential in all branches of science, but most researchers are never taught the equivalent of basic lab skills for research computing. As a result, data can get lost, analyses can take much longer than necessary, and researchers are limited in how effectively they can work with software and data. Computing workflows need to follow the same practices as lab projects and notebooks, with organized data, documented steps, and the project structured for reproducibility, but researchers new to computing often don't know where to start. This paper presents a set of good computing practices that every researcher can adopt, regardless of their current level of computational skill. These practices, which encompass data management, programming, collaborating with colleagues, organizing projects, tracking work, and writing manuscripts, are drawn from a wide variety of published sources from our daily lives and from our work with volunteer organizations that have delivered workshops to over 11,000 people since 2010.
Tourism. Leonardo da Vinci Series: Good Practices.

ERIC Educational Resources Information Center

Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

This brochure, part of a series about good practices in vocational training in the European Union, describes 10 projects that have promoted investment in human resources through training in the tourism sector to promote sustainable, or responsible, tourism. The projects and their countries of origin are as follows: (1) BEEFT, training of mobility…
21 CFR 606.140 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of scientifically...
21 CFR 606.140 - Laboratory controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of scientifically...
21 CFR 606.140 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of scientifically...
21 CFR 606.140 - Laboratory controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of scientifically...
[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.
78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...
Reducing the Environmental Impact of Clinical Laboratories.

PubMed

Lopez, Joseph B; Jackson, David; Gammie, Alistair; Badrick, Tony

2017-02-01

Healthcare is a significant contributor to environmental impact but this has received little attention. The typical laboratory uses far more energy and water per unit area than the typical office building. There is a need to sensitise laboratories to the importance of adopting good environmental practices. Since this comes at an initial cost, it is vital to obtain senior management support. Convincing management of the various tangible and intangible benefits that can accrue in the long run should help achieve this support. Many good environmental practices do not have a cost but will require a change in the culture and mind-set of the organisation. Continuing education and training are important keys to successful implementation of good practices. There is a need to undertake a rigorous cost-benefit analysis of every change that is introduced in going green. The adoption of good practices can eventually lead to ISO certification if this is desired. This paper provides suggestions that will allow a laboratory to start going green. It will allow the industry to enhance its corporate citizenship whilst improving its competitive advantage for long-term.
Good Policy, Good Practice II. Improving Outcomes and Productivity in Higher Education: A Guide for Policymakers

ERIC Educational Resources Information Center

Brenneman, Meghan Wilson; Callan, Patrick M.; Ewell, Peter T.; Finney, Joni E.; Jones, Dennis P.; Zis, Stacey

2010-01-01

This new edition of "Good Policy, Good Practice II" revises and updates the authors' 2007 publication. Like the earlier edition, it responds to one of the questions that is raised most frequently in the authors' work with public policy and education leaders as they begin to address the national and state imperatives to increase the proportion of…
[Identification of Good-Practice Projects in Promoting Physical Activity - Methods, Pitfalls and Sampled Outcomes].

PubMed

Henn, Annette; Karger, Claudia; Wöhlken, Katrin; Meier, Diana; Ungerer-Röhrich, Ulrike; Graf, Christine; Woll, Alexander

2017-03-01

The aim of this paper is to identify and show examples of good practice of public health promotion. For this, uniform quality criteria were worked out under consideration of national and international scientific literature.For the identification of examples of good practice, a comparison of different quality criteria was carried out and combined with each other in a first step. In the following step, examples of good practice were identified after a comprehensive search. The choice of the "good-practice" projects is exemplary and lays no claim to completeness.6 main quality criteria (QC) of programs promoting physical activity could be identified in the national and international context. The analysis showed altogether 10 projects which can exemplarily be classified as examples of good practice of the target groups of children and teenagers, adults, older people and people with pre-existing illnesses. These projects, however, show major differences in their (methodological) quality.The analysis reports a lack of "Good-Practice" examples. Deficits lie mainly in documentation and sustainability. Because of incomplete documentation, an assessment as a "Good-Practice" example is only possible to a limited extent; a lot of information, particularly in the evaluation, is missing. © Georg Thieme Verlag KG Stuttgart · New York.

Principles of Good Practice in SoTL

ERIC Educational Resources Information Center

Felten, Peter

2013-01-01

For the Scholarship of Teaching and Learning (SoTL) to be understood as significant intellectual work in the academy, SoTL practitioners need to identify shared principles of good practice. While honoring the diversity of SoTL in its many forms across the globe, such principles can serve as a heuristic for assessing work in our field. These…
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...
21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good manufacturing...
Investigating School-Wide Antecedents of Good Practice Dissemination from Individual Subject Projects

ERIC Educational Resources Information Center

Christophersen, Knut-Andreas; Elstad, Eyvind; Turmo, Are

2012-01-01

Good practice dissemination is an unsolved problem in education. This article describes how clear and "soft" leadership and perceptions of social and economic exchange operate in the bottom-up processes of school reforms and examines the relative impact of these factors on school-wide good practice dissemination and discusses how…
The Conditional Nature of High Impact/Good Practices on Student Learning Outcomes

ERIC Educational Resources Information Center

Seifert, Tricia A.; Gillig, Benjamin; Hanson, Jana M.; Pascarella, Ernest T.; Blaich, Charles F.

2014-01-01

Using a multi-institutional sample of undergraduate students, this study found that the relationships between engaging in high impact/good practices and liberal arts outcomes differ based on students' precollege and background characteristics. Findings suggest that high impact/good practices are not a panacea and require a greater degree of…
Emergency management training program: Guide to good practice

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

Not Available

1991-07-01

The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate componentsmore » of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager's point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.« less
Emergency management training program: Guide to good practice

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

Not Available

1991-07-01

The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate componentsmore » of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager`s point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.« less
Nursing practice: compassionate deception and the Good Samaritan.

PubMed

Tuckett, A

1999-09-01

This article reviews the literature on deception to illuminate the phenomenon as a background for an appraisal within nursing. It then describes nursing as a practice of caring. The character of the Good Samaritan is recommended as indicative of the virtue of compassion that ought to underpin caring in nursing practice. Finally, the article concludes that a caring nurse, responding virtuously, acts by being compassionate, for a time recognizing the prima facie nature of the rules or principles of truth telling.
Management Documentation: Indicators & Good Practice at Cultural Heritage Places

NASA Astrophysics Data System (ADS)

Eppich, R.; Garcia Grinda, J. L.

2015-08-01

Documentation for cultural heritage places usually refers to describing the physical attributes, surrounding context, condition or environment; most of the time with images, graphics, maps or digital 3D models in their various forms with supporting textural information. Just as important as this type of information is the documentation of managerial attributes. How do managers of cultural heritage places collect information related to financial or economic well-being? How are data collected over time measured, and what are significant indicators for improvement? What quality of indicator is good enough? Good management of cultural heritage places is essential for conservation longevity, preservation of values and enjoyment by the public. But how is management documented? The paper will describe the research methodology, selection and description of attributes or indicators related to good management practice. It will describe the criteria for indicator selection and why they are important, how and when they are collected, by whom, and the difficulties in obtaining this information. As importantly it will describe how this type of documentation directly contributes to improving conservation practice. Good practice summaries will be presented that highlight this type of documentation including Pamplona and Ávila, Spain and Valletta, Malta. Conclusions are drawn with preliminary recommendations for improvement of this important aspect of documentation. Documentation of this nature is not typical and presents a unique challenge to collect, measure and communicate easily. However, it is an essential category that is often ignored yet absolutely essential in order to conserve cultural heritage places.
The confusion in complying with good manufacturing practice requirements in Malaysia

NASA Astrophysics Data System (ADS)

Jali, Mohd Bakri; Ghani, Maaruf Abdul; Nor, Norazmir Md

2016-11-01

Food manufacturing operations need to fulfil regulatory requirements related to hygiene and good manufacturing practices (GMP) to successfully market their products as safe and quality products. GMP based on its ten elements used as guidelines to ensure control over biological, chemical and physical hazards. This study aims to investigate the confusion for design and facilities elements among food industries. Both qualitative and quantitative techniques are used as systematic tools. Design and facilities elements lay a firm foundation for good manufacturing practice to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines.
Online Assessment of Learning and Engagement in University Laboratory Practicals

ERIC Educational Resources Information Center

Whitworth, David E.; Wright, Kate

2015-01-01

In science education, laboratory practicals are frequently assessed through submission of a report. A large increase in student numbers necessitated us adapting a traditional practical report into an online test with automated marking. The assessment was designed to retain positive features of the traditional laboratory report but with added…
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.
FDA-Proposed Lab Practice Regulations Scored

ERIC Educational Resources Information Center

Murray, Chris

1977-01-01

Discusses the negative reactions to the Food & Drug Administration's proposed good laboratory practices for nonclinical laboratory practices. Industry representatives protest the inflexibility and excessive detail in the regulations. (MLH)
21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...
21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...
21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...
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...
Developing laboratory networks: a practical guide and application.

PubMed

Kirk, Carol J; Shult, Peter A

2010-01-01

The role of the public health laboratory (PHL) in support of public health response has expanded beyond testing to include a number of other core functions, such as emergency response, training and outreach, communications, laboratory-based surveillance, and laboratory data management. These functions can only be accomplished by a network that includes public health and other agency laboratories and clinical laboratories. It is a primary responsibility of the PHL to develop and maintain such a network. In this article, we present practical recommendations-based on 17 years of network development experience-for the development of statewide laboratory networks. These recommendations, and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of laboratory networks will enhance each state's public health system and is critical to the development of a robust national Laboratory Response Network.
"Inclusive Working Life" in Norway--experience from "Models of Good Practice" enterprises.

PubMed

Lie, Arve

2008-08-01

To determine whether enterprises belonging to the Bank of Models of Good Practice were more successful than average Norwegian enterprises in the reduction of sickness absence, promotion of early return to work, and prevention of early retirement. In 2004 we selected 86 enterprises with a total of approximately 90000 employees from the Inclusive Working Life (IWL) Bank of Models of Good Practice. One representative of workers and one of management from each enterprise received a questionnaire on the aims, organization, and the results of the IWL program by mail. Data on sickness absence, use of early retirement, and disability retirement in the 2000-2004 period were collected from the National Insurance Registry. Data on comparable enterprises were obtained from the National Bureau of Statistics. The response rate was 65%. Although the IWL campaign was directed at reducing sickness absence, preventing early retirement, and promoting employment of the functionally impaired, most attention was paid to reducing sickness absence. Sickness absence rate in Models of Good Practice enterprises (8.2%) was higher than in comparable enterprises that were not part of the Models of Good Practice (6.9%). Implementation of many IWL activities, empowerment and involvement of employees, and good cooperation with the occupational health service were associated with a lower rate of sickness absence. On average, 0.7% new employees per year received disability pension, which is a significantly lower percentage than expected on the basis of the rate of 1.3% per year in comparable enterprises. Frequent use of disability pensioning was associated with high rate of sickness absence and having many employees older than 50 years. On average, 0.4% employees per year received early retirement compensation, which was expected on the basis of national estimates. Frequent use of early retirement was associated with having many employees older than 50 years. Models of Good Practice enterprises had

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...
Good practices for quantitative bias analysis.

PubMed

Lash, Timothy L; Fox, Matthew P; MacLehose, Richard F; Maldonado, George; McCandless, Lawrence C; Greenland, Sander

2014-12-01

Quantitative bias analysis serves several objectives in epidemiological research. First, it provides a quantitative estimate of the direction, magnitude and uncertainty arising from systematic errors. Second, the acts of identifying sources of systematic error, writing down models to quantify them, assigning values to the bias parameters and interpreting the results combat the human tendency towards overconfidence in research results, syntheses and critiques and the inferences that rest upon them. Finally, by suggesting aspects that dominate uncertainty in a particular research result or topic area, bias analysis can guide efficient allocation of sparse research resources. The fundamental methods of bias analyses have been known for decades, and there have been calls for more widespread use for nearly as long. There was a time when some believed that bias analyses were rarely undertaken because the methods were not widely known and because automated computing tools were not readily available to implement the methods. These shortcomings have been largely resolved. We must, therefore, contemplate other barriers to implementation. One possibility is that practitioners avoid the analyses because they lack confidence in the practice of bias analysis. The purpose of this paper is therefore to describe what we view as good practices for applying quantitative bias analysis to epidemiological data, directed towards those familiar with the methods. We focus on answering questions often posed to those of us who advocate incorporation of bias analysis methods into teaching and research. These include the following. When is bias analysis practical and productive? How does one select the biases that ought to be addressed? How does one select a method to model biases? How does one assign values to the parameters of a bias model? How does one present and interpret a bias analysis?. We hope that our guide to good practices for conducting and presenting bias analyses will encourage
21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...
21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...
21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...
21 CFR 113.5 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...
21 CFR 129.1 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... drinking water are in conformance with or are operated or administered in conformity with good manufacturing practice to assure that bottled drinking water is safe and that it has been processed, bottled...) FOOD FOR HUMAN CONSUMPTION PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER General Provisions § 129.1...
21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...
21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...
21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...
21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...
21 CFR 120.5 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...
Using the Laboratory to Engage All Students in Science Practices

ERIC Educational Resources Information Center

Walker, J. P.; Sampson, V.; Southerland, S.; Enderle, P. J.

2016-01-01

This study examines the extent to which the type of instruction used during a general chemistry laboratory course affects students' ability to use core ideas to engage in science practices. We use Ford's (2008) description of the nature of scientific practices to categorize what students do in the laboratory as either empirical or…
ASSESSMENT OF GOOD PRACTICES IN HOSPITAL FOOD SERVICE BY COMPARING EVALUATION TOOLS.

PubMed

Macedo Gonçalves, Juliana; Lameiro Rodrigues, Kelly; Santiago Almeida, Ângela Teresinha; Pereira, Giselda Maria; Duarte Buchweitz, Márcia Rúbia

2015-10-01

since food service in hospitals complements medical treatment, it should be produced in proper hygienic and sanitary conditions. It is a well-known fact that food-transmitted illnesses affect with greater severity hospitalized and immunosuppressed patients. good practices in hospital food service are evaluated by comparing assessment instruments. good practices were evaluated by a verification list following Resolution of Collegiate Directory n. 216 of the Brazilian Agency for Sanitary Vigilance. Interpretation of listed items followed parameters of RCD 216 and the Brazilian Association of Collective Meals Enterprises (BACME). Fisher's exact test was applied to detect whether there were statistically significant differences. Analysis of data grouping was undertaken with Unweighted Pair-group using Arithmetic Averages, coupled to a correlation study between dissimilarity matrixes to verify disagreement between the two methods. Good Practice was classified with mean total rates above 75% by the two methods. There were statistically significant differences between services and food evaluated by BACME instrument. Hospital Food Services have proved to show conditions of acceptable good practices. the comparison of interpretation tools based on RCD n. 216 and BACME provided similar results for the two classifications. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
Good practices : incorporating safety into resurfacing and restoration projects

DOT National Transportation Integrated Search

2006-12-01

Integrating safety improvements into resurfacing and restoration projects is a subject of long-standing interest by Federal, State, and local transportation agencies. A Scan Tour was conducted to identify and subsequently observe good practices in th...
Good Practice in GNVQ Induction Programmes. Project Report.

ERIC Educational Resources Information Center

Benett, Yves

A 2-year research and development project was conducted to identify existing good practices for introducing students in the United Kingdom (UK) to General National Vocational Qualifications (GNVQs) and available teaching and learning materials for use in the induction of GNVQs in UK schools and colleges. The main activities of the project's three…
GUIDING PRINCIPLES FOR GOOD PRACTICES IN HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT UNITS.

PubMed

Sampietro-Colom, Laura; Lach, Krzysztof; Pasternack, Iris; Wasserfallen, Jean-Blaise; Cicchetti, Americo; Marchetti, Marco; Kidholm, Kristian; Arentz-Hansen, Helene; Rosenmöller, Magdalene; Wild, Claudia; Kahveci, Rabia; Ulst, Margus

2015-01-01

Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA units. A framework for good practice criteria was built inspired by the EFQM excellence business model and information from six literature reviews, 107 face-to-face interviews, forty case studies, large-scale survey, focus group, Delphi survey, as well as local and international validation. In total, 385 people from twenty countries have participated in defining the principles for good practices in HB-HTA units. Fifteen guiding principles for good practices in HB-HTA units are grouped in four dimensions. Dimension 1 deals with principles of the assessment process aimed at providing contextualized information for hospital decision makers. Dimension 2 describes leadership, strategy and partnerships of HB-HTA units which govern and facilitate the assessment process. Dimension 3 focuses on adequate resources that ensure the operation of HB-HTA units. Dimension 4 deals with measuring the short- and long-term impact of the overall performance of HB-HTA units. Finally, nine core guiding principles were selected as essential requirements for HB-HTA units based on the expertise of the HB-HTA units participating in the project. Guiding principles for good practices set up a benchmark for HB-HTA because they represent the ideal performance of HB-HTA units; nevertheless, when performing HTA at hospital level, context also matters; therefore, they should be adapted to ensure their applicability in the local context.
Guide to good practices for operations and administration updates through required reading

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

Not Available

1992-12-01

The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, Conduct of Operations Requirements for DOE Facilities.'' (JDB)
Guide to good practices for operations and administration updates through required reading

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

Not Available

1992-12-01

The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, ``Conduct of Operations Requirements for DOE Facilities.`` (JDB)
Safety and health practice among laboratory staff in Malaysian education sector

NASA Astrophysics Data System (ADS)

Husna Che Hassan, Nurul; Rasdan Ismail, Ahmad; Kamilah Makhtar, Nor; Azwadi Sulaiman, Muhammad; Syuhadah Subki, Noor; Adilah Hamzah, Noor

2017-10-01

Safety is the most important issue in industrial sector such as construction and manufacturing. Recently, the increasing number of accident cases reported involving school environment shows the important of safety issues in education sector. Safety awareness among staff in this sector is crucial in order to find out the method to prevent the accident occurred in future. This study was conducted to analyze the knowledge of laboratory staff in term of safety and health practice in laboratory. Survey questionnaires were distributing among 255 of staff laboratory from ten District Education Offices in Kelantan. Descriptive analysis shows that the understanding of safety and health practice are low while doing some job activities in laboratory. Furthermore, some of the staff also did not implemented safety practice that may contribute to unplanned event occur in laboratory. Suggestion that the staff at laboratory need to undergo on Occupational Safety and Health training to maintain and create safe environment in workplaces.

21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What is current good manufacturing practice for PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION...
Perceptions of good medical practice in the NHS: a survey of senior health professionals.

PubMed

Hutchinson, A; Williams, M; Meadows, K; Barbour, R S; Jones, R

1999-12-01

To categorize senior health professionals' experience with poor medical practice in hospitals and in general practice, to describe perceptions which senior NHS staff have of good medical practice, and to describe how problems of poor medical practice are currently managed. A postal questionnaire survey. The questionnaire sought perceptions of good medical practice, asked participants to characterise deviations from good practice, and to describe experience with managing poor performance at the time of the introduction of the General Medical Council (GMC) performance procedures. A range of NHS settings in the UK: hospital trusts, health authorities/boards, local medical committees, community health councils. Senior health professionals involved in the management of medical professional performance. Perceptions of what constitutes good medical practice. Most respondents considered that persistent problems related to clinical practice (diagnosis, management, and outcome and prescribing) would require local management and, possibly, referral to the GMC performance procedures. Informal mechanisms, including informal discussion, education, training, and work shifting, were the most usual means of handling a doctor whose performance was poor. Many took a less serious view of deficiencies in performance on manner and attitude and communication, although consultation skills rather than technical skills comprised the greatest number of complaints about doctors. Senior NHS professionals seem reluctant to consider persistently poor consultation skills in the same critical light as they do persistently poor technical practice. These attitudes may need to change with the implementation of clinical governance and updated guidance from the GMC on what constitutes good medical practice.
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…
Practical methodological guide for hydrometric inter-laboratory organisation

NASA Astrophysics Data System (ADS)

Besson, David; Bertrand, Xavier

2015-04-01

Discharge measurements performed by the French governmental hydrometer team feed a national database. This data is available for general river flows knowkedge, flood forecasting, low water survey, statistical calculations flow, control flow regulatory and many other uses. Regularly checking the measurements quality and better quantifying its accuracy is therefore an absolute need. The practice of inter-laboratory comparison in hydrometry particularly developed during the last decade. Indeed, discharge measurement can not easily be linked to a standard. Therefore, on-site measurement accuracy control is very difficult. Inter-laboratory comparison is thus a practical solution to this issue. However, it needs some regulations in order to ease its practice and legitimize its results. To do so, the French government hydrometrics teams produced a practical methodological guide for hydrometric inter-laboratory organisation in destination of hydrometers community in view of ensure the harmonization of inter-laboratory comparison practices for different materials (ADCP, current meter on wadind rod or gauging van, tracer dilution, surface speed) and flow range (flood, low water). Ensure the results formalization and banking. The realisation of this practice guide is grounded on the experience of the governmental teams & their partners (or fellows), following existing approaches (Doppler group especially). The guide is designated to validate compliance measures and identify outliers : Hardware, methodological, environmental, or human. Inter-laboratory comparison provides the means to verify the compliance of the instruments (devices + methods + operators) and provides methods to determine an experimental uncertainty of the tested measurement method which is valid only for the site and the measurement conditions but does not address the calibration or periodic monitoring of the few materials. After some conceptual definitions, the guide describes the different stages of an
76 FR 47593 - Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-05

...] Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' FDA has... consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency...
Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients

PubMed Central

Abdellah, Abubaker; Noordin, Mohamed Ibrahim; Wan Ismail, Wan Azman

2013-01-01

Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products’ quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines’ supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. The review outcomes demonstrate that there is a lack of accurately defined methods to evaluate and measure excipients’ safety. Furthermore good manufacturing practice requirements for excipients are not effectively globalized. PMID:25685037
21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2013 CFR

2013-04-01

... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...
21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2014 CFR

2014-04-01

... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...
21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

Code of Federal Regulations, 2012 CFR

2012-04-01

... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...
Tools to share good chairside teaching practice: a clinical scenario and appreciative questionnaire.

PubMed

Sweet, J; Wilson, J; Pugsley, L; Schofield, M

2008-12-13

This article provides a scenario for analysis of good chairside teaching practice to serve as a starting point for continued discussion in this complex field. Documented issues of good chairside teaching practice are cross-referenced to a clinical scenario with explanations in the form of a commentary. This provided the context for generating a set of questions that are provided as tools to support good chairside practice. These tools are designed to be used with 'Appreciative Inquiry', which claims that there is much to be gained by discovering where excellence is possible and elaborating upon this. Although this process can be carried out in single units or departments, it is proposed that collaboration between institutions would allow sharing of valuable innovations and greater understanding of educational training, production of good practice guidance and professional development of staff. This article is the third in a series of three and provides a scaffold for a scenario and questions to encourage collaboration in evolving and sharing good chairside teaching practice. The first article investigated the perceptions of stakeholders in chairside teaching at a single dental school and the second evaluated chairside teaching on a UK wide scale. A further accompanying article reviews some of the educational methodology and innovations in teaching and learning that may be applied to dentistry.
Distance Learning. Leonardo da Vinci Series: Good Practices.

ERIC Educational Resources Information Center

Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

This brochure, part of a series about good practices in vocational training in the European Union, describes 12 projects that use distance learning to promote lifelong learning in adults. The projects and their countries of origin are as follows: (1) 3D Project, training in the use of IT tools for 3D simulation and animation and practical…
Good practices in transportation evacuation preparedness and response : results of the FHWA workshop series.

DOT National Transportation Integrated Search

2009-08-01

This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...
Good practices in transportation evacuation preparedness and response : results of the FHWA Workshop Series

DOT National Transportation Integrated Search

2009-08-01

This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...
Mini-Special Issue: Taking Practical Work Beyond the Laboratory.

ERIC Educational Resources Information Center

Hodson, Derek

1998-01-01

Reviews the traditional definition of practical work in science, offers a different definition of it, and points out that practical work is not always laboratory based. Discusses the logistics of coordinating fieldwork. Contains 17 references. (DDR)
Sharing Good Practices: Teenage Girls, Sport, and Physical Activities.

ERIC Educational Resources Information Center

Vescio, Johanna A.; Crosswhite, Janice J.

2002-01-01

Investigated initiatives to increase teenage girls' participation in sport and physical activities, examining good practice case studies from Australia. Surveys of national, state, and regional sporting organizations and various community and school organizations (including culturally diverse girls and girls with disabilities) highlighted three…
Barriers to Implementation of Optimal Laboratory Biosafety Practices in Pakistan

PubMed Central

Shafaq, Humaira; Hasan, Rumina; Qureshi, Shahida M.; Dojki, Maqboola; Hughes, Molly A.; Zaidi, Anita K. M.; Khan, Erum

2016-01-01

The primary goal of biosafety education is to ensure safe practices among workers in biomedical laboratories. Despite several educational workshops by the Pakistan Biological Safety Association (PBSA), compliance with safe practices among laboratory workers remains low. To determine barriers to implementation of recommended biosafety practices among biomedical laboratory workers in Pakistan, we conducted a questionnaire-based survey of participants attending 2 workshops focusing on biosafety practices in Karachi and Lahore in February 2015. Questionnaires were developed by modifying the BARRIERS scale in which respondents are required to rate barriers on a 1-4 scale. Nineteen of the original 29 barriers were included and subcategorized into 4 groups: awareness, material quality, presentation, and workplace barriers. Workshops were attended by 64 participants. Among barriers that were rated as moderate to great barriers by at least 50% of respondents were: lack of time to read biosafety guidelines (workplace subscale), lack of staff authorization to change/improve practice (workplace subscale), no career or self-improvement advantages to the staff for implementing optimal practices (workplace subscale), and unclear practice implications (presentation subscale). A lack of recognition for employees' rights and benefits in the workplace was found to be a predominant reason for a lack of compliance. Based on perceived barriers, substantial improvement in work environment, worker facilitation, and enabling are needed for achieving improved or optimal biosafety practices in Pakistan. PMID:27400192
Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP).

PubMed

Zscharnack, Matthias; Krause, Christoph; Aust, Gabriela; Thümmler, Christian; Peinemann, Frank; Keller, Thomas; Smink, Jeske J; Holland, Heidrun; Somerson, Jeremy S; Knauer, Jens; Schulz, Ronny M; Lehmann, Jörg

2015-05-20

The clinical development of advanced therapy medicinal products (ATMPs), a new class of drugs, requires initial safety studies that deviate from standard non-clinical safety protocols. The study provides a strategy to address the safety aspects of biodistribution and tumorigenicity of ATMPs under good laboratory practice (GLP) conditions avoiding cell product manipulation. Moreover, the strategy was applied on a human ATMP for cartilage repair. The testing strategy addresses biodistribution and tumorigenicity using a multi-step analysis without any cell manipulation to exclude changes of test item characteristics. As a safeguard measurement for meeting regulatory expectations, the project design and goals were discussed continuously with the regulatory authority using a staggered scientific advice concept. Subsequently, the strategy was applied to co.don chondrosphere® (huChon spheroid), a tissue-engineered matrix-free ATMP of human normal chondrocytes. In both the biodistribution and tumorigenicity studies, huChon spheroids were implanted subcutaneously into 40 immunodeficient mice. Biodistribution was studied 1 month after implantation. A skin disc containing the huChon spheroid, two surrounding skin rings and selected organs were analyzed by validated, gender-specific, highly-sensitive triplex qPCR and by immunohistochemistry (IHC). No human DNA was detected in distant skin rings and analyzed organs. IHC revealed no direct or indirect indications of cell migration. Tumorigenicity was assessed 6 months after huChon spheroid implantation by palpation, macroscopic inspection, histology and IHC. No mice from the huChon spheroid group developed a tumor at the implantation site. In two mice, benign tumors were detected that were negative for HLA-ABC, suggesting that they were of spontaneous murine origin. In summary, the presented strategy using a multi-step analysis was confirmed to be suitable for safety studies of ATMPs.
Images of otoscopy: rate and extent of non-compliance with good practice standards.

PubMed

Crundwell, G; Harmer, J; Maltby, M; Mills, T; Neumann, C; Walsh, L; Baguley, D

2015-01-01

The British Society of Audiology has produced clear guidelines as to how otoscopy should be undertaken; however, no nationally recognised guidelines exist for the wider clinical community. Images of otoscopy appear in many books, journals, magazines and websites. This study aimed to determine the rate of non-compliance with good practice in images of otoscopy, the seriousness of the breach, and whether this is more common in sites for professionals or the general public. Google Images was searched using the terms 'otoscopy' and 'ear examination'. A total of 200 images were identified and collated. The images were reviewed for compliance with good practice standards. Only 12.75 per cent of the images were graded as having no breach of good practice standards. Professional websites have a responsibility to show best practice. When choosing an image, the source of the image needs to be carefully considered.
Designing easy DNA extraction: Teaching creativity through laboratory practice.

PubMed

Susantini, Endang; Lisdiana, Lisa; Isnawati; Tanzih Al Haq, Aushia; Trimulyono, Guntur

2017-05-01

Subject material concerning Deoxyribose Nucleic Acid (DNA) structure in the format of creativity-driven laboratory practice offers meaningful learning experience to the students. Therefore, a laboratory practice in which utilizes simple procedures and easy-safe-affordable household materials should be promoted to students to develop their creativity. This study aimed to examine whether designing and conducting DNA extraction with household materials could foster students' creative thinking. We also described how this laboratory practice affected students' knowledge and views. A total of 47 students participated in this study. These students were grouped and asked to utilize available household materials and modify procedures using hands-on worksheet. Result showed that this approach encouraged creative thinking as well as improved subject-related knowledge. Students also demonstrated positive views about content knowledge, social skills, and creative thinking skills. This study implies that extracting DNA with household materials is able to develop content knowledge, social skills, and creative thinking of the students. © 2016 by The International Union of Biochemistry and Molecular Biology, 45(3):216-225, 2017. © 2016 The International Union of Biochemistry and Molecular Biology.
Prakriti-based research: Good reporting practices.

PubMed

Bhalerao, Supriya; Patwardhan, Kishor

2016-03-01

The recent advances in the fields of genomics, personalized medicine, and Ayurveda have motivated many researchers to look at the relationship between Prakriti (phenotype-based Ayurveda constitution) and various objective biological parameters. As a result, a number of studies reporting such a relationship have made their way into mainstream scholarly journals. However, when it comes to the protocols that these workers follow to identify one's Prakriti, there are several issues that are yet to be resolved. In this communication, we propose a few reporting practices that such workers are required to be encouraged to follow, while submitting their work on Prakriti to scholarly journals. We have arranged this proposal under the following domains that may serve as a preliminary checklist in this context: The textual references, validation process, assessment of characters, scoring pattern, weightage assignment, criterion for expressing the final Prakriti type, and a need to publish the complete Prakriti-determination tool. We advocate that only if the workers in the field adhere to these good reporting practices, one will be able to draw meaningful, generalizable, and applicable interpretations out of such studies. We also suggest that the editors of relevant scholarly journals may recommend these reporting practices while considering such reports for publication. Copyright © 2016 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Published by Elsevier B.V. All rights reserved.

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...
21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...
21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...
[Identifying indicators of good practice in clinical and healthcare management].

PubMed

Bermúdez Tamayo, C; Olry de Labry Lima, A; García Mochón, L

To identify good practices in order to develop and implement indicators of health outcomes for clinical and healthcare management, as well as the characteristics for an indicator to be considered adequate. A scoping review was performed, with the following phases: 1) Search and identification of bibliography. 2) Selection of relevant documents. Including those studies that discussed issues related to good practices for the use of health indicators in the management field. Those published in a language other than English or Spanish or before 2006 were excluded. 3) Analysis and extraction of information. 4) Consultation with stakeholders, using a qualitative methodology through Concept Mapping, with the participation of 40 experts (decision-makers, scientific societies, and health professionals). The data collection process included an inductive and structured procedure, with prioritisation of ideas grouped into clusters, according to feasibility and importance criteria (0-10 scale). Good practices identified 2 levels: 1) macro-management: Define a framework for the evaluation of indicators and establish a benchmark of indicators. 2) meso-management: Establish indicators according to evidence and expert consensus, taking into account priority areas and topics, testing before final use, and communicate results adequately. The characteristics of a suitable indicator are: 1) Approach of an important issue, 2) Scientific validity, 3) Possibility of measurement with reliable data, 4) Meaning of useful and applicable measurement, and 5) Wide scope. The best practices for the use of indicators in clinical and healthcare management can make it easier to monitor performance and accountability, as well as to support the decision-making addressed at the development of initiatives for quality improvement. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.
Standards of Good Practice for Education Abroad. Fourth Edition

ERIC Educational Resources Information Center

Forum on Education Abroad, 2011

2011-01-01

This fourth edition of the Forum on Education Abroad's "Standards of Good Practice for Education Abroad" augments previous editions of the "Standards." Since the last edition was published in 2008, Forum member institutions and organizations have implemented the Standards in program development and assessment, using the Standards in the Forum's…
21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...
21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...
21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...
21 CFR 1271.150 - Current good tissue practice requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...
VET Providers Planning to Deliver Degrees: Good Practice Guide

ERIC Educational Resources Information Center

National Centre for Vocational Education Research (NCVER), 2015

2015-01-01

This good practice guide is intended to assist public and private registered training organisations (RTOs) planning to commence higher education (HE) delivery. The guide is based on research undertaken by Victor Callan and Kaye Bowman, who completed case studies with six providers currently delivering higher education qualifications in addition to…
Knowledge, attitude and practice of aspects of laboratory safety in Pathology Laboratories at the University of Port Harcourt Teaching Hospital, Nigeria.

PubMed

Ejilemele, A A; Ojule, A C

2005-12-01

To assess current knowledge, attitudes and practice of aspects of laboratory safety in pathology laboratories at the University of Port Harcourt Teaching Hospital in view of perceived inadequacies in safety practices in clinical laboratories in developing countries. Sixty (60) self- administered questionnaires were distributed to all cadres of staff in four (4) different laboratories (Chemical Pathology, Haematology, Blood bank and Medical Microbiology) at the Hospital. Gross deficiencies were found in the knowledge, attitudes and practice of laboratory safety by laboratory staff in areas of use of personal protective equipment, specimen collection and processing, centrifuge--related hazards, infective hazards waste disposal and provision and use of First Aid Kits. Issues pertaining to laboratory safety are not yet given adequate attention by both employers and employees in developing countries in this ear of resurgence of diseases such as HIV/AIDS and Hepatitis Band C, is emphasized.
Implementing Good Practices Programs to Encourage Production of High-Quality, Safer Produce in Mississippi

ERIC Educational Resources Information Center

Mahmoud, Barakat S. M.; Stafne, Eric T.; Coker, Christine H.; Bachman, Gary R.; Bell, Nicole

2016-01-01

Fifty-four growers/producers attended four 1-day good agricultural practices (GAP) and good handling practices (GHP) workshops at four locations in Mississippi. Pre- and post workshop survey data indicated that the participants' food safety knowledge increased by 15%. Furthermore, the workshops helped producers develop their own food safety plans.…
Defending the four principles approach as a good basis for good medical practice and therefore for good medical ethics.

PubMed

Gillon, Raanan

2015-01-01

This paper argues that the four prima facie principles-beneficence, non-maleficence, respect for autonomy and justice-afford a good and widely acceptable basis for 'doing good medical ethics'. It confronts objections that the approach is simplistic, incompatible with a virtue-based approach to medicine, that it requires respect for autonomy always to have priority when the principles clash at the expense of clinical obligations to benefit patients and global justice. It agrees that the approach does not provide universalisable methods either for resolving such moral dilemmas arising from conflict between the principles or their derivatives, or universalisable methods for resolving disagreements about the scope of these principles-long acknowledged lacunae but arguably to be found, in practice, with all other approaches to medical ethics. The value of the approach, when properly understood, is to provide a universalisable though prima facie set of moral commitments which all doctors can accept, a basic moral language and a basic moral analytic framework. These can underpin an intercultural 'moral mission statement' for the goals and practice of medicine. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
A Remote PLC Laboratory (RLab) for Distance Practical Work of Industrial Automation

NASA Astrophysics Data System (ADS)

Haritman, E.; Somantri, Y.; Wahyudin, D.; Mulyana, E.

2018-02-01

A laboratory is an essential equipment for engineering students to do a useful practical work. Therefore, universities should provide an adequate facility for practical work. On the other hand, industrial automation laboratory would offer students beneficial experience by using various educational PLC kits. This paper describes the development of Web-based Programmable Logic Controller (PLC) remote laboratory called RLab. It provides an environment for learners to study PLC application to control the level of the non-interacting tank. The RLab architecture is based on a Moodle and Remote Desktop, which also manages the booking system of the schedule of practical work in the laboratory. The RLab equipped by USB cameras providing a real-time view of PLC environment. To provide a secured system, the RLab combines Moodle and Remote Desktop application for the authentication system and management of remote users. Moodle will send PartnerID and password to connect to TeamViewer. It has been examined that the laboratory requirement, time and flexibility restrictions constitute a significant obstacle facing traditional students desiring to finish the course. A remote access laboratory can be eliminating time and flexibility restrictions. The preliminary study of RLab usability proved that such system is adequate to give the learners a distance practical work environment.
Guide of good practices for occupational radiological protection in plutonium facilities

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

NONE

1998-06-01

This Technical Standard (TS) does not contain any new requirements. Its purpose is to provide guides to good practice, update existing reference material, and discuss practical lessons learned relevant to the safe handling of plutonium. the technical rationale is given to allow US Department of Energy (DOE) health physicists to adapt the recommendations to similar situations throughout the DOE complex. Generally, DOE contractor health physicists will be responsible to implement radiation protection activities at DOE facilities and DOE health physicists will be responsible for oversight of those activities. This guidance is meant to be useful for both efforts. This TSmore » replaces PNL-6534, Health Physics Manual of Good Practices for Plutonium Facilities, by providing more complete and current information and by emphasizing the situations that are typical of DOE`s current plutonium operations; safe storage, decontamination, and decommissioning (environmental restoration); and weapons disassembly.« less
Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3.

PubMed

Battisti, Wendy P; Wager, Elizabeth; Baltzer, Lise; Bridges, Dan; Cairns, Angela; Carswell, Christopher I; Citrome, Leslie; Gurr, James A; Mooney, LaVerne A; Moore, B Jane; Peña, Teresa; Sanes-Miller, Carol H; Veitch, Keith; Woolley, Karen L; Yarker, Yvonne E

2015-09-15

This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus. The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations.
Helping Displaced Older Workers Get Back into Employment: Good Practice Guide

ERIC Educational Resources Information Center

Callahan, Victor J.; Bowman, Kaye

2015-01-01

This good practice guide is based on the report "Industry Restructuring and Job Loss: Helping Older Workers Get Back into Employment" by Victor J. Callan and Kaye Bowman. The aim of the research was to identify evidence-based practices that led to successful skills transfer, re-skilling, training and the attainment of new jobs for older…
Proper laboratory notebook practices: protecting your intellectual property.

PubMed

Nickla, Jason T; Boehm, Matthew B

2011-03-01

A laboratory notebook contains a wealth of knowledge that can be critical for establishing evidence in support of intellectual property rights and for refuting claims of research misconduct. The proper type, organization, use, maintenance, and storage of laboratory notebooks should be a priority for everyone at research institutions. Failure to properly document research activities can lead to serious problems, including the loss of valuable patent rights. Consequences of improper laboratory notebook practices can be harsh; numerous examples are described in court cases and journal articles, indicating a need for research institutions to develop strict policies on the proper use and storage of research documentation.
Laboratory considerations of United States Pharmacopeia Chapter <71> sterility tests and its application to pharmaceutical compounding.

PubMed

Hyde, Tiffany D

2014-01-01

The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.
What makes a good GP? An empirical perspective on virtue in general practice

PubMed Central

Braunack-Mayer, A

2005-01-01

This paper takes a virtuist approach to medical ethics to explore, from an empirical angle, ideas about settled ways of living a good life. Qualitative research methods were used to analyse the ways in which a group of 15 general practitioners (GPs) articulated notions of good doctoring and the virtues in their work. I argue that the GPs, whose talk is analysed here, defined good general practice in terms of the ideals of accessibility, comprehensiveness, and continuity. They regarded these ideals significant both for the way they dealt with morally problematic situations and for how they conducted their professional lives more generally. In addition, I argue that the GPs who articulated these ideals most clearly were able to, in part, because they shared the experience of working in rural areas. This experience helped them to develop an understanding of the nature of general practice that their urban colleagues were less able to draw on. In that sense, the structural and organisational framework of general practice in rural areas provided the context for their understanding of ideals in general practice. PMID:15681671

Good vaccination practice: it all starts with a good vaccine storage temperature.

PubMed

Vangroenweghe, Frédéric

2017-01-01

Recent introduction of strategies to reduce antibiotic use in food animal production implies an increased use of vaccines in order to prevent the economic impact of several important diseases in swine. Good Vaccination Practice (GVP) is an overall approach on the swine farm aiming to obtain maximal efficacy of vaccination through good storage, preparation and finally correct application to the target animals. In order to have a better insight into GVP on swine farms and the vaccine storage conditions, a survey on vaccination practices was performed on a farmers' fair and temperatures in the vaccine storage refrigerators were measured during farm visits over a period of 1 year. The survey revealed that knowledge on GVP, such as vaccine storage and handling, needle management and injection location could be improved. Less than 10% had a thermometer in their vaccine storage refrigerator on the moment of the visit. Temperature measurement revealed that only 71% of the measured refrigerators were in line with the recommended temperature range of +2 °C to +8 °C. Both below +2 °C and above +8 °C temperatures were registered during all seasons of the year. Compliance was lower during summer with an average temperature of 9.2 °C while only 43% of the measured temperatures were within the recommended range. The present study clearly showed the need for continuous education on GVP for swine veterinarians, swine farmers and their farm personnel in general and vaccine storage management in particular. In veterinary medicine, the correct storage of vaccines is crucial since both too low and too high temperatures can provoke damage to specific vaccine types. Adjuvanted killed or subunit vaccines can be damaged (e.g. structure of aluminiumhydroxide in adjuvans) by too low temperatures (below 0 °C), whereas lyophilized live vaccines are susceptible (e.g. loss of vaccine potency) to heat damage by temperatures above +8 °C. In conclusion, knowledge and awareness of GVP
Survey of safety practices among hospital laboratories in Oromia Regional State, Ethiopia.

PubMed

Sewunet, Tsegaye; Kebede, Wakjira; Wondafrash, Beyene; Workalemau, Bereket; Abebe, Gemeda

2014-10-01

Unsafe working practices, working environments, disposable waste products, and chemicals in clinical laboratories contribute to infectious and non-infectious hazards. Staffs, the community, and patients are less safe. Furthermore, such practices compromise the quality of laboratory services. We conducted a study to describe safety practices in public hospital laboratories of Oromia Regional State, Ethiopia. Randomly selected ten public hospital laboratories in Oromia Regional State were studied from Oct 2011- Feb 2012. Self-administered structured questionnaire and observation checklists were used for data collection. The respondents were heads of the laboratories, senior technicians, and safety officers. The questionnaire addressed biosafety label, microbial hazards, chemical hazards, physical/mechanical hazards, personal protective equipment, first aid kits and waste disposal system. The data was analyzed using descriptive analysis with SPSS version16 statistical software. All of the respondents reported none of the hospital laboratories were labeled with the appropriate safety label and safety symbols. These respondents also reported they may contain organisms grouped under risk group IV in the absence of microbiological safety cabinets. Overall, the respondents reported that there were poor safety regulations or standards in their laboratories. There were higher risks of microbial, chemical and physical/mechanical hazards. Laboratory safety in public hospitals of Oromia Regional State is below the standard. The laboratory workers are at high risk of combined physical, chemical and microbial hazards. Prompt recognition of the problem and immediate action is mandatory to ensure safe working environment in health laboratories.
Computerized Grading of Anatomy Laboratory Practical Examinations

ERIC Educational Resources Information Center

Krippendorf, Beth B.; Bolender, David L.; Kolesari, Gary L.

2008-01-01

At the Medical College of Wisconsin, a procedure was developed to allow computerized grading and grade reporting of laboratory practical examinations in the Clinical Human Anatomy course. At the start of the course, first year medical students were given four Lists of Structures. On these lists, numbered items were arranged alphabetically; the…
Practices for Identifying and Rejecting Hemolyzed Specimens Are Highly Variable in Clinical Laboratories.

PubMed

Howanitz, Peter J; Lehman, Christopher M; Jones, Bruce A; Meier, Frederick A; Horowitz, Gary L

2015-08-01

Hemolysis is an important clinical laboratory quality attribute that influences result reliability. To determine hemolysis identification and rejection practices occurring in clinical laboratories. We used the College of American Pathologists Survey program to distribute a Q-Probes-type questionnaire about hemolysis practices to Chemistry Survey participants. Of 3495 participants sent the questionnaire, 846 (24%) responded. In 71% of 772 laboratories, the hemolysis rate was less than 3.0%, whereas in 5%, it was 6.0% or greater. A visual scale, an instrument scale, and combination of visual and instrument scales were used to identify hemolysis in 48%, 11%, and 41% of laboratories, respectively. A picture of the hemolysis level was used as an aid to technologists' visual interpretation of hemolysis levels in 40% of laboratories. In 7.0% of laboratories, all hemolyzed specimens were rejected; in 4% of laboratories, no hemolyzed specimens were rejected; and in 88% of laboratories, some specimens were rejected depending on hemolysis levels. Participants used 69 different terms to describe hemolysis scales, with 21 terms used in more than 10 laboratories. Slight and moderate were the terms used most commonly. Of 16 different cutoffs used to reject hemolyzed specimens, moderate was the most common, occurring in 30% of laboratories. For whole blood electrolyte measurements performed in 86 laboratories, 57% did not evaluate the presence of hemolysis, but for those that did, the most common practice in 21 laboratories (24%) was centrifuging and visually determining the presence of hemolysis in all specimens. Hemolysis practices vary widely. Standard assessment and consistent reporting are the first steps in reducing interlaboratory variability among results.
Quality management for the international transport of laboratory animals.

PubMed

Leary, Steven L

2008-01-01

Increased collaboration between investigators at different institutions has increased the number of laboratory animals being transported. The current system of laws and regulations governing animal shipments is inconsistent and government agencies often have areas of overlapping regulatory management. Furthermore, the lack of industry-wide shipping standards and good practices contributes to confusion among those responsible for shipment. One answer to these quality control issues would be the establishment of independent, industry-regulated 'good practices' for animal transport, similar to those used in laboratories for experimental design. These good practices could be based on the existing International Air Transport Association Live Animals Regulations, with contributions from representatives of the specialties involved. Additionally, quality control under the current system of patchwork regulations could be improved if each institution, both academic and commercial, would designate a single point of contact to follow each shipment from start to finish.
Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

PubMed

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

2016-12-12

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.
Laboratory medicine handoff gaps experienced by primary care practices: A report from the shared networks of collaborative ambulatory practices and partners (SNOCAP).

PubMed

West, David R; James, Katherine A; Fernald, Douglas H; Zelie, Claire; Smith, Maxwell L; Raab, Stephen S

2014-01-01

The majority of errors in laboratory medicine testing are thought to occur in the pre- and postanalytic testing phases, and a large proportion of these errors are secondary to failed handoffs. Because most laboratory tests originate in ambulatory primary care, understanding the gaps in handoff processes within and between laboratories and practices is imperative for patient safety. Therefore, the purpose of this study was to understand, based on information from primary care practice personnel, the perceived gaps in laboratory processes as a precursor to initiating process improvement activities. A survey was used to assess perceptions of clinicians, staff, and management personnel of gaps in handoffs between primary care practices and laboratories working in 21 Colorado primary care practices. Data were analyzed to determine statistically significant associations between categorical variables. In addition, qualitative analysis of responses to open-ended survey questions was conducted. Primary care practices consistently reported challenges and a desire/need to improve their efforts to systematically track laboratory test status, confirm receipt of laboratory results, and report results to patients. Automated tracking systems existed in roughly 61% of practices, and all but one of those had electronic health record-based tracking systems in place. One fourth of these electronic health record-enabled practices expressed sufficient mistrust in these systems to warrant the concurrent operation of an article-based tracking system as backup. Practices also reported 12 different procedures used to notify patients of test results, varying by test result type. The results highlight the lack of standardization and definition of roles in handoffs in primary care laboratory practices for test ordering, monitoring, and receiving and reporting test results. Results also identify high-priority gaps in processes and the perceptions by practice personnel that practice improvement
Developing a policy for paediatric biobanks: principles for good practice

PubMed Central

Hens, Kristien; Van El, Carla E; Borry, Pascal; Cambon-Thomsen, Anne; Cornel, Martina C; Forzano, Francesca; Lucassen, Anneke; Patch, Christine; Tranebjaerg, Lisbeth; Vermeulen, Eric; Salvaterra, Elena; Tibben, Aad; Dierickx, Kris

2013-01-01

The participation of minors in biobank research can offer great benefits for science and health care. However, as minors are a vulnerable population they are also in need of adequate protective measures when they are enrolled in research. Research using biobanked biological samples from children poses additional ethical issues to those raised by research using adult biobanks. For example, small children have only limited capacity, if any, to understand the meaning and implications of the research and to give a documented agreement to it. Older minors are gradually acquiring this capacity. We describe principles for good practice related to the inclusion of minors in biobank research, focusing on issues related to benefits and subsidiarity, consent, proportionality and return of results. Some of these issues are currently heavily debated, and we conclude by providing principles for good practice for policy makers of biobanks, researchers and anyone involved in dealing with stored tissue samples from children. Actual implementation of the principles will vary according to different jurisdictions. PMID:22713814
Ask the right question: a critical step for practicing evidence-based laboratory medicine.

PubMed

Price, Christopher P; Christenson, Robert H

2013-07-01

The purpose of laboratory medicine is to facilitate better decision making in clinical practice and healthcare delivery. Decision making implies an unresolved issue, problem or unmet need. The most important criterion for any investigation to be of value in clinical practice is that it addresses an unmet need. The different ways in which laboratory investigations are utilized in patient care can be represented in the form of questions. It is important that these questions are articulated to highlight the variables that will impact on the effectiveness of the investigation in the scenario being considered. These variables include the characteristics of the patient (or population) and clinical setting, the nature of the decision and action taken on receipt of the test result and the expected outcome. Asking a question is the first step of the evidence-based laboratory medicine (EBLM) cycle, the other steps being acquiring the evidence, critically appraising the evidence, applying the evidence and auditing use of the evidence. Getting the question right determines the quality of the whole process, thus, defines the quality in practice of laboratory medicine. Whilst the main focus of the EBLM cycle is to provide a strong evidence base for use in clinical practice, it is clear that the five steps are equally applicable in commissioning, delivery and audit (performance management) of services. Asking the right question is crucial to improving the quality of evidence, and practice, in laboratory medicine, and should be used in routine laboratory medicine practice and management throughout healthcare.
Autoclaving practice in microbiology laboratories: report of a survey. The Public Health Laboratory Service Subcommittee on laboratory autoclaves.

PubMed Central

1978-01-01

The performance of autoclaves in 27 laboratories, operated in accordance with the normal routine of local practice, has been monitored using thermometric equipment. Sterilising performance was unsatisfactory on 10 of 62 occasions, and cooling was inadequate on 52 of 60 occasions. PMID:649767
Promoting good health research practice in low- and middle-income countries

PubMed Central

Mahendradhata, Yodi; Nabieva, Jamila; Ahmad, Riris Andono; Henley, Patricia; Launois, Pascal; Merle, Corinne; Maure, Christine; Horstick, Olaf; Elango, Varalakshmi

2016-01-01

Background Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative. Objective To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs). Design The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014–2015). The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data) collected during course implementation and qualitative email-based pre- and post-course evaluation. Results Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation. Conclusions There is an urgent need to harness the momentum to promote high-quality and ethical health research in LMICs through scaling
Practice-based Research Network Research Good Practices (PRGPs): Summary of Recommendations.

PubMed

Dolor, Rowena J; Campbell-Voytal, Kimberly; Daly, Jeanette; Nagykaldi, Zsolt J; O'Beirne, Maeve; Sterling, Pamela; Fagnan, Lyle J; Levy, Barcey; Michaels, LeAnn; Louks, Hannah A; Smith, Paul; Aspy, Cheryl B; Patterson, V Beth; Kano, Miria; Sussman, Andrew L; Williams, Robert; Neale, Anne Victoria

2015-12-01

Practice-based research networks (PBRNs) conduct research in community settings, which poses quality control challenges to the integrity of research, such as study implementation and data collection. A foundation for improving research processes within PBRNs is needed to ensure research integrity. Network directors and coordinators from seven U.S.-based PBRNs worked with a professional team facilitator during semiannual in-person meetings and monthly conference calls to produce content for a compendium of recommended research practices specific to the context of PBRNs. Participants were assigned to contribute content congruent with their expertise. Feedback on the draft document was obtained from attendees at the preconference workshop at the annual PBRN meeting in 2013. A revised document was circulated to additional PBRN peers prior to finalization. The PBRN Research Good Practices (PRGPs) document is organized into four chapters: (1) Building PBRN Infrastructure; (2) Study Development and Implementation; (3) Data Management, and (4) Dissemination Policies. Each chapter contains an introduction, detailed procedures for each section, and example resources with information links. The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. © 2015 Wiley Periodicals, Inc.
Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

ERIC Educational Resources Information Center

Hanson, Jana Marie

2013-01-01

This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at four-year colleges and universities. Using College Choice and College Outcomes models as a theoretical foundation, I examined whether eight good…
Multiple Criteria Decision Analysis for Health Care Decision Making--Emerging Good Practices: Report 2 of the ISPOR MCDA Emerging Good Practices Task Force.

PubMed

Marsh, Kevin; IJzerman, Maarten; Thokala, Praveen; Baltussen, Rob; Boysen, Meindert; Kaló, Zoltán; Lönngren, Thomas; Mussen, Filip; Peacock, Stuart; Watkins, John; Devlin, Nancy

2016-01-01

Health care decisions are complex and involve confronting trade-offs between multiple, often conflicting objectives. Using structured, explicit approaches to decisions involving multiple criteria can improve the quality of decision making. A set of techniques, known under the collective heading, multiple criteria decision analysis (MCDA), are useful for this purpose. In 2014, ISPOR established an Emerging Good Practices Task Force. The task force's first report defined MCDA, provided examples of its use in health care, described the key steps, and provided an overview of the principal methods of MCDA. This second task force report provides emerging good-practice guidance on the implementation of MCDA to support health care decisions. The report includes: a checklist to support the design, implementation and review of an MCDA; guidance to support the implementation of the checklist; the order in which the steps should be implemented; illustrates how to incorporate budget constraints into an MCDA; provides an overview of the skills and resources, including available software, required to implement MCDA; and future research directions. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Knowledge for the good of the individual and society: linking philosophy, disciplinary goals, theory, and practice.

PubMed

McCurry, Mary K; Revell, Susan M Hunter; Roy, Sr Callista

2010-01-01

Nursing as a profession has a social mandate to contribute to the good of society through knowledge-based practice. Knowledge is built upon theories, and theories, together with their philosophical bases and disciplinary goals, are the guiding frameworks for practice. This article explores a philosophical perspective of nursing's social mandate, the disciplinary goals for the good of the individual and society, and one approach for translating knowledge into practice through the use of a middle-range theory. It is anticipated that the integration of the philosophical perspective and model into nursing practice will strengthen the philosophy, disciplinary goal, theory, and practice links and expand knowledge within the discipline. With the focus on humanization, we propose that nursing knowledge for social good will embrace a synthesis of the individual and the common good. This approach converges vital and agency needs described by Hamilton and the primacy of maintaining the heritage of the good within the human species as outlined by Maritain. Further, by embedding knowledge development in a changing social and health care context, nursing focuses on the goals of clinical reasoning and action. McCubbin and Patterson's Double ABCX Model of Family Adaptation was used as an example of a theory that can guide practice at the community and global level. Using the theory-practice link as a foundation, the Double ABCX model provides practising nurses with one approach to meet the needs of individuals and society. The integration of theory into nursing practice provides a guide to achieve nursing's disciplinary goals of promoting health and preventing illness across the globe. When nursing goals are directed at the synthesis of the good of the individual and society, nursing's social and moral mandate may be achieved.
A Good Name and Great Riches: Rebranding Solid State Physics for the National Laboratories

NASA Astrophysics Data System (ADS)

Martin, Joseph

2012-03-01

In 1943 Oliver Buckley, lamenting the inadequacy of term ``physics'' to evoke what physicists did, quoted the proverb, ``A good name is rather to be chosen than great riches.'' Some forty years later, solid state physicists confronted similar discontent with their name, precipitating the rise of the appellation ``condensed matter physics.'' Ostensibly a rebranding of a well-established field, the change signaled deeper conceptual and institutional realignment. Whereas ``solid state'' emerged in the 1940s in the service of institutional aims, ``condensed matter'' more accurately captured a distinct set of theoretical and experimental approaches. Reimagining the field around core conceptual approaches set condensed matter apart from the inchoate field of materials science, which subsumed a growing proportion of solid state funding and personnel through the 1980s. Federally funded research installations were the source of ``great riches'' for scientific research. The DOE National Laboratory System and the DARPA network of Interdisciplinary Laboratories, given their responsiveness to shifts in national funding priorities, provide a sensitive historical instrument through which to trace the transition from solid state to condensed matter. The reorganization of solid state in response to the evolution of national priorities and funding practices precipitated a sharpening of the field's intellectual mission. At the same time, it reflected the difficulties solid state faced articulating its intellectual--as opposed to technological--merit. The proverb continues, `` and loving favor rather than silver and gold.'' The adoption of a name that emphasized intellectual cohesion and associated social esteem exposed the growing tension between technology-oriented national funding goals for materials research and condensed matter physics' ascendant intellectual identity.
Investigating Good Practice in Supporting Deaf Pupils in Mainstream Schools.

ERIC Educational Resources Information Center

Powers, Steve

2001-01-01

A survey of parents, teachers, therapists, psychologists, and deaf adults (n=628) and 15 case study sites were used to identify the following good practices supporting deaf students in mainstream schools: direct support for teachers of the deaf, joint planning by support and mainstream teachers, student involvement in decision making, and…
Variable implementation of good practice recommendations for the assessment and management of UK children with neurodisability.

PubMed

Gray, L; Gibbs, J; Jolleff, N; Williams, J; McConachie, H; Parr, J R

2015-11-01

The aims of this study were to determine whether UK child development teams (CDTs) have implemented good practice recommendations for the co-ordinated assessment and support of children with neurodisability and to explore some of the factors associated with variations in good practice implementation. Surveys were sent to every UK CDT in 2009/2010. Responses about CDT provision and ways of working were compared with good practice recommendations from national policy documents and professional organizations. The extent to which CDTs in England and Wales met 11 selected good practice recommendations was scored; teams in Scotland and Northern Ireland were given a score out of 9 to reflect the optional use of the common assessment framework and early support materials in these countries. Responses were received from 225/240 (94%) UK CDTs. Thirty-seven per cent of CDTs in England and Wales had implemented nine or more of the 11 recommendations. Fifty-nine per cent of teams in Scotland and 78% of teams in Northern Ireland met between six and nine recommendations of good working practice. Higher levels of implementation of recommendations were found when the CDT had a Child Development Centre base and for teams who had received increased funding in the 5 years preceding the survey. There was considerable variability in the degree to which CDTs implemented good practice recommendations for the diagnosis and management of children with neurodisability. Evidence about child and parent satisfaction, and the effectiveness of CDT practices and provision, is required, so policymakers, healthcare commissioners and clinicians can provide the most appropriate services to children with neurodisability and their families. © 2015 John Wiley & Sons Ltd.
[Teaching design and practice of human blood type traits in genetics comprehensive laboratory course].

PubMed

Zhao, Jian; Hu, Dong-mei; Yu, Da-de; Dong, Ming-liang; Li, Yun; Fan, Ying-ming; Wang, Yan-wei; Zhang, Jin-feng

2016-05-01

Comprehensive laboratory courses, which enable students to aptly apply theoretic knowledge and master experiment skills, play an important role in the present educational reform of laboratory courses. We utilized human ABO blood type as the experimental subject, and designed the experiment--"Molecular Genotyping of Human ABO Blood Type and Analysis of Population Genetic Equilibrium". In the experiment, DNA in mucosal cells is extracted from students' saliva, and each student's genotype is identified using a series of molecular genetics technologies, including PCR amplification of target fragments, enzymatic digestion, and electrophoretic separation. Then, taking the whole class as an analogous Mendel population, a survey of genotype frequency of ABO blood type is conducted, followed with analyses of various population genetic parameters using Popgene. Through the open laboratory course, students can not only master molecular genetic experimental skills, but also improve their understanding of theoretic knowledge through independent design and optimization of molecular techniques. After five years of research and practice, a stable experimental system of molecular genetics has been established to identify six genotypes of ABO blood types, namely I(A)I(A), I(A)i, I(B)I(B), I(B)i, I(A)I(B) and ii. Laboratory courses of molecular and population genetics have been integrated by calculating the frequencies of the six genotypes and three multiple alleles and testing population genetic equilibrium. The goal of the open laboratory course with independent design and implementation by the students has been achieved. This laboratory course has proved effective and received good reviews from the students. It could be applied as a genetics laboratory course for the biology majors directly, and its ideas and methods could be promoted and applied to other biological laboratory courses.
Good Practice Recommendations in the Field of Heating, Ventilation, and Air Conditioning for Health Related Research Laboratories.

ERIC Educational Resources Information Center

Laboratory Design Notes, 1966

1966-01-01

A collection of laboratory design notes to set forth minimum criteria required in the design of basic medical research laboratory buildings. Recommendations contained are primarily concerned with features of design which affect quality of performance and future flexibility of facility systems. Subjects of economy and safety are discussed where…

Knowledge, attitude, and practice (KAP) of 'teaching laboratory' technicians towards laboratory safety and waste management: a pilot interventional study.

PubMed

El-Gilany, A-H; El-Shaer, S; Khashaba, E; El-Dakroory, S A; Omar, N

2017-06-01

A quasi-experimental study was performed on 20 technicians working in the Faculty of Medicine, Mansoura University, Egypt. The knowledge, attitude, and practice (KAP) of laboratory technicians was measured before and two months after enrolling them in an intervention programme about laboratory best practice procedures. The programme addressed laboratory safety and medical waste management. The assessment was performed using a validated Arabic self-administered questionnaire. Pre- and post-intervention scores were compared using non-parametric tests. There are significant increases in the scores of KAP after implementation of the training programme. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.
Knowledge Gained from Good Agricultural Practices Courses for Iowa Growers

ERIC Educational Resources Information Center

Shaw, Angela; Strohbehn, Catherine; Naeve, Linda; Domoto, Paul; Wilson, Lester

2015-01-01

Good Agricultural Practices (GAP) educational courses provide produce growers with the fundamental information for producing and processing safe produce. To determine the effectiveness of the current 7-hour GAP course provided in Iowa, growers were surveyed before and 7-14 days after the course to determine changes in knowledge and opinions.…
Student Accommodation Projects: A Guide to PFI Contracts. Good Practice.

ERIC Educational Resources Information Center

Curtis, Pinsent

This guide is intended for higher education institutions in England that are about to embark on student residential accommodation projects. It focuses on procurements under the Private Financial Initiative (PFI), a form of Public Private Partnership in the United Kingdom, but other approaches are considered. The guide draws on good practices from…
[Biosafety in laboratories concerning exposure to biological agents].

PubMed

Vonesch, N; Tomao, P; Di Renzi, S; Vita, S; Signorini, S

2006-01-01

Laboratory workers are exposed to a variety of potential occupational health hazards including those deriving from infectious materials and cultures, radiations, toxic and flammable chemicals, as well as mechanical and electrical hazard. Although all of them are significant, this paper will focus on biological hazards present in clinical and research laboratories. In fact, in spite of numerous publications, guidelines and regulations, laboratory workers are still subject to infections acquired in the course of their researches. This paper describes some aspects that include good microbiological practices (GMPs), appropriate containment equipment, practices and operational procedures to minimize workers' risk of injury or illness.
Laboratory Practices of Beginning Secondary Science Teachers: A Five-Year Study

ERIC Educational Resources Information Center

Wong, Sissy S.; Firestone, Jonah B.; Luft, Julie A.; Weeks, Charles B.

2013-01-01

During the beginning years of teaching, science teachers develop the knowledge and skills needed to design and implement science laboratories. In this regard, this quantitative study focused on the reported laboratory practices of 61 beginning secondary science teachers who participated in four different induction programs. The results…
The Development and Implementation of an Integrating Pharmacy Practice Laboratory.

ERIC Educational Resources Information Center

Newton, Gail D.; And Others

1990-01-01

The intent of an integrating laboratory was to help pharmacy students learn to solve problems, make decisions, and develop good communication skills. Educational units included exercises in guided design, patient profile review, patient inquiries, extemporaneous prescription compounding, clinical literature evaluation, and videotapes of simulated…
Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures.

PubMed

Acquadro, Catherine; Patrick, Donald L; Eremenco, Sonya; Martin, Mona L; Kuliś, Dagmara; Correia, Helena; Conway, Katrin

2017-01-01

This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.
HEALTH TECHNOLOGY ASSESSMENT FOR DECISION MAKING IN LATIN AMERICA: GOOD PRACTICE PRINCIPLES.

PubMed

Pichon-Riviere, Andrés; Soto, Natalie C; Augustovski, Federico Ariel; García Martí, Sebastián; Sampietro-Colom, Laura

2018-06-11

The aim of this study was to identify good practice principles for health technology assessment (HTA) that are the most relevant and of highest priority for application in Latin America and to identify potential barriers to their implementation in the region. HTA good practice principles proposed at the international level were identified and then explored during a deliberative process in a forum of assessors, funders, and product manufacturers. Forty-two representatives from ten Latin American countries participated. Good practice principles proposed at the international level were considered valid and potentially relevant to Latin America. Five principles were identified as priority and with the greatest potential to be strengthened at this time: transparency in the production of HTA, involvement of relevant stakeholders in the HTA process, mechanisms to appeal decisions, clear priority-setting processes in HTA, and a clear link between HTA and decision making. The main challenge identified was to find a balance between the application of these principles and the available resources in a way that would not detract from the production of reports and adaptation to the needs of decision makers. The main recommendation was to progress gradually in strengthening HTA and its link to decision making by developing appropriate processes for each country, without trying to impose, in the short-term, standards taken from examples at the international level without adequate adaptation of these to local contexts.
Adaptive governance good practice: Show me the evidence!

PubMed

Sharma-Wallace, Lisa; Velarde, Sandra J; Wreford, Anita

2018-09-15

-based adaptive governance good practice within and across diverse sectors, issues, and contexts. Copyright © 2018. Published by Elsevier Ltd.
Liberal Arts Colleges and Good Practices in Undergraduate Education: Additional Evidence

ERIC Educational Resources Information Center

Seifert, Tricia A.; Pascarella, Ernest T.; Goodman, Kathleen M.; Salisbury, Mark H.; Blaich, Charles F.

2010-01-01

Liberal arts colleges have prided themselves on providing students with a quality undergraduate education among a scholarly community who are interested in their holistic development. Past research has found students who attended liberal arts colleges more frequently experienced Chickering and Gamson's (1987, 1991) good practices in undergraduate…
Internal Quality Control Practices in Coagulation Laboratories: recommendations based on a patterns-of-practice survey.

PubMed

McFarlane, A; Aslan, B; Raby, A; Moffat, K A; Selby, R; Padmore, R

2015-12-01

Internal quality control (IQC) procedures are crucial for ensuring accurate patient test results. The IQMH Centre for Proficiency Testing conducted a web-based survey to gather information on the current IQC practices in coagulation testing. A questionnaire was distributed to 174 Ontario laboratories licensed to perform prothrombin time (PT) and activated partial thromboplastin time (APTT). All laboratories reported using two levels of commercial QC (CQC); 12% incorporate pooled patient plasma into their IQC program; >68% run CQC at the beginning of each shift; 56% following maintenance, with reagent changes, during a shift, or with every repeat sample; 6% only run CQC at the beginning of the day and 25% when the instruments have been idle for a defined period of time. IQC run frequency was determined by manufacturer recommendations (71%) but also influenced by the stability of test (27%), clinical impact of an incorrect test result (25%), and sample's batch number (10%). IQC was monitored using preset limits based on standard deviation (66%), precision goals (46%), or allowable performance limits (36%). 95% use multirules. Failure actions include repeating the IQC (90%) and reporting patient results; if repeat passes, 42% perform repeat analysis of all patient samples from last acceptable IQC. Variability exists in coagulation IQC practices among Ontario clinical laboratories. The recommendations presented here would be useful in encouraging standardized IQC practices. © 2015 John Wiley & Sons Ltd.
Healthcare associated infection: good practices, knowledge and the locus of control in heatlhcare professionals.

PubMed

Taffurelli, Chiara; Sollami, Alfonso; Camera, Carmen; Federa, Francesca; Grandi, Annise; Marino, Marcella; Marrosu, Tiziano; Sarli, Leopoldo

2017-07-18

The incidence of Healthcare Associated Infections (HAI) is an important indicator of the quality of care. The behaviors associated with the prevention of infections are not only supported by rational knowledge or motivation, but are mediated by social, emotional and often stereotyped behaviors. The awarness of the good practices related to HAI, may be a factor. Other studies, identify how the perception of the problem in healthcare professionals is often influenced by a tendency towards an external Locus of Control: the patient, the family, the other wards, other care settings. The aim of this study is to investigate the perception of healthcare professionals. In particular they have been measured their awarness of the good practices, perceptions of the potential contamination level of some commonly used objects, knowledge about the management of invasive devices, Locus of Control. A cross-sectional correlational design was utilized. An ad hoc questionnaire was interviewed by 222 health professionals nurses and physicians in a northern hospital of Italy. The percentage of professionals who have attended training courses over the last 5 years was quite high, both for upgrades on HAI (78.7%) and Vascular Catheters (78.8%), while the percentage of professionals who updated on bladder catheterization (59.46%) was lower. The mean score of good practice awareness towards HAI (5.06), is high. The perception of the potential level of contamination of some devices had a mean ranging from 4.62 (for the drip) to 5.26 (for the door handle). The average value of the Locus of Control (43.54) indicates that participants demonstrated a value that is midway between External and Internal. The correlation test analysis revealed no significant relationships among professionals'age, knowledge about HAI, or infection related venus catheter. Also, results revealed that there were statistically significant positive relationships between professionals' Good Practices
Factors associated with good TB infection control practices among primary healthcare workers in the Free State Province, South Africa.

PubMed

Engelbrecht, Michelle; Janse van Rensburg, André; Kigozi, Gladys; van Rensburg, Hcj Dingie

2016-11-04

Despite the availability of TB infection control guidelines, and good levels of healthcare worker knowledge about infection control, often these measures are not well implemented. This study sought to determine the factors associated with healthcare workers' good TB infection control practices in primary health care facilities in the Free State Province, South Africa. A cross-sectional self-administered survey among nurses (n = 202) and facility-based community healthcare workers (n = 34) as well as facility observations were undertaken at all 41 primary health care facilities in a selected district of the Free State Province. The majority of respondents were female (n = 200; 87.7 %) and the average age was 44.19 years (standard deviation ±10.82). Good levels of knowledge were recorded, with 42.8 % (n = 101) having an average score (i.e. 65-79 %) and 31.8 % (n = 75) a good score (i.e. ≥ 80 %). Most respondents (n = 189; 80.4 %) had positive attitudes towards TB infection control practices (i.e. ≥ 80 %). While good TB infection control practices were reported by 72.9 % (n = 161) of the respondents (i.e. ≥75 %), observations revealed this to not necessarily be the case. For every unit increase in attitudes, good practices increased 1.090 times (CI:1.016-1.169). Respondents with high levels of knowledge (≥80 %) were 4.029 (CI: 1.550-10.469) times more likely to have good practices when compared to respondents with poor levels of knowledge (<65 %). The study did not find TB/HIV-related training to be a predictor of good practices. Positive attitudes and good levels of knowledge regarding TB infection control were the main factors associated with good infection control practices. Although many respondents reported good infection control practices - which was somewhat countered by the observations - there are areas that require attention, particularly those related to administrative controls and the use of personal
Do Liberal Arts Colleges Really Foster Good Practices in Undergraduate Education?

ERIC Educational Resources Information Center

Pascarella, Ernest T.; Cruce, Ty M.; Wolniak, Gregory C.; Blaich, Charles F.

2004-01-01

Researchers estimated the net effects of liberal arts colleges on 19 measures of good practices in undergraduate education grouped into seven categories. Analyses of 3-year longitudinal data from five liberal arts colleges, four research universities, and seven regional universities were conducted. Net of a battery of student precollege…
Values Education as Good Practice Pedagogy: Evidence from Australian Empirical Research

ERIC Educational Resources Information Center

Lovat, Terence

2017-01-01

This article focuses on the Australian Government's Values Education Program and, within its context, the "Values Education Good Practice Schools Project" (VEGPSP) Reports and the "Project to Test and Measure the Impact of Values Education on Student Effects and School Ambience," funded federally from 2003 to 2010. Findings…
Identification of Good Practices in the Implementation of Innovative Learning Methodologies

ERIC Educational Resources Information Center

Lincaru, Cristina; Ciuca, Vasilica; Grecu, Liliana; Atanasiu, Draga; Dragoiu, Codruta

2011-01-01

We intend to present the partial issues resulted from the development of the European Project DeInTRA "cooperation for innovative training methodologies deployment in the European Labour Market"--Stage 4: Identification of good practices in the implementation of innovative learning methodologies. This project is included into the…
Syphilis testing in antenatal care: Policies and practices among laboratories in the Americas.

PubMed

Luu, Minh; Ham, Cal; Kamb, Mary L; Caffe, Sonja; Hoover, Karen W; Perez, Freddy

2015-06-01

To asses laboratory syphilis testing policies and practices among laboratories in the Americas. Laboratory directors or designees from PAHO member countries were invited to participate in a structured, electronically-delivered survey between March and August, 2014. Data on syphilis tests, algorithms, and quality control (QC) practices were analyzed, focusing on laboratories receiving specimens from antenatal clinics (ANCs). Surveys were completed by 69 laboratories representing 30 (86%) countries. Participating laboratories included 36 (52%) national or regional reference labs and 33 (48%) lower-level laboratories. Most (94%) were public sector facilities and 71% reported existence of a national algorithm for syphilis testing in pregnancy, usually involving both treponemal and non-treponemal testing (72%). Less than half (41%) used rapid syphilis tests (RSTs); and only seven laboratories representing five countries reported RSTs were included in the national algorithm for pregnant women. Most (83%) laboratories serving ANCs reported using some type of QC system; 68% of laboratories reported participation in external QC. Only 36% of laboratories reported data to national/local surveillance. Half of all laboratories serving ANC settings reported a stockout of one or more essential supplies during the previous year (median duration, 30days). Updating laboratory algorithms, improving testing standards, integrating data into existing surveillance, and improved procurement and distribution of commodities may be needed to ensure elimination of MTCT of syphilis in the Americas. Copyright © 2015. Published by Elsevier Ireland Ltd.
Prostate needle biopsy processing: a survey of laboratory practice across Europe.

PubMed

Varma, Murali; Berney, Daniel M; Algaba, Ferran; Camparo, Philippe; Compérat, Eva; Griffiths, David F R; Kristiansen, Glen; Lopez-Beltran, Antonio; Montironi, Rodolfo; Egevad, Lars

2013-02-01

To determine the degree of variation in the handling of prostate needle biopsies (PBNx) in laboratories across Europe. A web based survey was emailed to members of the European Network of Uropathology and the British Association of Urological Pathologists. Responses were received from 241 laboratories in 15 countries. PNBx were generally taken by urologists (93.8%) or radiologists (23.7%) but in 8.7% were also taken by non-medical personnel such as radiographers, nurses or biomedical assistants. Of the responding laboratories, 40.8% received cores in separate containers, 42.3% processed one core/block, 54.2% examined three levels/block, 49.4% examined one H&E section/level and 56.1% retained spare sections for potential immunohistochemistry. Of the laboratories, 40.9% retained unstained spares for over a year while 36.2% discarded spares within 1 month of reporting. Only two (0.8%) respondents routinely performed immunohistochemistry on all PNBx. There were differences in laboratory practice between the UK and the rest of Europe (RE). Procurement of PNBx by non-medical personnel was more common in the UK. RE laboratories more commonly received each core in a separate container, processed one core/block, examined fewer levels/block and examined more H&E sections/level. RE laboratories also retained spares for potential immunohistochemistry less often and for shorter periods. Use of p63 as the sole basal cell marker was more common in RE. There are marked differences in procurement, handling and processing of PNBx in laboratories across Europe. This data can help the development of best practice guidelines.
Launching a Laboratory Testing Process Quality Improvement Toolkit: From the Shared Networks of Colorado Ambulatory Practices and Partners (SNOCAP).

PubMed

Fernald, Douglas; Hamer, Mika; James, Kathy; Tutt, Brandon; West, David

2015-01-01

Family medicine and internal medicine physicians order diagnostic laboratory tests for nearly one-third of patient encounters in an average week, yet among medical errors in primary care, an estimated 15% to 54% are attributed to laboratory testing processes. From a practice improvement perspective, we (1) describe the need for laboratory testing process quality improvements from the perspective of primary care practices, and (2) describe the approaches and resources needed to implement laboratory testing process quality improvements in practice. We applied practice observations, process mapping, and interviews with primary care practices in the Shared Networks of Colorado Ambulatory Practices and Partners (SNOCAP)-affiliated practice-based research networks that field-tested in 2013 a laboratory testing process improvement toolkit. From the data collected in each of the 22 participating practices, common testing quality issues included, but were not limited to, 3 main testing process steps: laboratory test preparation, test tracking, and patient notification. Three overarching qualitative themes emerged: practices readily acknowledge multiple laboratory testing process problems; practices know that they need help addressing the issues; and practices face challenges with finding patient-centered solutions compatible with practice priorities and available resources. While practices were able to get started with guidance and a toolkit to improve laboratory testing processes, most did not seem able to achieve their quality improvement aims unassisted. Providing specific guidance tools with practice facilitation or other rapid-cycle quality improvement support may be an effective approach to improve common laboratory testing issues in primary care. © Copyright 2015 by the American Board of Family Medicine.
Prevention of occupational injuries: Evidence for effective good practices in foundries.

PubMed

Porru, Stefano; Calza, Stefano; Arici, Cecilia

2017-02-01

Occupational injuries are a relevant research and practical issue. However, intervention studies evaluating the effectiveness of workplace injury prevention programs are seldom performed. The effectiveness of a multifaceted intervention aimed at reducing occupational injury rates (incidence/employment-based=IR, frequency/hours-based=FR, severity=SR) was evaluated between 2008 and 2013 in 29 Italian foundries (22 ferrous; 7 non-ferrous; 3,460 male blue collar workers/year) of varying sizes. Each foundry established an internal multidisciplinary prevention team for risk assessment, monitoring and prevention of occupational injuries, involving employers, occupational physicians, safety personnel, workers' representatives, supervisors. Targets of intervention were workers, equipment, organization, workplace, job tasks. An interrupted time series (ITS) design was applied. 4,604 occupational injuries and 83,156 lost workdays were registered between 2003 and 2013. Statistical analysis showed, after intervention, a reduction of all injury rates (-26% IR, -15% FR, -18% SR) in ferrous foundries and of SR (-4%) in non-ferrous foundries. A significant (p=0.021) 'step-effect' was shown for IR in ferrous foundries, independent of secular trends (p<0.001). Sector-specific benchmarks for all injury rates were developed separately for ferrous and non-ferrous foundries. Strengths of the study were: ITS design, according to standardized quality criteria (i.e., at least three data points before and three data points after intervention; clearly defined intervention point); pragmatic approach, with good external validity; promotion of effective good practices. Main limitations were the non-randomized nature and a medium length post-intervention period. In conclusion, a multifaceted, pragmatic and accountable intervention is effective in reducing the burden of occupational injuries in small-, medium- and large-sized foundries. Practical Applications: The study poses the basis for

Conditions for building a community of practice in an advanced physics laboratory

NASA Astrophysics Data System (ADS)

Irving, Paul W.; Sayre, Eleanor C.

2014-06-01

We use the theory of communities of practice and the concept of accountable disciplinary knowledge to describe how a learning community develops in the context of an upper-division physics laboratory course. The change in accountable disciplinary knowledge motivates students' enculturation into a community of practice. The enculturation process is facilitated by four specific structural features of the course and supported by a primary instructional choice. The four structural features are "paucity of instructor time," "all in a room together," "long and difficult experiments," and "same experiments at different times." The instructional choice is the encouragement of the sharing and development of knowledge and understanding by the instructor. The combination of the instructional choice and structural features promotes the development of the learning community in which students engage in authentic practices of a physicist. This results in a classroom community that can provide students with the opportunity to have an accelerated trajectory towards being a more central participant of the community of a practice of physicists. We support our claims with video-based observations of laboratory classroom interactions and individual, semistructured interviews with students about their laboratory experiences and physics identity.
A Rapid Assessment Tool for affirming good practice in midwifery education programming.

PubMed

Fullerton, Judith T; Johnson, Peter; Lobe, Erika; Myint, Khine Haymar; Aung, Nan Nan; Moe, Thida; Linn, Nay Aung

2016-03-01

to design a criterion-referenced assessment tool that could be used globally in a rapid assessment of good practices and bottlenecks in midwifery education programs. a standard tool development process was followed, to generate standards and reference criteria; followed by external review and field testing to document psychometric properties. review of standards and scoring criteria were conducted by stakeholders around the globe. Field testing of the tool was conducted in Myanmar. eleven of Myanmar׳s 22 midwifery education programs participated in the assessment. the clinimetric tool was demonstrated to have content validity and high inter-rater reliability in use. a globally validated tool, and accompanying user guide and handbook are now available for conducting rapid assessments of compliance with good practice criteria in midwifery education programming. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
Good quantification practices of flavours and fragrances by mass spectrometry.

PubMed

Begnaud, Frédéric; Chaintreau, Alain

2016-10-28

Over the past 15 years, chromatographic techniques with mass spectrometric detection have been increasingly used to monitor the rapidly expanded list of regulated flavour and fragrance ingredients. This trend entails a need for good quantification practices suitable for complex media, especially for multi-analytes. In this article, we present experimental precautions needed to perform the analyses and ways to process the data according to the most recent approaches. This notably includes the identification of analytes during their quantification and method validation, when applied to real matrices, based on accuracy profiles. A brief survey of application studies based on such practices is given.This article is part of the themed issue 'Quantitative mass spectrometry'. © 2016 The Authors.
Understanding variations in secondary findings reporting practices across U.S. genome sequencing laboratories.

PubMed

Ackerman, Sara L; Koenig, Barbara A

2018-01-01

Increasingly used for clinical purposes, genome and exome sequencing can generate clinically relevant information that is not directly related to the reason for testing (incidental or secondary findings). Debates about the ethical implications of secondary findings were sparked by the American College of Medical Genetics (ACMG) 2013 policy statement, which recommended that laboratories report pathogenic alterations in 56 genes. Although wide variation in laboratories' secondary findings policies has been reported, little is known about its causes. We interviewed 18 laboratory directors and genetic counselors at 10 U.S. laboratories to investigate the motivations and interests shaping secondary findings reporting policies for clinical exome sequencing. Analysis of interview transcripts and laboratory documents was informed by sociological theories of standardization. Laboratories varied widely in terms of the types of secondary findings reported, consent-form language, and choices offered to patients. In explaining their adaptation of the ACMG report, our participants weighed genetic information's clinical, moral, professional, and commercial value in an attempt to maximize benefits for patients and families, minimize the costs of sequencing and analysis, adhere to professional norms, attract customers, and contend with the uncertain clinical implications of much of the genetic information generated. Nearly all laboratories in our study voluntarily adopted ACMG's recommendations, but their actual practices varied considerably and were informed by laboratory-specific judgments about clinical utility and patient benefit. Our findings offer a compelling example of standardization as a complex process that rarely leads simply to uniformity of practice. As laboratories take on a more prominent role in decisions about the return of genetic information, strategies are needed to inform patients, families, and clinicians about the differences between laboratories' practices
Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges.

PubMed

Sivris, Kelly C; Leka, Stavroula

2015-12-01

While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013-2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation.
Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges

PubMed Central

Sivris, Kelly C.; Leka, Stavroula

2015-01-01

Background While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Methods Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. Results The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013–2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. Conclusion The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation. PMID:26929841
Commentary on the MID3 Good Practices Paper.

PubMed

Manolis, Efthymios; Brogren, Jacob; Cole, Susan; Hay, Justin L; Nordmark, Anna; Karlsson, Kristin E; Lentz, Frederike; Benda, Norbert; Wangorsch, Gaby; Pons, Gerard; Zhao, Wei; Gigante, Valeria; Serone, Francesca; Standing, Joseph F; Dokoumetzidis, Aris; Vakkilainen, Juha; van den Heuvel, Michiel; Mangas Sanjuan, Victor; Taminiau, Johannes; Kerwash, Essam; Khan, David; Musuamba, Flora Tshinanu; Skottheim Rusten, Ine

2017-07-01

During the last 10 years the European Medicines Agency (EMA) organized a number of workshops on modeling and simulation, working towards greater integration of modeling and simulation (M&S) in the development and regulatory assessment of medicines. In the 2011 EMA - European Federation of Pharmaceutical Industries and Associations (EFPIA) Workshop on Modelling and Simulation, European regulators agreed to the necessity to build expertise to be able to review M&S data provided by companies in their dossier. This led to the establishment of the EMA Modelling and Simulation Working Group (MSWG). Also, there was agreement reached on the need for harmonization on good M&S practices and for continuing dialog across all parties. The MSWG acknowledges the initiative of the EFPIA Model-Informed Drug Discovery and Development (MID3) group in promoting greater consistency in practice, application, and documentation of M&S and considers the paper is an important contribution towards achieving this objective. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.
A pharmacy practice laboratory exercise to apply biochemistry concepts.

PubMed

Harrold, Marc W; McFalls, Marsha A

2010-10-11

To develop exercises that allow pharmacy students to apply foundational knowledge discussed in a first-professional year (P1) biochemistry course to specific disease states and patient scenarios. A pharmacy practice laboratory exercise was developed to accompany a lecture sequence pertaining to purine biosynthesis and degradation. The assignment required students to fill a prescription, provide patient counseling tips, and answer questions pertaining to the disease state, the underlying biochemical problem, and the prescribed medication. Students were graded on the accuracy with which they filled the prescription, provided patient counseling, and answered the questions provided. Overall, students displayed mastery in all of these areas. Additionally, students completed a course survey on which they rated this exercise favorably, noting that it helped them to integrate basic science concepts and pharmacy practice. A laboratory exercise provided an opportunity for P1 students to apply foundational pharmacy knowledge to a patient case and can serve as a template for the design of additional exercises.
Good practices of publishing AYUSH research: A practical checklist for authors.

PubMed

Patwardhan, Kishor; Tillu, Girish; Jadhav, Priyanka M

Since its inception, Journal of Ayurveda and Integrative Medicine (J-AIM) has been constantly striving to create an environment that inculcates and strengthens "Good Publication Practices (GPP)" amongst students, practitioners and researchers in AYUSH community. The J-AIM has been doing this in the form of conducting workshops on scientific writing and research methods on different platforms. This article is based on our experiences and varied discussions that we have had with students, teachers, practitioners and researchers during these interactive sessions, and is intended at addressing the gap that prevails in the domain. The need for such awareness is felt even more strongly ever since the Beall's list of predatory journals has been unpublished. This article tries to fill the void this disappearance has created. We analyze the current scenario of AYUSH publications, enumerate the common perceptions and concerns among the workers in the field, and consider the periodicals where the doctoral and postgraduate level of Ayurveda research works are being published at present. The article also presents a practical checklist that will be helpful for students and teachers to refer authentic resources and submit their work to an appropriate scholarly journal. Copyright © 2017 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Published by Elsevier B.V. All rights reserved.
21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...
21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...
21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...
21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...
Analysis of good practice of public health Emergency Operations Centers.

PubMed

Xu, Min; Li, Shi-Xue

2015-08-01

To study the public health Emergency Operations Centers (EOCs)in the US, the European Union, the UK and Australia, and summarize the good practice for the improvement of National Health Emergency Response Command Center in Chinese National Health and Family Planning Commission. Literature review was conducted to explore the EOCs of selected countries. The study focused on EOC function, organizational structure, human resources and information management. The selected EOCs had the basic EOC functions of coordinating and commanding as well as the public health related functions such as monitoring the situation, risk assessment, and epidemiological briefings. The organizational structures of the EOCs were standardized, scalable and flexible. Incident Command System was the widely applied organizational structure with a strong preference. The EOCs were managed by a unit of emergency management during routine time and surge staff were engaged upon emergencies. The selected EOCs had clear information management framework including information collection, assessment and dissemination. The performance of National Health Emergency Response Command Center can be improved by learning from the good practice of the selected EOCs, including setting clear functions, standardizing the organizational structure, enhancing the human resource capacity and strengthening information management. Copyright © 2015 Hainan Medical College. Production and hosting by Elsevier B.V. All rights reserved.
Personal Transferable Skills in Higher Education: The Problems of Implementing Good Practice.

ERIC Educational Resources Information Center

Drummond, Ian; Nixon, Iain; Wiltshire, John

1998-01-01

Promotion of effective development of personal transferable skills has had limited success in British higher education. Difficulties inherent in implementing established good practice include institutional inertia, issues of academic freedom, resources, high levels of commitment to a particular discipline, and modularization. (SK)
National Survey on Internal Quality Control Practice for Lipid Parameters in Laboratories of China from 2014 to 2016.

PubMed

Ye, Yuanyuan; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2017-09-01

To investigate the situation of Internal Quality Control (IQC) practice for total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol from 2014 to 2016 in laboratories in China and provide improvement measurements. A web-based External Quality Assessment (EQA) system was used to collect IQC data of lipid parameters in laboratories which continuously participated in the national EQA programs in China from 2014 to 2016. Pass rate of the coefficients of variation (CVs) of two level quality controls in four lipid parameters were calculated according to six quality specifications for precision to evaluate the current status of precision level of the four lipid parameters and their change over time in China. 533, 512, 504, and 466 laboratories continuously reported the data of level one for total cholesterol, triglyceride, HDL-cholesterol and LDL-cholesterol, and 212, 210, 208 and 198 laboratories reported the level two, respectively. The percentage of laboratories meeting the quality specification varied based on different criteria. Non-significant change can be found in the pass rate of CVs over time. The number of laboratories using a closed system increased over time, but still only accounted for a small proportion. There is no significant difference in the pass rate of CVs between closed and open systems. Triglycerides currently have a fairly good performance in China. While the performance of laboratories on total cholesterol, HDL-cholesterol and LDL-cholesterol has yet to be improved.
Good manufacturing practices for medicinal products for human use.

PubMed

Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.
Good manufacturing practices for medicinal products for human use

PubMed Central

Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511
A survey of current practices for genomic sequencing test interpretation and reporting processes in US laboratories.

PubMed

O'Daniel, Julianne M; McLaughlin, Heather M; Amendola, Laura M; Bale, Sherri J; Berg, Jonathan S; Bick, David; Bowling, Kevin M; Chao, Elizabeth C; Chung, Wendy K; Conlin, Laura K; Cooper, Gregory M; Das, Soma; Deignan, Joshua L; Dorschner, Michael O; Evans, James P; Ghazani, Arezou A; Goddard, Katrina A; Gornick, Michele; Farwell Hagman, Kelly D; Hambuch, Tina; Hegde, Madhuri; Hindorff, Lucia A; Holm, Ingrid A; Jarvik, Gail P; Knight Johnson, Amy; Mighion, Lindsey; Morra, Massimo; Plon, Sharon E; Punj, Sumit; Richards, C Sue; Santani, Avni; Shirts, Brian H; Spinner, Nancy B; Tang, Sha; Weck, Karen E; Wolf, Susan M; Yang, Yaping; Rehm, Heidi L

2017-05-01

While the diagnostic success of genomic sequencing expands, the complexity of this testing should not be overlooked. Numerous laboratory processes are required to support the identification, interpretation, and reporting of clinically significant variants. This study aimed to examine the workflow and reporting procedures among US laboratories to highlight shared practices and identify areas in need of standardization. Surveys and follow-up interviews were conducted with laboratories offering exome and/or genome sequencing to support a research program or for routine clinical services. The 73-item survey elicited multiple choice and free-text responses that were later clarified with phone interviews. Twenty-one laboratories participated. Practices highly concordant across all groups included consent documentation, multiperson case review, and enabling patient opt-out of incidental or secondary findings analysis. Noted divergence included use of phenotypic data to inform case analysis and interpretation and reporting of case-specific quality metrics and methods. Few laboratory policies detailed procedures for data reanalysis, data sharing, or patient access to data. This study provides an overview of practices and policies of experienced exome and genome sequencing laboratories. The results enable broader consideration of which practices are becoming standard approaches, where divergence remains, and areas of development in best practice guidelines that may be helpful.Genet Med advance online publication 03 Novemeber 2016.
Unlocking the Laboratory: Autonomous Wireless Sensor Authentication in Practice

ERIC Educational Resources Information Center

Huggard, Meriel; McGoldrick, Ciaran

2013-01-01

Purpose: The purpose of this study is to evaluate a practical laboratory task where final year undergraduate students design, implement and validate an inferred security wireless sensor access system. Design/methodology/approach: The quality of the learning and technical environment was evaluated from a number of perspectives using a mixed methods…

Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research. The Chemical Manufacturers Association's Epidemiology Task Group.

PubMed

1991-12-01

The Guidelines for Good Epidemiology Practices (GEPs) for Occupational and Environmental Epidemiologic Research address the conduct of studies generally undertaken to answer questions about human health in relationship to the work place or the environment. The GEPs propose minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The GEPs address the process of conducting individual epidemiologic studies and do not prescribe specific research methods. The Guidelines for Good Epidemiology Practices propose minimum practices and procedures in the following areas: I. Organization and Personnel II. Facilities, Resource Commitment, and Contractors III. Protocol IV. Review and Approval V. Study Conduct VI. Communication VII. Archiving VIII. Quality Assurance Although the Guidelines for Good Epidemiology Practices will not guarantee good epidemiology, they do provide a useful framework for ensuring that all research issues are adequately addressed. This framework is proposed as a first step in improving epidemiologic research practices through adherence to sound scientific research principles. Appendices provide an overview of standard operating procedures, a glossary of terms used in the Guidelines, and suggested references on occupational epidemiology methods.
Practical Laboratory Planning.

ERIC Educational Resources Information Center

Ferguson, W. R.

This book is intended as a guide for people who are planning chemistry and physics research laboratories. It deals with the importance of effective communication between client and architect, the value of preliminary planning, and the role of the project officer. It also discusses the size and layout of individual laboratories, the design of…
If You Don't Have a Good Laboratory, Find a Good Volcano: Mount Vesuvius as a Natural Chemical Laboratory in Eighteenth-Century Italy.

PubMed

Guerra, Corinna

2015-08-01

This essay that examines the role of the volcano as a chemical site in the late eighteenth century, as the "new chemistry" spread throughout the southern Italian Kingdom of Naples, resulting in lively debates. In Naples itself, these scientific debates were not confined to academies, courts, and urban spaces. In the absence of well-equipped chemical laboratories, Neapolitan scholars also carried out research on chemistry on the slopes of Mount Vesuvius, a natural site that furnished them with all the tools and substances necessary for practising chemistry. By examining various Neapolitan publications on Vesuvius and the chemical reactions and products associated with its periodic eruptions, I argue that the volcano's presence contributed to a distinctive, local approach to chemical theory and practice. Several case studies examine the ways in which proximity to Vesuvius was exploited by Neapolitan scholars as they engaged with the new chemistry, including Giuseppe Vairo, Michele Ferrara, Francesco Semmola, and Emanuele Scotti.
Current safety practices in nano-research laboratories in China.

PubMed

Zhang, Can; Zhang, Jing; Wang, Guoyu

2014-06-01

China has become a key player in the global nanotechnology field, however, no surveys have specifically examined safety practices in the Chinese nano-laboratories in depth. This study reports results of a survey of 300 professionals who work in research laboratories that handle nanomaterials in China. We recruited participants at three major nano-research laboratories (which carry out research in diverse fields such as chemistry, material science, and biology) and the nano-chemistry session of the national meeting of the Chinese Chemical Society. Results show that almost all nano-research laboratories surveyed had general safety regulations, whereas less than one third of respondents reported having nanospecific safety rules. General safety measures were in place in most surveyed nano-research laboratories, while nanospecific protective measures existed or were implemented less frequently. Several factors reported from the scientific literature including nanotoxicology knowledge gaps, technical limitations on estimating nano-exposure, and the lack of nano-occupational safety legislation may contribute to the current state of affairs. With these factors in mind and embracing the precautionary principle, we suggest strengthening or providing nanosafety training (including raising risk awareness) and establishing nanosafety guidelines in China, to better protect personnel in the nano-workplace.
Computer ergonomics: the medical practice guide to developing good computer habits.

PubMed

Hills, Laura

2011-01-01

Medical practice employees are likely to use computers for at least some of their work. Some sit several hours each day at computer workstations. Therefore, it is important that members of your medical practice team develop good computer work habits and that they know how to align equipment, furniture, and their bodies to prevent strain, stress, and computer-related injuries. This article delves into the field of computer ergonomics-the design of computer workstations and work habits to reduce user fatigue, discomfort, and injury. It describes practical strategies medical practice employees can use to improve their computer work habits. Specifically, this article describes the proper use of the computer workstation chair, the ideal placement of the computer monitor and keyboard, and the best lighting for computer work areas and tasks. Moreover, this article includes computer ergonomic guidelines especially for bifocal and progressive lens wearers and offers 10 tips for proper mousing. Ergonomically correct posture, movements, positioning, and equipment are all described in detail to enable the frequent computer user in your medical practice to remain healthy, pain-free, and productive.
[Implementation of good quality and safety practices. Descriptive study in a occupational mutual health centre].

PubMed

Manzanera, R; Plana, M; Moya, D; Ortner, J; Mira, J J

2016-01-01

To describe the level of implementation of quality and safety good practice elements in a Mutual Society health centre. A Cross-sectional study was conducted to assess the level of implementation of good practices using a questionnaire. Some quality dimensions were also assessed (scale 0 to 10) by a set of 87 quality coordinators of health centres and a random sample of 54 healthcare professionals working in small centres. Seventy quality coordinators and 27 professionals replied (response rates 80% and 50%, respectively. There were no differences in the assessment of quality attributes between both groups. They identified as areas for improvement: use of practice guidelines (7.6/10), scientific and technical skills (7.5/10), and patient satisfaction (7.7/10). Availability and accessibility to clinical reports, informed consent, availability of hydro-alcoholic solution, and to record allergies, were considered of high importance to be implemented, with training and research, improvements in equipment and technology plans, adherence to clinical practice guidelines and the preparation of risk maps, being of less importance. The good practices related to equipment and resources have a higher likelihood to be implemented, meanwhile those related to quality and safety attitudes have more barriers before being implemented. The mutual has a similar behaviour than other healthcare institutions. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.
Prepare, Do, Review: A skills-based approach for laboratory practical classes in biochemistry and molecular biology.

PubMed

Arthur, Peter; Ludwig, Martha; Castelli, Joane; Kirkwood, Paul; Attwood, Paul

2016-05-06

A new laboratory practical system is described which is comprised of a number of laboratory practical modules, each based around a particular technique or set of techniques, related to the theory part of the course but not designed to be dependent on it. Each module comprises an online recorded pre-lab lecture, the laboratory practical itself and a post-lab session in which students make oral presentations on different aspects of the practical. Each part of the module is assessed with the aim of providing rapid feedback to staff and students. Each laboratory practical is the responsibility of a single staff member and through this "ownership," continual review and updating is promoted. Examples of changes made by staff to modules as a result of student feedback are detailed. A survey of students who had experienced both the old-style laboratory course and the new one provided evidence of increased satisfaction with the new program. The assessment of acquired shills in the new program showed that it was much more effective than the old course. © 2016 by The International Union of Biochemistry and Molecular Biology, 44:276-287, 2016. © 2016 The International Union of Biochemistry and Molecular Biology.
Creating Opportunities: Good Practice in Small Business Training for Australian Rural Women.

ERIC Educational Resources Information Center

Simpson, Lyn; Daws, Leonie; Wood, Leanne

2002-01-01

To overcome barriers to participation in small business training faced by rural Australian women, training needs and delivery issues were identified and a good practice matrix was developed with the following components: marketing, content, delivery, support, impact, and innovation. Underlying principles included unique needs, diversity, use of…
A survey of coagulation laboratory practices and satisfaction ratings of member laboratories of the Thailand National External Quality Assessment Scheme for blood coagulation.

PubMed

Chuntarut, A; Tientadakul, P; Wongkrajang, P

2016-06-01

The Thailand National External Quality Assessment Scheme (NEQAS) for blood coagulation was established in 2005. The objective of this study was to collect data of coagulation laboratory practices and satisfaction of NEQAS member. Two hundred seventy-six questionnaires were sent to laboratories that are members of NEQAS to obtain data relating to coagulation laboratory practice and satisfaction in 2014. Data from this survey were compared with data from the survey conducted in 2005 to evaluate levels of improvement. Of 276 questionnaires sent, 212 (76.8%) were returned. Improvements were characterized by the number of laboratories that (i) decreased use of 3.8% sodium citrate as anticoagulant; (ii) implemented use of at least two control levels for internal quality control; and (iii) implemented reporting of reference values with results, as well as establishing their own reference range and using geometric mean as the denominator for international normalized ratio calculation. For overall satisfaction, 179 of 206 (86.9%) participant laboratories reported being satisfied or very satisfied. Improvements in coagulation laboratory practices in Thailand were observed in every step of the total testing process. However, additional improvements are still needed, such as determination and use of a local reference range. © 2016 John Wiley & Sons Ltd.
Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

PubMed

Tulina, M A; Pyatigorskaya, N V

2018-03-01

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.
eLearning Hands-On: Blending Interactive eLearning with Practical Engineering Laboratory

ERIC Educational Resources Information Center

Kiravu, Cheddi; Yanev, Kamen M.; Tunde, Moses O.; Jeffrey, Anna M.; Schoenian, Dirk; Renner, Ansel

2016-01-01

Purpose: Integrating laboratory work into interactive engineering eLearning contents augments theory with practice while simultaneously ameliorating the apparent theory-practice gap in traditional eLearning. The purpose of this paper is to assess and recommend media that currently fulfil this desirable dual pedagogical goal.…
9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

Code of Federal Regulations, 2011 CFR

2011-01-01

... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...) Allow no visitors except under controlled conditions to minimize the introduction of Salmonella and...
Securing the Adoption of Good Practice in Scotland's Colleges. A Report by HM Inspectors of Education for the Scottish Funding Council

ERIC Educational Resources Information Center

Her Majesty's Inspectorate of Education, 2006

2006-01-01

The purpose of this report is to describe the main mechanisms currently in use in Scotland's colleges to ensure that the adoption of good practice actually happens. It investigates how colleges identify and promote good practice in their own institutions; how they develop strategies and processes to ensure good practice is shared, adopted and…
Taking personal responsibility: Nurses' and assistant nurses' experiences of good nursing practice in psychiatric inpatient care.

PubMed

Gabrielsson, Sebastian; Sävenstedt, Stefan; Olsson, Malin

2016-10-01

Therapeutic nurse-patient relationships are considered essential for good nursing practice in psychiatric inpatient care. Previous research suggests that inpatient care fails to fulfil patients' expectations in this regard, and that nurses might experience the reality of inpatient care as an obstruction. The aim of the present study was to explore nurses' and assistant nurses' experiences of good nursing practice in the specific context of psychiatric inpatient care. Qualitative interviews were conducted with 12 skilled, relationship-oriented nurses and assistant nurses in order to explore their experiences with nursing practice related to psychiatric inpatient care. Interviews were transcribed and analysed using an interpretive descriptive approach. Findings describe good nursing practice as a matter of nurses and assistant nurses taking personal responsibility for their actions and for the individual patient as a person. Difficulties in providing dignified nursing care and taking personal responsibility cause them to experience feelings of distress and frustration. Shared values and nursing leadership supports being moral and treating patients with respect, having enough time supports being present and connecting with patients, and working as a part of a competent team with critical daily discussions and diversity supports being confident and building trust. The findings suggest that taking personal responsibility is integral to good nursing practice. If unable to improve poor circumstances, nurses might be forced to promote their own survival by refuting or redefining their responsibility. Nurses need to prioritize being with patients and gain support in shaping their own nursing practice. Nursing leadership should provide moral direction and defend humanistic values. © 2016 Australian College of Mental Health Nurses Inc.
A New Survey of "Good Practices" Could Be an Alternative to Rankings.

ERIC Educational Resources Information Center

Gose, Ben

1999-01-01

A new national survey, developed by professionals in higher education assessment, seeks to measure the extent to which colleges use "good practices" that encourage learning. Creators of the National Survey of Student Engagement will study undergraduates at 750 colleges over three years to establish benchmarks for different institution…
Audit of clinical-laboratory practices in haematology and blood transfusion at Muhimbili National Hospital in Tanzania.

PubMed

Makubi, Abel N; Meda, Collins; Magesa, Alex; Minja, Peter; Mlalasi, Juliana; Salum, Zubeda; Kweka, Rumisha E; Rwehabura, James; Quaresh, Amrana; Magesa, Pius M; Robert, David; Makani, Julie; Kaaya, Ephata

2012-10-01

In Tanzania, there is paucity of data for monitoring laboratory medicine including haematology. This therefore calls for audits of practices in haematology and blood transfusion in order to provide appraise practice and devise strategies that would result in improved quality of health care services. This descriptive cross-sectional study which audited laboratory practice in haematology and blood transfusion at Muhimbili National Hospital (MNH) aimed at assessing the pre-analytical stage of laboratory investigations including laboratory request forms and handling specimen processing in the haematology laboratory and assessing the chain from donor selection, blood component processing to administration of blood during transfusion. A national standard checklist was used to audit the laboratory request forms (LRF), phlebotomists' practices on handling and assessing the from donor selection to administration 6f blood during transfusion. Both interview and observations were used. A total of 195 LRF were audited and 100% of had incomplete information such as patients' identification numbers, time sample ordered, reason for request, summary of clinical assessment and differential diagnoses. The labelling of specimens was poorly done by phlebotomists/clinicians in 82% of the specimens. Also 65% (132/202) of the blood samples delivered in the haematology laboratory did not contain the recommended volume of blood. There was no laboratory request form specific for ordering blood and there were no guidelines for indication of blood transfusion in the wards/ clinics. The blood transfusion laboratory section was not participating in external quality assessment and the hospital transfusion committee was not in operation. It is recommended that a referral hospital like MNH should have a transfusion committee to provide an active forum to facilitate communication between those involved with transfusion, monitor, coordinate and audit blood transfusion practices as per national
Good manufacturing practice and viral safety.

PubMed

Kerner, B

1995-07-01

The concept of virus inactivation during the manufacture of blood products raises questions about possible recontamination of the product by the environment. A strict regime of good manufacturing practice (GMP) is mandatory. The guidelines originally issued by the World Health Organization (WHO), and now law in most countries, are an excellent basis for the operation of a production plant. The following elements of GMP require special concern: (i) All functions shall be defined in a clear organization chart. (ii) Personnel shall be appropriately trained for the job and to perfect hygiene. (iii) Buildings and facilities, as well as supply systems, shall exclude the possibility of recontamination of already virus-inactivated materials. (iv) Equipment shall be easy to clean and fully sterilizable. (v) Production shall follow appropriate written procedures. (vi) The Quality Control Organization shall monitor the process by in-process controls and review the records for possible deviations. All GMP issues are coordinated by a Quality Assurance Organization that also reviews the overall performance of the operation. The maintenance of viral safety of the products basically depends upon the full commitment of all bodies involved to proper and non-negotiable GMP.
9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

Code of Federal Regulations, 2012 CFR

2012-01-01

... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...
9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

Code of Federal Regulations, 2014 CFR

2014-01-01

... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...
9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

Code of Federal Regulations, 2013 CFR

2013-01-01

... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...

Laboratory Medicine Best Practice Guideline: Vitamins A, E and the Carotenoids in Blood

PubMed Central

Greaves, Ronda F; Woollard, Gerald A; Hoad, Kirsten E; Walmsley, Trevor A; Johnson, Lambro A; Briscoe, Scott; Koetsier, Sabrina; Harrower, Tamantha; Gill, Janice P

2014-01-01

Despite apparent method similarities between laboratories there appear to be confounding factors inhibiting uniform reporting and standardisation of vitamin assays. The Australasian Association of Clinical Biochemists (AACB) Vitamins Working Party, in conjunction with The Royal College of Pathologists of Australasia Quality Assurance Programs, has formulated a guideline to improve performance, reproducibility and accuracy of fat-soluble vitamin results. The aim of the guideline is to identify critical pre-analytical, analytical and post-analytical components of the analysis of vitamins A, E and carotenoids in blood to promote best practice and harmonisation. This best practice guideline has been developed with reference to the Centers for Disease Control and Prevention (CDC) “Laboratory Medicine Best Practices: Developing an Evidence-Based Review and Evaluation Process”. The CDC document cites an evaluation framework for generating best practice recommendations that are specific to laboratory medicine. These 50 recommendations proposed herein, were generated from a comprehensive literature search and the extensive combined experience of the AACB Vitamins Working Party members. They were formulated based on comparison between an impact assessment rating and strength of evidence and were classified as either: (1) strongly recommend, (2) recommend, (3) no recommendation for or against, or (4) recommend against. These best practice recommendations represent the consensus views, in association with peer reviewed evidence of the AACB Vitamins Working Party, towards best practice for the collection, analysis and interpretation of vitamins A, E and carotenoids in blood. PMID:25210208
Practical Application of Electrochemical Nitrate Sensor under Laboratory and Forest Nursery Conditions.

PubMed

Caron, William-Olivier; Lamhamedi, Mohammed S; Viens, Jeff; Messaddeq, Younès

2016-07-28

The reduction of nitrate leaching to ensure greater protection of groundwater quality has become a global issue. The development of new technologies for more accurate dosing of nitrates helps optimize fertilization programs. This paper presents the practical application of a newly developed electrochemical sensor designed for in situ quantification of nitrate. To our knowledge, this paper is the first to report the use of electrochemical impedance to determine nitrate concentrations in growing media under forest nursery conditions. Using impedance measurements, the sensor has been tested in laboratory and compared to colorimetric measurements of the nitrate. The developed sensor has been used in water-saturated growing medium and showed good correlation to certified methods, even in samples obtained over a multi-ion fertilisation season. A linear and significant relationship was observed between the resistance and the concentration of nitrates (R² = 0.972), for a range of concentrations of nitrates. We also observed stability of the sensor after exposure of one month to the real environmental conditions of the forest nursery.
Practical Application of Electrochemical Nitrate Sensor under Laboratory and Forest Nursery Conditions

PubMed Central

Caron, William-Olivier; Lamhamedi, Mohammed S.; Viens, Jeff; Messaddeq, Younès

2016-01-01

The reduction of nitrate leaching to ensure greater protection of groundwater quality has become a global issue. The development of new technologies for more accurate dosing of nitrates helps optimize fertilization programs. This paper presents the practical application of a newly developed electrochemical sensor designed for in situ quantification of nitrate. To our knowledge, this paper is the first to report the use of electrochemical impedance to determine nitrate concentrations in growing media under forest nursery conditions. Using impedance measurements, the sensor has been tested in laboratory and compared to colorimetric measurements of the nitrate. The developed sensor has been used in water-saturated growing medium and showed good correlation to certified methods, even in samples obtained over a multi-ion fertilisation season. A linear and significant relationship was observed between the resistance and the concentration of nitrates (R2 = 0.972), for a range of concentrations of nitrates. We also observed stability of the sensor after exposure of one month to the real environmental conditions of the forest nursery. PMID:27483266
Advances in participatory occupational health aimed at good practices in small enterprises and the informal sector.

PubMed

Kogi, Kazutaka

2006-01-01

Participatory programmes for occupational risk reduction are gaining importance particularly in small workplaces in both industrially developing and developed countries. To discuss the types of effective support, participatory steps commonly seen in our "work improvement-Asia" network are reviewed. The review covered training programmes for small enterprises, farmers, home workers and trade union members. Participatory steps commonly focusing on low-cost good practices locally achieved have led to concrete improvements in multiple technical areas including materials handling, workstation ergonomics, physical environment and work organization. These steps take advantage of positive features of small workplaces in two distinct ways. First, local key persons are ready to accept local good practices conveyed through personal, informal approaches. Second, workers and farmers are capable of understanding technical problems affecting routine work and taking flexible actions leading to solving them. This process is facilitated by the use of locally adjusted training tools such as local good examples, action checklists and group work methods. It is suggested that participatory occupational health programmes can work in small workplaces when they utilize low-cost good practices in a flexible manner. Networking of these positive experiences is essential.
Designing and Conducting a Purification Scheme as an Organic Chemistry Laboratory Practical

ERIC Educational Resources Information Center

Graham, Kate J.; Johnson, Brian J.; Jones, T. Nicholas; McIntee, Edward J.; Schaller, Chris P.

2008-01-01

An open-ended laboratory practical has been developed that challenges students to evaluate when different purification techniques are appropriate. In contrast to most lab practicals, the overall grade includes an evaluation of spectral analysis as well as writing skills. However, a significant portion of the grade lies in successful execution of a…
Practical Strategies for Integrating Final Ecosystem Goods and Services into Community Decision-Making.

EPA Science Inventory

The concept of Final Ecosystem Goods and Services (FEGS) explicitly connects ecosystem services to the people that benefit from them. This report presents a number of practical strategies for incorporating FEGS, and more broadly ecosystem services, into the decision-making proces...
[Good professional practices of French CICs - version # 2].

PubMed

Chevassus, Hugues; Duchesne, Charlène; Sailly, Annabelle; Vigouroux, Céline; Foulon, Christine; Kubiak, Christine; Binquet, Christine; Felin, Alexandra Lamotte; Chaud, Pascal; Thalamas, Claire; Cornu, Catherine

2017-10-01

French clinical investigation centers (CICs) are academic platforms dedicated to clinical research. The QUALI-CIC working group helps to improve and harmonize practices within the CIC network. After some years of implementation, the manual of good professional practices of CICs (MGPP CIC) completed in 2010, needed to be revised to best fit with the large panel of CIC activities. The aim was also to make it more accurate and to reinforce requirements about participants safety and data security. In its second version published in the present article, the MGPP CIC includes 255 items divided into 15 chapters. An explanatory document, currently being drafted, will complete the manual to facilitate its implementation. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.
Establishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development

PubMed Central

Overgaard, RV; Ingwersen, SH; Tornøe, CW

2015-01-01

This tutorial aims at promoting good practices for exposure–response (E-R) analyses of clinical endpoints in drug development. The focus is on practical aspects of E-R analyses to assist modeling scientists with a process of performing such analyses in a consistent manner across individuals and projects and tailored to typical clinical drug development decisions. This includes general considerations for planning, conducting, and visualizing E-R analyses, and how these are linked to key questions. PMID:26535157
Perceptions of Science Teachers on Implementation of Seven Principles for Good Practice in Education by Chickering and Gamson in Courses

ERIC Educational Resources Information Center

Ugras, Mustafa; Asiltürk, Erol

2018-01-01

The present study aimed to determine the perceptions of science teachers on the implementation of the seven principles for good practice in education by Chickering and Gamson in their courses. Seven principles for good science education were used as a data collection tool in the survey. "The seven principles for good practice in science…
CHRODIS criteria applied to the MASK (MACVIA-ARIA Sentinel NetworK) Good Practice in allergic rhinitis: a SUNFRAIL report.

PubMed

Bousquet, J; Onorato, G L; Bachert, C; Barbolini, M; Bedbrook, A; Bjermer, L; de Sousa, J Correia; Chavannes, N H; Cruz, A A; De Manuel Keenoy, E; Devillier, P; Fonseca, J; Hun, S; Kostka, T; Hellings, P W; Illario, M; Ivancevich, J C; Larenas-Linnemann, D; Millot-Keurinck, J; Ryan, D; Samolinski, B; Sheikh, A; Yorgancioglu, A; Agache, I; Arnavielhe, S; Bewick, M; Annesi-Maesano, I; Anto, J M; Bergmann, K C; Bindslev-Jensen, C; Bosnic-Anticevich, S; Bouchard, J; Caimmi, D P; Camargos, P; Canonica, G W; Cardona, V; Carriazo, A M; Cingi, C; Colgan, E; Custovic, A; Dahl, R; Demoly, P; De Vries, G; Fokkens, W J; Fontaine, J F; Gemicioğlu, B; Guldemond, N; Gutter, Z; Haahtela, T; Hellqvist-Dahl, B; Jares, E; Joos, G; Just, J; Khaltaev, N; Keil, T; Klimek, L; Kowalski, M L; Kull, I; Kuna, P; Kvedariene, V; Laune, D; Louis, R; Magnan, A; Malva, J; Mathieu-Dupas, E; Melén, E; Menditto, E; Morais-Almeida, M; Mösges, R; Mullol, J; Murray, R; Neffen, H; O'Hehir, R; Palkonen, S; Papadopoulos, N G; Passalacqua, G; Pépin, J L; Portejoie, F; Price, D; Pugin, B; Raciborski, F; Simons, F E R; Sova, M; Spranger, O; Stellato, C; Todo Bom, A; Tomazic, P V; Triggiani, M; Valero, A; Valovirta, E; VandenPlas, O; Valiulis, A; van Eerd, M; Ventura, M T; Wickman, M; Young, I; Zuberbier, T; Zurkuhlen, A; Senn, A

2017-01-01

A Good Practice is a practice that works well, produces good results, and is recommended as a model. MACVIA-ARIA Sentinel Network (MASK), the new Allergic Rhinitis and its Impact on Asthma (ARIA) initiative, is an example of a Good Practice focusing on the implementation of multi-sectoral care pathways using emerging technologies with real life data in rhinitis and asthma multi-morbidity. The European Union Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS) has developed a checklist of 28 items for the evaluation of Good Practices. SUNFRAIL (Reference Sites Network for Prevention and Care of Frailty and Chronic Conditions in community dwelling persons of EU Countries), a European Union project, assessed whether MASK is in line with the 28 items of JA-CHRODIS. A short summary was proposed for each item and 18 experts, all members of ARIA and SUNFRAIL from 12 countries, assessed the 28 items using a Survey Monkey-based questionnaire. A visual analogue scale (VAS) from 0 (strongly disagree) to 100 (strongly agree) was used. Agreement equal or over 75% was observed for 14 items (50%). MASK is following the JA-CHRODIS recommendations for the evaluation of Good Practices.
Evaluation of the status of laboratory practices and the need for continuing education in medical mycology.

PubMed

Rosner, Eunice R; Reiss, Errol; Warren, Nancy G; Shadomy, H Jean; Lipman, Harvey B

2002-08-01

A survey to determine the need for training in medical mycology was sent to 605 US laboratories. Training needs were determined by comparing actual laboratory mycology practices with recommended practices, documenting the extent of mycology training reported by employees, and asking respondents to specify the fungi they considered most difficult to identify. The response rate was 56.7% (with only 316 laboratories providing sufficient information). Results showed a large degree of interlaboratory variation in practices and suggested that more judicious practices could lower costs and improve clinical relevance. Only 55.6% of laboratories reported that at least 1 employee attended a formal mycology continuing education program in the 4 years before the survey. Species of dermatophytes, dematiaceous fungi, and non-Candida yeasts were the most difficult to identify. Training may be needed in basic isolation procedures and in advanced topics such as identification of problematic molds and yeasts and antifungal susceptibility testing. Educators should consider clinical relevance and cost-containment without sacrificing quality when designing courses. Support for additional mycology training may improve if hospital and laboratory administrators are alerted to potential dangers and costs involved in treating patients with invasive fungal infections.
[Qualitative evaluation of employer requirements associated with occupational health and safety as good practice in small-scale enterprises].

PubMed

Kuroki, Naomi; Miyashita, Nana; Hino, Yoshiyuki; Kayashima, Kotaro; Fujino, Yoshihisa; Takada, Mikio; Nagata, Tomohisa; Yamataki, Hajime; Sakuragi, Sonoko; Kan, Hirohiko; Morita, Tetsuya; Ito, Akiyoshi; Mori, Koji

2009-09-01

The purpose of this study was to identify what motivates employers to promote good occupational health and safety practices in small-scale enterprises. Previous studies have shown that small-scale enterprises generally pay insufficient attention to issues of occupational health and safety. These findings were mainly derived from questionnaire based surveys. Nevertheless, some small-scale enterprises in which employers exercise good leadership do take a progressive approach to occupational health and safety. Although good practices can be identified in small-scale enterprises, it remains unclear what motivates employers in small-scale enterprises to actively implement occupational health and safety practices. We speculated that identifying employer motivations in promoting occupational health would help to spread good practices among small-scale enterprises. Using a qualitative approach based on the KJ methods, we interviewed ten employers who actively promote occupational health and safety in the workplace. The employers were asked to discuss their views of occupational health and safety in their own words. A semi-structured interview format was used, and transcripts were made of the interviews. Each transcript was independently coded by two or more researchers. These transcripts and codes were integrated and then the research group members discussed the heading titles and structural relationships between them according to the KJ method. Qualitative analysis revealed that all the employers expressed a strong interest in a "good company" and "good management". They emphasized four elements of "good management", namely "securing human resources", "trust of business partners", "social responsibility" and "employer's health condition itself", and considered that addressing occupational health and safety was essential to the achievement of these four elements. Consistent with previous findings, the results showed that implementation of occupational health and safety
Media fill for validation of a good manufacturing practice-compliant cell production process.

PubMed

Serra, Marta; Roseti, Livia; Bassi, Alessandra

2015-01-01

According to the European Regulation EC 1394/2007, the clinical use of Advanced Therapy Medicinal Products, such as Human Bone Marrow Mesenchymal Stem Cells expanded for the regeneration of bone tissue or Chondrocytes for Autologous Implantation, requires the development of a process in compliance with the Good Manufacturing Practices. The Media Fill test, consisting of a simulation of the expansion process by using a microbial growth medium instead of the cells, is considered one of the most effective ways to validate a cell production process. Such simulation, in fact, allows to identify any weakness in production that can lead to microbiological contamination of the final cell product as well as qualifying operators. Here, we report the critical aspects concerning the design of a Media Fill test to be used as a tool for the further validation of the sterility of a cell-based Good Manufacturing Practice-compliant production process.
Preoperative Site Marking: Are We Adhering to Good Surgical Practice?

PubMed

Bathla, Sonia; Chadwick, Michael; Nevins, Edward J; Seward, Joanna

2017-06-29

Wrong-site surgery is a never event and a serious, preventable patient safety incident. Within the United Kingdom, national guidance has been issued to minimize the risk of such events. The mandate includes preoperative marking of all surgical patients. This study aimed to quantify regional variation in practice within general surgery and opinions of the surgeons, to help guide the formulation and implementation of a regional general surgery preoperative marking protocol. A SurveyMonkey questionnaire was designed and distributed to 120 surgeons within the Mersey region, United Kingdom. This included all surgical trainees in Mersey (47 registrars, 56 core trainees), 15 consultants, and 2 surgical care practitioners. This sought to ascertain their routine practice and how they would choose to mark for 12 index procedures in general surgery, if mandated to do so. A total of 72 responses (60%) were obtained to the SurveyMonkey questionnaire. Only 26 (36.1%) said that they routinely marked all of their patients preoperatively. The operating surgeon marked the patient in 69% of responses, with the remainder delegating this task. Markings were visible after draping in only 55.6% of marked cases. Based on our findings, surgeons may not be adhering to "Good Surgical Practice"; practice is widely variable and surgeons are largely opposed and resistant to marking patients unless laterality is involved. We suggest that all surgeons need to be actively engaged in the design of local marking protocols to gain support, change practice, and reduce errors.
Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice.

PubMed

Gándara, Carolina; Affleck, Valerie; Stoll, Elizabeth Ann

2018-02-01

Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet, the manufacture of these vectors is challenging, especially at high titers required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation. The goals of this paper are to report the protocol for manufacturing high-titer third-generation lentivirus for preclinical testing and to provide detailed information on considerations for translating preclinical viral vector manufacture toward scaled-up platforms and processes in order to make gene therapies under Good Manufacturing Practice that are suitable for clinical trials.
Who Sleeps by Whom Revisited: A Method for Extracting the Moral Goods Implicit in Practice.

ERIC Educational Resources Information Center

Schweder, Richard A; And Others

1995-01-01

Explores the specific family practice of determining which family members share a bed or sleeping space. Discusses ways of extracting the moral principles implicit in the practice of arranging where family members sleep at night. Examines similarities and differences in the preferred moral goods of two culture regions--rural Hindu India and urban…
[Good practices and techniques for prevention of accidents at work and occupational diseases. New database of Inail].

PubMed

Bindi, L; Ossicini, A

2007-01-01

The project "The publication of good practices and good techniques for prevention" is one the priorities of nail. This computerized system for the collection of good practices and standards of Good Technology is aimed to health and safety of workers. The basic objective of the database is to provide a valuable tool, usable, dynamic and implemented, in order to facilitate and direct the access to BP and BT it by people responsible for SSL. At the same time constitutes a tool strategically important for enterprises (especially SMEs) in terms of technological innovation and competitiveness, related to the prevention, safety and health of workers. The realization of this project has involved many of the professionals (chemists, engineers, doctors, biologists, geologists, etc.), and everyone gives his intake of qualified professional competence.
Good Education, the Good Teacher, and a Practical Art of Living a Good Life: A Catholic Perspective

ERIC Educational Resources Information Center

Hermans, Chris

2017-01-01

What is good education? We value education for reasons connected to the good provided by education in society. This good is connected to be the pedagogical aim of education. This article distinguishes five criteria for good education based on the concept of "Bildung". Next, these five criteria are used to develop the idea of the good…
How good are the internal controls in your group practice? Ten questions to contemplate.

PubMed

Grant, Barbara J; Foley, Lori A

2002-01-01

Internal controls are the methods and procedures used by any business to prevent or detect errors, safeguard assets (especially cash) from being misappropriated, and encourage staff adherence to prescribed managerial policies. Internal controls in a medical practice differ depending on the size and complexity of the practice. The key, however, is that they prevent or detect errors and efforts to circumvent the established policies and procedures of the organization. How good are the internal controls in your group practice? This article identifies ten questions you should use to evaluate your risk of asset misappropriation.
Impacts of Good Practices on Cognitive Development, Learning Orientations, and Graduate Degree Plans during the First Year of College

ERIC Educational Resources Information Center

Cruce, Ty M.; Wolniak, Gregory C.; Seifert, Tricia A.; Pascarella, Ernest T.

2006-01-01

This study estimated separately the unique effects of three dimensions of good practice and the global effects of a composite measure of good practices on the cognitive development, orientations to learning, and educational aspirations of students during their first year of college. Analyses of longitudinal data from a representative sample of…

Multiple Images, Common Threads. Case Studies of Good Practice in Adult Community Education.

ERIC Educational Resources Information Center

Bradshaw, Delia

This document presents 10 case studies of adult community education programs (ACE) in the state of Victoria, Australia, in the mid 1990s, that were identified as exemplifying the following principles of good practice in ACE: expansiveness, integration, responsiveness, innovation, belonging, explicitness, autonomy, accessibility, synthesis, and…
Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation

PubMed Central

Burghaus, R; Cosson, V; Cheung, SYA; Chenel, M; DellaPasqua, O; Frey, N; Hamrén, B; Harnisch, L; Ivanow, F; Kerbusch, T; Lippert, J; Milligan, PA; Rohou, S; Staab, A; Steimer, JL; Tornøe, C; Visser, SAG

2016-01-01

This document was developed to enable greater consistency in the practice, application, and documentation of Model‐Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. A collection of “good practice” recommendations are assembled here in order to minimize the heterogeneity in both the quality and content of MID3 implementation and documentation. The three major objectives of this white paper are to: i) inform company decision makers how the strategic integration of MID3 can benefit R&D efficiency; ii) provide MID3 analysts with sufficient material to enhance the planning, rigor, and consistency of the application of MID3; and iii) provide regulatory authorities with substrate to develop MID3 related and/or MID3 enabled guidelines. PMID:27069774
Setting good practices to assess the efficiency of iron fertilizers.

PubMed

El-Jendoubi, Hamdi; Melgar, Juan Carlos; Alvarez-Fernández, Ana; Sanz, Manuel; Abadía, Anunciación; Abadía, Javier

2011-05-01

The most prevalent nutritional disorder in fruit tree crops growing in calcareous soils is Fe deficiency chlorosis. Iron-deficient, chlorotic tree orchards require Fe-fertilization, since chlorosis causes decreases in tree vegetative growth as well as fruit yield and quality losses. When assessing the effectiveness of Fe-fertilizers, it is necessary to use sound practices based in the state-of-the art knowledge on the physiology and biochemistry of Fe deficiency. This review provides an overview on how to carry out the assessment of the efficiency of Fe-fertilizers, discussing common errors found in the literature, outlining adequate procedures and giving real examples of practical studies carried out in our laboratory in the past decade. The review focuses on: i) the design of Fe-fertilization experiments, discussing several issues such as the convenience of using controlled conditions or field experiments, whether fertilizer assessment experiments should mimic usual fertilization practices, as well as aspects regarding product formulations, dosages, control references and number of replicates; ii) the assessment of chlorosis recovery upon Fe-fertilization by monitoring leaf chlorophyll, and iii) the analysis of the plant responses upon Fe-fertilization, discussing the phases of leaf chlorosis recovery and the control of other leaf nutritional parameters. Copyright © 2011 Elsevier Masson SAS. All rights reserved.
Defense programs beryllium good practice guide

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

Herr, M.

1997-07-01

Within the DOE, it has recently become apparent that some contractor employees who have worked (or are currently working) with and around beryllium have developed chronic beryllium disease (CBD), an occupational granulomatous lung disorder. Respiratory exposure to aerosolized beryllium, in susceptible individuals, causes an immunological reaction that can result in granulomatous scarring of the lung parenchyma, shortness of breath, cough, fatigue, weight loss, and, ultimately, respiratory failure. Beryllium disease was originally identified in the 1940s, largely in the fluorescent light industry. In 1950, the Atomic Energy Commission (AEC) introduced strict exposure standards that generally curtailed both the acute and chronicmore » forms of the disease. Beginning in 1984, with the identification of a CBD case in a DOE contractor worker, there was increased scrutiny of both industrial hygiene practices and individuals in this workforce. To date, over 100 additional cases of beryllium-specific sensitization and/or CBD have been identified. Thus, a disease previously thought to be largely eliminated by the adoption of permissible exposure standards 45 years ago is still a health risk in certain workforces. This good practice guide forms the basis of an acceptable program for controlling workplace exposure to beryllium. It provides (1) Guidance for minimizing worker exposure to beryllium in Defense Programs facilities during all phases of beryllium-related work, including the decontamination and decommissioning (D&D) of facilities. (2) Recommended controls to be applied to the handling of metallic beryllium and beryllium alloys, beryllium oxide, and other beryllium compounds. (3) Recommendations for medical monitoring and surveillance of workers exposed (or potentially exposed) to beryllium, based on the best current understanding of beryllium disease and medical diagnostic tests available. (4) Site-specific safety procedures for all processes of beryllium that is
Policies and practices in haemostasis testing among laboratories in Croatia: a survey on behalf of a Working Group for Laboratory Coagulation of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Bronić, Ana; Herak, Desiree Coen; Margetić, Sandra; Milić, Marija

2017-02-15

The objective of this survey was to assess current policies and practice in haemostasis testing among both hospital and outpatient laboratories in Republic of Croatia. A questionnaire with seventy questions divided into nine sections was created in May 2015. Participants were asked about their practice related to test request form, sample collection, prothrombin time (PT) and activated partial thromboplastin time assays, other individual haemostasis assays, point-of-care testing (POCT), reporting of coagulation tests results and quality assurance of procedures, the personnel and other laboratory resources, as well as on issues related to education and implementation of additional coagulation assays in their laboratory. The survey was administered and data were collected between June and September 2015. A total survey response rate was 104/170 (61.2%). Most respondents were faced with incomplete information on prescribed therapy and diagnosis on the test request or inappropriate samples withdrawn on distant locations, but also do not have protocols for handling samples with high haematocrit values. Reporting of PT-INR and D-dimer results was different between laboratories. Although almost all laboratories developed a critical value reporting system, reporting a value to general practitioners is still a problem. Result on coagulation POCT testing showed that not all devices were supervised by laboratories, which is not in compliance with Croatian Chamber of Medical Biochemistry acts. Obtained results highlighted areas that need improvement and different practice patterns in particular field of haemostasis testing among laboratories. A harmonization of the overall process of haemostasis testing at national level should be considered and undertaken.
Practice Makes Pretty Good: Assessment of Primary Literature Reading Abilities across Multiple Large-Enrollment Biology Laboratory Courses

ERIC Educational Resources Information Center

Sato, Brian K.; Kadandale, Pavan; He, Wenliang; Murata, Paige M. N.; Latif, Yama; Warschauer, Mark

2014-01-01

Primary literature is essential for scientific communication and is commonly utilized in undergraduate biology education. Despite this, there is often little time spent "training" our students how to critically analyze a paper. To address this, we introduced a primary literature module in multiple upper-division laboratory courses. In…
Encouraging Good Writing Practice in First-Year Psychology Students: An Intervention Using Turnitin

ERIC Educational Resources Information Center

Betts, Lucy R.; Bostock, Stephen J.; Elder, Tracey J.; Trueman, Mark

2012-01-01

There is growing concern among many regarding plagiarism within student writing. This has promoted investigation into both the factors that predict plagiarism and potential methods of reducing plagiarism. Consequently, we developed and evaluated an intervention to enhance good practice within academic writing through the use of the plagiarism…
Building Skills and Qualifications among SME Employees. Leonardo da Vinci Good Practices Series.

ERIC Educational Resources Information Center

Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

This document profiles 10 European programs that exemplify good practice in building skills and qualifications among employees of small and medium enterprises (SMEs). The programs profiled are as follows: (1) TRICTSME (a program providing World Wide Web-based information and communication technologies training for SMEs in manufacturing); (2)…
Autonomy and Privacy in Clinical Laboratory Science Policy and Practice.

PubMed

Leibach, Elizabeth Kenimer

2014-01-01

Rapid advancements in diagnostic technologies coupled with growth in testing options and choices mandate the development of evidence-based testing algorithms linked to the care paths of the major chronic diseases and health challenges encountered most frequently. As care paths are evaluated, patient/consumers become partners in healthcare delivery. Clinical laboratory scientists find themselves firmly embedded in both quality improvement and clinical research with an urgent need to translate clinical laboratory information into knowledge required by practitioners and patient/consumers alike. To implement this patient-centered care approach in clinical laboratory science, practitioners must understand their roles in (1) protecting patient/consumer autonomy in the healthcare informed consent process and (2) assuring patient/consumer privacy and confidentiality while blending quality improvement study findings with protected health information. A literature review, describing the current ethical environment, supports a consultative role for clinical laboratory scientists in the clinical decision-making process and suggests guidance for policy and practice regarding the principle of autonomy and its associated operational characteristics: informed consent and privacy.
[How to promote the respect of good infusion practices by meeting health care professionals?].

PubMed

Le Reste, C; Fiedler, A; Dubois, S; Dewailly, A; Le Du, I; Cogulet, V

2016-05-01

Health care professionals often forget that there are risks associated with infusion therapy even if it is a common care. In order to assess this practice and to draw potential improvement actions, an audit of local gravity-flow intravenous infusion practices was conducted. The audit, based on a grid including 66 items from the medical prescription to the end of the infusion therapy administration, was conducted in the 6 units which use the most gravity-flow intravenous infusion devices. A multidisciplinary working group was created to decide and organize priority corrective measures in order to improve infusion practices and quality of healthcare. The audit enabled to observe 90hours of nurse's practices (96 infusions) and highlighted heterogeneity in infusion, in some cases inappropriate infusion practices and misuse of infusion devices. We found 4 main issues: labelling infusion therapy, training of health care professionals on good practices, support the purchase of infusion pumps and standardize perfusion line. An interactive educational program for nurses (workshops) was organized to enhance the respect of good practices: infusion identification at any time, respect of hygiene rules, flow rate regulation by counting drops, appropriate use of pumps and flow rate regulators. The audit drew up work priorities. The workshops made easier exchanges between professionals and had a warm welcome that's why it is essential to carry on such training. This collaborative approach between pharmacists, nurses, hygienists and biomedical technicians contribute to drug management improvement and promote optimal patient care. Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.
Rainmakers: why bad weather means good productivity.

PubMed

Lee, Jooa Julia; Gino, Francesca; Staats, Bradley R

2014-05-01

People believe that weather conditions influence their everyday work life, but to date, little is known about how weather affects individual productivity. Contrary to conventional wisdom, we predict and find that bad weather increases individual productivity and that it does so by eliminating potential cognitive distractions resulting from good weather. When the weather is bad, individuals appear to focus more on their work than on alternate outdoor activities. We investigate the proposed relationship between worse weather and higher productivity through 4 studies: (a) field data on employees' productivity from a bank in Japan, (b) 2 studies from an online labor market in the United States, and (c) a laboratory experiment. Our findings suggest that worker productivity is higher on bad-, rather than good-, weather days and that cognitive distractions associated with good weather may explain the relationship. We discuss the theoretical and practical implications of our research. (c) 2014 APA, all rights reserved.
What Is "Good" Mentoring? Understanding Mentoring Practices of Teacher Induction through Case Studies of Finland and Australia

ERIC Educational Resources Information Center

Pennanen, Matti; Bristol, Laurette; Wilkinson, Jane; Heikkinen, Hannu L. T.

2016-01-01

Mentoring is a practice widely utilised to support new teachers. However, in locally formed systems, the practice of mentoring is conditioned by traditions and arrangements specific to the site. To understand "good" mentoring, these local arrangements cannot be ignored. In this article, the theory of practice architectures is employed to…
Discrimination and Good Practice Activities in Education: Trends and Developments in the 27 EU Member States

ERIC Educational Resources Information Center

Pollak, Alexander

2008-01-01

The European Union Agency for Fundamental Rights collects, through its network of observation points, information on discrimination and good practice in the areas of legislation, employment, housing, racist violence, and education. Data on education includes information on: access to education for vulnerable groups, discriminatory practices,…
Students integrate knowledge acquisition and practical work in the laboratory.

PubMed

Agüera, E I; Sánchez-Hermosín, P; Díz-Pérez, J; Tovar, P; Camacho, R; Escribano, B M

2015-09-01

The aim of the present work was to transfer a wider concept of teamwork and self-learning to the laboratory, encouraging students' capabilities when seeking, acquiring, and processing knowledge. This educational innovation was carried out with a total of 38 students (fourth year of degree in Biology) in the area of physiology (Advances in Reproduction course) at University of Córdoba in Córdoba, Spain. The design of the project's application methodology consisted of establishing a way in which problems would be tackled in the practical classes. For this purpose, the different tasks were set up so that students could relate them to the concepts learned in the theory classes. On the first day of class, the project was presented to the students. Groups of two to three students worked in the laboratory and set up an outline of the protocol of the practical work that they had done. This outline was performed individually and sent to the lecturers through a learning management system (Moodle). The teachers gave feedback and assessed student submissions. Upon finishing the course, students completed a survey. The project-based learning method promotes practical self-learning on the part of students. This methodology demonstrated to us that it stimulates a critical and self-critical capacity in students, both individually and in groups, and that writing didactic practical material helped students to enhance their theory knowledge. The experiment was a success in view of the scores obtained upon finishing the subject. Copyright © 2015 The American Physiological Society.
Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force.

PubMed

Garrison, Louis P; Towse, Adrian; Briggs, Andrew; de Pouvourville, Gerard; Grueger, Jens; Mohr, Penny E; Severens, J L Hans; Siviero, Paolo; Sleeper, Miguel

2013-01-01

There is a significant and growing interest among both payers and producers of medical products for agreements that involve a "pay-for-performance" or "risk-sharing" element. These payment schemes-called "performance-based risk-sharing arrangements" (PBRSAs)-involve a plan by which the performance of the product is tracked in a defined patient population over a specified period of time and the amount or level of reimbursement is based on the health and cost outcomes achieved. There has always been considerable uncertainty at product launch about the ultimate real-world clinical and economic performance of new products, but this appears to have increased in recent years. PBRSAs represent one mechanism for reducing this uncertainty through greater investment in evidence collection while a technology is used within a health care system. The objective of this Task Force report was to set out the standards that should be applied to "good practices"-both research and operational-in the use of a PBRSA, encompassing questions around the desirability, design, implementation, and evaluation of such an arrangement. This report provides practical recommendations for the development and application of state-of-the-art methods to be used when considering, using, or reviewing PBRSAs. Key findings and recommendations include the following. Additional evidence collection is costly, and there are numerous barriers to establishing viable and cost-effective PBRSAs: negotiation, monitoring, and evaluation costs can be substantial. For good research practice in PBRSAs, it is critical to match the appropriate study and research design to the uncertainties being addressed. Good governance processes are also essential. The information generated as part of PBRSAs has public good aspects, bringing ethical and professional obligations, which need to be considered from a policy perspective. The societal desirability of a particular PBRSA is fundamentally an issue as to whether the cost of
An international survey of current practice in the laboratory assessment of anticoagulant therapy with heparin.

PubMed

Favaloro, Emmanuel J; Bonar, Roslyn; Sioufi, John; Wheeler, Michael; Low, Joyce; Aboud, Margaret; Lloyd, John; Street, Alison; Marsden, Katherine

2005-06-01

We conducted a survey of laboratory practice for assessment of heparin anticoagulant therapy by participants of the Royal College of Pathologists of Australasia Quality Assurance Program (RCPA QAP). A questionnaire was sent to 646 laboratories enrolled in the Haematology component of the QAP, requesting details of tests used for monitoring heparin therapy. Seventy laboratories (10.8%) returned results that indicated that they performed laboratory monitoring of heparin therapy. Most laboratories (69/70 = 98.6%) use the activated partial thromboplastin time (APTT) to monitor unfractionated heparin, with eight (11.4%) also using the APTT for monitoring low molecular weight (LMW) heparin. Five (7.1%) laboratories use the thrombin time (TT) test to help monitor heparin therapy and 37 (52.9%) laboratories use an anti-Xa assay to monitor heparin (either LMW or unfractionated). Normal reference ranges (NRR) for APTT differed considerably between laboratories, even those using the same reagent. Therapeutic ranges (TR) also differed considerably between laboratories, for both APTT and the anti-Xa assay. Laboratory differences in NRR and TR using the same reagents could only be partly explained by the use of different instrumentation. There is a large variation in current laboratory practice relating to monitoring of heparin anticoagulant therapy. This finding is similar to that of a similar survey conducted by the RCPA QAP almost a decade ago. This study suggests that better standardisation is still required for laboratory monitoring of heparin therapy.
VET Retention in Remote Aboriginal and Torres Strait Islander Communities. Good Practice Guide

ERIC Educational Resources Information Center

National Centre for Vocational Education Research (NCVER), 2017

2017-01-01

This good practice guide is based on the research project "Enhancing training advantage for remote Aboriginal and Torres Strait Islander learners" by John Guenther et al. on behalf of Ninti One Limited. The project examines five unique and successful vocational education and training (VET) programs in remote areas and identifies how…
Social and Occupational Integration of Disadvantaged People. Leonardo da Vinci Good Practices Series.

ERIC Educational Resources Information Center

Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

This document profiles nine European programs that exemplify good practice in social and occupational integration of disadvantaged people. The programs profiled are as follows: (1) Restaurant Venezia (a CD-ROM program to improve the reading and writing skills of young people in Luxembourg who have learning difficulties); (2) an integrated…
Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice

PubMed Central

Gándara, Carolina; Affleck, Valerie; Stoll, Elizabeth Ann

2018-01-01

Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet, the manufacture of these vectors is challenging, especially at high titers required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation. The goals of this paper are to report the protocol for manufacturing high-titer third-generation lentivirus for preclinical testing and to provide detailed information on considerations for translating preclinical viral vector manufacture toward scaled-up platforms and processes in order to make gene therapies under Good Manufacturing Practice that are suitable for clinical trials. PMID:29212357
Evaluation of the Implementation of Good Handling Practices in Food and Beverage Areas of Hotels.

PubMed

Serafim, A L; Hecktheuer, L H R; Stangarlin-Fiori, L; Medeiros, L B; Martello, L; Machado, C E

2015-11-01

Because of the major international-level events that have recently been held in Brazil, concerns about the sensory and hygienic-sanitary conditions of food have increased. The objective of this study was to evaluate the implementation of good handling practices in food and beverage areas of hotels, with and without outsourced professional intervention. We evaluated 19 food and beverage areas in hotels in Porto Alegre, Rio do Sul, Brazil, using a checklist that was developed by a municipal surveillance team based on existing laws for good handling practices. The evaluation was done by a skilled professional in the food safety area on two occasions, at the beginning of the study (January to May 2013) and at the end (July to November 2014), and the establishments were classified as good, regular, or poor. After the baseline evaluation, an action plan listing the noncompliance found at each location was given to those responsible for the establishments, and a period of 1 year 6 months was stipulated for improvements to be made. In the repeat evaluation, those responsible for the establishments were asked whether they had hired an outsourced professional to assist them in the improvements. The hotels showed improvement during the repeat evaluation, but a significant increase in the percentage of overall adequacy was seen only in the food and beverages areas of the 12 hotels that used the intervention of an outsourced professional. The better percentage of adequacy in establishments with outsourced professional intervention underlines the importance of an external and impartial view of routine activities in the implementation of good handling practices.

Practical, transparent prospective risk analysis for the clinical laboratory.

PubMed

Janssens, Pim Mw

2014-11-01

Prospective risk analysis (PRA) is an essential element in quality assurance for clinical laboratories. Practical approaches to conducting PRA in laboratories, however, are scarce. On the basis of the classical Failure Mode and Effect Analysis method, an approach to PRA was developed for application to key laboratory processes. First, the separate, major steps of the process under investigation are identified. Scores are then given for the Probability (P) and Consequence (C) of predefined types of failures and the chances of Detecting (D) these failures. Based on the P and C scores (on a 10-point scale), an overall Risk score (R) is calculated. The scores for each process were recorded in a matrix table. Based on predetermined criteria for R and D, it was determined whether a more detailed analysis was required for potential failures and, ultimately, where risk-reducing measures were necessary, if any. As an illustration, this paper presents the results of the application of PRA to our pre-analytical and analytical activities. The highest R scores were obtained in the stat processes, the most common failure type in the collective process steps was 'delayed processing or analysis', the failure type with the highest mean R score was 'inappropriate analysis' and the failure type most frequently rated as suboptimal was 'identification error'. The PRA designed is a useful semi-objective tool to identify process steps with potential failures rated as risky. Its systematic design and convenient output in matrix tables makes it easy to perform, practical and transparent. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
An Analysis of Agricultural Mechanics Safety Practices in Agricultural Science Laboratories.

ERIC Educational Resources Information Center

Swan, Michael K.

North Dakota secondary agricultural mechanics instructors were surveyed regarding instructional methods and materials, safety practices, and equipment used in the agricultural mechanics laboratory. Usable responses were received from 69 of 89 instructors via self-administered mailed questionnaires. Findings were consistent with results of similar…
Creating Best Practices for the Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories.

PubMed

Wangsness, Kathryn; Salfinger, Yvonne; Randolph, Robyn; Shea, Shari; Larson, Kirsten

2017-07-01

Laboratory accreditation provides a level of standardization in laboratories and confidence in generated food and feed testing results. For some laboratories, ISO/IEC 17025:2005 accreditation may not be fiscally viable, or a requested test method may be out of the scope of the laboratory's accreditation. To assist laboratories for whom accreditation is not feasible, the Association of Public Health Laboratories Data Acceptance Work Group developed a white paper entitled "Best Practices for Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories." The basic elements of a quality management system, along with other best practices that state and local food and feed testing laboratories should follow, are included in the white paper. It also covers program-specific requirements that may need to be addressed. Communication with programs and end data users is regarded as essential for establishing the reliability and accuracy of laboratory data. Following these suggested best practices can facilitate the acceptance of laboratory data, which can result in swift regulatory action and the quick removal of contaminated product from the food supply, improving public health nationally.
The constraints of good governance practice in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

NASA Astrophysics Data System (ADS)

Wee, Seow Ta; Abas, Muhamad Azahar; Chen, Goh Kai; Mohamed, Sulzakimin

2017-10-01

Nowadays, international donors have emphasised on the adoption of good governance practices in solid waste management which include policy implementation. In Malaysia, the National Solid Waste Management Policy (NSWMP) was introduced as the main guideline for its solid waste management and the Malaysian government has adopted good governance practice in the NSMWP implementation. However, the good governance practices implemented by the Malaysian government encountered several challenges. This study was conducted to explore the good governance constraints experienced by stakeholders in the NSWMP implementation. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires that involved in the NSWMP implementation in Malaysia. A total of six respondents took part in this study. The findings revealed three main good governance constraints in the NSWMP implementation, namely inadequate fund, poor staff's competency, and ambiguity of policy implementation system. Moreover, this study also disclosed that the main constraint influenced the other constraints. Hence, it is crucial to identify the main constraint in order to minimise its impact on the other constraints.
Status of Biology Laboratory and Practical Activities in Some Selected Secondary and Preparatory Schools of Borena Zone, South Ethiopia

ERIC Educational Resources Information Center

Daba, Tolessa Muleta; Anbassa, Baressa; Oda, Bula Kere; Degefa, Itefa

2016-01-01

Science laboratory is a very important resource input for teaching science. Learning science is enhanced and the understanding level is improved when students are engaged in science laboratory for practical experiments. The current study aimed to assess the status of Biology laboratory and practical activities in some selected secondary and…
Policies and practices in haemostasis testing among laboratories in Croatia: a survey on behalf of a Working Group for Laboratory Coagulation of the Croatian Society of Medical Biochemistry and Laboratory Medicine

PubMed Central

Bronić, Ana; Herak, Desiree Coen; Margetić, Sandra; Milić, Marija

2017-01-01

Introduction The objective of this survey was to assess current policies and practice in haemostasis testing among both hospital and outpatient laboratories in Republic of Croatia. Materials and methods A questionnaire with seventy questions divided into nine sections was created in May 2015. Participants were asked about their practice related to test request form, sample collection, prothrombin time (PT) and activated partial thromboplastin time assays, other individual haemostasis assays, point-of-care testing (POCT), reporting of coagulation tests results and quality assurance of procedures, the personnel and other laboratory resources, as well as on issues related to education and implementation of additional coagulation assays in their laboratory. The survey was administered and data were collected between June and September 2015. Results A total survey response rate was 104/170 (61.2%). Most respondents were faced with incomplete information on prescribed therapy and diagnosis on the test request or inappropriate samples withdrawn on distant locations, but also do not have protocols for handling samples with high haematocrit values. Reporting of PT-INR and D-dimer results was different between laboratories. Although almost all laboratories developed a critical value reporting system, reporting a value to general practitioners is still a problem. Result on coagulation POCT testing showed that not all devices were supervised by laboratories, which is not in compliance with Croatian Chamber of Medical Biochemistry acts. Conclusion Obtained results highlighted areas that need improvement and different practice patterns in particular field of haemostasis testing among laboratories. A harmonization of the overall process of haemostasis testing at national level should be considered and undertaken. PMID:28392741
Spectroscopy 101: A Practical Introduction to Spectroscopy and Analysis for Undergraduate Organic Chemistry Laboratories

ERIC Educational Resources Information Center

Morrill, Lucas A.; Kammeyer, Jacquelin K.; Garg, Neil K.

2017-01-01

An undergraduate organic chemistry laboratory that provides an introduction to various spectroscopic techniques is reported. Whereas organic spectroscopy is most often learned and practiced in the context of reaction analyses, this laboratory experiment allows students to become comfortable with [superscript 1]H NMR, [superscript 13]C NMR, and IR…
Decision-making in general practice: the effect of financial incentives on the use of laboratory analyses.

PubMed

Munkerud, Siri Fauli

2012-04-01

This paper examines the reaction of general practitioners (GPs) to a reform in 2004 in the remuneration system for using laboratory services in general practice. The purpose of this paper is to study whether income motivation exists regarding the use of laboratory services in general practice, and if so, the degree of income motivation among general practitioners (GPs) in Norway. We argue that the degree of income motivation is stronger when the physicians are uncertain about the utility of the laboratory service in question. We have panel data from actual physician-patient encounters in general practices in the years 2001-2004 and use discrete choice analysis and random effects models. Estimation results show that an increase in the fees will lead to a small but significant increase in use. The reform led to minor changes in the use of laboratory analyses in GPs' offices, and we argue that financial incentives were diluted because they were in conflict with medical recommendations and existing medical practice. The patient's age has the most influence and the results support the hypothesis that the impact of income increases with increasing uncertainty about diagnosis and treatment. The policy implication of our results is that financial incentives alone are not an effective tool for influencing the use of laboratory services in GPs' offices.
An audit of immunofixation requesting practices at a South African referral laboratory

PubMed Central

Rampursat, Yashna

2014-01-01

Background It is common practice in most chemical pathology laboratories for reflective immunofixation electrophoresis (IFE) to occur following the detection or suspicion of a paraprotein on serum protein electrophoresis (SPEP). The chemical pathology laboratory at Inkosi Albert Luthuli Central Hospital (IALCH) in Durban, South Africa, is currently the only non-private laboratory in the KwaZulu Natal province that performs SPEP analysis, with current practice requiring that the clinician request IFE following suggestion by the laboratory after a suspicious SPEP result. Objectives To review the current process for IFE at IALCH in the context of reflective testing and to examine the use of the alpha-2-globulin/alpha-1-globulin ratio as a predictor of a positive IFE result. Methods Data for 1260 consecutive SPEP tests performed at the IALCH National Health Laboratory Service were collected between February and July 2011. SPEP and IFE were performed with a Sebia Hydrasys automated electrophoresis system. The alpha-2-globulin/alpha-1-globulin ratio was calculated using density of corresponding fractions on SPEP. Results Analysis revealed that of the 1260 SPEPs performed during the analysis period, 304 IFEs were suggested by the reviewing pathologist. A total of 45 (15%) of the suggested IFEs were subsequently requested by the attending clinicians. Almost half (46.5%) (n = 20) of the suggested IFEs that were performed revealed the presence of a paraprotein. There was no statistically-significant difference between the alpha-2-globulin/alpha-1-globulin ratio for patients with positive or negative IFEs (p-value = 0.2). Conclusions This study reveals the need for reflective addition of IFE testing by the laboratory following suspicious findings on SPEP. PMID:29043173
Knowledge, attitude and practice of medical laboratory practitioners in the fight against Ebola virus disease.

PubMed

Hamid, Kabir M; Yusuf, Ibrahim; Onoja, Bernard A; Koki, Abdullahi Y

2018-01-01

Ebola virus disease (EVD) in West Africa was an enormous public health challenge. Nigeria was able to contain the spread of the virus with a concerted effort and an effective public health response in terms of identification of contacts, rapid laboratory diagnosis, quarantine and symptomatic treatment. We determined the knowledge, attitude and practice of medical laboratory practitioners (MLPs) in this post-Ebola epidemic era. This cross-sectional study was carried out in eight hospitals in Kano State for 6 months, between January and June 2016. It involved medical laboratory scientists (MLS), medical laboratory technicians (MLT) and medical laboratory assistants (MLA). Questionnaires were administered and analysed. Of the 75 participants, mean knowledge score was 5.54 (standard deviation [SD] ±1.44) while the mean attitude score was 13.72 ±2.80, and mean practice score was 3.10 ±0.80. Mean age of participants was 36.82 ± 8.07 years. There was full awareness of EVD among all 75 participants; however, many medical laboratory practitioners (52.7%) did not know EVD prevention methods. The majority (86.1%) knew the source of disease outbreak and most MLPs (66.7%) practised improper hand washing to prevent Ebola transmission. In addition, they had a negative attitude and practice towards EVD. Of 71 MLPs, 52 (73.2%) strongly disagreed that a traditional remedy was preferable in EVD treatment. Fear of EVD among MLPs has declined.
Enhancing the Student Experience of Laboratory Practicals through Digital Video Guides

ERIC Educational Resources Information Center

Croker, Karen; Andersson, Holger; Lush, David; Prince, Rob; Gomez, Stephen

2010-01-01

Laboratory-based learning allows students to experience bioscience principles first hand. In our experience, practical content and equipment may have changed over time, but teaching methods largely remain the same, typically involving; whole class introduction with a demonstration, students emulating the demonstration in small groups, gathering…
[Errors in laboratory daily practice].

PubMed

Larrose, C; Le Carrer, D

2007-01-01

Legislation set by GBEA (Guide de bonne exécution des analyses) requires that, before performing analysis, the laboratory directors have to check both the nature of the samples and the patients identity. The data processing of requisition forms, which identifies key errors, was established in 2000 and in 2002 by the specialized biochemistry laboratory, also with the contribution of the reception centre for biological samples. The laboratories follow a strict criteria of defining acceptability as a starting point for the reception to then check requisition forms and biological samples. All errors are logged into the laboratory database and analysis report are sent to the care unit specifying the problems and the consequences they have on the analysis. The data is then assessed by the laboratory directors to produce monthly or annual statistical reports. This indicates the number of errors, which are then indexed to patient files to reveal the specific problem areas, therefore allowing the laboratory directors to teach the nurses and enable corrective action.
Quality Indicators in Laboratory Medicine: from theory to practice. Preliminary data from the IFCC Working Group Project "Laboratory Errors and Patient Safety".

PubMed

Sciacovelli, Laura; O'Kane, Maurice; Skaik, Younis Abdelwahab; Caciagli, Patrizio; Pellegrini, Cristina; Da Rin, Giorgio; Ivanov, Agnes; Ghys, Timothy; Plebani, Mario

2011-05-01

The adoption of Quality Indicators (QIs) has prompted the development of tools to measure and evaluate the quality and effectiveness of laboratory testing, first in the hospital setting and subsequently in ambulatory and other care settings. While Laboratory Medicine has an important role in the delivery of high-quality care, no consensus exists as yet on the use of QIs focussing on all steps of the laboratory total testing process (TTP), and further research in this area is required. In order to reduce errors in laboratory testing, the IFCC Working Group on "Laboratory Errors and Patient Safety" (WG-LEPS) developed a series of Quality Indicators, specifically designed for clinical laboratories. In the first phase of the project, specific QIs for key processes of the TTP were identified, including all the pre-, intra- and post-analytic steps. The overall aim of the project is to create a common reporting system for clinical laboratories based on standardized data collection, and to define state-of-the-art and Quality Specifications (QSs) for each QI independent of: a) the size of organization and type of activities; b) the complexity of processes undertaken; and c) different degree of knowledge and ability of the staff. The aim of the present paper is to report the results collected from participating laboratories from February 2008 to December 2009 and to identify preliminary QSs. The results demonstrate that a Model of Quality Indicators managed as an External Quality Assurance Program can serve as a tool to monitor and control the pre-, intra- and post-analytical activities. It might also allow clinical laboratories to identify risks that lead to errors resulting in patient harm: identification and design of practices that eliminate medical errors; the sharing of information and education of clinical and laboratory teams on practices that reduce or prevent errors; the monitoring and evaluation of improvement activities.
Guide to good practices for operations and administration updates through required reading

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

NONE

1998-12-01

This Guide to Good Practices is written to enhance understanding of, and provide direction for, Required Reading, Chapter XIV of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing programs for updating personnel with operations and administration information through required reading. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Required Reading is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a coordinated requiredmore » reading program to promote safe and efficient operations.« less
Salaries and compensation practices in public health, environmental, and agricultural laboratories: findings from a 2010 national survey.

PubMed

DeBoy, John M; Boulton, Matthew L; Carpenter, David F

2013-01-01

The public health, environmental, and agricultural laboratory (PHEAL) workforce is a key component of the public health infrastructure. The national laboratory workforce faces an ongoing challenge of recruitment and retention of workers often related to pay and other compensation issues. To collect information on laboratory salaries and laboratory compensation practices using a national compensation survey targeting the PHEAL workforce. Seventy-three of 109 (67%) PHEAL directors in the 50 states and District of Columbia collectively employ 3723/4830 (77%) PHEAL employees in the United States. A standardized survey was developed and administered in 2010. Compensation data were compiled by job classification, geographic region, laboratory gross operating budget size, laboratory staff size, and laboratory type. Laboratory staff size ranged from 3 to 327 individuals (mean = 74 and median = 51). Median base salaries were lowest in the Southwest and South and highest in the Mountain and Pacific regions. Mean and median laboratory gross operating budgets for all participating PHEALs were $8 609 238 and $5 671 500, respectively. Extra cash compensation, used by 8 of 60 (13.3%) PHEALs, was more likely to go to a scientist-manager or scientist-supervisor. In 2010, a standardized national compensation survey of technical and scientific public health employees working in 73 PHEALs was effective in collecting previously unavailable data about laboratory salaries, laboratory budgets, and payroll practices. Laboratory salaries varied by geographic region and there was an uneven distribution of extra cash compensation among job classifications. The compensation data collected may be useful in characterizing and improving laboratory salary structures and practices to better support workforce recruitment and retention.
A Survey of the Practices, Procedures, and Techniques in Undergraduate Organic Chemistry Teaching Laboratories

ERIC Educational Resources Information Center

Martin, Christopher B.; Schmidt, Monica; Soniat, Michael

2011-01-01

A survey was conducted of four-year institutions that teach undergraduate organic chemistry laboratories in the United States. The data include results from over 130 schools, describes the current practices at these institutions, and discusses the statistical results such as the scale of the laboratories performed, the chemical techniques applied,…
Twenty-Two Good Educational Practices.

ERIC Educational Resources Information Center

Mark, Jorie Lester

1989-01-01

Twenty-two educational practices are drawn from nine settings: K-12, vocational and continuing education, proprietary schools, military training, corporate training, union-sponsored programs, second-chance training, job training, and adult education. They are categorized as process-type practices, techniques, and physical teaching props. (SK)
Characteristics of good quality pharmaceutical services common to community pharmacies and dispensing general practices.

PubMed

Grey, Elisabeth; Harris, Michael; Rodham, Karen; Weiss, Marjorie C

2016-10-01

In the United Kingdom, pharmaceutical services can be delivered by both community pharmacies (CPs) and dispensing doctor practices (DPs). Both must adhere to minimum standards set out in NHS regulations; however, no common framework exists to guide quality improvement. Previous phases of this research had developed a set of characteristics indicative of good pharmaceutical service provision. To ask key stakeholders to confirm, and rank the importance of, a set of characteristics of good pharmaceutical service provision. A two-round Delphi-type survey was conducted in south-west England and was sent to participants representing three stakeholder groups: DPs, CPs and patients/lay members. Participants were asked to confirm, and rank, the importance of these characteristics as representing good quality pharmaceutical services. Thirty people were sent the first round survey; 22 participants completed both rounds. Median ratings for the 23 characteristics showed that all were seen to represent important aspects of pharmaceutical service provision. Participants' comments highlighted potential problems with the practicality of the characteristics. Characteristics relating to patient safety were deemed to be the most important and those relating to public health the least important. A set of 23 characteristics for providing good pharmaceutical services in CPs and DPs was developed and attained approval from a sample of stakeholders. With further testing and wider discussion, it is hoped that the characteristics will form the basis of a quality improvement tool for CPs and DPs. © 2016 Royal Pharmaceutical Society.
Alternative Realities: Faculty and Student Perceptions of Instructional Practices in Laboratory Courses

PubMed Central

Beck, Christopher W.; Blumer, Lawrence S.

2016-01-01

Curricular reform efforts depend on our ability to determine how courses are taught and how instructional practices affect student outcomes. In this study, we developed a 30-question survey on inquiry-based learning and assessment in undergraduate laboratory courses that was administered to 878 students in 54 courses (41 introductory level and 13 upper level) from 20 institutions (four community colleges, 11 liberal arts colleges, and five universities, of which four were minority-serving institutions). On the basis of an exploratory factor analysis, we defined five constructs: metacognition, feedback and assessment, scientific synthesis, science process skills, and instructor-directed teaching. Using our refined survey of 24 items, we compared student and faculty perceptions of instructional practices both across courses and across instructors. In general, faculty and student perceptions were not significantly related. Although mean perceptions were often similar, faculty perceptions were more variable than those of students, suggesting that faculty may have more nuanced views than students. In addition, student perceptions of some instructional practices were influenced by their previous experience in laboratory courses and their self-efficacy. As student outcomes, such as learning gains, are ultimately most important, future research should examine the degree to which faculty and student perceptions of instructional practices predict student outcomes in different contexts. PMID:27810867
Self-assessed competency at working with a medical interpreter is not associated with knowledge of good practice.

PubMed

Hudelson, Patricia; Perneger, Thomas; Kolly, Véronique; Perron, Noëlle Junod

2012-01-01

Specific knowledge and skills are needed to work effectively with an interpreter, but most doctors have received limited training. Self-assessed competency may not accurately identify training needs. The purpose of this study is to explore the association between self-assessed competency at working with an interpreter and the ability to identify elements of good practice, using a written vignette. A mailed questionnaire was sent to 619 doctors and medical students in Geneva, Switzerland. 58.6% of respondents considered themselves to be highly competent at working with a professional interpreter, but 22% failed to mention even one element of good practice in response to the vignette, and only 39% could name more than one. There was no association between self-rated competency and number of elements mentioned. Training efforts should challenge the assumption that working with an interpreter is intuitive. Evaluation of clinicians' ability to work with an interpreter should not be limited to self-ratings. In the context of large-scale surveys, written vignettes may provide a simple method for identifying knowledge of good practice and topics requiring further training.

Good Practice Guide: Bringing a Social Capital Approach into the Teaching of Adult Literacy and Numeracy

ERIC Educational Resources Information Center

National Centre for Vocational Education Research (NCVER), 2010

2010-01-01

This good practice guide is based on research that looked at how to teach adult literacy and numeracy using a social capital approach. The guide suggests ways vocational education and training (VET) practitioners can adopt a social capital approach to their teaching practice. A social capital approach refers to the process in which networks are…
Simulation of changes on the psychosocial risk in the nursing personnel after implementing the policy of good practices on the risk treatment.

PubMed

Bolívar Murcia, María Paula; Cruz González, Joan Paola; Rodríguez Bello, Luz Angélica

2018-02-01

Evaluate the change over time of psychosocial risk management for the nursing personnel of an intermediate complexity clinic of Bogota (Colombia). Descriptive and correlational research performed under the approach of risk management (identification, analysis, assessment and treatment). The psychosocial risk of the nursing personnel was studied through 10-year system dynamics models (with and without the implementation of the policy of good practices on the risk treatment) in two scenarios: when the nursing personnel works shifts of 6 hours (morning or afternoon) and when they work over 12 hours (double shift or night shift). When implementing a policy of good practices on the risk treatment, the double shift scenario shows an improvement among 25% to 88% in the variables of: health, labor motivation, burnout, service level and productivity; as well as in the variables of the organization associated to number of patients, nursing personnel and profit. Likewise, the single shift scenario with good practices improves in all the above-mentioned variables and generates stability on the variables of absenteeism and resignations. The best scenario is the single shift scenario with the application of good practices of risk treatment in comparison with the double shift scenario with good practices, which allows concluding that the good practices have a positive effect on the variables of nursing personnel and on those associated to the organization. Copyright© by the Universidad de Antioquia.
Are general practice characteristics predictors of good glycaemic control in patients with diabetes? A cross-sectional study.

PubMed

Esterman, Adrian J; Fountaine, Tim; McDermott, Robyn

2016-01-18

To determine whether certain characteristics of general practices are associated with good glycaemic control in patients with diabetes and with completing an annual cycle of care (ACC). Our cross-sectional analysis used baseline data from the Australian Diabetes Care Project conducted between 2011 and 2014. Practice characteristics were self-reported. Characteristics of the patients that were assessed included glycaemic control (HbA1c level ≤ 53 mmol/mol), age, sex, duration of diabetes, socio-economic disadvantage (SEIFA) score, the complexity of the patient's condition, and whether the patient had completed an ACC for diabetes in the past 18 months. Clustered logistic regression was used to establish predictors of glycaemic control and a completed ACC. Data were available from 147 general practices and 5455 patients with established type 1 or type 2 diabetes in three Australian states. After adjustment for other patient characteristics, only the patient completing an ACC was statistically significant as a predictor of glycaemic control (P = 0.011). In a multivariate model, the practice having a chronic disease-focused practice nurse (P = 0.036) and running educational events for patients with diabetes (P = 0.004) were statistically significant predictors of the patient having complete an ACC. Patient characteristics are moderately good predictors of whether the patient is in glycaemic control, whereas practice characteristics appear to predict only the likelihood of patients completing an ACC. The ACC is an established indicator of good diabetes management. This is the first study to report a positive association between having completed an ACC and the patient being in glycaemic control.
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.
Good practices and health policy analysis in European sports stadia: results from the 'Healthy Stadia' project.

PubMed

Drygas, Wojciech; Ruszkowska, Joanna; Philpott, Matthew; Björkström, Olav; Parker, Mike; Ireland, Robin; Roncarolo, Federico; Tenconi, Maria

2013-06-01

Sport plays an important role within society and sports stadia provide significant settings for public health strategies. In addition to being places of mass gathering, stadia are often located in less affluent areas and are traditionally attended by 'harder to reach' communities. Unfortunately sports stadia and the clubs they host are rarely perceived as places that promote healthy lifestyles. Fast food, alcohol and tobacco are commonly advertized, served and consumed during sports games giving the spectators and TV fans contradictory messages concerning healthy choices. As part of a wider programme of work part-funded by the European Union, a study was therefore designed to explore current 'good practice' relating to positive health interventions in sports stadia across a number of European countries. Using a specially designed questionnaire, information about health policies and good practices relating to food offerings in stadia, physical activity promotion among local communities, tobacco policy, positive mental health initiatives, environmental sustainability practices and social responsibility policies were collected in 10 European countries (England and Northern Ireland, Finland, Georgia, Greece, Ireland, Italy, Latvia, Poland, Spain and Sweden) involving 88 stadia. The audit results show that stadia health policies differ considerably between specific countries and sports. Based on the literature analysed, the examples of good practices collected through the study, and the subsequent instigation of a European Healthy Stadia Network, it shows that there is considerable potential for stadia to become health promoting settings.
Validation of good agricultural practices (GAP) on Minnesota vegetable farms.

PubMed

Hamilton, Karin E; Umber, Jamie; Hultberg, Annalisa; Tong, Cindy; Schermann, Michele; Diez-Gonzalez, Francisco; Bender, Jeff B

2015-02-01

The United States Food and Drug Administration and the Department of Agriculture jointly published the "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," which is used as a basis for Good Agricultural Practices (GAP) audits. To understand barriers to incorporation of GAP by Minnesota vegetable farmers, a mail survey completed in 2008 was validated with visits to a subset of the farms. This was done to determine the extent to which actual practices matched perceived practices. Two hundred forty-six producers completed the mail survey, and 27 participated in the on-farm survey. Over 75% of the on-farm survey respondents produced vegetables on 10 acres or less and had 10 or fewer employees. Of 14 questions, excellent agreement between on-farm interviews and mail survey responses was observed on two questions, four questions had poor or slight agreement, and eight questions had no agreement. Ninety-two percent of respondents by mail said "they took measures to keep animals and pests out of packing and storage buildings." However, with the on-site visit only 45% met this requirement. Similarly, 81% of respondents by mail said "measures were taken to reduce the risk of wild and/or domestic animals entering into fruit and vegetable growing areas." With direct observation, 70% of farms actually had taken measures to keep animals out of the growing areas. Additional, on-farm assessments were done regarding employee hygiene, training, presence of animals, water sources, and composting practices. This validation study demonstrated the challenge of creating nonleading and concise questions that are not open to broad interpretation from the respondents. If mail surveys are used to assess GAP, they should include open-ended questions and ranking systems to better assess farm practices. To provide the most accurate survey data for educational purposes or GAP audits, on-farm visits are recommended.
Quality assurance practices in Europe: a survey of molecular genetic testing laboratories

PubMed Central

Berwouts, Sarah; Fanning, Katrina; Morris, Michael A; Barton, David E; Dequeker, Elisabeth

2012-01-01

In the 2000s, a number of initiatives were taken internationally to improve quality in genetic testing services. To contribute to and update the limited literature available related to this topic, we surveyed 910 human molecular genetic testing laboratories, of which 291 (32%) from 29 European countries responded. The majority of laboratories were in the public sector (81%), affiliated with a university hospital (60%). Only a minority of laboratories was accredited (23%), and 26% was certified. A total of 22% of laboratories did not participate in external quality assessment (EQA) and 28% did not use reference materials (RMs). The main motivations given for accreditation were to improve laboratory profile (85%) and national recognition (84%). Nearly all respondents (95%) would prefer working in an accredited laboratory. In accredited laboratories, participation in EQA (P<0.0001), use of RMs (P=0.0014) and availability of continuous education (CE) on medical/scientific subjects (P=0.023), specific tasks (P=0.0018), and quality assurance (P<0.0001) were significantly higher than in non-accredited laboratories. Non-accredited laboratories expect higher restriction of development of new techniques (P=0.023) and improvement of work satisfaction (P=0.0002) than accredited laboratories. By using a quality implementation score (QIS), we showed that accredited laboratories (average score 92) comply better than certified laboratories (average score 69, P<0.001), and certified laboratories better than other laboratories (average score 44, P<0.001), with regard to the implementation of quality indicators. We conclude that quality practices vary widely in European genetic testing laboratories. This leads to a potentially dangerous situation in which the quality of genetic testing is not consistently assured. PMID:22739339
[A Perspective on Innovation for Efficient Medical Practice in View of Undergraduate and Postgraduate Education and Training in Laboratory Medicine].

PubMed

Kawai, Tadashi

2015-10-01

Continuous advances in medical laboratory technology have driven major changes in the practice of laboratory medicine over the past two decades. The importance of the overall quality of a medical laboratory has been ever-increasing in order to improve and ensure the quality and safety of clinical practice by physicians in any type of medical facility. Laboratory physicians and professional staff should challenge themselves more than ever in various ways to cooperate and contribute with practicing physicians for the appropriate utilization of laboratory testing. This will certainly lead to a decrease in inappropriate or unnecessary laboratory testing, resulting in reducing medical costs. In addition, not only postgraduate, but also undergraduate medical education/training systems must be markedly innovated, considering recent rapid progress in electronic information and communication technologies.
The practical epistemologies of the classroom: A study of laboratory work

NASA Astrophysics Data System (ADS)

Wickman, Per-Olof

2004-05-01

The practical epistemologies of university students during laboratory work in chemistry are analyzed to enhance understanding of how teaching practices interact with learners. The purpose is to develop a theoretical framework of learning as action that can be used by educational researchers to examine meaning-making, but also by teachers in close association with their daily work to understand the course learning takes in their own classrooms. Here this framework is adopted to demonstrate how the sequence of learning may affect the subject content learnt. It is also demonstrated how learning can be understood in terms of habits, and how observations of such habits could be used by a teacher to inform her/his teaching. The theory of practical epistemologies is based on the later Wittgenstein, pragmatics, and sociocultural approaches identifying learning with talk, action, and habits situated in practices.
Accommodating Learning Styles: Relevance and Good Practice in Vocational Education and Training--Supporting Documents

ERIC Educational Resources Information Center

Smith, Peter; Dalton, Jennifer; Henry, John

2005-01-01

This document was produced by the author(s) based on their research for the Australian report, "Accommodating Learning Styles: Relevance and Good Practice in Vocational Education and Training," and contains three parts. Part 1, Research Methodology and Findings (Peter Smith and Jennifer Dalton), contains: (1) Research Questions; (2)…
Development of good modelling practice for phsiologically based pharmacokinetic models for use in risk assessment: The first steps

EPA Science Inventory

The increasing use of tissue dosimetry estimated using pharmacokinetic models in chemical risk assessments in multiple countries necessitates the need to develop internationally recognized good modelling practices. These practices would facilitate sharing of models and model eva...
An examination of the usefulness of repeat testing practices in a large hospital clinical chemistry laboratory.

PubMed

Deetz, Carl O; Nolan, Debra K; Scott, Mitchell G

2012-01-01

A long-standing practice in clinical laboratories has been to automatically repeat laboratory tests when values trigger automated "repeat rules" in the laboratory information system such as a critical test result. We examined 25,553 repeated laboratory values for 30 common chemistry tests from December 1, 2010, to February 28, 2011, to determine whether this practice is necessary and whether it may be possible to reduce repeat testing to improve efficiency and turnaround time for reporting critical values. An "error" was defined to occur when the difference between the initial and verified values exceeded the College of American Pathologists/Clinical Laboratory Improvement Amendments allowable error limit. The initial values from 2.6% of all repeated tests (668) were errors. Of these 668 errors, only 102 occurred for values within the analytic measurement range. Median delays in reporting critical values owing to repeated testing ranged from 5 (blood gases) to 17 (glucose) minutes.
Singing in Primary Schools: Case Studies of Good Practice in Whole Class Vocal Tuition

ERIC Educational Resources Information Center

Lamont, Alexandra; Daubney, Alison; Spruce, Gary

2012-01-01

Within the context of British initiatives in music education such as the Wider Opportunities programme in England and the recommendations of the Music Manifesto emphasising the importance of singing in primary schools, the current paper explores examples of good practice in whole-class vocal tuition. The research included seven different primary…
Long-term effects of good handling practices during the pre-weaning period of crossbred dairy heifer calves.

PubMed

Silva, Luciana Pontes; Sant'Anna, Aline Cristina; Silva, Lívia Carolina Magalhães; Paranhos da Costa, Mateus José Rodrigues

2017-01-01

The aim of this study was to determine whether applying good practices of handling during the pre-weaning period have long-term effects on behavioral and physiological indicators, health status, and average daily gain (ADG) of crossbred Bos taurus × Bos indicus heifer calves. During the pre-weaning period, 98 crossbred of Holstein × Gir heifer calves were allotted into three treatments: (1) good practices of handling + brushing (GPB; n = 25), (2) good practices of handling (GP; n = 25), and (3) control (n = 48). Every 2 months, four evaluation periods (EV 1 to EV 4 ) were conducted to record data. Behavioral indicators comprised time to drive (TD), flight speed (FS), flight distance (FD), and composite reactivity score (CRS). Physiological indicators of acute stress during handling comprised respiratory and heart rates. Health status comprised data regarding occurrence of most common diseases (i.e., pneumonia and anaplasmosis). Collected data were analyzed by using a linear mixed model for repeated measures, Tukey's test, and chi-squared procedures. Treatment influenced (P < 0.05) TD, FS, and FD but not CRS (P = 0.78). From EV 1 to EV 3 , the control calves had the lowest TD. The GPB group had lower FS than the control but did not differ from GP. The GPB group had lower FD means than the other two groups in EV 2 , EV 3 , and EV 4 . No differences (P > 0.05) due to treatment were observed on heart and respiratory rates, ADG, or occurrence of pneumonia and anaplasmosis. It was concluded that adoption of good practices of handling during pre-weaning period may lead to long-term positive effects.
Analytic Validation of Immunohistochemical Assays: A Comparison of Laboratory Practices Before and After Introduction of an Evidence-Based Guideline.

PubMed

Fitzgibbons, Patrick L; Goldsmith, Jeffrey D; Souers, Rhona J; Fatheree, Lisa A; Volmar, Keith E; Stuart, Lauren N; Nowak, Jan A; Astles, J Rex; Nakhleh, Raouf E

2017-09-01

- Laboratories must demonstrate analytic validity before any test can be used clinically, but studies have shown inconsistent practices in immunohistochemical assay validation. - To assess changes in immunohistochemistry analytic validation practices after publication of an evidence-based laboratory practice guideline. - A survey on current immunohistochemistry assay validation practices and on the awareness and adoption of a recently published guideline was sent to subscribers enrolled in one of 3 relevant College of American Pathologists proficiency testing programs and to additional nonsubscribing laboratories that perform immunohistochemical testing. The results were compared with an earlier survey of validation practices. - Analysis was based on responses from 1085 laboratories that perform immunohistochemical staining. Of 1057 responses, 65.4% (691) were aware of the guideline recommendations before this survey was sent and 79.9% (550 of 688) of those have already adopted some or all of the recommendations. Compared with the 2010 survey, a significant number of laboratories now have written validation procedures for both predictive and nonpredictive marker assays and specifications for the minimum numbers of cases needed for validation. There was also significant improvement in compliance with validation requirements, with 99% (100 of 102) having validated their most recently introduced predictive marker assay, compared with 74.9% (326 of 435) in 2010. The difficulty in finding validation cases for rare antigens and resource limitations were cited as the biggest challenges in implementing the guideline. - Dissemination of the 2014 evidence-based guideline validation practices had a positive impact on laboratory performance; some or all of the recommendations have been adopted by nearly 80% of respondents.
The Health Behavior Checklist: Factor structure in community samples and validity of a revised good health practices scale.

PubMed

Hampson, Sarah E; Edmonds, Grant W; Goldberg, Lewis R

2017-01-01

This study examined the factor structure and predictive validity of the commonly used multidimensional Health Behavior Checklist. A three-factor structure was found in two community samples that included men and women. The new 16-item Good Health Practices scale and the original Wellness Maintenance scale were the only Health Behavior Checklist scales to be related to cardiovascular and metabolic risk factors. While the other Health Behavior Checklist scales require further validation, the Good Health Practices scale could be used where more objective or longer measures are not feasible.
VirTUal remoTe labORatories managEment System (TUTORES): Using Cloud Computing to Acquire University Practical Skills

ERIC Educational Resources Information Center

Caminero, Agustín C.; Ros, Salvador; Hernández, Roberto; Robles-Gómez, Antonio; Tobarra, Llanos; Tolbaños Granjo, Pedro J.

2016-01-01

The use of practical laboratories is a key in engineering education in order to provide our students with the resources needed to acquire practical skills. This is specially true in the case of distance education, where no physical interactions between lecturers and students take place, so virtual or remote laboratories must be used. UNED has…
Laboratory containment practices for arthropod vectors of human and animal pathogens.

PubMed

Tabachnick, Walter J

2006-03-01

Arthropod-borne pathogens have an impact on the health and well-being of humans and animals throughout the world. Research involving arthropod vectors of disease is often dependent on the ability to maintain the specific arthropod species in laboratory colonies. The author reviews current arthropod containment practices and discusses their importance from public health and ecological perspectives.
The Pathology Laboratory Act 2007 explained.

PubMed

Looi, Lai-Meng

2008-06-01

laboratory practices are left to be specified by the Director-General of Health, providing for a formal recognition process and room for revision as pathology practices evolve. Encompassed in the responsibilities of the licensee is the requirement that samples are received and results issued through, and management vested in, a registered medical or dental practitioner. This effectively prohibits "walk-ins" to the laboratory and indiscriminate public screening. The requirement for a person-in-charge in accordance with class and speciality of laboratory ensures that the laboratory is under the charge of the pathology profession. Examined carefully, the requirements of the Act are similar to laboratory accreditation, but are backed by legislation. Many of these details will be spelt out in the Regulations, and these in turn are likely to fall back on National professional guidelines, as accreditation does. Although not at first obvious, enforcement of the Act is based on self-regulation by pathology laboratory professionals. Sincere professional input is thus required to embrace its philosophy, ensure rational and transparent enforcement of legislation, and develop National guidelines for good pathology practices upon which enforcement may be based.
Conjoint analysis applications in health--a checklist: a report of the ISPOR Good Research Practices for Conjoint Analysis Task Force.

PubMed

Bridges, John F P; Hauber, A Brett; Marshall, Deborah; Lloyd, Andrew; Prosser, Lisa A; Regier, Dean A; Johnson, F Reed; Mauskopf, Josephine

2011-06-01

The application of conjoint analysis (including discrete-choice experiments and other multiattribute stated-preference methods) in health has increased rapidly over the past decade. A wider acceptance of these methods is limited by an absence of consensus-based methodological standards. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Research Practices for Conjoint Analysis Task Force was established to identify good research practices for conjoint-analysis applications in health. The task force met regularly to identify the important steps in a conjoint analysis, to discuss good research practices for conjoint analysis, and to develop and refine the key criteria for identifying good research practices. ISPOR members contributed to this process through an extensive consultation process. A final consensus meeting was held to revise the article using these comments, and those of a number of international reviewers. Task force findings are presented as a 10-item checklist covering: 1) research question; 2) attributes and levels; 3) construction of tasks; 4) experimental design; 5) preference elicitation; 6) instrument design; 7) data-collection plan; 8) statistical analyses; 9) results and conclusions; and 10) study presentation. A primary question relating to each of the 10 items is posed, and three sub-questions examine finer issues within items. Although the checklist should not be interpreted as endorsing any specific methodological approach to conjoint analysis, it can facilitate future training activities and discussions of good research practices for the application of conjoint-analysis methods in health care studies. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Evaluating Students' Perspectives about Virtual Classrooms with Regard to Seven Principles of Good Practice

ERIC Educational Resources Information Center

Çakýroðlu, Ünal

2014-01-01

This study assesses the quality of distance learning (DL) in higher education assessed by considering the Seven Principles of Good Practice (SPGP). The participants were 77 second-year students from the Computer and Instructional Technologies Program (CEIT) of a Faculty of Education in Turkey. A questionnaire was developed in line with the SPGP…
Sharing Good Practice: Prevention and Support Concerning Pupils Presenting Social, Emotional and Behavioural Difficulties.

ERIC Educational Resources Information Center

Lloyd, Gwynedd, Ed.; Munn, Pamela, Ed.

This book is the result of a project to identify and disseminate examples of good practice in providing for children experiencing social, emotional, and behavioral difficulties in schools. The focus is on whole-school or classroom approaches to mainstreaming with experience from teachers of preschool to secondary grades. A major theme is providing…
Integration of Pharmacy Practice and Pharmaceutical Analysis: Quality Assessment of Laboratory Performance.

ERIC Educational Resources Information Center

McGill, Julian E.; Holly, Deborah R.

1996-01-01

Laboratory portions of courses in pharmacy practice and pharmaceutical analysis at the Medical University of South Carolina are integrated and coordinated to provide feedback on student performance in compounding medications. Students analyze the products they prepare, with early exposure to compendia requirements and other references. Student…
77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...
77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...
Cerebrospinal fluid protein and glucose examinations and tuberculosis: Will laboratory safety regulations force a change of practice?

PubMed

Tormey, William P; O'Hagan, Christopher

2015-01-01

Cerebrospinal fluid (CSF) protein and glucose examinations are usually performed in chemical pathology departments on autoanalysers. Tuberculosis (TB) is a group 3 biological agent under Directive 2000/54/EC of the European Parliament but in the biochemistry laboratory, no extra precautions are taken in its analysis in possible TB cases. The issue of laboratory practice and safety in the biochemical analyses of CSF specimens, when tuberculosis infection is in question is addressed in the context of ambiguity in the implementation of current national and international health and safety regulations. Additional protective measures for laboratory staff during the analysis of CSF TB samples should force a change in current laboratory practice and become a regulatory issue under ISO 15189. Annual Mantoux skin test or an interferon-γ release assay for TB should be mandatory for relevant staff. This manuscript addresses the issue of biochemistry laboratory practice and safety in the biochemical analyses of CSF specimens when tuberculosis infection is in question in the context of the ambiguity of statutory health and safety regulations.
Occupational safety and health status of medical laboratories in Kajiado County, Kenya.

PubMed

Tait, Fridah Ntinyari; Mburu, Charles; Gikunju, Joseph

2018-01-01

Despite the increasing interest in Occupational Safety and Health (OSH), seldom studies are available on OSH in medical laboratories from developing countries in general although a high number of injuries occur without proper documentation. It is estimated that every day 6,300 people die as a result of occupational accidents or work-related diseases resulting in over 2.3 million deaths per year. Medical laboratories handle a wide range of materials, potentially dangerous pathogenic agents and exposes health workers to numerous potential hazards. This study evaluated the status of OSH in medical laboratories in Kajiado County, Kenya. The objectives included establishment of biological, chemical and physical hazards; reviewing medical laboratories control measures; and enumerating factors hindering implementation of good practices in OSH. This was a cross-sectional descriptive study research design. Observation check lists, interview schedules and structured questionnaires were used. The study was carried out in 108 medical laboratories among 204 sampled respondents. Data was analysed using statistical package for social science (SPSS) 20 software. The commonest type of hazards in medical laboratories include; bacteria (80%) for Biological hazards; handling un-labelled and un-marked chemicals (38.2%) for chemical hazards; and laboratory equipment's dangerously placed (49.5%) for Physical hazards. According to Pearson's Product Moment Correlation analysis, not-wearing personal protective equipment's was statistically associated with exposure to hazards. Individual control measures were statistically significant at 0.01 significance level. Only 65.1% of the factors influencing implementation of OSH in medical laboratories were identified. Training has the highest contribution to good OSH practices.
Good Manufacturing Practices production and analysis of a DNA vaccine against dental caries.

PubMed

Yang, Ya-ping; Li, Yu-hong; Zhang, Ai-hua; Bi, Lan; Fan, Ming-wen

2009-11-01

To prepare a clinical-grade anti-caries DNA vaccine pGJA-P/VAX and explore its immune effect and protective efficacy against a cariogenic bacterial challenge. A large-scale industrial production process was developed under Good Manufacturing Practices (GMP) by combining and optimizing common unit operations such as alkaline lysis, precipitation, endotoxin removal and column chromatography. Quality controls of the purified bulk and final lyophilized vaccine were conducted according to authoritative guidelines. Mice and gnotobiotic rats were intranasally immunized with clinical-grade pGJA-P/VAX with chitosan. Antibody levels of serum IgG and salivary SIgA were assessed by an enzyme-linked immunosorbent assay (ELISA), and caries activity was evaluated by the Keyes method. pGJA-P/VAX and pVAX1 prepared by a laboratory-scale commercial kit were used as controls. The production process proved to be scalable and reproducible. Impurities including host protein, residual RNA, genomic DNA and endotoxin in the purified plasmid were all under the limits of set specifications. Intranasal vaccination with clinical-grade pGJA-P/VAX induced higher serum IgG and salivary SIgA in both mice and gnotobiotic rats. While in the experimental caries model, the enamel (E), dentinal slight (Ds), and dentinal moderate (Dm) caries lesions were reduced by 21.1%, 33.0%, and 40.9%, respectively. The production process under GMP was efficient in preparing clinical-grade pGJA-P/VAX with high purity and intended effectiveness, thus facilitating future clinical trials for the anti-caries DNA vaccine.
Good Laboratory Practice Preclinical Safety Studies for GSK2696273 (MLV Vector-Based Ex Vivo Gene Therapy for Adenosine Deaminase Deficiency Severe Combined Immunodeficiency) in NSG Mice.

PubMed

Carriglio, Nicola; Klapwijk, Jan; Hernandez, Raisa Jofra; Vezzoli, Michela; Chanut, Franck; Lowe, Rhiannon; Draghici, Elena; Nord, Melanie; Albertini, Paola; Cristofori, Patrizia; Richards, Jane; Staton, Hazel; Appleby, Jonathan; Aiuti, Alessandro; Sauer, Aisha V

2017-03-01

GSK2696273 (autologous CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] enzyme) is a gamma-retroviral ex vivo gene therapy of bone marrow-derived CD34+ cells for the treatment of adenosine deaminase deficiency severe combined immunodeficiency (ADA-SCID). ADA-SCID is a severe monogenic disease characterized by immunologic and nonimmunologic symptoms. Bone-marrow transplant from a matched related donor is the treatment of choice, but it is available for only a small proportion of patients. Ex vivo gene therapy of patient bone-marrow CD34+ cells is an alternative treatment. In order to prepare for a marketing authorization application in the European Union, preclinical safety studies in mice were requested by the European Medicines Agency (EMA). A pilot study and a main biodistribution study were performed according to Good Laboratory Practice (GLP) at the San Raffaele Telethon Institute for Gene Therapy test facility. In the main study, human umbilical cord blood (UCB)-derived CD34+ cells were transduced with gamma-retroviral vector used in the production of GSK2696273. Groups of 10 male and 10 female NOD-SCID gamma (NSG) mice were injected intravenously with a single dose of transduced- or mock-transduced UCB CD34+ cells, and they were observed for 4 months. Engraftment and multilineage differentiation of blood cells was observed in the majority of animals in both groups. There was no significant difference in the level of chimerism between the two groups. In the gene therapy group, vector was detectable in lymphohemopoietic and nonlymphohemopoietic tissues, consistent with the presence of gene-modified human hematopoietic donor cells. Given the absence of relevant safety concerns in the data, the nonclinical studies and the clinical experience with GSK2696273 supported a successful application for market authorization in the European Union for the treatment of ADA-SCID patients, for whom no suitable human leukocyte
Assessing Clinical Microbiology Practice Guidelines: American Society for Microbiology Ad Hoc Committee on Evidence-Based Laboratory Medicine Practice Guidelines Assessment.

PubMed

Nachamkin, Irving; Kirn, Thomas J; Westblade, Lars F; Humphries, Romney

2017-11-01

As part of the American Society for Microbiology (ASM) Evidence-Based Laboratory Medicine Practice Guidelines Committee of the Professional Practice Committee, an ad hoc committee was formed in 2014 to assess guidelines published by the committee using an assessment tool, Appraisal of Guidelines for Research Evaluation II (AGREE II). The AGREE II assessment helps reviewers determine whether published guidelines are robust, transparent, and clear in presenting practice recommendations in a standardized manner. Identifying strengths and weaknesses of practice guidelines by ad hoc assessments helps with improving future guidelines through the participation of key stakeholders. This minireview describes the development of the ad hoc committee and results from their review of several ASM best practices guidelines and a non-ASM practice guideline from the Emergency Nurses Association. Copyright © 2017 American Society for Microbiology.
Assessing Clinical Microbiology Practice Guidelines: American Society for Microbiology Ad Hoc Committee on Evidence-Based Laboratory Medicine Practice Guidelines Assessment

PubMed Central

Kirn, Thomas J.; Westblade, Lars F.; Humphries, Romney

2017-01-01

ABSTRACT As part of the American Society for Microbiology (ASM) Evidence-Based Laboratory Medicine Practice Guidelines Committee of the Professional Practice Committee, an ad hoc committee was formed in 2014 to assess guidelines published by the committee using an assessment tool, Appraisal of Guidelines for Research Evaluation II (AGREE II). The AGREE II assessment helps reviewers determine whether published guidelines are robust, transparent, and clear in presenting practice recommendations in a standardized manner. Identifying strengths and weaknesses of practice guidelines by ad hoc assessments helps with improving future guidelines through the participation of key stakeholders. This minireview describes the development of the ad hoc committee and results from their review of several ASM best practices guidelines and a non-ASM practice guideline from the Emergency Nurses Association. PMID:28835476
Missed detection of significant positive and negative shifts in gentamicin assay: implications for routine laboratory quality practices.

PubMed

Koerbin, Gus; Liu, Jiakai; Eigenstetter, Alex; Tan, Chin Hon; Badrick, Tony; Loh, Tze Ping

2018-02-15

A product recall was issued for the Roche/Hitachi Cobas Gentamicin II assays on 25 th May 2016 in Australia, after a 15 - 20% positive analytical shift was discovered. Laboratories were advised to employ the Thermo Fisher Gentamicin assay as an alternative. Following the reintroduction of the revised assay on 12 th September 2016, a second reagent recall was made on 20 th March 2017 after the discovery of a 20% negative analytical shift due to erroneous instrument adjustment factor. The practices of an index laboratory were examined to determine how the analytical shifts evaded detection by routine internal quality control (IQC) and external quality assurance (EQA) systems. The ability of the patient result-based approaches, including moving average (MovAvg) and moving sum of outliers (MovSO) approaches in detecting these shifts were examined. Internal quality control data of the index laboratory were acceptable prior to the product recall. The practice of adjusting IQC target following a change in assay method resulted in the missed negative shift when the revised Roche assay was reintroduced. While the EQA data of the Roche subgroup showed clear negative bias relative to other laboratory methods, the results were considered as possible 'matrix effect'. The MovAvg method detected the positive shift before the product recall. The MovSO did not detect the negative shift in the index laboratory but did so in another laboratory 5 days before the second product recall. There are gaps in current laboratory quality practices that leave room for analytical errors to evade detection.
Blood sample collection and patient identification demand improvement: a questionnaire study of preanalytical practices in hospital wards and laboratories.

PubMed

Wallin, Olof; Söderberg, Johan; Van Guelpen, Bethany; Stenlund, Hans; Grankvist, Kjell; Brulin, Christine

2010-09-01

Scand J Caring Sci; 2010; 24; 581-591   Blood sample collection and patient identification demand improvement: a questionnaire study of preanalytical practices in hospital wards and laboratories Most errors in venous blood testing result from human mistakes occurring before the sample reach the laboratory. To survey venous blood sampling (VBS) practices in hospital wards and to compare practices with hospital laboratories. Staff in two hospitals (all wards) and two hospital laboratories (314 respondents, response rate 94%), completed a questionnaire addressing issues relevant to the collection of venous blood samples for clinical chemistry testing. The findings suggest that instructions for patient identification and the collection of venous blood samples were not always followed. For example, 79% of the respondents reported the undesirable practice (UDP) of not always using wristbands for patient identification. Similarly, 87% of the respondents noted the UDP of removing venous stasis after the sampling is finished. Compared with the ward staff, a significantly higher proportion of the laboratory staff reported desirable practices regarding the collection of venous blood samples. Neither education nor the existence of established sampling routines was clearly associated with VBS practices among the ward staff. The results of this study, the first of its kind, suggest that a clinically important risk of error is associated with VBS in the surveyed wards. Most important is the risk of misidentification of patients. Quality improvement of blood sample collection is clearly needed, particularly in hospital wards. © 2009 The Authors. Journal compilation © 2009 Nordic College of Caring Science.
Effectiveness of practices to reduce blood culture contamination: a Laboratory Medicine Best Practices systematic review and meta-analysis.

PubMed

Snyder, Susan R; Favoretto, Alessandra M; Baetz, Rich Ann; Derzon, James H; Madison, Bereneice M; Mass, Diana; Shaw, Colleen S; Layfield, Christopher D; Christenson, Robert H; Liebow, Edward B

2012-09-01

This article is a systematic review of the effectiveness of three practices for reducing blood culture contamination rates: venipuncture, phlebotomy teams, and prepackaged preparation/collection (prep) kits. The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used. Studies included as evidence were: 9 venipuncture (vs. versus intravenous catheter), 5 phlebotomy team; and 7 prep kit. All studies for venipuncture and phlebotomy teams favored these practices, with meta-analysis mean odds ratios for venipuncture of 2.69 and phlebotomy teams of 2.58. For prep kits 6 studies' effect sizes were not statistically significantly different from no effect (meta-analysis mean odds ratio 1.12). Venipuncture and the use of phlebotomy teams are effective practices for reducing blood culture contamination rates in diverse hospital settings and are recommended as evidence-based "best practices" with high overall strength of evidence and substantial effect size ratings. No recommendation is made for or against prep kits based on uncertain improvement. Copyright © 2012 The Canadian Society of Clinical Chemists. All rights reserved.
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.
Errors in laboratory medicine: practical lessons to improve patient safety.

PubMed

Howanitz, Peter J

2005-10-01

Patient safety is influenced by the frequency and seriousness of errors that occur in the health care system. Error rates in laboratory practices are collected routinely for a variety of performance measures in all clinical pathology laboratories in the United States, but a list of critical performance measures has not yet been recommended. The most extensive databases describing error rates in pathology were developed and are maintained by the College of American Pathologists (CAP). These databases include the CAP's Q-Probes and Q-Tracks programs, which provide information on error rates from more than 130 interlaboratory studies. To define critical performance measures in laboratory medicine, describe error rates of these measures, and provide suggestions to decrease these errors, thereby ultimately improving patient safety. A review of experiences from Q-Probes and Q-Tracks studies supplemented with other studies cited in the literature. Q-Probes studies are carried out as time-limited studies lasting 1 to 4 months and have been conducted since 1989. In contrast, Q-Tracks investigations are ongoing studies performed on a yearly basis and have been conducted only since 1998. Participants from institutions throughout the world simultaneously conducted these studies according to specified scientific designs. The CAP has collected and summarized data for participants about these performance measures, including the significance of errors, the magnitude of error rates, tactics for error reduction, and willingness to implement each of these performance measures. A list of recommended performance measures, the frequency of errors when these performance measures were studied, and suggestions to improve patient safety by reducing these errors. Error rates for preanalytic and postanalytic performance measures were higher than for analytic measures. Eight performance measures were identified, including customer satisfaction, test turnaround times, patient identification
The Utilization of the Seven Principles for Good Practices of Full-Time and Adjunct Faculty in Teaching Health & Science in Community Colleges

ERIC Educational Resources Information Center

Musaitif, Linda M.

2013-01-01

Purpose: The purpose of this study was to determine the degree to which undergraduate full-time and adjunct faculty members in the health and science programs at community colleges in Southern California utilize the seven principles of good practice as measured by the Faculty Inventory of the Seven Principles for Good Practice in Undergraduate…
Estimating the harms and benefits of prostate cancer screening as used in common practice versus recommended good practice: A microsimulation screening analysis.

PubMed

Carlsson, Sigrid V; de Carvalho, Tiago M; Roobol, Monique J; Hugosson, Jonas; Auvinen, Anssi; Kwiatkowski, Maciej; Villers, Arnauld; Zappa, Marco; Nelen, Vera; Páez, Alvaro; Eastham, James A; Lilja, Hans; de Koning, Harry J; Vickers, Andrew J; Heijnsdijk, Eveline A M

2016-11-15

Prostate-specific antigen (PSA) screening and concomitant treatment can be implemented in several ways. The authors investigated how the net benefit of PSA screening varies between common practice versus "good practice." Microsimulation screening analysis (MISCAN) was used to evaluate the effect on quality-adjusted life-years (QALYs) if 4 recommendations were followed: limited screening in older men, selective biopsy in men with elevated PSA, active surveillance for low-risk tumors, and treatment preferentially delivered at high-volume centers. Outcomes were compared with a base model in which annual screening started at ages 55 to 69 years and were simulated using data from the European Randomized Study of Screening for Prostate Cancer. In terms of QALYs gained compared with no screening, for 1000 screened men who were followed over their lifetime, recommended good practice led to 73 life-years (LYs) and 74 QALYs gained compared with 73 LYs and 56 QALYs for the base model. In contrast, common practice led to 78 LYs gained but only 19 QALYs gained, for a greater than 75% relative reduction in QALYs gained from unadjusted LYs gained. The poor outcomes for common practice were influenced predominantly by the use of aggressive treatment for men with low-risk disease, and PSA testing in older men also strongly reduced potential QALY gains. Commonly used PSA screening and treatment practices are associated with little net benefit. Following a few straightforward clinical recommendations, particularly greater use of active surveillance for low-risk disease and reducing screening in older men, would lead to an almost 4-fold increase in the net benefit of prostate cancer screening. Cancer 2016;122:3386-3393. © 2016 American Cancer Society. © 2016 American Cancer Society.
Teaching Laboratory Management Principles and Practices Through Mentorship and Graduated Responsibility: The Assistant Medical Directorship.

PubMed

Hanley, Timothy; Sowder, Aleksandra M; Palmer, Cheryl Ann; Weiss, Ronald L

2016-01-01

With the changing landscape of medicine in general, and pathology in particular, a greater emphasis is being placed on laboratory management as a means of controlling spiraling medical costs and improving health-care efficiency. To meet this challenge, pathology residency programs have begun to incorporate formal laboratory management training into their curricula, using institutional curricula and/or online laboratory management courses offered by professional organizations. At the University of Utah, and its affiliated national reference laboratory, ARUP Laboratories, Inc, interested residents are able to supplement the departmental lecture-based and online laboratory management curriculum by participating in assistant medical directorship programs in one of several pathology subspecialty disciplines. The goals of many of the assistant medical directorship positions include the development of laboratory management skills and competencies. A survey of current and recent assistant medical directorship participants revealed that the assistant medical directorship program serves as an excellent means of improving laboratory management skills, as well as improving performance as a fellow and practicing pathologist.
Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.

PubMed

Micoulaud-Franchi, J-A; McGonigal, A; Lopez, R; Daudet, C; Kotwas, I; Bartolomei, F

2015-12-01

The technique of electroencephalographic neurofeedback (EEG NF) emerged in the 1970s and is a technique that measures a subject's EEG signal, processes it in real time, extracts a parameter of interest and presents this information in visual or auditory form. The goal is to effectuate a behavioural modification by modulating brain activity. The EEG NF opens new therapeutic possibilities in the fields of psychiatry and neurology. However, the development of EEG NF in clinical practice requires (i) a good level of evidence of therapeutic efficacy of this technique, (ii) a good practice guide for this technique. Firstly, this article investigates selected trials with the following criteria: study design with controlled, randomized, and open or blind protocol, primary endpoint related to the mental and brain disorders treated and assessed with standardized measurement tools, identifiable EEG neurophysiological targets, underpinned by pathophysiological relevance. Trials were found for: epilepsies, migraine, stroke, chronic insomnia, attentional-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, major depressive disorder, anxiety disorders, addictive disorders, psychotic disorders. Secondly, this article investigates the principles of neurofeedback therapy in line with learning theory. Different underlying therapeutic models are presented didactically between two continua: a continuum between implicit and explicit learning and a continuum between the biomedical model (centred on "the disease") and integrative biopsychosocial model of health (centred on "the illness"). The main relevant learning model is to link neurofeedback therapy with the field of cognitive remediation techniques. The methodological specificity of neurofeedback is to be guided by biologically relevant neurophysiological parameters. Guidelines for good clinical practice of EEG NF concerning technical issues of electrophysiology and of learning are suggested. These require validation by

Prospective, observational study comparing automated and visual point-of-care urinalysis in general practice

PubMed Central

van Delft, Sanne; Goedhart, Annelijn; Spigt, Mark; van Pinxteren, Bart; de Wit, Niek; Hopstaken, Rogier

2016-01-01

Objective Point-of-care testing (POCT) urinalysis might reduce errors in (subjective) reading, registration and communication of test results, and might also improve diagnostic outcome and optimise patient management. Evidence is lacking. In the present study, we have studied the analytical performance of automated urinalysis and visual urinalysis compared with a reference standard in routine general practice. Setting The study was performed in six general practitioner (GP) group practices in the Netherlands. Automated urinalysis was compared with visual urinalysis in these practices. Reference testing was performed in a primary care laboratory (Saltro, Utrecht, The Netherlands). Primary and secondary outcome measures Analytical performance of automated and visual urinalysis compared with the reference laboratory method was the primary outcome measure, analysed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and Cohen's κ coefficient for agreement. Secondary outcome measure was the user-friendliness of the POCT analyser. Results Automated urinalysis by experienced and routinely trained practice assistants in general practice performs as good as visual urinalysis for nitrite, leucocytes and erythrocytes. Agreement for nitrite is high for automated and visual urinalysis. κ's are 0.824 and 0.803 (ranked as very good and good, respectively). Agreement with the central laboratory reference standard for automated and visual urinalysis for leucocytes is rather poor (0.256 for POCT and 0.197 for visual, respectively, ranked as fair and poor). κ's for erythrocytes are higher: 0.517 (automated) and 0.416 (visual), both ranked as moderate. The Urisys 1100 analyser was easy to use and considered to be not prone to flaws. Conclusions Automated urinalysis performed as good as traditional visual urinalysis on reading of nitrite, leucocytes and erythrocytes in routine general practice. Implementation of automated
Laboratory Diagnosis and Characterization of Fungal Disease in Patients with Cystic Fibrosis (CF): A Survey of Current UK Practice in a Cohort of Clinical Microbiology Laboratories.

PubMed

Boyle, Maeve; Moore, John E; Whitehouse, Joanna L; Bilton, Diana; Downey, Damian G

2018-03-02

There is much uncertainty as to how fungal disease is diagnosed and characterized in patients with cystic fibrosis (CF). A 19-question anonymous electronic questionnaire was developed and distributed to ascertain current practice in clinical microbiology laboratories providing a fungal laboratory service to CF centres in the UK. Analyses of responses identified the following: (1) current UK laboratory practice, in general, follows the current guidelines, but the scope and diversity of what is currently being delivered by laboratories far exceeds what is detailed in the guidelines; (2) there is a lack of standardization of fungal tests amongst laboratories, outside of the current guidelines; (3) both the UK CF Trust Laboratory Standards for Processing Microbiological Samples from People with Cystic Fibrosis and the US Cumulative Techniques and Procedures in Clinical Microbiology (Cumitech) Guidelines 43 Cystic Fibrosis Microbiology need to be updated to reflect both new methodological innovations, as well as better knowledge of fungal disease pathophysiology in CF; (4) there is a need for clinical medicine to decide upon a stratification strategy for the provision of new fungal assays that will add value to the physician in the optimal management of CF patients; (5) there is also a need to rationale what assays should be performed at local laboratory level and those which are best served at National Mycology Reference Laboratory level; and (6) further research is required in developing laboratory assays, which will help ascertain the clinical importance of 'old' fungal pathogens, as well as 'emerging' fungal pathogens.
Home-based vs. laboratory-based practical activities in the learning of human physiology: the perception of students.

PubMed

Neves, Ben-Hur S; Altermann, Caroline; Gonçalves, Rithiele; Lara, Marcus Vinícius; Mello-Carpes, Pâmela B

2017-03-01

Different tools have been used to facilitate the teaching and learning process in different areas of knowledge. Practical activities represent a form of teaching in which students not only listen to theoretical concepts but are also able to link theory and practice, and their importance in the biological sciences is notable. Sometimes, however, there is neither the time nor the resources to promote laboratory practices in physiology classes. In this sense, home-based practical activities may be an interesting alternative. Here, different approaches of practical activities were used and students' perceptions of the contributions of home-based practical activities (HBPA) and laboratory-based practical activities (LBPA) for physiology learning were collected. After each approach, the students evaluated the activities through an anonymous questionnaire. A total of 49 students completed the questionnaires, and the results demonstrate that both HBPA and LBPA were considered important contributors to physiology learning but that this contribution was more significant in the case of LBPA (χ 2 = 4.356, P = 0.037). Copyright © 2017 the American Physiological Society.
Genomics Virtual Laboratory: A Practical Bioinformatics Workbench for the Cloud

PubMed Central

Afgan, Enis; Sloggett, Clare; Goonasekera, Nuwan; Makunin, Igor; Benson, Derek; Crowe, Mark; Gladman, Simon; Kowsar, Yousef; Pheasant, Michael; Horst, Ron; Lonie, Andrew

2015-01-01

Background Analyzing high throughput genomics data is a complex and compute intensive task, generally requiring numerous software tools and large reference data sets, tied together in successive stages of data transformation and visualisation. A computational platform enabling best practice genomics analysis ideally meets a number of requirements, including: a wide range of analysis and visualisation tools, closely linked to large user and reference data sets; workflow platform(s) enabling accessible, reproducible, portable analyses, through a flexible set of interfaces; highly available, scalable computational resources; and flexibility and versatility in the use of these resources to meet demands and expertise of a variety of users. Access to an appropriate computational platform can be a significant barrier to researchers, as establishing such a platform requires a large upfront investment in hardware, experience, and expertise. Results We designed and implemented the Genomics Virtual Laboratory (GVL) as a middleware layer of machine images, cloud management tools, and online services that enable researchers to build arbitrarily sized compute clusters on demand, pre-populated with fully configured bioinformatics tools, reference datasets and workflow and visualisation options. The platform is flexible in that users can conduct analyses through web-based (Galaxy, RStudio, IPython Notebook) or command-line interfaces, and add/remove compute nodes and data resources as required. Best-practice tutorials and protocols provide a path from introductory training to practice. The GVL is available on the OpenStack-based Australian Research Cloud (http://nectar.org.au) and the Amazon Web Services cloud. The principles, implementation and build process are designed to be cloud-agnostic. Conclusions This paper provides a blueprint for the design and implementation of a cloud-based Genomics Virtual Laboratory. We discuss scope, design considerations and technical and
Genomics Virtual Laboratory: A Practical Bioinformatics Workbench for the Cloud.

PubMed

Afgan, Enis; Sloggett, Clare; Goonasekera, Nuwan; Makunin, Igor; Benson, Derek; Crowe, Mark; Gladman, Simon; Kowsar, Yousef; Pheasant, Michael; Horst, Ron; Lonie, Andrew

2015-01-01

Analyzing high throughput genomics data is a complex and compute intensive task, generally requiring numerous software tools and large reference data sets, tied together in successive stages of data transformation and visualisation. A computational platform enabling best practice genomics analysis ideally meets a number of requirements, including: a wide range of analysis and visualisation tools, closely linked to large user and reference data sets; workflow platform(s) enabling accessible, reproducible, portable analyses, through a flexible set of interfaces; highly available, scalable computational resources; and flexibility and versatility in the use of these resources to meet demands and expertise of a variety of users. Access to an appropriate computational platform can be a significant barrier to researchers, as establishing such a platform requires a large upfront investment in hardware, experience, and expertise. We designed and implemented the Genomics Virtual Laboratory (GVL) as a middleware layer of machine images, cloud management tools, and online services that enable researchers to build arbitrarily sized compute clusters on demand, pre-populated with fully configured bioinformatics tools, reference datasets and workflow and visualisation options. The platform is flexible in that users can conduct analyses through web-based (Galaxy, RStudio, IPython Notebook) or command-line interfaces, and add/remove compute nodes and data resources as required. Best-practice tutorials and protocols provide a path from introductory training to practice. The GVL is available on the OpenStack-based Australian Research Cloud (http://nectar.org.au) and the Amazon Web Services cloud. The principles, implementation and build process are designed to be cloud-agnostic. This paper provides a blueprint for the design and implementation of a cloud-based Genomics Virtual Laboratory. We discuss scope, design considerations and technical and logistical constraints, and explore the
[Fundamentals of quality control systems in medical-biochemical laboratories--the role of marketing].

PubMed

Topić, E; Turek, S

2000-01-01

The basic criterion for the overall quality system in medical biochemistry laboratories concerning equipment, premises and laboratory staff in primary health care (PHC) (Regulations on quality systems and good laboratory practice of the Croatian Medical Biochemists Chamber, 1995, Regulations on categorization of medical biochemistry laboratories of the Croatian Medical Biochemists Chamber, 1996, EC4: Essential criteria for quality systems in medical laboratories. Eur J Clin Chem Clin Biochem 1997 in medical biochemical laboratories included in the First Croatia health project, Primary health care subproject, has been met by the marketing approach to the project. The equipment ensuring implementation of the complete laboratory program (NN/96), more accurate and precise analytical procedures, and higher reliability of laboratory test results compared with previous equipment, has been purchased by an international tender. Uniform technology and methods of analysis have ensured high standards of good laboratory services, yielding test results than can be transferred from primary to secondary health care level. The new equipment has improved organization between central and detached medical biochemistry laboratory units, while the high quality requirement has led to improvement in the staff structure, e.g., medical biochemists have been employed in laboratories that had previously worked without such a professional. Equipment renewal has been accompanied by proper education for all levels of PHC professionals.
Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines.

PubMed

Ravinetto, Raffaella; De Nys, Katelijne; Boelaert, Marleen; Diro, Ermias; Meintjes, Graeme; Adoke, Yeka; Tagbor, Harry; Casteels, Minne

2015-12-30

Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder's policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a "sponsor" of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today's reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other
[Proposed recommendations for the practical use of internal quality controls (IQC) in a medical biology laboratory].

PubMed

Giannoli, Jean-Marc; Szymanowicz, Anton

2011-01-01

We propose a set of recommendations and practices to optimize the use of quality control of medical biology examinations. The fundamentals are reviewed: definition of a series of analysis, IQC at one or more level, Westgard alert rules and rejection, practical remedial actions to take for the technician, corrective and preventive actions to be implemented by the biologist. We have also formalized three flowcharts to guide the technician in their daily practice to ensure analytical quality of investigations carried out. These decision trees are the result of the experience submitted by an accredited and professional laboratory attentive to the ongoing improvement of IQC. This article can provide useful assistance to biologists for accreditation but also aims to foster collaboration reliable medical biology laboratory at the appropriate management of patients.
Safety and quality of food contact materials. Part 1: evaluation of analytical strategies to introduce migration testing into good manufacturing practice.

PubMed

Feigenbaum, A; Scholler, D; Bouquant, J; Brigot, G; Ferrier, D; Franzl, R; Lillemarktt, L; Riquet, A M; Petersen, J H; van Lierop, B; Yagoubi, N

2002-02-01

The results of a research project (EU AIR Research Programme CT94-1025) aimed to introduce control of migration into good manufacturing practice and into enforcement work are reported. Representative polymer classes were defined on the basis of chemical structure, technological function, migration behaviour and market share. These classes were characterized by analytical methods. Analytical techniques were investigated for identification of potential migrants. High-temperature gas chromatography was shown to be a powerful method and 1H-magnetic resonance provided a convenient fingerprint of plastic materials. Volatile compounds were characterized by headspace techniques, where it was shown to be essential to differentiate volatile compounds desorbed from those generated during the thermal desorption itself. For metal trace analysis, microwave mineralization followed by atomic absorption was employed. These different techniques were introduced into a systematic testing scheme that is envisaged as being suitable both for industrial control and for enforcement laboratories. Guidelines will be proposed in the second part of this paper.
Practical experience with graphical user interfaces and object-oriented design in the clinical laboratory.

PubMed

Wells, I G; Cartwright, R Y; Farnan, L P

1993-12-15

The computing strategy in our laboratories evolved from research in Artificial Intelligence, and is based on powerful software tools running on high performance desktop computers with a graphical user interface. This allows most tasks to be regarded as design problems rather than implementation projects, and both rapid prototyping and an object-oriented approach to be employed during the in-house development and enhancement of the laboratory information systems. The practical application of this strategy is discussed, with particular reference to the system designer, the laboratory user and the laboratory customer. Routine operation covers five departments, and the systems are stable, flexible and well accepted by the users. Client-server computing, currently undergoing final trials, is seen as the key to further development, and this approach to Pathology computing has considerable potential for the future.
Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.

PubMed

Sheth-Shah, Radhika; Vernon, Amanda J; Seetharaman, Shankar; Neale, Michael H; Daniels, Julie T

2016-04-01

In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.
Effectiveness of practices to reduce blood culture contamination: A Laboratory Medicine Best Practices systematic review and meta-analysis☆

PubMed Central

Snyder, Susan R.; Favoretto, Alessandra M.; Baetz, Rich Ann; Derzon, James H.; Madison, Bereneice M.; Mass, Diana; Shaw, Colleen S.; Layfield, Christopher D.; Christenson, Robert H.; Liebow, Edward B.

2015-01-01

Objectives This article is a systematic review of the effectiveness of three practices for reducing blood culture contamination rates: venipuncture, phlebotomy teams, and prepackaged preparation/collection (prep) kits. Design and methods The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used. Results Studies included as evidence were: 9 venipuncture (vs. versus intravenous catheter), 5 phlebotomy team; and 7 prep kit. All studies for venipuncture and phlebotomy teams favored these practices, with meta-analysis mean odds ratios for venipuncture of 2.69 and phlebotomy teams of 2.58. For prep kits 6 studies’ effect sizes were not statistically significantly different from no effect (meta-analysis mean odds ratio 1.12). Conclusions Venipuncture and the use of phlebotomy teams are effective practices for reducing blood culture contamination rates in diverse hospital settings and are recommended as evidence-based “best practices” with high overall strength of evidence and substantial effect size ratings. No recommendation is made for or against prep kits based on uncertain improvement. PMID:22709932
Current issues of personnel and laboratory practices in genetic testing

PubMed Central

Mark, Hon Fong Louie; Kelly, Thaddeus; Watson, Michael S; Hoeltge, Gerald; Miller, Wayne A; Beauregard, Laurent

1995-01-01

As genetic testing is an area with implications extending far beyond that of the primary patient, it is appropriately an area that is under increased scrutiny. To ensure that high quality is maintained in the delivery of genetic services, several agencies have developed standards and guidelines. The present article summarises important recommendations made by the American College of Medical Genetics (ACMG), the College of American Pathologists (CAP), the US Health Care Financing Administration (HCFA), and the US Food and Drug Administration (FDA) as they relate to genetic testing. Some of the standards are based on voluntary compliance, whereas others have the force of regulation. They all address issues of personnel credentials, laboratory operations, and the most critical quality assurance and control measures for diagnostic laboratories from the perspective of various agencies. In most instances, the standards promulgated by these agencies are offered as minimum criteria. The exact impact of these regulations on the practice of medical genetics has yet to be established. Images PMID:8558555
Good practices in normal childbirth: reliability analysis of an instrument by Cronbach's Alpha.

PubMed

Gottems, Leila Bernarda Donato; Carvalho, Elisabete Mesquita Peres De; Guilhem, Dirce; Pires, Maria Raquel Gomes Maia

2018-01-01

to analyze the internal consistency of the evaluation instrument of the adherence to the good practices of childbirth and birth care in the professionals, through Cronbach's Alpha Coefficient for each of the dimensions and for the total instrument. this is a descriptive and cross-sectional study performed in obstetric centers of eleven public hospitals in the Federal District, with a questionnaire applied to 261 professionals who worked in the delivery care. The study was attended by 261 professionals, 42.5% (111) nurses and 57.5% (150) physicians. The reliability evaluation of the instrument by the Cronbach Alfa resulted in 0.53, 0.78 and 0.76 for dimensions 1, 2 and 3, after debugging that resulted in the exclusion of 11 items. the instrument obtained Cronbach's alpha of 0.80. There is a need for improvement in the items of dimension 1 that refer to attitudes, knowledge, and practices of the organization of the network of care to gestation, childbirth, and birth. However, it can be applied in the way it is used to evaluate practices based on scientific evidence of childbirth care.
Biosafety perspective of clinical laboratory workers: a profile of Pakistan.

PubMed

Nasim, Sadia; Shahid, Anjum; Mustufa, Muhammad Ayaz; Arain, Ghazala Mohyuddin; Ali, Ghazanfer; Taseer, Ijaz-ul-Haque; Talreja, Kanaya Lal; Firdous, Rukhsana; Iqbal, Rizwan; Siddique, Shameem Ahmed; Naz, Saima; Akhter, Tasleem

2012-08-21

Biosafety during lab work is an important concern in developing countries. Some critical issues concerning biosafety are lack of training, exceeding workload, working too fast, deciding not to follow safe practices, and skepticism about biohazards. This study aimed to determine biosafety perception and practices of laboratory technicians during routine work in clinical laboratories of Pakistan. A total of 1,782 laboratory technicians were interviewed from major public sector hospitals and a few private hospital laboratories throughout Pakistan. A total of 1,647 (92.4%) males and 135 (7.6%) females participated in the study, with over half (59.7%) having more than five years of work experience. Results showed that 28.4% of the laboratory technicians from Punjab, 35.7% from Sindh, 32% from Balochistan and 38.4% from Khyber Pakhtoon Khawa (KPK) did not use any personal protective equipment. Almost 46% of the respondents (34.2% from Punjab, 61.9% from Sindh, 25.2% from Balochistan and 85% from KPK) said they reused syringes either occasionally or regularly. Furthermore, 30.7% of the respondents said they discard used syringes directly into municipal dustbins. The majority (66.7%) claimed there are no separate bins for sharps, so they throw these in municipal dustbins. Mouth pipetting was reported by 28.3% technicians. Standard operating procedures were not available in 67.2% labs, and accident records were not maintained in 83.4%. No formal biosafety training had been provided to 84.2% of the respondents. Laboratory technicians in Pakistan lack awareness of good laboratory practices and biosafety measures, and also face a lack of resources.
A Critical Analysis of the INQAAHE Guidelines of Good Practice for Higher Education Quality Assurance Agencies

ERIC Educational Resources Information Center

Blackmur, Douglas

2008-01-01

The International Network of Quality Assurance Agencies in Higher Education's Guidelines of Good Practice by higher education quality assurance agencies need substantial revision before they can be considered adequate by stakeholders in any national higher education system. Various revisions are proposed in this article. But the International…
Alternative Realities: Faculty and Student Perceptions of Instructional Practices in Laboratory Courses.

PubMed

Beck, Christopher W; Blumer, Lawrence S

2016-01-01

Curricular reform efforts depend on our ability to determine how courses are taught and how instructional practices affect student outcomes. In this study, we developed a 30-question survey on inquiry-based learning and assessment in undergraduate laboratory courses that was administered to 878 students in 54 courses (41 introductory level and 13 upper level) from 20 institutions (four community colleges, 11 liberal arts colleges, and five universities, of which four were minority-serving institutions). On the basis of an exploratory factor analysis, we defined five constructs: metacognition, feedback and assessment, scientific synthesis, science process skills, and instructor-directed teaching. Using our refined survey of 24 items, we compared student and faculty perceptions of instructional practices both across courses and across instructors. In general, faculty and student perceptions were not significantly related. Although mean perceptions were often similar, faculty perceptions were more variable than those of students, suggesting that faculty may have more nuanced views than students. In addition, student perceptions of some instructional practices were influenced by their previous experience in laboratory courses and their self-efficacy. As student outcomes, such as learning gains, are ultimately most important, future research should examine the degree to which faculty and student perceptions of instructional practices predict student outcomes in different contexts. © 2016 C. W. Beck and L. S. Blumer. CBE—Life Sciences Education © 2016 The American Society for Cell Biology. This article is distributed by The American Society for Cell Biology under license from the author(s). It is available to the public under an Attribution–Noncommercial–Share Alike 3.0 Unported Creative Commons License (http://creativecommons.org/licenses/by-nc-sa/3.0).
Practical Strategies for Integrating Final Ecosystem Goods and ...

EPA Pesticide Factsheets

The concept of Final Ecosystem Goods and Services (FEGS) explicitly connects ecosystem services to the people that benefit from them. This report presents a number of practical strategies for incorporating FEGS, and more broadly ecosystem services, into the decision-making process. Whether a decision process is in early or late stages, or whether a process includes informal or formal decision analysis, there are multiple points where ecosystem services concepts can be integrated. This report uses Structured Decision Making (SDM) as an organizing framework to illustrate the role ecosystem services can play in a values-focused decision-process, including: • Clarifying the decision context: Ecosystem services can help clarify the potential impacts of an issue on natural resources together with their spatial and temporal extent based on supply and delivery of those services, and help identify beneficiaries for inclusion as stakeholders in the deliberative process. • Defining objectives and performance measures: Ecosystem services may directly represent stakeholder objectives, or may be means toward achieving other objectives. • Creating alternatives: Ecosystem services can bring to light creative alternatives for achieving other social, economic, health, or general well-being objectives. • Estimating consequences: Ecosystem services assessments can implement ecological production functions (EPFs) and ecological benefits functions (EBFs) to link decision alt
Educational area for learning of optics and technologies: union of open laboratories of ideas, methods and practices (OLIMP)

NASA Astrophysics Data System (ADS)

Ivashchenko, Maksim; Bodrov, Kirill; Tolstoba, Nadezhda

2016-09-01

The paper deals with the concept of creating the union of Open Laboratories of Ideas, Methods and Practices (OLIMP). It describes the structure designed to simplify the relationship, such as business incubators, start-up accelerators, small innovative enterprises, fabrication laboratories and student centers. We consider their advantages and disadvantages for the specific audience of students and enthusiasts who do not have funding for their own projects. The experience of interaction between the Open Laboratories of Ideas, Methods and Practices and the Student Research Laboratory for Optical Engineering shows the relative impact of structures on each other and the value of using such interaction in the learning process. The paper also addresses issues such as: the motivation of students, enthusiasm for the direction the lab participants identify and maintain the initiatives, profiling in the design, scientific, commercial, social sphere.
Good Practices in Undergraduate Education from the Students' and Faculty's View: Consensus or Disagreement. AIR 1996 Annual Forum Paper.

ERIC Educational Resources Information Center

Negron-Morales, Patricia; And Others

This study examined teaching practices in undergraduate education by surveying 180 undergraduate students and 29 faculty, most in the school of education, at the Rio Piedras Campus of the University of Puerto Rico. Factors investigated include: (1) degree of agreement between faculty and students on good teaching practices; (2) relationship…

Team Science Approach to Developing Consensus on Research Good Practices for Practice-Based Research Networks: A Case Study.

PubMed

Campbell-Voytal, Kimberly; Daly, Jeanette M; Nagykaldi, Zsolt J; Aspy, Cheryl B; Dolor, Rowena J; Fagnan, Lyle J; Levy, Barcey T; Palac, Hannah L; Michaels, LeAnn; Patterson, V Beth; Kano, Miria; Smith, Paul D; Sussman, Andrew L; Williams, Robert; Sterling, Pamela; O'Beirne, Maeve; Neale, Anne Victoria

2015-12-01

Using peer learning strategies, seven experienced PBRNs working in collaborative teams articulated procedures for PBRN Research Good Practices (PRGPs). The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. This paper describes the team science processes which culminated in the PRGPs. Skilled facilitators used team science strategies and methods from the Technology of Participation (ToP®), and the Consensus Workshop Method to support teams to codify diverse research expertise in practice-based research. The participatory nature of "sense-making" moved through identifiable stages. Lessons learned include (1) team input into the scope of the final outcome proved vital to project relevance; (2) PBRNs with diverse domains of research expertise contributed broad knowledge on each topic; and (3) ToP® structured facilitation techniques were critical for establishing trust and clarifying the "sense-making" process. © 2015 Wiley Periodicals, Inc.
78 FR 64425 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16, 225, 500, 507, and 579 [Docket No. FDA-2011-N-0922] Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Food for Animals; Public Meeting on Proposed Rule AGENCY: Food and...
Practical recommendations for strengthening national and regional laboratory networks in Africa in the Global Health Security era.

PubMed

Best, Michele; Sakande, Jean

2016-01-01

The role of national health laboratories in support of public health response has expanded beyond laboratory testing to include a number of other core functions such as emergency response, training and outreach, communications, laboratory-based surveillance and data management. These functions can only be accomplished by an efficient and resilient national laboratory network that includes public health, reference, clinical and other laboratories. It is a primary responsibility of the national health laboratory in the Ministry of Health to develop and maintain the national laboratory network in the country. In this article, we present practical recommendations based on 17 years of network development experience for the development of effective national laboratory networks. These recommendations and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of resilient, integrated laboratory networks will enhance each state's public health system and is critical to the development of a robust national laboratory response network to meet global health security threats.
Practical recommendations for strengthening national and regional laboratory networks in Africa in the Global Health Security era

PubMed Central

2016-01-01

The role of national health laboratories in support of public health response has expanded beyond laboratory testing to include a number of other core functions such as emergency response, training and outreach, communications, laboratory-based surveillance and data management. These functions can only be accomplished by an efficient and resilient national laboratory network that includes public health, reference, clinical and other laboratories. It is a primary responsibility of the national health laboratory in the Ministry of Health to develop and maintain the national laboratory network in the country. In this article, we present practical recommendations based on 17 years of network development experience for the development of effective national laboratory networks. These recommendations and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of resilient, integrated laboratory networks will enhance each state’s public health system and is critical to the development of a robust national laboratory response network to meet global health security threats. PMID:28879137
Establishing good collaborative research practices in the responsible conduct of research in nursing science.

PubMed

Ulrich, Connie M; Wallen, Gwenyth R; Cui, Naixue; Chittams, Jesse; Sweet, Monica; Plemmons, Dena

2015-01-01

Team science is advocated to speed the pace of scientific discovery, yet the goals of collaborative practice in nursing science and the responsibilities of nurse stakeholders are sparse and inconclusive. The purpose of this study was to examine nurse scientists' views on collaborative research as part of a larger study on standards of scientific conduct. Web-based descriptive survey of nurse scientists randomly selected from 50 doctoral graduate programs in the United States. Nearly forty percent of nurse respondents were not able to identify good collaborative practices for the discipline; more than three quarters did not know of any published guidelines available to them. Successful research collaborations were challenged by different expectations of authorship and data ownership, lack of timeliness and communication, poorly defined roles and responsibilities, language barriers, and when they involve junior and senior faculty working together on a project. Individual and organizational standards, practices, and policies for collaborative research needs clarification within the discipline. Copyright © 2015 Elsevier Inc. All rights reserved.
QA/QC in the laboratory

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

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less
Recommended practice for laboratory reporting of non‐invasive prenatal testing of trisomies 13, 18 and 21: a consensus opinion

PubMed Central

Allen, Stephanie; Jenkins, Lucy; Khawaja, Farrah; Hastings, Ros J.; Mann, Kathy; Patton, Simon J.; Sistermans, Erik A.; Chitty, Lyn S.

2017-01-01

Abstract Objective Non‐invasive prenatal testing (NIPT) for trisomies 13, 18 and 21 is used worldwide. Laboratory reports should provide clear, concise results with test limitations indicated, yet no national or local guidelines are currently available. Here, we aim to present minimum best practice guidelines. Methods All laboratories registered in the three European quality assurance schemes for molecular and cytogenetics were invited to complete an online survey focused on services provided for NIPT and non‐invasive prenatal diagnosis. Laboratories delivering NIPT for aneuploidy were asked to submit two example reports; one high and one low risk result. Reports were reviewed for content and discussed at a meeting of laboratory providers and clinicians held at the ISPD 2016 conference in Berlin. Results Of the 122 laboratories that responded, 50 issued reports for NIPT and 43 of these submitted sample reports. Responses and reports were discussed by 72 attendees at the meeting. Consensus opinion was determined in several areas and used to develop best practice guidelines for reporting of NIPT results. Conclusions Across Europe, there is considerable variation in reporting NIPT results. Here, we describe minimum best practice guidelines, which will be distributed to European laboratories, and reports audited in subsequent external quality assurance cycles. © 2017 The Authors. Prenatal Diagnosis published by John Wiley & Sons, Ltd. PMID:28497584
The Euroversity Good Practice Framework (EGPF) and Its Application to Minority Languages and Elder Learners

ERIC Educational Resources Information Center

Motteram, Gary; Koenraad, Ton; Outakoski, Hanna; Jauregi, Kristi; Molka-Danielsen, Judith; Schneider, Christel

2014-01-01

The Euroversity Network project (2011-2014) has built a Good Practice Framework (GPF) that functions as a heuristic for course and activity designers wishing to develop courses and other materials for use in a range of virtual worlds. This framework has been tested with a number of courses during the running of the project and the aim is that it…
[The 1, 2, 3 of laboratory animal experimentation].

PubMed

Romero-Fernandez, Wilber; Batista-Castro, Zenia; De Lucca, Marisel; Ruano, Ana; García-Barceló, María; Rivera-Cervantes, Marta; García-Rodríguez, Julio; Sánchez-Mateos, Soledad

2016-06-01

The slow scientific development in Latin America in recent decades has delayed the incorporation of laboratory animal experimentation; however, this situation has started to change. Today, extraordinary scientific progress is evident, which has promoted the introduction and increased use of laboratory animals as an important tool for the advancement of biomedical sciences. In the aftermath of this boom, the need to provide the scientific community with training and guidance in all aspects related to animal experimentation has arisen. It is the responsibility of each country to regulate this practice, for both bioethical and legal reasons, to ensure consideration of the animals' rights and welfare. The following manuscript is the result of papers presented at the International Workshop on Laboratory Animal Testing held at the Technical University of Ambato, Ecuador; it contains information regarding the current state of affairs in laboratory animal testing and emphasizes critical aspects such as main species used, ethical and legal principles, and experimental and alternative designs for animal use. These works aim to ensure good practices that should define scientific work. This document will be relevant to both researchers who aim to newly incorporate animal testing into their research and those who seek to update their knowledge.
Laboratory safety handbook

USGS Publications Warehouse

Skinner, E.L.; Watterson, C.A.; Chemerys, J.C.

1983-01-01

Safety, defined as 'freedom from danger, risk, or injury,' is difficult to achieve in a laboratory environment. Inherent dangers, associated with water analysis and research laboratories where hazardous samples, materials, and equipment are used, must be minimized to protect workers, buildings, and equipment. Managers, supervisors, analysts, and laboratory support personnel each have specific responsibilities to reduce hazards by maintaining a safe work environment. General rules of conduct and safety practices that involve personal protection, laboratory practices, chemical handling, compressed gases handling, use of equipment, and overall security must be practiced by everyone at all levels. Routine and extensive inspections of all laboratories must be made regularly by qualified people. Personnel should be trained thoroughly and repetitively. Special hazards that may involve exposure to carcinogens, cryogenics, or radiation must be given special attention, and specific rules and operational procedures must be established to deal with them. Safety data, reference materials, and texts must be kept available if prudent safety is to be practiced and accidents prevented or minimized.
Safety Precautions and Operating Procedures in an (A)BSL-4 Laboratory: 2. General Practices.

PubMed

Mazur, Steven; Holbrook, Michael R; Burdette, Tracey; Joselyn, Nicole; Barr, Jason; Pusl, Daniela; Bollinger, Laura; Coe, Linda; Jahrling, Peter B; Lackemeyer, Matthew G; Wada, Jiro; Kuhn, Jens H; Janosko, Krisztina

2016-10-03

Work in a biosafety level 4 (BSL-4) containment laboratory requires time and great attention to detail. The same work that is done in a BSL-2 laboratory with non-high-consequence pathogens will take significantly longer in a BSL-4 setting. This increased time requirement is due to a multitude of factors that are aimed at protecting the researcher from laboratory-acquired infections, the work environment from potential contamination and the local community from possible release of high-consequence pathogens. Inside the laboratory, movement is restricted due to air hoses attached to the mandatory full-body safety suits. In addition, disinfection of every item that is removed from Class II biosafety cabinets (BSCs) is required. Laboratory specialists must be trained in the practices of the BSL-4 laboratory and must show high proficiency in the skills they are performing. The focus of this article is to outline proper procedures and techniques to ensure laboratory biosafety and experimental accuracy using a standard viral plaque assay as an example procedure. In particular, proper techniques to work safely in a BSL-4 environment when performing an experiment will be visually emphasized. These techniques include: setting up a Class II BSC for experiments, proper cleaning of the Class II BSC when finished working, waste management and safe disposal of waste generated inside a BSL-4 laboratory, and the removal of inactivated samples from inside a BSL-4 laboratory to the BSL-2 laboratory.
Survey of Clinical Laboratory Practices for 2015 Middle East Respiratory Syndrome Coronavirus Outbreak in the Republic of Korea.

PubMed

Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak; Kim, Jeong-Ho

2016-03-01

It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections.
Survey of Clinical Laboratory Practices for 2015 Middle East Respiratory Syndrome Coronavirus Outbreak in the Republic of Korea

PubMed Central

Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak

2016-01-01

Background It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. Methods We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. Results A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Conclusions Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections. PMID:26709263
Applying the Seven Principles of Good Practice: Technology as a Lever--In an Online Research Course

ERIC Educational Resources Information Center

Johnson, Sherryl

2014-01-01

This article provides an overview of the seven principles of good practice with emphasis on the implementation of technology in an online healthcare research class in a southwest Georgia (United States) university. The seven principles are outlined using various elements of the online course. Historical and philosophical reasoning are applied to…
[Good practice guidelines for health information].

PubMed

2016-01-01

Evidence-based health information is distinguished by the provision of an unbiased and trustworthy description of the current state of medical knowledge. It enables people to learn more about health and disease, and to make health-related decisions - on their own or together with others - reflecting their attitudes and lifestyle. To adequately serve this purpose, health information must be evidence-based. A working group from the German Network for Evidence-based Medicine (Deutsches Netzwerk Evidenzbasierte Medizin) has developed a first draft of good practice guidelines for health information (Gute Praxis Gesundheitsinformation) with the aim of providing support for authors and publishers of evidence-based health information. The group included researchers, patient representatives, journalists and developers of health information. The criteria for evidence-based health information were developed and agreed upon within this author group, and then made available for public comment. All submitted comments were documented and assessed regarding the need to revise or amend the draft. Changes were subsequently implemented following approval by the author group. Gute Praxis Gesundheitsinformation calls for a transparent methodological approach in the development of health information. To achieve this, evidence-based information must be based on (a) a systematic literature search, (b) a justified selection of evidence, (c) unbiased reporting of relevant results, (d) appropriate factual and linguistic communication of uncertainties, (e) either avoidance of any direct recommendations or a strict division between the reporting of results and the derivation of recommendations, (f) the consideration of current evidence on the communication of figures, risks and probabilities, and (g) transparent information about the authors and publishers of the health information, including their funding sources. Gute Praxis Gesundheitsinformation lists a total of 16 aspects to be addressed
Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

PubMed Central

Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation
Learning to Walk the Talk: Designing a Teacher Leadership EdD Program as a Laboratory of Practice

ERIC Educational Resources Information Center

Sawyer, Richard D.

2013-01-01

This article tries to "put a face" on the complex and abstract process of program change in relation to key principles from the Carnegie Project on the Education Doctorate (CPED). We examine the principles of the "scholarship of practice," "laboratory of practice," and "signature pedagogy" within a…
Knowledge and Practices of Toxoplasmosis among Clinical Laboratory Professionals: A Cross-Sectional Study in Durango, Mexico.

PubMed

Alvarado-Esquivel, Cosme; Sánchez-Anguiano, Luis Francisco; Berumen-Segovia, Luis Omar; Hernández-Tinoco, Jesús; Rico-Almochantaf, Yazmin Del Rosario; Cisneros-Camacho, Alfredo; Cisneros-Martínez, Jorge Arturo

2017-11-18

Background : The aim of this study was to determine the level of knowledge and practices about toxoplasmosis in a sample of clinical laboratory professionals in Mexico. Methods : 192 clinical laboratory professionals were surveyed. They were asked about (1) Toxoplasma gondii ; (2) clinical manifestations, diagnosis, treatment, and epidemiology of toxoplasmosis; and (3) their practices with respect to toxoplasmosis. Results : The range of animals infected by T. gondii was known by 44.8% of participants. Clinical aspects of toxoplasmosis were known by up to 44.3% of subjects. Correct answers about the interpretation of serological markers of T. gondii infection were provided by up to 32.8% of participants. A minority (32.2%) of participants knew about a high number of false positive results of anti- T. gondii IgM antibody tests. Most participants (90.1%) did not know what the anti- T. gondii IgG avidity test was. Up to 55.7% of participants provided incorrect answers about the interpretation of serology tests for the treatment of pregnant women. Common routes of T. gondii infection were known by <15% of participants. Most (84.4%) participants had not performed tests for detection T. gondii infection. Conclusions : Results indicate incomplete knowledge of T. gondii infection and toxoplasmosis and a limited practice of laboratory tests among the professionals surveyed.
Pay for performance of Estonian family doctors and impact of different practice- and patient-related characteristics on a good outcome: A quantitative assessment.

PubMed

Merilind, Eero; Salupere, Rauno; Västra, Katrin; Kalda, Ruth

2016-01-01

Several practice- and patient-related characteristics are reported to have an influence on a good quality outcome. Estonia started the pay-for-performance (P4P) system for family doctors (FDs) in 2006. Every year the number of FDs participating in P4P has increased, but only half of the FDs achieved good outcome. The aim of this study was to find out which practice- and patient-related characteristics could have an impact on a good outcome. The study was conducted using the database from the Estonian Health Insurance Fund. All working FDs were divided into two groups (with "good" and "poor" outcomes) according their achievements in P4P. We chose characteristics which described structure (practice list size, number of doctors, composition of FDs list: age, number of chronically ill patients) during the observation period 2006-2012. During the observation period 2006-2012, the number of FDs with a good outcome in P4P increased from 6% (2006) to 53% (2012). The high number of FDs in primary care teams, longer experience of participation in P4P and the smaller number of patients on FDs' lists all have an impact on a good outcome. The number of chronically ill patients in FDs lists has no significant effect on an outcome, but P4P increases the number of disease-diagnosed patients. Different practice and patient-related characteristics have an impact on a good outcome. As workload increases, smaller lists of FDs patients or increased staff levels are needed in order to maintain a good outcome. Copyright © 2016 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.
Achieving Consensus on Principles of Good Practice for School Health in Independent Schools: A Delphi Study

ERIC Educational Resources Information Center

Marshall, Miguel G.; Allegrante, John P.

2017-01-01

Background: Although the 8 components of the coordinated school health (CSH) framework have been implemented to various degrees in the nation's public schools, principles of good practice (PGPs) to guide health promotion efforts in independent schools do not exist. The purpose of this study was to generate PGPs and rate their feasibility of…

A checklist for health research priority setting: nine common themes of good practice.

PubMed

Viergever, Roderik F; Olifson, Sylvie; Ghaffar, Abdul; Terry, Robert F

2010-12-15

Health research priority setting processes assist researchers and policymakers in effectively targeting research that has the greatest potential public health benefit. Many different approaches to health research prioritization exist, but there is no agreement on what might constitute best practice. Moreover, because of the many different contexts for which priorities can be set, attempting to produce one best practice is in fact not appropriate, as the optimal approach varies per exercise. Therefore, following a literature review and an analysis of health research priority setting exercises that were organized or coordinated by the World Health Organization since 2005, we propose a checklist for health research priority setting that allows for informed choices on different approaches and outlines nine common themes of good practice. It is intended to provide generic assistance for planning health research prioritization processes. The checklist explains what needs to be clarified in order to establish the context for which priorities are set; it reviews available approaches to health research priority setting; it offers discussions on stakeholder participation and information gathering; it sets out options for use of criteria and different methods for deciding upon priorities; and it emphasizes the importance of well-planned implementation, evaluation and transparency.
The Effects of Using Jigsaw Method Based on Cooperative Learning Model in the Undergraduate Science Laboratory Practices

ERIC Educational Resources Information Center

Karacop, Ataman

2017-01-01

The main aim of the present study is to determine the influence of a Jigsaw method based on cooperative learning and a confirmatory laboratory method on prospective science teachers' achievements of physics in science teaching laboratory practice courses. The sample of this study consisted of 33 female and 15 male third-grade prospective science…
Practical guidelines for setting up neurosurgery skills training cadaver laboratory in India.

PubMed

Suri, Ashish; Roy, Tara Sankar; Lalwani, Sanjeev; Deo, Rama Chandra; Tripathi, Manjul; Dhingra, Renu; Bhardwaj, Daya Nand; Sharma, Bhawani Shankar

2014-01-01

Though the necessity of cadaver dissection is felt by the medical fraternity, and described as early as 600 BC, in India, there are no practical guidelines available in the world literature for setting up a basic cadaver dissection laboratory for neurosurgery skills training. Hands-on dissection practice on microscopic and endoscopic procedures is essential in technologically demanding modern neurosurgery training where ethical issues, cost constraints, medico-legal pitfalls, and resident duty time restrictions have resulted in lesser opportunities to learn. Collaboration of anatomy, forensic medicine, and neurosurgery is essential for development of a workflow of cadaver procurement, preservation, storage, dissection, and disposal along with setting up the guidelines for ethical and legal concerns.
Recasting a Traditional Laboratory Practical as a "Design-Your-Own Protocol" to Teach a Universal Research Skill

ERIC Educational Resources Information Center

Whitworth, David E.

2016-01-01

Laboratory-based practical classes are a common feature of life science teaching, during which students learn how to perform experiments and generate/interpret data. Practical classes are typically instructional, concentrating on providing topic- and technique-specific skills, however to produce research-capable graduates it is also important to…
12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...
IT-supported integrated care pathways for diabetes: A compilation and review of good practices.

PubMed

Vrijhoef, Hubertus Jm; de Belvis, Antonio Giulio; de la Calle, Matias; de Sabata, Maria Stella; Hauck, Bastian; Montante, Sabrina; Moritz, Annette; Pelizzola, Dario; Saraheimo, Markku; Guldemond, Nick A

2017-06-01

Integrated Care Pathways (ICPs) are a method for the mutual decision-making and organization of care for a well-defined group of patients during a well-defined period. The aim of a care pathway is to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. To describe this concept, different names are used, e.g. care pathways and integrated care pathways. Modern information technologies (IT) can support ICPs by enabling patient empowerment, better management, and the monitoring of care provided by multidisciplinary teams. This study analyses ICPs across Europe, identifying commonalities and success factors to establish good practices for IT-supported ICPs in diabetes care. A mixed-method approach was applied, combining desk research on 24 projects from the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) with follow-up interviews of project participants, and a non-systematic literature review. We applied a Delphi technique to select process and outcome indicators, derived from different literature sources which were compiled and applied for the identification of successful good practices. Desk research identified sixteen projects featuring IT-supported ICPs, mostly derived from the EIP on AHA, as good practices based on our criteria. Follow-up interviews were then conducted with representatives from 9 of the 16 projects to gather information not publicly available and understand how these projects were meeting the identified criteria. In parallel, the non-systematic literature review of 434 PubMed search results revealed a total of eight relevant projects. On the basis of the selected EIP on AHA project data and non-systematic literature review, no commonalities with regard to defined process or outcome indicators could be identified through our approach. Conversely, the research produced a heterogeneous picture in all aspects of the projects
Practice‐based Research Network Research Good Practices (PRGPs): Summary of Recommendations

PubMed Central

Campbell‐Voytal, Kimberly; Daly, Jeanette; Nagykaldi, Zsolt J.; O'Beirne, Maeve; Sterling, Pamela; Fagnan, Lyle J.; Levy, Barcey; Michaels, LeAnn; Louks, Hannah A.; Smith, Paul; Aspy, Cheryl B.; Patterson, V. Beth; Kano, Miria; Sussman, Andrew L.; Williams, Robert; Neale, Anne Victoria

2015-01-01

Abstract Introduction Practice‐based research networks (PBRNs) conduct research in community settings, which poses quality control challenges to the integrity of research, such as study implementation and data collection. A foundation for improving research processes within PBRNs is needed to ensure research integrity. Methods Network directors and coordinators from seven U.S.‐based PBRNs worked with a professional team facilitator during semiannual in‐person meetings and monthly conference calls to produce content for a compendium of recommended research practices specific to the context of PBRNs. Participants were assigned to contribute content congruent with their expertise. Feedback on the draft document was obtained from attendees at the preconference workshop at the annual PBRN meeting in 2013. A revised document was circulated to additional PBRN peers prior to finalization. Results The PBRN Research Good Practices (PRGPs) document is organized into four chapters: (1) Building PBRN Infrastructure; (2) Study Development and Implementation; (3) Data Management, and (4) Dissemination Policies. Each chapter contains an introduction, detailed procedures for each section, and example resources with information links. Conclusion The PRGPs is a PBRN‐specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. PMID:26296309
21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

Code of Federal Regulations, 2014 CFR

2014-04-01

... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...
21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

Code of Federal Regulations, 2013 CFR

2013-04-01

... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...
Prospective, observational study comparing automated and visual point-of-care urinalysis in general practice.

PubMed

van Delft, Sanne; Goedhart, Annelijn; Spigt, Mark; van Pinxteren, Bart; de Wit, Niek; Hopstaken, Rogier

2016-08-08

Point-of-care testing (POCT) urinalysis might reduce errors in (subjective) reading, registration and communication of test results, and might also improve diagnostic outcome and optimise patient management. Evidence is lacking. In the present study, we have studied the analytical performance of automated urinalysis and visual urinalysis compared with a reference standard in routine general practice. The study was performed in six general practitioner (GP) group practices in the Netherlands. Automated urinalysis was compared with visual urinalysis in these practices. Reference testing was performed in a primary care laboratory (Saltro, Utrecht, The Netherlands). Analytical performance of automated and visual urinalysis compared with the reference laboratory method was the primary outcome measure, analysed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and Cohen's κ coefficient for agreement. Secondary outcome measure was the user-friendliness of the POCT analyser. Automated urinalysis by experienced and routinely trained practice assistants in general practice performs as good as visual urinalysis for nitrite, leucocytes and erythrocytes. Agreement for nitrite is high for automated and visual urinalysis. κ's are 0.824 and 0.803 (ranked as very good and good, respectively). Agreement with the central laboratory reference standard for automated and visual urinalysis for leucocytes is rather poor (0.256 for POCT and 0.197 for visual, respectively, ranked as fair and poor). κ's for erythrocytes are higher: 0.517 (automated) and 0.416 (visual), both ranked as moderate. The Urisys 1100 analyser was easy to use and considered to be not prone to flaws. Automated urinalysis performed as good as traditional visual urinalysis on reading of nitrite, leucocytes and erythrocytes in routine general practice. Implementation of automated urinalysis in general practice is justified as automation is expected to reduce
Awareness and practice of safety precautions among healthcare workers in the laboratories of two public health facilities in Nigeria.

PubMed

Fadeyi, A; Fowotade, A; Abiodun, M O; Jimoh, A K; Nwabuisi, C; Desalu, O O

2011-06-01

To determine the level of awareness and practice of SP among laboratory workers at two tertiary public health facilities in Nigeria. A semi-structured, self-administered questionnaire was used to assess the awareness, attitude and adherence to SP among laboratory workers. Information on the availability of safety equipment was also sought. The laboratory safety practice of respondents was assessed based on self-reported observance of basic principles of universal precautions in clinical settings. Study participants were 130, mean age: 28.2 years (SD±6.6), number of years in hospital employment: 3.7 years (SD±2.4) and the male to female ratio was 1.8:1. Many (41.5%) were unaware and 25.4% do not observe SP. Participants attest to availability of various safety devices and equipment including hand gloves (86.2%), disinfectants (84.6%), HBV immunisation (46.2%) and post exposure prophylaxis (PEP) for HIV and HBV (79.6%). Attitude to safety is unsatisfactory as 60.0% eat and drink in the laboratory, 50.8% recap needles and 56.9% use sharps box. Even though 83.1% are willing to take PEP, only 1.5% will present self following laboratory injury. This study shows the deficit in the awareness of SP among laboratory personnel and demonstrates that attitude and practice of safety rules are unsatisfactory. Training and re-training on SP is therefore desired. Counselling to induce a positive attitudinal change on HBV immunisation and PEP is similarly necessary.

12 CFR 1780.7 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Good faith certification. 1780.7 Section 1780.7... DEVELOPMENT RULES OF PRACTICE AND PROCEDURE RULES OF PRACTICE AND PROCEDURE General Rules § 1780.7 Good faith... record is well-grounded in fact and is warranted by existing law or a good faith, nonfrivolous argument...
12 CFR 1780.7 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Good faith certification. 1780.7 Section 1780.7... DEVELOPMENT RULES OF PRACTICE AND PROCEDURE RULES OF PRACTICE AND PROCEDURE General Rules § 1780.7 Good faith... record is well-grounded in fact and is warranted by existing law or a good faith, nonfrivolous argument...
Good collaborative practice: reforming capacity building governance of international health research partnerships.

PubMed

Ward, Claire Leonie; Shaw, David; Sprumont, Dominique; Sankoh, Osman; Tanner, Marcel; Elger, Bernice

2018-01-08

In line with the policy objectives of the United Nations Sustainable Development Goals, this commentary seeks to examine the extent to which provisions of international health research guidance promote capacity building and equitable partnerships in global health research. Our evaluation finds that governance of collaborative research partnerships, and in particular capacity building, in resource-constrained settings is limited but has improved with the implementation guidance of the International Ethical Guidelines for Health-related Research Involving Humans by The Council for International Organizations of Medical Sciences (CIOMS) (2016). However, more clarity is needed in national legislation, industry and ethics guidelines, and regulatory provisions to address the structural inequities and power imbalances inherent in international health research partnerships. Most notably, ethical partnership governance is not supported by the principal industry ethics guidelines - the International Conference on Harmonization Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) Good Clinical Practice (ICH-GCP). Given the strategic value of ICH-GCP guidelines in defining the role and responsibility of global health research partners, we conclude that such governance should stipulate the minimal requirements for creating an equitable environment of inclusion, mutual learning, transparency and accountability. Procedurally, this can be supported by i) shared research agenda setting with local leadership, ii) capacity assessments, and iii) construction of a memorandum of understanding (MoU). Moreover, the requirement of capacity building needs to be coordinated amongst partners to support good collaborative practice and deliver on the public health goals of the research enterprise; improving local conditions of health and reducing global health inequality. In this respect, and in order to develop consistency between sources of research governance, ICH
Educating for Good Work: From Research to Practice

ERIC Educational Resources Information Center

Mucinskas, Daniel; Gardner, Howard

2013-01-01

Launched in 1995, the GoodWork Project is a long-term, multi-site effort to understand the nature of good work across the professional landscape and to promote its achievement by relevant groups of students and professionals. In this essay, the authors review the goals and methods of the initial research project and its most salient findings. They…
Bringing Theory into Practice: A Study of Effective Leadership at Lawrence Livermore National Laboratory

ERIC Educational Resources Information Center

Khoury, Anne

2006-01-01

Leadership development, a component of HRD, is becoming an area of increasingly important practice for all organizations. When companies such as Lawrence Livermore National Laboratory rely on knowledge workers for success, leadership becomes even more important. This research paper tests the hypothesis that leadership credibility and the courage…
The procurement of cells for the derivation of human embryonic stem cell lines for therapeutic use: recommendations for good practice.

PubMed

Murdoch, Alison; Braude, Peter; Courtney, Aidan; Brison, Daniel; Hunt, Charles; Lawford-Davies, James; Moore, Harry; Stacey, Glyn; Sethe, Sebastian

2012-03-01

The donation of human embryos for the derivation of embryonic stem cell lines that may be used in the development of therapeutic products raises more complex ethical, practical and regulatory problems than the donation of embryos for non-clinical research. This review considers these issues and offers recommendations for good practice.
Constraints on good child-care practices and nutritional status in urban Dar-es-Salaam, Tanzania.

PubMed

Kulwa, Kissa B M; Kinabo, Joyce L D; Modest, Beata

2006-09-01

Care is increasingly being recognized as a crucial input to child health and nutrition, along with food security, availability of health services, and a healthy environment. Although significant gains have been made in the fight against malnutrition in Tanzania, the nutritional status of preschool children in urban areas is not improving. To assess child-care practices and the nutritional status of infants and young children with the aim of improvingfeeding practices and child nutritional status. A cross-sectional study was undertaken in urban Dar-es-Salaam, Tanzania. The study involved 100 randomly selected mothers of children 6 to 24 months old from households in Ilala Municipality, one of the three municipalities that constitute the Dar-es-Salaam City Council. Data were collected by a structured questionnaire, spot-check observations, and anthropometric measurements. The prevalence rates of stunting, underweight, wasting, and morbidity were 43%, 22%, 3%, and 80%, respectively. The prevalence of exclusive breastfeeding was very low (9%), and most stunted children (88%) were not exclusively breastfed for the first 6 months. The mean age at which complementary foods and fluids were introduced was 3.26 +/- 1.12 months (range, 1 to 5 months). The fluids given were mainly water and thin cereal-based porridge. More than half of the households practiced good hygiene. Most of the psychosocial practices (e.g., caregiver's attention, affection, and involvement in child feeding, hygiene, health care, and training) were performed by mothers, except for cooking and feeding the children and child training, which were done mostly by alternative caregivers. Nearly half of the mothers (44%) worked out of the home. The mean number of working hours per day was long (10.32 +/- 2.13), necessitating the use of alternative caregivers. A negative correlation was found between height-for-age z-scores and the number of hours mothers worked outside the home. The prevalence rates of chronic
ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories.

PubMed

Flatland, Bente; Freeman, Kathy P; Friedrichs, Kristen R; Vap, Linda M; Getzy, Karen M; Evans, Ellen W; Harr, Kendal E

2010-09-01

Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance Guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. ©2010 American Society for Veterinary Clinical Pathology.
Current practice in laboratory diagnostics of autoimmune diseases in Croatia.  Survey of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Kuna, Andrea Tešija; Đerek, Lovorka; Kozmar, Ana; Drvar, Vedrana

2016-10-15

With the trend of increasing incidence of autoimmune diseases, laboratories are faced with exponential growth of the requests for tests relating the diagnosis of these diseases. Unfortunately, the lack of laboratory personnel experienced in this specific discipline of laboratory diagnostic, as well as an unawareness of a method limitation often results in confusion for clinicians. The aim was to gain insight into number and type of Croatian laboratories that perform humoral diagnostics with the final goal to improve and harmonize laboratory diagnostics of autoimmune diseases in Croatia. In order to get insight into current laboratory practice two questionnaires, consisting of 42 questions in total, were created. Surveys were conducted using SurveyMonkey application and were sent to 88 medical biochemistry laboratories in Croatia for the first survey. Out of 33 laboratories that declared to perform diagnostic from the scope, 19 were selected for the second survey based on the tests they pleaded to perform. The survey comprised questions regarding autoantibody hallmarks of systemic autoimmune diseases while regarding organ-specific autoimmune diseases was limited to diseases of liver, gastrointestinal and nervous system. Response rate was high with 80 / 88 (91%) laboratories which answered the first questionnaire, and 19 / 19 (1.0) for the second questionnaire. Obtained results of surveys indicate high heterogeneity in the performance of autoantibody testing among laboratories in Croatia. Results indicate the need of creating recommendations and algorithms in order to harmonize the approach to laboratory diagnostics of autoimmune diseases in Croatia.
Knowledge and Practices of Toxoplasmosis among Clinical Laboratory Professionals: A Cross-Sectional Study in Durango, Mexico

PubMed Central

Sánchez-Anguiano, Luis Francisco; Berumen-Segovia, Luis Omar; Hernández-Tinoco, Jesús; Rico-Almochantaf, Yazmin del Rosario; Cisneros-Camacho, Alfredo; Cisneros-Martínez, Jorge Arturo

2017-01-01

Background: The aim of this study was to determine the level of knowledge and practices about toxoplasmosis in a sample of clinical laboratory professionals in Mexico. Methods: 192 clinical laboratory professionals were surveyed. They were asked about (1) Toxoplasma gondii; (2) clinical manifestations, diagnosis, treatment, and epidemiology of toxoplasmosis; and (3) their practices with respect to toxoplasmosis. Results: The range of animals infected by T. gondii was known by 44.8% of participants. Clinical aspects of toxoplasmosis were known by up to 44.3% of subjects. Correct answers about the interpretation of serological markers of T. gondii infection were provided by up to 32.8% of participants. A minority (32.2%) of participants knew about a high number of false positive results of anti-T. gondii IgM antibody tests. Most participants (90.1%) did not know what the anti-T. gondii IgG avidity test was. Up to 55.7% of participants provided incorrect answers about the interpretation of serology tests for the treatment of pregnant women. Common routes of T. gondii infection were known by <15% of participants. Most (84.4%) participants had not performed tests for detection T. gondii infection. Conclusions: Results indicate incomplete knowledge of T. gondii infection and toxoplasmosis and a limited practice of laboratory tests among the professionals surveyed. PMID:29156547
[Analysis of good practices for inhabitant participation in the clinical management units of the Andalusian Health Service (Spain)].

PubMed

Gómez Martínez, M Eugenia; Pastor Moreno, Guadalupe; Pérez Corral, Olivia; Iriarte de Los Santos, M Teresa; Mena Jiménez, Ángel Luis; Escudero Espinosa, M Cecilia; García Romera, Inmaculada; Blanco García, Martín Germán; Martín Barato, Amelia

To discover good practices for inhabitant participation in the clinical management units (CMUs) of the Andalusian Health Service (AHS) (Spain) and to explore the reasons perceived by CMU and AHS professionals that may influence the presence and distribution of those good practices among the CMU. Study with mixed methodology carried out in Andalusia (Spain) in two phases (2013-2015). Firstly, an online survey was delivered to the Directors of the CMUs which had set up an inhabitant participation commission. In a second phase, a qualitative study was carried out through semi-structured interviews with professionals from the Andalusian Health Service with previous experience in inhabitant participation. A descriptive analysis of the quantitative information and a semantic content analysis of the qualitative information were carried out. 530 CMUs took part in the survey. The inhabitant participation practices more often implemented in the CMUs are those related to the informing and consultation levels. Twelve professionals were interviewed in the second phase. Other practices with higher inhabitant involvement and delegation are secondary. The barriers which were identified by professionals are related to the beliefs and attitudes of the inhabitants, the professionals, the health system and the environment. The main practices for inhabitant participation in the CMUs are related to the most basic levels of participation. The method and dynamics which facilitate inhabitant empowerment within the health system are not clearly recognised. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.
Addressing the challenge of diversity in the graduate ranks: good practices yield good outcomes.

PubMed

Thompson, Nancy L; Campbell, Andrew G

2013-01-01

In this paper, we examine the impact of implementing three systemic practices on the diversity and institutional culture in biomedical and public health PhD training at Brown University. We hypothesized that these practices, designed as part of the National Institutes of Health-funded Initiative to Maximize Student Development (IMSD) program in the Division of Biology and Medicine, would have a positive effect on underrepresented minority (URM) recruitment and retention and objective measures of student success. These practices include: 1) develop strategic partnerships with selected undergraduate institutions; 2) provide a personalized education program of student support and skill-based modules to supplement discipline-based course work; and 3) transform institutional culture by engaging faculty in supporting diversity-related goals and practices. Data comparing URM numbers and key academic milestones before and after implementation of IMSD practices support the initial hypothesis and effectiveness of these practices at Brown. Program components are broadly applicable as best practices for others seeking to improve URM recruitment and achievements of graduate students traditionally underrepresented in the sciences.
Addressing the Challenge of Diversity in the Graduate Ranks: Good Practices Yield Good Outcomes

PubMed Central

Thompson, Nancy L.; Campbell, Andrew G.

2013-01-01

In this paper, we examine the impact of implementing three systemic practices on the diversity and institutional culture in biomedical and public health PhD training at Brown University. We hypothesized that these practices, designed as part of the National Institutes of Health–funded Initiative to Maximize Student Development (IMSD) program in the Division of Biology and Medicine, would have a positive effect on underrepresented minority (URM) recruitment and retention and objective measures of student success. These practices include: 1) develop strategic partnerships with selected undergraduate institutions; 2) provide a personalized education program of student support and skill-based modules to supplement discipline-based course work; and 3) transform institutional culture by engaging faculty in supporting diversity-related goals and practices. Data comparing URM numbers and key academic milestones before and after implementation of IMSD practices support the initial hypothesis and effectiveness of these practices at Brown. Program components are broadly applicable as best practices for others seeking to improve URM recruitment and achievements of graduate students traditionally underrepresented in the sciences. PMID:23463225
Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

PubMed

Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of
Good life good death according to Christiaan Barnard.

PubMed

Toledo-Pereyra, Luis H

2010-06-01

Christiaan Barnard (1922-2002), pioneering heart transplant surgeon, introduced his ideas on euthanasia in a well-written and researched book, Good Life Good Death. A Doctor's Case for Euthanasia and Suicide, published in 1980. His courage in analyzing this topic in a forthright and clear manner is worth reviewing today. In essence, Barnard supported and practiced passive euthanasia (the ending of life by indirect methods, such as stopping of life support) and discussed, but never practiced, active euthanasia (the ending of life by direct means). Barnard believed that "the primary goal of medicine was to alleviate suffering-not merely to prolong life-he argued that advances in modern medical technology demanded that we evaluate our view of death and the handling of terminal illness." Some in the surgical community took issue with Barnard when he publicized his personal views on euthanasia. We discuss Barnard's beliefs and attempt to clarify some misunderstandings regarding this particular controversial area of medicine.
Has compliance with CLIA requirements really improved quality in US clinical laboratories?

PubMed

Ehrmeyer, Sharon S; Laessig, Ronald H

2004-08-02

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. The CLIA'88 regulations do include PT performance standards, which intentionally or unintentionally, define intra-laboratory performance. Passing PT has become a prime motivation for improving laboratory performance; it can also be used as an objective indicator to assess whether compliance to CLIA has improved intra-laboratory quality. Data from 1994 through 2002 indicate that the percentage of laboratories passing PT has increased. In addition to PT performance, subjective indicators of improved quality--frequency of inspection deficiencies, the number of government sanctions for non-compliance, and customer satisfaction--were evaluated. The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.
Things you never thought of that make a difference: personal goals, common sense, and good behavior in practice.

PubMed

Watson, J Tracy

2011-12-01

There are many aspects of your practice that you never think of when you first get into your new practice environment. You have spent the better part of your life training in a rigorous surgical residency and possibly fellowship. You have worked hard to get to this station in life. Because of your training and the obvious fact that you are a hard-driving individual, there are certain subtleties to a successful practice that you might have overlooked or never thought about during your training years. In many ways, it is the "little things" that you never learned or never thought of that will affect your overall long-term practice success, personal happiness, and relationships the most. This article reviews aspects of practice that at first glance are merely good common sense.
[The school doctorand suspected child abuse : towards good practice recommendations in the child's interest].

PubMed

Noirhomme-Renard, F; Blavier, A; Lachaussée, S; Monville, C; Nihoul, C; Gosset, C

2016-10-01

Child maltreatment, including all forms of mal¬treatment, remains a major public health problem in high-income countries. Healthcare professionals only contribute to a small proportion of reports. In French-speaking Belgium, almost 100 % of school-aged children are regularly submitted to periodical school health visits. The school health doctor is well placed to recognize neglected or abused children. Based on international good practice recommendations, this paper proposes means for the detection and management of child abuse in the context of school medicine.
A Simple Laboratory Practical to Illustrate RNA Mediated Gene Interference Using Drosophila Cell Culture

ERIC Educational Resources Information Center

Buluwela, Laki; Kamalati, Tahereh; Photiou, Andy; Heathcote, Dean A.; Jones, Michael D.; Ali, Simak

2010-01-01

RNA mediated gene interference (RNAi) is now a key tool in eukaryotic cell and molecular biology research. This article describes a five session laboratory practical, spread over a seven day period, to introduce and illustrate the technique. During the exercise, students working in small groups purify PCR products that encode "in vitro"…
Implementation of Good Agricultural Practices Food Safety Standards on Mid-Atlantic States and New York Produce Farms

ERIC Educational Resources Information Center

Nayak, Roshan

2016-01-01

In the wake of multistate outbreaks and subsequent economic cost and health causalities, food industry stakeholders formulated policies for their produce suppliers. The U.S. Food and Drug Administration's guidance on Good Agricultural Practices (GAPs) have been the basis for most of the industry initiated GAP certifications or audit processes. In…

Sense and nonsense in the process of accreditation of a pathology laboratory.

PubMed

Long-Mira, Elodie; Washetine, Kevin; Hofman, Paul

2016-01-01

The aim of accreditation of a pathology laboratory is to control and optimize, in a permanent manner, good professional practice in clinical and molecular pathology, as defined by internationally established standards. Accreditation of a pathology laboratory is a key element in fine in increasing recognition of the quality of the analyses performed by a laboratory and in improving the care it provides to patients. One of the accreditation standards applied to clinical chemistry and pathology laboratories in the European Union is the ISO 15189 norm. Continued functioning of a pathology laboratory might in time be determined by whether or not it has succeeded the accreditation process. Necessary requirements for accreditation, according to the ISO 15189 norm, include an operational quality management system and continuous control of the methods used for diagnostic purposes. Given these goals, one would expect that all pathologists would agree on the positive effects of accreditation. Yet, some of the requirements stipulated in the accreditation standards, coming from the bodies that accredit pathology laboratories, and certain normative issues are perceived as arduous and sometimes not adapted to or even useless in daily pathology practice. The aim of this review is to elaborate why it is necessary to obtain accreditation but also why certain requirements for accreditation might be experienced as inappropriate.
Good practice in social care: the views of people with severe and complex needs and those who support them.

PubMed

Gridley, Kate; Brooks, Jenni; Glendinning, Caroline

2014-11-01

This paper reports findings drawn from a study of good practice in English social care for adults with disability and older people with severe and complex needs. People with severe and complex needs are a relatively small proportion of adult social care service users, but they are growing in numbers and have resource-intensive needs. The study involved qualitative research with adults with disability and older people with severe and complex needs, family carers and members of specialist organisations (n = 67), focusing on the features of social care services they considered to be good practice. Data were collected between August 2010 and June 2011. The approach to data collection was flexible, to accommodate participants' communication needs and preferences, including face-to-face and telephone interviews, Talking Mats(©) sessions and a focus group. Data were managed using Framework and analysed thematically. Features of good practice were considered at three levels: (i) everyday support; (ii) service organisation; and (iii) commissioning. Findings relating to the first two of these are presented here. Participants emphasised the importance of person-centred ways of working at all levels. Personalisation, as currently implemented in English social care, aims to shift power from professionals to service users through the allocation of personal budgets. This approach focuses very much on the role of the individual in directing his/her own support arrangements. However, participants in this study also stressed the importance of ongoing professional support, for example, from a specialist key worker or case manager to co-ordinate diverse services and ensure good practice at an organisational level. The paper argues that, despite the recent move to shift power from professionals to service users, people with the most complex needs still value support from professionals and appropriate organisational support. Without these, they risk being excluded from the benefits
Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice.

PubMed

Schot, Marjolein J C; van Delft, Sanne; Kooijman-Buiting, Antoinette M J; de Wit, Niek J; Hopstaken, Rogier M

2015-05-18

Various point-of-care testing (POCT) urine analysers are commercially available for routine urine analysis in general practice. The present study compares analytical performance, agreement and user-friendliness of six different POCT urine analysers for diagnosing urinary tract infection in general practice. All testing procedures were performed at a diagnostic centre for primary care in the Netherlands. Urine samples were collected at four general practices. Analytical performance and agreement of the POCT analysers regarding nitrite, leucocytes and erythrocytes, with the laboratory reference standard, was the primary outcome measure, and analysed by calculating sensitivity, specificity, positive and negative predictive value, and Cohen's κ coefficient for agreement. Secondary outcome measures were the user-friendliness of the POCT analysers, in addition to other characteristics of the analysers. The following six POCT analysers were evaluated: Uryxxon Relax (Macherey Nagel), Urisys 1100 (Roche), Clinitek Status (Siemens), Aution 11 (Menarini), Aution Micro (Menarini) and Urilyzer (Analyticon). Analytical performance was good for all analysers. Compared with laboratory reference standards, overall agreement was good, but differed per parameter and per analyser. Concerning the nitrite test, the most important test for clinical practice, all but one showed perfect agreement with the laboratory standard. For leucocytes and erythrocytes specificity was high, but sensitivity was considerably lower. Agreement for leucocytes varied between good to very good, and for the erythrocyte test between fair and good. First-time users indicated that the analysers were easy to use. They expected higher productivity and accuracy when using these analysers in daily practice. The overall performance and user-friendliness of all six commercially available POCT urine analysers was sufficient to justify routine use in suspected urinary tract infections in general practice. Published by
Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice

PubMed Central

Schot, Marjolein J C; van Delft, Sanne; Kooijman-Buiting, Antoinette M J; de Wit, Niek J; Hopstaken, Rogier M

2015-01-01

Objective Various point-of-care testing (POCT) urine analysers are commercially available for routine urine analysis in general practice. The present study compares analytical performance, agreement and user-friendliness of six different POCT urine analysers for diagnosing urinary tract infection in general practice. Setting All testing procedures were performed at a diagnostic centre for primary care in the Netherlands. Urine samples were collected at four general practices. Primary and secondary outcome measures Analytical performance and agreement of the POCT analysers regarding nitrite, leucocytes and erythrocytes, with the laboratory reference standard, was the primary outcome measure, and analysed by calculating sensitivity, specificity, positive and negative predictive value, and Cohen's κ coefficient for agreement. Secondary outcome measures were the user-friendliness of the POCT analysers, in addition to other characteristics of the analysers. Results The following six POCT analysers were evaluated: Uryxxon Relax (Macherey Nagel), Urisys 1100 (Roche), Clinitek Status (Siemens), Aution 11 (Menarini), Aution Micro (Menarini) and Urilyzer (Analyticon). Analytical performance was good for all analysers. Compared with laboratory reference standards, overall agreement was good, but differed per parameter and per analyser. Concerning the nitrite test, the most important test for clinical practice, all but one showed perfect agreement with the laboratory standard. For leucocytes and erythrocytes specificity was high, but sensitivity was considerably lower. Agreement for leucocytes varied between good to very good, and for the erythrocyte test between fair and good. First-time users indicated that the analysers were easy to use. They expected higher productivity and accuracy when using these analysers in daily practice. Conclusions The overall performance and user-friendliness of all six commercially available POCT urine analysers was sufficient to justify routine
21 CFR 111.310 - What are the requirements for the laboratory facilities that you use?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What are the requirements for the laboratory facilities that you use? 111.310 Section 111.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
21 CFR 111.310 - What are the requirements for the laboratory facilities that you use?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What are the requirements for the laboratory facilities that you use? 111.310 Section 111.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
21 CFR 111.310 - What are the requirements for the laboratory facilities that you use?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What are the requirements for the laboratory facilities that you use? 111.310 Section 111.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
21 CFR 111.310 - What are the requirements for the laboratory facilities that you use?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the requirements for the laboratory facilities that you use? 111.310 Section 111.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
21 CFR 111.310 - What are the requirements for the laboratory facilities that you use?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What are the requirements for the laboratory facilities that you use? 111.310 Section 111.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...
Current practice in laboratory diagnostics of autoimmune diseases in Croatia.  Survey of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine

PubMed Central

Kuna, Andrea Tešija; Đerek, Lovorka; Kozmar, Ana; Drvar, Vedrana

2016-01-01

Introduction With the trend of increasing incidence of autoimmune diseases, laboratories are faced with exponential growth of the requests for tests relating the diagnosis of these diseases. Unfortunately, the lack of laboratory personnel experienced in this specific discipline of laboratory diagnostic, as well as an unawareness of a method limitation often results in confusion for clinicians. The aim was to gain insight into number and type of Croatian laboratories that perform humoral diagnostics with the final goal to improve and harmonize laboratory diagnostics of autoimmune diseases in Croatia. Materials and methods In order to get insight into current laboratory practice two questionnaires, consisting of 42 questions in total, were created. Surveys were conducted using SurveyMonkey application and were sent to 88 medical biochemistry laboratories in Croatia for the first survey. Out of 33 laboratories that declared to perform diagnostic from the scope, 19 were selected for the second survey based on the tests they pleaded to perform. The survey comprised questions regarding autoantibody hallmarks of systemic autoimmune diseases while regarding organ-specific autoimmune diseases was limited to diseases of liver, gastrointestinal and nervous system. Results Response rate was high with 80 / 88 (91%) laboratories which answered the first questionnaire, and 19 / 19 (1.0) for the second questionnaire. Obtained results of surveys indicate high heterogeneity in the performance of autoantibody testing among laboratories in Croatia. Conclusions Results indicate the need of creating recommendations and algorithms in order to harmonize the approach to laboratory diagnostics of autoimmune diseases in Croatia. PMID:27812306
The utilization of the seven principles for good practices of full-time and adjunct faculty in teaching health & science in community colleges

NASA Astrophysics Data System (ADS)

Musaitif, Linda M.

Purpose. The purpose of this study was to determine the degree to which undergraduate full-time and adjunct faculty members in the health and science programs at community colleges in Southern California utilize the seven principles of good practice as measured by the Faculty Inventory of the Seven Principles for Good Practice in Undergraduate Education. A second purpose was to compare degree of utilization for gender and class size. Methodology. This is a quantitative study wherein there exists a systematic and mathematical assessment of data gathered through the use of a Likert scale survey to process and determine the mathematical model of the use of the principles by the target population of both full-time and adjunct faculty of health/science programs of community colleges in Southern California. Findings. Examination of the data revealed that both full-time and adjunct faculty members of Southern California community colleges perceive themselves a high degree of utilization of the seven principles of good practice. There was no statistically significant data to suggest a discrepancy between full-time and adjunct professors' perceptions among the utilization of the seven principles. Overall, male faculty members perceived themselves as utilizing the principles to a greater degree than female faculty. Data suggest that faculty with class size 60 or larger showed to utilize the seven principles more frequently than the professors with smaller class sizes. Conclusions. Full-time and adjunct professors of the health and sciences in Southern California community colleges perceive themselves as utilizing the seven principles of good practice to a high degree. Recommendations. This study suggests many recommendations for future research, including the degree to which negative economic factors such as budget cuts and demands affect the utilization of the seven principles. Also recommended is a study comparing students' perceptions of faculty's utilization of the seven
19 CFR 102.12 - Fungible goods.

Code of Federal Regulations, 2010 CFR

2010-04-01

... RULES OF ORIGIN Rules of Origin § 102.12 Fungible goods. When fungible goods of different countries of origin are commingled the country of origin of the goods: (a) Is the countries of origin of those... the origin of the commingled good is not practical, the country or countries of origin may be...
Supporting good practice in the provision of services to people with comorbid mental health and alcohol and other drug problems in Australia: describing key elements of good service models.

PubMed

Merkes, Monika; Lewis, Virginia; Canaway, Rachel

2010-12-03

The co-occurrence of mental illness and substance use problems (referred to as "comorbidity" in this paper) is common, and is often reported by service providers as the expectation rather than the exception. Despite this, many different treatment service models are being used in the alcohol and other drugs (AOD) and mental health (MH) sectors to treat this complex client group. While there is abundant literature in the area of comorbidity treatment, no agreed overarching framework to describe the range of service delivery models is apparent internationally or at the national level. The aims of the current research were to identify and describe elements of good practice in current service models of treatment of comorbidity in Australia. The focus of the research was on models of service delivery. The research did not aim to measure the client outcomes achieved by individual treatment services, but sought to identify elements of good practice in services. Australian treatment services were identified to take part in the study through a process of expert consultation. The intent was to look for similarities in the delivery models being implemented across a diverse set of services that were perceived to be providing good quality treatment for people with comorbidity problems. A survey was designed based on a concept map of service delivery devised from a literature review. Seventeen Australian treatment services participated in the survey, which explored the context in which services operate, inputs such as organisational philosophy and service structure, policies and procedures that guide the way in which treatment is delivered by the service, practices that reflect the way treatment is provided to clients, and client impacts. The treatment of people with comorbidity of mental health and substance use disorders presents complex problems that require strong but flexible service models. While the treatment services included in this study reflected the diversity of
[Assessment of learning activities using streaming video for laboratory practice education: aiming for development of E-learning system that promotes self-learning].

PubMed

Takeda, Naohito; Takeuchi, Isao; Haruna, Mitsumasa

2007-12-01

In order to develop an e-learning system that promotes self-learning, lectures and basic operations in laboratory practice of chemistry were recorded and edited on DVD media, consisting of 8 streaming videos as learning materials. Twenty-six students wanted to watch the DVD, and answered the following questions after they had watched it: "Do you think the video would serve to encourage you to study independently in the laboratory practice?" Almost all students (95%) approved of its usefulness, and more than 60% of them watched the videos repeatedly in order to acquire deeper knowledge and skill of the experimental operations. More than 60% answered that the demonstration-experiment should be continued in the laboratory practice, in spite of distribution of the DVD media.
Good surgeon: A search for meaning.

PubMed

Akopov, Andrey L; Artioukh, Dmitri Y

2017-01-01

The art and philosophy of surgery are not as often discussed as scientific discoveries and technological advances in the modern era of surgery. Although these are difficult to teach and pass on to the next generations of surgeons they are no less important for training good surgeons and maintaining their high standards. The authors of this review and opinion article tried to define what being a good surgeon really means and to look into the subject by analysing the essential conditions for being a good surgeon and the qualities that such a specialist should possess. In addition to a strong theoretic knowledge and practical skills and among the several described professional and personal characteristics, a good surgeon is expected to have common sense. It enables a surgeon to make a sound practical judgment independent of specialized medical knowledge and training. The possible ways of developing and/or enhancing common sense during surgical training and subsequent practice require separate analysis.
Consensus Guidelines for Practical Competencies in Anatomic Pathology and Laboratory Medicine for the Undifferentiated Graduating Medical Student

PubMed Central

Shah, Darshana T.; Cambor, Carolyn L.; Conran, Richard M.; Lin, Amy Y.; Peerschke, Ellinor I.B.; Pessin, Melissa S.; Harris, Ilene B.

2015-01-01

The practice of pathology is not generally addressed in the undergraduate medical school curriculum. It is desirable to develop practical pathology competencies in the fields of anatomic pathology and laboratory medicine for every graduating medical student to facilitate (1) instruction in effective utilization of these services for optimal patient care, (2) recognition of the role of pathologists and laboratory scientists as consultants, and (3) exposure to the field of pathology as a possible career choice. A national committee was formed, including experts in anatomic pathology and/or laboratory medicine and in medical education. Suggested practical pathology competencies were developed in 9 subspecialty domains based on literature review and committee deliberations. The competencies were distributed in the form of a survey in late 2012 through the first half of 2013 to the medical education community for feedback, which was subjected to quantitative and qualitative analysis. An approval rate of ≥80% constituted consensus for adoption of a competency, with additional inclusions/modifications considered following committee review of comments. The survey included 79 proposed competencies. There were 265 respondents, the majority being pathologists. Seventy-two percent (57 of 79) of the competencies were approved by ≥80% of respondents. Numerous comments (N = 503) provided a robust resource for qualitative analysis. Following committee review, 71 competencies (including 27 modified and 3 new competencies) were considered to be essential for undifferentiated graduating medical students. Guidelines for practical pathology competencies have been developed, with the hope that they will be implemented in undergraduate medical school curricula. PMID:28725750
Consensus Guidelines for Practical Competencies in Anatomic Pathology and Laboratory Medicine for the Undifferentiated Graduating Medical Student.

PubMed

Magid, Margret S; Shah, Darshana T; Cambor, Carolyn L; Conran, Richard M; Lin, Amy Y; Peerschke, Ellinor I B; Pessin, Melissa S; Harris, Ilene B

2015-01-01

The practice of pathology is not generally addressed in the undergraduate medical school curriculum. It is desirable to develop practical pathology competencies in the fields of anatomic pathology and laboratory medicine for every graduating medical student to facilitate (1) instruction in effective utilization of these services for optimal patient care, (2) recognition of the role of pathologists and laboratory scientists as consultants, and (3) exposure to the field of pathology as a possible career choice. A national committee was formed, including experts in anatomic pathology and/or laboratory medicine and in medical education. Suggested practical pathology competencies were developed in 9 subspecialty domains based on literature review and committee deliberations. The competencies were distributed in the form of a survey in late 2012 through the first half of 2013 to the medical education community for feedback, which was subjected to quantitative and qualitative analysis. An approval rate of ≥80% constituted consensus for adoption of a competency, with additional inclusions/modifications considered following committee review of comments. The survey included 79 proposed competencies. There were 265 respondents, the majority being pathologists. Seventy-two percent (57 of 79) of the competencies were approved by ≥80% of respondents. Numerous comments (N = 503) provided a robust resource for qualitative analysis. Following committee review, 71 competencies (including 27 modified and 3 new competencies) were considered to be essential for undifferentiated graduating medical students. Guidelines for practical pathology competencies have been developed, with the hope that they will be implemented in undergraduate medical school curricula.
[ISMP-Spain questionnaire and strategy for improving good medication practices in the Andalusian health system].

PubMed

Padilla-Marín, V; Corral-Baena, S; Domínguez-Guerrero, F; Santos-Rubio, M D; Santana-López, V; Moreno-Campoy, E

2012-01-01

To describe the strategy employed by Andalusian public health service hospitals to foster safe medication use. The self-evaluation questionnaire on drug system safety in hospitals, adapted by the Spanish Institute for Safe Medication Practices was used as a fundamental tool to that end. The strategy is developed in several phases. We analyse the report evaluating drug system safety in Andalusian public hospitals published by the Spanish Ministry of Health and Consumption in 2008 and establish a grading system to assess safe medication practices in Andalusian hospitals and prioritise areas needing improvement. We developed a catalogue of best practices available in the web environment belonging to the Andalusian health care quality agency's patient safety observatory. We publicised the strategy through training seminars and implemented a system allowing hospitals to evaluate the degree of compliance for each of the best practices, and based on that system, we were able to draw up a map of centres of reference. We found areas for improvement among several of the questionnaire's fundamental criteria. These areas for improvement were related to normal medication procedures in daily clinical practice. We therefore wrote 7 best practice guides that provide a cross-section of the assessment components of the questionnaire related to the clinical process needing improvement. The self-evaluation questionnaire adapted by ISMP-Spain is a good tool for designing a systematic, rational intervention to promote safe medication practices and intended for a group of hospitals that share the same values. Copyright © 2011 SEFH. Published by Elsevier Espana. All rights reserved.
Practical solution for control of the pre-analytical phase in decentralized clinical laboratories for meeting the requirements of the medical laboratory accreditation standard DIN EN ISO 15189.

PubMed

Vacata, Vladimir; Jahns-Streubel, Gerlinde; Baldus, Mirjana; Wood, William Graham

2007-01-01

This report was written in response to the article by Wood published recently in this journal. It describes a practical solution to the problems of controlling the pre-analytical phase in the clinical diagnostic laboratory. As an indicator of quality in the pre-analytical phase of sample processing, a target analyte was chosen which is sensitive to delay in centrifugation and/or analysis. The results of analyses of the samples sent by satellite medical practitioners were compared with those from an on-site hospital laboratory with a controllable optimized pre-analytical phase. The aim of the comparison was: (a) to identify those medical practices whose mean/median sample values significantly deviate from those of the control situation in the hospital laboratory due to the possible problems in the pre-analytical phase; (b) to aid these laboratories in the process of rectifying these problems. A Microsoft Excel-based Pre-Analytical Survey tool (PAS tool) has been developed which addresses the above mentioned problems. It has been tested on serum potassium which is known to be sensitive to delay and/or irregularities in sample treatment. The PAS tool has been shown to be one possibility for improving the quality of the analyses by identifying the sources of problems within the pre-analytical phase, thus allowing them to be rectified. Additionally, the PAS tool has an educational value and can also be adopted for use in other decentralized laboratories.
Publishing integrity and good practices in editing in biomedicine.

PubMed

Polenakovic, Momir; Gucev, Zoran

2014-01-01

The Macedonian Academy of Sciences and Arts (MASA), held a scientific workshop for journal editors in biomedicine: "Publishing integrity and good practices in editing in biomedicine" on April 25, 2014 in MASA, Skopje. The meeting looked into old problems and new situations in editing and publishing, with emphasis on the situation in developing countries. This global knowledge-based society is founded on the results obtained from scientific research. The data from basic research in developed countries contribute in a quite substantial manner to the newly added economic value. One of the main reasons for underdevelopment in South Eastern Europe (SEE) is certainly a low or non-existent contribution of scientific research in the newly added economic value. This has largely to do with the perception of the political elites which simply lack the insight on the crucial importance of science in development. In the long term this leads to societies in which there are distortions in the understanding of the most basic values. Academic publishing has experienced tremendous growth: so far there are at least 50 million scientific articles. Interestingly, publishing in developing countries has experienced a rate of growth higher than in developed countries. However, this is not the case with the Balkan countries. The meeting looked at some old and some newly emerging problems in editing and publishing. First, the high cost for universities and researchers to purchase journals adversely affects both publishing and editing. In developing countries the high cost of purchasing scientific literature is an almost insurmountable problem in spite of the fact that some publishing companies offer discounted fees. Open access journals in South Eastern European (SEE) countries are hardly achievable as this also incurs costs that have to be covered in some way or other. The peer review process has the fundamental difficulty that reviewers are in the situation of a Procrustean bed, tending to

Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications.

PubMed

Wuchter, Patrick; Bieback, Karen; Schrezenmeier, Hubert; Bornhäuser, Martin; Müller, Lutz P; Bönig, Halvard; Wagner, Wolfgang; Meisel, Roland; Pavel, Petra; Tonn, Torsten; Lang, Peter; Müller, Ingo; Renner, Matthias; Malcherek, Georg; Saffrich, Rainer; Buss, Eike C; Horn, Patrick; Rojewski, Markus; Schmitt, Anita; Ho, Anthony D; Sanzenbacher, Ralf; Schmitt, Michael

2015-02-01

Human mesenchymal stem or stromal cells (MSCs) represent a potential resource not only for regenerative medicine but also for immunomodulatory cell therapies. The application of different MSC culture protocols has significantly hampered the comparability of experimental and clinical data from different laboratories and has posed a major obstacle for multicenter clinical trials. Manufacturing of cell products for clinical application in the European Community must be conducted in compliance with Good Manufacturing Practice and requires a manufacturing license. In Germany, the Paul-Ehrlich-Institut as the Federal Authority for Vaccines and Biomedicines is critically involved in the approval process. This report summarizes a consensus meeting between researchers, clinicians and regulatory experts on standard quality requirements for MSC production. The strategy for quality control testing depends on the product's cell composition, the manufacturing process and the indication and target patient population. Important quality criteria in this sense are, among others, the immunophenotype of the cells, composition of the culture medium and the risk for malignant transformation, as well as aging and the immunosuppressive potential of the manufactured MSCs. This position paper intends to provide relevant information to interested parties regarding these criteria to foster the development of scientifically valid and harmonized quality standards and to support approval of MSC-based investigational medicinal products. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.
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.
Developing Guided Inquiry-Based Student Lab Worksheet for Laboratory Knowledge Course

NASA Astrophysics Data System (ADS)

Rahmi, Y. L.; Novriyanti, E.; Ardi, A.; Rifandi, R.

2018-04-01

The course of laboratory knowledge is an introductory course for biology students to follow various lectures practicing in the biology laboratory. Learning activities of laboratory knowledge course at this time in the Biology Department, Universitas Negeri Padang has not been completed by supporting learning media such as student lab worksheet. Guided inquiry learning model is one of the learning models that can be integrated into laboratory activity. The study aimed to produce student lab worksheet based on guided inquiry for laboratory knowledge course and to determine the validity of lab worksheet. The research was conducted using research and developmet (R&D) model. The instruments used in data collection in this research were questionnaire for student needed analysis and questionnaire to measure the student lab worksheet validity. The data obtained was quantitative from several validators. The validators consist of three lecturers. The percentage of a student lab worksheet validity was 94.18 which can be categorized was very good.
Deterring Violent Extremism in America by Utilizing Good Counter-Radicalization Practices from Abroad: A Policy Perspective

DTIC Science & Technology

2017-03-01

offering rehabilitation programs to former extremists. This thesis provides a way ahead for American policy makers by sharing good practices in each of...and offering training to prevent terrorism from when individuals are young. Understanding that humans are fallible, American policy makers and...in the United Kingdom that provided trained Islamic scholars to offer advice about the true teaching of Islam.102 The hotline “El-Hatef el- Islami’s
Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final rule.

PubMed

2007-06-25

The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.
Good manufacturing practice (GMP) compliance in the biologics sector: plasma fractionation.

PubMed

Ways, J P; Preston, M S; Baker, D; Huxsoll, J; Bablak, J

1999-12-01

The U.S. blood supply is the safest it has ever been. Due to blood safety and the introduction of viral inactivation/clearance technologies, protein therapies derived from human blood have also in recent years had a history of product safety. Nevertheless, since 1995, the plasma-fractionation industry has experienced increased compliance-related actions by the Food and Drug Administration (FDA), as shown by a substantive increase in the number of FDA 483 inspectional observations, FDA warning letters and other FDA regulatory action. An evaluation of these trends shows that they reflect the implementation by the FDA of increased inspectional interest in the plasma-fractionation industry and an evolution of inspectional practices and standards of current good manufacturing practice (cGMP). Plasma fractionators have responded to FDA actions by carefully evaluating and addressing each inspectional observation, assessing impact to product and taking appropriate actions, including corrective actions to prevent future occurrence. They have made major investments in facilities, quality systems, personnel and training to meet the evolving standards of cGMP and in an effort to implement these standards systemically. Through industry associations, manufacturers have further enhanced product safety by adopting additional voluntary standards for plasma to prevent the entry of potentially unsuitable plasma into the production process. The industry remains committed to application of cGMP and to working with the FDA in further evolution of these standards while striving to assure a continued supply of safe, pure and effective plasma-derived therapies.
Health care for immigrants in Europe: Is there still consensus among country experts about principles of good practice? A Delphi study

PubMed Central

2011-01-01

Background European Member States are facing a challenge to provide accessible and effective health care services for immigrants. It remains unclear how best to achieve this and what characterises good practice in increasingly multicultural societies across Europe. This study assessed the views and values of professionals working in different health care contexts and in different European countries as to what constitutes good practice in health care for immigrants. Methods A total of 134 experts in 16 EU Member States participated in a three-round Delphi process. The experts represented four different fields: academia, Non-Governmental Organisations, policy-making and health care practice. For each country, the process aimed to produce a national consensus list of the most important factors characterising good practice in health care for migrants. Results The scoring procedures resulted in 10 to 16 factors being identified as the most important for each participating country. All 186 factors were aggregated into 9 themes: (1) easy and equal access to health care, (2) empowerment of migrants, (3) culturally sensitive health care services, (4) quality of care, (5) patient/health care provider communication, (6) respect towards migrants, (7) networking in and outside health services, (8) targeted outreach activities, and (9) availability of data about specificities in migrant health care and prevention. Although local political debate, level of immigration and the nature of local health care systems influenced the selection and rating of factors within each country, there was a broad European consensus on most factors. Yet, discordance remained both within countries, e.g. on the need for prioritising cultural differences, and between countries, e.g. on the need for more consistent governance of health care services for immigrants. Conclusions Experts across Europe asserted the right to culturally sensitive health care for all immigrants. There is a broad consensus
Good modeling practice guidelines for applying multimedia models in chemical assessments.

PubMed

Buser, Andreas M; MacLeod, Matthew; Scheringer, Martin; Mackay, Don; Bonnell, Mark; Russell, Mark H; DePinto, Joseph V; Hungerbühler, Konrad

2012-10-01

Multimedia mass balance models of chemical fate in the environment have been used for over 3 decades in a regulatory context to assist decision making. As these models become more comprehensive, reliable, and accepted, there is a need to recognize and adopt principles of Good Modeling Practice (GMP) to ensure that multimedia models are applied with transparency and adherence to accepted scientific principles. We propose and discuss 6 principles of GMP for applying existing multimedia models in a decision-making context, namely 1) specification of the goals of the model assessment, 2) specification of the model used, 3) specification of the input data, 4) specification of the output data, 5) conduct of a sensitivity and possibly also uncertainty analysis, and finally 6) specification of the limitations and limits of applicability of the analysis. These principles are justified and discussed with a view to enhancing the transparency and quality of model-based assessments. Copyright © 2012 SETAC.
Good manufacturing practices production of a purification-free oral cholera vaccine expressed in transgenic rice plants.

PubMed

Kashima, Koji; Yuki, Yoshikazu; Mejima, Mio; Kurokawa, Shiho; Suzuki, Yuji; Minakawa, Satomi; Takeyama, Natsumi; Fukuyama, Yoshiko; Azegami, Tatsuhiko; Tanimoto, Takeshi; Kuroda, Masaharu; Tamura, Minoru; Gomi, Yasuyuki; Kiyono, Hiroshi

2016-03-01

The first Good Manufacturing Practices production of a purification-free rice-based oral cholera vaccine (MucoRice-CTB) from transgenic plants in a closed cultivation system yielded a product meeting regulatory requirements. Despite our knowledge of their advantages, plant-based vaccines remain unavailable for human use in both developing and industrialized countries. A leading, practical obstacle to their widespread use is producing plant-based vaccines that meet governmental regulatory requirements. Here, we report the first production according to current Good Manufacturing Practices of a rice-based vaccine, the cholera vaccine MucoRice-CTB, at an academic institution. To this end, we established specifications and methods for the master seed bank (MSB) of MucoRice-CTB, which was previously generated as a selection-marker-free line, evaluated its propagation, and given that the stored seeds must be renewed periodically. The production of MucoRice-CTB incorporated a closed hydroponic system for cultivating the transgenic plants, to minimize variations in expression and quality during vaccine manufacture. This type of molecular farming factory can be operated year-round, generating three harvests annually, and is cost- and production-effective. Rice was polished to a ratio of 95 % and then powdered to produce the MucoRice-CTB drug substance, and the identity, potency, and safety of the MucoRice-CTB product met pre-established release requirements. The formulation of MucoRice-CTB made by fine-powdering of drug substance and packaged in an aluminum pouch is being evaluated in a physician-initiated phase I study.
QA/QC in the laboratory. Session F

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

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less
The importance of Good Clinical Practice guidelines and its role in clinical trials

PubMed Central

Vijayananthan, A; Nawawi, O

2008-01-01

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights. PMID:21614316
Single laboratory validation of the determination of yohimbine in yohimbe bark and related dietary supplements using UHPLC/UV/MS

USDA-ARS?s Scientific Manuscript database

A single laboratory validation has been performed on a practical ultra high-performance liquid chromatography (UHPLC), diode array detection (DAD), and tandem mass spectrometry (MS) method for determination of yohimbine in yohimbe barks and related dietary supplements. Good separation was achieved u...
Critical laboratory values in hemostasis: toward consensus.

PubMed

Lippi, Giuseppe; Adcock, Dorothy; Simundic, Ana-Maria; Tripodi, Armando; Favaloro, Emmanuel J

2017-09-01

The term "critical values" can be defined to entail laboratory test results that significantly lie outside the normal (reference) range and necessitate immediate reporting to safeguard patient health, as well as those displaying a highly and clinically significant variation compared to previous data. The identification and effective communication of "highly pathological" values has engaged the minds of many clinicians, health care and laboratory professionals for decades, since these activities are vital to good laboratory practice. This is especially true in hemostasis, where a timely and efficient communication of critical values strongly impacts patient management. Due to the heterogeneity of available data, this paper is hence aimed to analyze the state of the art and provide an expert opinion about the parameters, measurement units and alert limits pertaining to critical values in hemostasis, thus providing a basic document for future consultation that assists laboratory professionals and clinicians alike. KEY MESSAGES Critical values are laboratory test results significantly lying outside the normal (reference) range and necessitating immediate reporting to safeguard patient health. A broad heterogeneity exists about critical values in hemostasis worldwide. We provide here an expert opinion about the parameters, measurement units and alert limits pertaining to critical values in hemostasis.
Laboratory Sequence in Computational Methods for Introductory Chemistry

NASA Astrophysics Data System (ADS)

Cody, Jason A.; Wiser, Dawn C.

2003-07-01

A four-exercise laboratory sequence for introductory chemistry integrating hands-on, student-centered experience with computer modeling has been designed and implemented. The progression builds from exploration of molecular shapes to intermolecular forces and the impact of those forces on chemical separations made with gas chromatography and distillation. The sequence ends with an exploration of molecular orbitals. The students use the computers as a tool; they build the molecules, submit the calculations, and interpret the results. Because of the construction of the sequence and its placement spanning the semester break, good laboratory notebook practices are reinforced and the continuity of course content and methods between semesters is emphasized. The inclusion of these techniques in the first year of chemistry has had a positive impact on student perceptions and student learning.
Collaborative Testing in Practical Laboratories: An Effective Teaching-Learning Method in Histology.

PubMed

Guo, Yuping; Li, Enzhong

2016-01-01

This article presents an experimental teaching and learning program used in histology with first-year students in the second term in the Faculty of Biology at Huanghuai University, China. Eighty-six students were divided randomly into two groups (n=43 per group). Tests were conducted at the end of each practical laboratory (10 laboratories in total) in which collaborative testing was used in the experimental group and traditional testing in the control group. To assess achievement, a final examination in histology was carried out at the end of the course. To determine students' attitude to the teaching styles, a questionnaire survey was conducted at the end of the term. Results showed that students preferred the collaborative testing format. In the experimental group, students' scores were significantly higher than those of students in the control group in final examinations. These findings indicate that collaborative testing enhances student learning and understanding of the material taught, and suggest that collaborative testing is an effective teaching-learning method in histology.
Irrigation water quality and the benefits of implementing good agricultural practices during tomato (Lycopersicum esculentum) production.

PubMed

Estrada-Acosta, M; Jiménez, M; Chaidez, C; León-Félix, J; Castro-Del Campo, N

2014-07-01

The implementation of good agricultural practices (GAP) from irrigation water to the tomato packaging process enhances the safety of fresh produce and its value throughout the food chain. The aim of the present study was to show that fresh produce farms that apply and enforce GAP could reduce the presence of Salmonella in finished produce. Samples were collected biweekly from six packing houses from the central region of Sinaloa, México, for the isolation of Salmonella spp by the ISO 6579:2002 method, and the isolated strains were serotyped and genotyped by the Kauffmman-White scheme and pulsed field gel electrophoresis (PFGE), respectively. Salmonella strains were detected in 13 (36.1 %) irrigation water samples, while only two tomato samples were positive (5.5 %). Eight different serotypes were identified in irrigation water, and Salmonella Oranienburg (34 %) was the most prevalent; however, only Salmonella Agona and Salmonella Weltevreden were present on tomatoes. Salmonella Oranienburg was the most widely dispersed and variable serotype, with 10 different PFGE profiles. Salmonella Weltevreden was isolated from both types of samples, albeit with distinct genetic profiles, implying that the sources of contamination differ. These results confirm the utility of implementing good agricultural practices to reduce Salmonella contamination in irrigation water and the packaging process.
Good Practice in Promoting Gender Equality in Higher Education in Central and Eastern Europe. Studies on Higher Education.

ERIC Educational Resources Information Center

Grunberg, Laura

This volume publishes the results of the United Nations Educational, Scientific, and Cultural Organization (UNESCO) European Centre for Higher Education (CEPES) project, Good Practice in Promoting Gender Inequality in Higher Education in Central and Eastern Europe and the former Soviet Countries. These case studies offer hope for a future in which…
Discourse Patterns at Laboratory Practices and the Co-Construction of Knowledge by Applying SDIS-GSEQ

ERIC Educational Resources Information Center

Carrillo, Edgardo Ruiz; González, José Luis Cruz; Martínez, Samuel Meraz; Sánchez, Luisa Bravo

2015-01-01

The purpose of this study is to analyze the discourse through IRE (Intervention-Response-Evaluation) in the co-construction of knowledge of Biology students during laboratory practices by applying the SDIS-GSEQ software to assess IRE discourse patterns developed during the same. The study group consisted of second semester students of the…
Decision-Making, Tacit Knowledge, and Motivation in Semi-Professional Practice: Humanizing the Environment through Anthropomorphism in Clinical Laboratory Science

ERIC Educational Resources Information Center

Mortier, Teresa

2017-01-01

The clinical laboratory science field requires an abundance of technical knowledge; however, the importance of implicit or tacit knowledge gained through observation and practice is often discounted in this field, even though it is a critical part of reflective thinking, critical thinking, and reflective practice. The "de-skilling" of…
The Status of Implementation of Good Manufacturing Practices (GMP) Shredded Fish Production in UMKM Az-Zahrah, Makassar

NASA Astrophysics Data System (ADS)

Latif, Rindam; Dirpan, Andi; Indriani, Sylvia

2017-12-01

Good manufacturing practices (GMP) describes the requirements that an industry should follow throughout the production process starting from sorting raw materials to handling final products. The purpose of this research is to disclose each phase of GMP in making shredded fish and to assess the status of the practices implemented by the UMKM Az-zahrah in producing its product. This descriptive study is conducted by doing interview with owner followed by observation and documentation of all activities related to the production process in order to assess the status of GMP applied by the UMKM Az-zahrah. In assessing the status, we referred to Permenperin RI No.75 / M-Ind / Per / 7/2010 and KBPOM regulation no. HK 03.1.23.04.12.22007 Year 2012. The findings indicate some deviation occurred when UMKM Az-zahrah implemented it, those are (1) there is a pet in production room (2) production employees are not yet wearing work uniform (3) production room has directly access to toilet (4) there is no health label about health and nutritional claims. The status of applied GMP in the UMKM Az-zahrah is at D level (less good) with rating IV.

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.
Good practice in reviewing and publishing studies on herbal medicine, with special emphasis on traditional Chinese medicine and Chinese materia medica.

PubMed

Chan, Kelvin; Shaw, Debbie; Simmonds, Monique S J; Leon, Christine J; Xu, Qihe; Lu, Aiping; Sutherland, Ian; Ignatova, Svetlana; Zhu, You-Ping; Verpoorte, Rob; Williamson, Elizabeth M; Duez, Pierre

2012-04-10

Studies on traditional Chinese medicine (TCM), like those of other systems of traditional medicine (TM), are very variable in their quality, content and focus, resulting in issues around their acceptability to the global scientific community. In an attempt to address these issues, an European Union funded FP7 consortium, composed of both Chinese and European scientists and named "Good practice in traditional Chinese medicine" (GP-TCM), has devised a series of guidelines and technical notes to facilitate good practice in collecting, assessing and publishing TCM literature as well as highlighting the scope of information that should be in future publications on TMs. This paper summarises these guidelines, together with what has been learned through GP-TCM collaborations, focusing on some common problems and proposing solutions. The recommendations also provide a template for the evaluation of other types of traditional medicine such as Ayurveda, Kampo and Unani. GP-TCM provided a means by which experts in different areas relating to TCM were able to collaborate in forming a literature review good practice panel which operated through e-mail exchanges, teleconferences and focused discussions at annual meetings. The panel involved coordinators and representatives of each GP-TCM work package (WP) with the latter managing the testing and refining of such guidelines within the context of their respective WPs and providing feedback. A Good Practice Handbook for Scientific Publications on TCM was drafted during the three years of the consortium, showing the value of such networks. A "deliverable - central questions - labour division" model had been established to guide the literature evaluation studies of each WP. The model investigated various scoring systems and their ability to provide consistent and reliable semi-quantitative assessments of the literature, notably in respect of the botanical ingredients involved and the scientific quality of the work described. This
STP Position Paper: Recommended Practices for Sampling and Processing the Nervous System (Brain, Spinal Cord, Nerve, and Eye) during Nonclinical General Toxicity Studies

EPA Science Inventory

The Society of Toxicologic Pathology charged a Nervous System Sampling Working Group with devising recommended practices to routinely screen the central and peripheral nervous systems in Good Laboratory Practice-type nonclinical general toxicity studies. Brains should be trimmed ...
Public health laboratory workforce outreach in Hawai'i: CLIA-focused student internship pilot program at the state laboratories.

PubMed

Whelen, A Christian; Kitagawa, Kent

2013-01-01

Chronically understaffed public health laboratories depend on a decreasing number of employees who must assume broader responsibilities in order to sustain essential functions for the many clients the laboratories support. Prospective scientists considering a career in public health are often not aware of the requirements associated with working in a laboratory regulated by the Clinical Laboratory Improvement Amendments (CLIA). The purpose of this pilot internship was two-fold; introduce students to operations in a regulated laboratory early enough in their academics so that they could make good career decisions, and evaluate internship methodology as one possible solution to workforce shortages. Four interns were recruited from three different local universities, and were paired with an experienced State Laboratories Division (SLD) staff mentor. Students performed tasks that demonstrated the importance of CLIA regulations for 10-15 hours per week over a 14 week period. Students also attended several directed group sessions on regulatory lab practice and quality systems. Both interns and mentors were surveyed periodically during the semester. Surveys of mentors and interns indicated overall positive experiences. One-on-one pairing of experienced public health professionals and students seems to be a mutually beneficial arrangement. Interns reported that they would participate if the internship was lower paid, unpaid, or for credit only. The internship appeared to be an effective tool to expose students to employment in CLIA-regulated laboratories, and potentially help address public health laboratory staffing shortfalls. Longer term follow up with multiple classes of interns may provide a more informed assessment.
Caught between the global economy and local bureaucracy: the barriers to good waste management practice in South Africa.

PubMed

Godfrey, Linda; Scott, Dianne; Trois, Cristina

2013-03-01

Empirical research shows that good waste management practice in South Africa is not always under the volitional control of those tasked with its implementation. While intention to act may exist, external factors, within the distal and proximal context, create barriers to waste behaviour. In addition, these barriers differ for respondents in municipalities, private industry and private waste companies. The main barriers to implementing good waste management practice experienced by respondents in municipalities included insufficient funding for waste management and resultant lack of resources; insufficient waste knowledge; political interference in decision-making; a slow decision-making process; lack of perceived authority to act by waste staff; and a low priority afforded to waste. Barriers experienced by respondents in private industry included insufficient funding for waste and the resultant lack of resources; insufficient waste knowledge; and government bureaucracy. Whereas, barriers experienced in private waste companies included increasing costs; government bureaucracy; global markets; and availability of waste for recycling. The results suggest that respondents in public and private waste organizations are subject to different structural forces that shape, enable and constrain waste behaviour.
Multi-site Field Verification of Laboratory Derived FDOM Sensor Corrections: The Good, the Bad and the Ugly

NASA Astrophysics Data System (ADS)

Saraceno, J.; Shanley, J. B.; Aulenbach, B. T.

2014-12-01

Fluorescent dissolved organic matter (FDOM) is an excellent proxy for dissolved organic carbon (DOC) in natural waters. Through this relationship, in situ FDOM can be utilized to capture both high frequency time series and long term fluxes of DOC in small streams. However, in order to calculate accurate DOC fluxes for comparison across sites, in situ FDOM data must be compensated for matrix effects. Key matrix effects, include temperature, turbidity and the inner filter effect due to color. These interferences must be compensated for to develop a reasonable relationship between FDOM and DOC. In this study, we applied laboratory-derived correction factors to real time data from the five USGS WEBB headwater streams in order to gauge their effectiveness across a range of matrix effects. The good news is that laboratory derived correction factors improved the predicative relationship (higher r2) between DOC and FDOM when compared to uncorrected data. The relative importance of each matrix effect (i.e. temperature) varied by site and by time, implying that each and every matrix effect should be compensated for when available. In general, temperature effects were more important on longer time scales, while corrections for turbidity and DOC inner filter effects were most prevalent during hydrologic events, when the highest instantaneous flux of DOC occurred. Unfortunately, even when corrected for matrix effects, in situ FDOM is a weaker predictor of DOC than A254, a common surrogate for DOC, implying that either DOC fluoresces at varying degrees (but should average out over time), that some matrix effects (e.g. pH) are either unaccounted for or laboratory-derived correction factors do not encompass the site variability of particles and organics. The least impressive finding is that the inherent dependence on three variables in the FDOM correction algorithm increases the likelihood of record data gaps which increases the uncertainty in calculated DOC flux values.
Good practices in normal childbirth: reliability analysis of an instrument by Cronbach’s Alpha 1

PubMed Central

Gottems, Leila Bernarda Donato; Carvalho, Elisabete Mesquita Peres De; Guilhem, Dirce; Pires, Maria Raquel Gomes Maia

2018-01-01

ABSTRACT Objectives: to analyze the internal consistency of the evaluation instrument of the adherence to the good practices of childbirth and birth care in the professionals, through Cronbach’s Alpha Coefficient for each of the dimensions and for the total instrument. Method: this is a descriptive and cross-sectional study performed in obstetric centers of eleven public hospitals in the Federal District, with a questionnaire applied to 261 professionals who worked in the delivery care. Results: The study was attended by 261 professionals, 42.5% (111) nurses and 57.5% (150) physicians. The reliability evaluation of the instrument by the Cronbach Alfa resulted in 0.53, 0.78 and 0.76 for dimensions 1, 2 and 3, after debugging that resulted in the exclusion of 11 items. Conclusions: the instrument obtained Cronbach’s alpha of 0.80. There is a need for improvement in the items of dimension 1 that refer to attitudes, knowledge, and practices of the organization of the network of care to gestation, childbirth, and birth. However, it can be applied in the way it is used to evaluate practices based on scientific evidence of childbirth care. PMID:29791667
Defining the Path Forward: Guidance for Laboratory Medicine Guidelines

PubMed Central

Jones, Patricia M.; Chin, Alex C.; Christenson, Robert H.

2015-01-01

The National Academy of Clinical Biochemistry (NACB) has developed consensus-based guidelines for the laboratory evaluation and monitoring of patients with specified disorders for two decades. In 1997, the NACB recognized the need to standardize the process of guideline development and promulgated its first Standard Operating Procedure (SOP) for this purpose. In 2010, the American Association of Clinical Chemistry (AACC) and NACB created the Evidence-Based Laboratory Medicine Committee (EBLMC). Among other roles, this group was given responsibility to provide oversight of clinical practice guideline development in accordance with SOP guidance and using currently accepted good practices. In 2011, the U.S. Institute of Medicine (IOM) published two reports of relevance: ‘Clinical Practice Guidelines We Can Trust’ and ‘Finding What Works in Health Care – Standards for Systematic Reviews.’ These reports were created as part of a response to a legislative mandate from the U.S. Congress requesting that steps be taken to implement recommendations from lOM’s report on ‘Knowing What Works in Health Care’ (2008). The latest revision of the laboratory medicine practice guidelines (LMPG) SOP was in part driven by these reports. NACB continues to develop LMPGs at a rate of roughly one per year through standard processes detailed in its 2014 revision of the SOP. This article describes the NACB and EBLMC experience in developing LMPGs with a focus on the evolution and use of the latest SOP. AACC and NACB have established a solid track record in collaboratively working with many clinical societies and professional organizations on clinical practice guideline development. Presently, three LMPG’s are in various stages of development and all with the collaboration of other clinical/professional groups. The practices and tools being used for current LMPGs in progress are also highlighted in the context of the challenges that presently exist for effective clinical
Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.

PubMed

MacQueen, Kathleen M; Eley, Natalie T; Frick, Mike; Mingote, Laia Ruiz; Chou, Alicia; Seidel, Stephanie S; Hannah, Stacey; Hamilton, Carol

2016-07-01

Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials. © The Author(s) 2016.
Addressing the Challenge of Diversity in the Graduate Ranks: Good Practices Yield Good Outcomes

ERIC Educational Resources Information Center

Thompson, Nancy L.; Campbell, Andrew G.

2013-01-01

In this paper, we examine the impact of implementing three systemic practices on the diversity and institutional culture in biomedical and public health PhD training at Brown University. We hypothesized that these practices, designed as part of the National Institutes of Health-funded Initiative to Maximize Student Development (IMSD) program in…
Subsistence Food Production Practices: An Approach to Food Security and Good Health.

PubMed

Rankoana, Sejabaledi A

2017-10-05

Food security is a prerequisite for health. Availability and accessibility of food in rural areas is mainly achieved through subsistence production in which community members use local practices to produce and preserve food. Subsistence food production ensures self-sufficiency and reduction of poverty and hunger. The main emphasis with the present study is examining subsistence farming and collection of edible plant materials to fulfill dietary requirements, thereby ensuring food security and good health. Data collected from a purposive sample show that subsistence crops produced in the home-gardens and fields, and those collected from the wild, are sources of grain, vegetables and legumes. Sources of grain and legumes are produced in the home-gardens and fields, whereas vegetables sources are mostly collected in the wild and fewer in the home-gardens. These food sources have perceived health potential in child and maternal care of primary health care.
Clinical Practice as Natural Laboratory for Psychotherapy Research: A Guide to Case-Based Time-Series Analysis

ERIC Educational Resources Information Center

Borckardt, Jeffrey J.; Nash, Michael R.; Murphy, Martin D.; Moore, Mark; Shaw, Darlene; O'Neil, Patrick

2008-01-01

Both researchers and practitioners need to know more about how laboratory treatment protocols translate to real-world practice settings and how clinical innovations can be systematically tested and communicated to a skeptical scientific community. The single-case time-series study is well suited to opening a productive discourse between practice…
Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

PubMed

Goedecke, Thomas; Ord, Kathryn; Newbould, Victoria; Brosch, Sabine; Arlett, Peter

2016-06-01

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the 'adverse reaction' definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA(®) terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product's life-cycle, particularly the main sources and types of medication errors during product development. This article
Characterizing Instructional Practices in the Laboratory: The Laboratory Observation Protocol for Undergraduate STEM

ERIC Educational Resources Information Center

Velasco, Jonathan B.; Knedeisen, Adam; Xue, Dihua; Vickrey, Trisha L.; Abebe, Marytza; Stains, Marilyne

2016-01-01

Chemistry laboratories play an essential role in the education of undergraduate Science, Technology, Engineering, and Mathematics (STEM) and non-STEM students. The extent of student learning in any educational environment depends largely on the effectiveness of the instructors. In chemistry laboratories at large universities, the instructors of…
Improvement of coagulation laboratory practice in Thailand: the first-year experience of the national external quality assessment scheme for blood coagulation.

PubMed

Tientadakul, Panutsaya; Opartkiattikul, Nisarat; Wongtiraporn, Wanida

2009-01-01

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

PubMed

Kageura, Mitsuyoshi

2002-09-01

In this paper, the status quo of forensic toxicology in Japan and the West is surveyed and a strategy to address future goals of Japanese forensic toxicology is proposed. Forensic toxicology in the West consists of three main areas--post-mortem forensic toxicology, human-performance forensic toxicology and forensic urine drug testing. In Japan, post-mortem forensic toxicology is practiced in university forensic medicine departments while most of the human-performance forensic toxicology is carried out in police laboratories. However, at least at present, strictly controlled workplace urine drug testing is not being performed, despite the abuse of drugs even by uniformed members of the National Defence Forces and police. For several years, the author has been introducing Western forensic toxicology guidelines and recommendations, translated into Japanese with the help of Western forensic toxicologists, to Japanese forensic toxicologists. Western forensic toxicology practice is at an advanced stage, whereas Japanese practice is in a critical condition and holds many problems awaiting solution, as exemplified by the urine drug testing in police laboratories. There is never any sample left for re-examination by the defence in all cases, though the initial volume of the urine sample available for examination is 30-50 ml. Only one organisation carries out everything from sampling to reporting and, in addition, the parent drug and its metabolites are not quantified. It is clear that the police laboratories do not work within good laboratory practice guidelines, nor do they have quality manuals or standard operating procedures manuals. A basic change in Japanese forensic toxicology practice is now essential. The author strongly recommends that, first of all, Japanese toxicologists should prepare forensic toxicology guidelines based on the Western models. The guidelines would progress the following objectives for forensic toxicology laboratories: 1) to have documented good
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.
Social determinants of good hand-washing practice (GHP) among adolescents in a rural Indian community.

PubMed

Dobe, Madhumita; Mandal, Ram Narayan; Jha, Ayan

2013-01-01

A cross-sectional study was conducted in 5 randomly selected villages to assess prevalence of good hand-washing practice (GHP) among adolescents, and describe the social determinants. The prevalence of adolescent GHP was 32.1% (95% CI = 27.1, 37.1). Logistic regression established 5 significant positive predictors-maternal GHP, presence of sanitary latrine, availability of soap at hand-washing locations, in-house water supply, and higher per capita income. Our research provides a scope for better understanding of the socioeconomic determinants of GHP in a rural Indian setting, and may find implications in the Total Sanitation Campaign launched by Government of India.
Teaching Laboratory Renovation

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

Al-Zuhairi, Ali Jassim; Al-Dahhan, Wedad; Hussein, Falah

Scientists at universities across Iraq are actively working to report actual incidents and accidents occurring in their laboratories, as well as structural improvements made to improve safety and security, to raise awareness and encourage openness, leading to widespread adoption of robust Chemical Safety and Security (CSS) practices. The improvement of students’ understanding of concepts in science and its applications, practical scientific skills and understanding of how science and scientists work in laboratory experiences have been considered key aspects of education in science for over 100 years. Facility requirements for the necessary level of safety and security combined with specific requirementsmore » relevant to the course to be conducted dictate the structural design of a particular laboratory, and the design process must address both. This manuscript is the second in a series of five case studies describing laboratory incidents, accidents, and laboratory improvements. We summarize the process used to guide a major renovation of the chemistry instructional laboratory facilities at Al-Nahrain University and discuss lessons learned from the project.« less
Minor corral changes and adoption of good handling practices can improve the behavior and reduce cortisol release in Nellore cows.

PubMed

Lima, Maria Lúcia Pereira; Negrão, João Alberto; de Paz, Claudia Cristina Paro; Grandin, Temple

2018-03-01

Inadequate corral facilities and improper handling are major causes of stress in beef cattle. The purpose of this study was to evaluate the effects of minor changes in the corral and adoption of good handling practices on the behavior, cortisol release, and time spent taking blood samples in Nellore cows. Minor corral changes included obstructing the cow's vision when the handler walked deep into the animal's flight zone and the elimination of bright objects, color contrasts, puddles, shadows, and darkness in the corral. Handling was improved by eliminating dogs, electric goads (prods), and yelling, as well as adopting a calm behavior. A total of 141 Nellore cows from two typical extensive livestock farms were studied. The cows were evaluated individually before and after the corral changes. Blood samples were collected in the restraint device for cortisol measurement. The minor corral changes and the adoption of good handling practices result in better results for all variables studied. The results showed differences in the interactions between treatment and ranch for chute score (P = 0.0091) and exit score (P < 0.0001). The cortisol release was lower (P < 0.001) and better for the improved methods, resulting in calmer cows compared to cortisol released before the minor changes (41.03 ± 2.9 vs 60.40 ± 3.8 ng/mL). Minor changes made in the corrals and the adoption of good handling practices were effective in improving cow behavior in the chute and in reducing exit velocity, cortisol released, and the time spent taking blood samples.

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