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1

Selvakumar, R. "Good Laboratory Practices." Indian Journal of Clinical Biochemistry 25, no. 3 (2010): 221–24. http://dx.doi.org/10.1007/s12291-010-0077-z.

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Guindo, Merepen A., Renion Saye, Ruth D. Ellis, et al. "Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa." American Journal of Tropical Medicine and Hygiene 86, no. 4 (2012): 573–79. http://dx.doi.org/10.4269/ajtmh.2012.11-0691.

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3

Avani, Reddy Alla, T. Cherian Kevin, Surapaneni Ramya, et al. "IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN PHARMACEUTICAL QUALITY CONTROL." International Journal of Current Pharmaceutical Review and Research 13, no. 4 (2021): 38–41. https://doi.org/10.5281/zenodo.12666981.

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Good Laboratory Practice (GLP) is a quality assurance system that sets forth guidelines andprinciples for the conduct of non-clinical laboratory studies. It encompasses a set ofstandardized practices and procedures that ensure the reliability, integrity, and validity of datagenerated during research and testing in various scientific fields, including pharmaceuticals,chemicals, agrochemicals, and cosmetics. Adhering to GLP promotes the generation of highquality and reliable data, enhances the credibility of scientific research, and contributes to thesafety and efficacy of products developed and
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4

Zhang, Helen L., Michael W. Omondi, Augustine M. Musyoka, et al. "Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings." American Journal of Clinical Pathology 146, no. 2 (2016): 199–206. http://dx.doi.org/10.1093/ajcp/aqw083.

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Ravinetto, Raffaella, Emilie Alirol, Yodi Mahendradhata, et al. "Clinical Research in Neglected Tropical Diseases: The Challenge of Implementing Good Clinical (Laboratory) Practices." PLOS Neglected Tropical Diseases 10, no. 11 (2016): e0004654. http://dx.doi.org/10.1371/journal.pntd.0004654.

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Veit, Markus. "Good Clinical, Laboratory and Manufacturing Practices. Von Philip Carson, Nigel Dent (Editors)." Pharmazie in unserer Zeit 37, no. 4 (2008): 341. http://dx.doi.org/10.1002/pauz.200890056.

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7

Dugal, Robert. "Quality assurance and good laboratory practices in analytical doping control." Fresenius' Zeitschrift für analytische Chemie 330, no. 4-5 (1988): 337–38. http://dx.doi.org/10.1007/bf00469259.

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8

Dent, N. J. "European Regulatory Compliance Issues: Good Research Practices." Journal of the American College of Toxicology 13, no. 1 (1994): 79–85. http://dx.doi.org/10.3109/10915819409140658.

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Since the inception of the 1976 Food and Drug Administration (FDA) regulations governing preclinical toxicology, the world has seen an explosion of guidelines, principles, and regulations. The objective of this report is to clarify the situation in Europe as to the status of Good Laboratory Practices (GLPs). An overview of the harmonisation currently underway in Europe is given, although this changes frequently with new countries applying to join the European Community (EC) or undertaking aspects of GLP compliance. Where interactions have occurred between the GLPs and Good Clinical Practices (
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Kavsak, Peter A., and Catherine A. Hammett-Stabler. "Clinical Biochemistry year in review — The clinical “good”, the analytical “bad”, and the “ugly” laboratory practices." Clinical Biochemistry 47, no. 18 (2014): 255–56. http://dx.doi.org/10.1016/j.clinbiochem.2014.11.015.

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10

Ibrahim, Faisal, David Dosoo, Karl C. Kronmann, et al. "Good Clinical Laboratory Practices Improved Proficiency Testing Performance at Clinical Trials Centers in Ghana and Burkina Faso." PLoS ONE 7, no. 6 (2012): e39098. http://dx.doi.org/10.1371/journal.pone.0039098.

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Maikore, Fatima Sabiu, Emma Haddi, and Larisa Soldatova. "A Framework for IT Support of Clinical Laboratory Standards." International Journal of Privacy and Health Information Management 6, no. 2 (2018): 13–25. http://dx.doi.org/10.4018/ijphim.2018070102.

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This article presents SmartSOP, a framework for IT support of clinical laboratory standards. Adoption of laboratory standards and good practices is critical for ensuring high-quality health services, but clinical labs are dealing with many challenges in following lab standards. The proposed IT framework facilitates an easy access to standardised procedures, monitoring their execution and recording laboratory test results. The SmartSOP framework has been positively evaluated by clinical practitioners from a hospital in Nigeria. The results of the evaluation indicate that lab scientists are like
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12

Tworek, Joseph A., Michael R. Henry, Barbara Blond, and Bruce Allen Jones. "College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on Good Laboratory Practices in Gynecologic Cytology: Background, Rationale, and Organization." Archives of Pathology & Laboratory Medicine 137, no. 2 (2013): 158–63. http://dx.doi.org/10.5858/arpa.2012-0111-cc.

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Context.—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. Objective.—To determine good laboratory practices in quality assurance of gynecologic cytopathology. Data Sources.—Data were collected through a wri
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13

Niraula, A., and M. Bataju. "External Quality Assessment Practices in Clinical Biochemistry Laboratory: What is the need?" Kathmandu University Medical Journal 18, no. 1 (2020): 86–92. http://dx.doi.org/10.3126/kumj.v18i1.34660.

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Health Care services is considered as an amalgamation between the doctor undergoing the examination and laboratory personnel behind the proper diagnosis of the patient. It has evolved to a large extent from a simple process of examination to handling the prescription to the patient. During this evolution, there has been a remarkable development in the field of laboratory diagnosis. A good laboratory is abided by the rule of quality services including quality control; both internal and external. External quality assessment program contributes to the long term accuracy of the analytical method u
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14

Gabrielle Novais Manzoli, Maria Conceição Moares Lima, Leticia de Alencar Pereira Rodrigues, Afrânio Ferreira Evangelista, and Bruna Aparecida Souza Machado. "Market Analysis for Implementing Good Laboratory Practices at the SENAI Institute of Innovation in Advanced Health Systems (ISI-SAS) of SENAI CIMATEC." JOURNAL OF BIOENGINEERING, TECHNOLOGIES AND HEALTH 7, no. 2 (2024): 178–81. http://dx.doi.org/10.34178/jbth.v7i2.391.

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Good Laboratory Practices (GLP) comprise a quality system encompassing organizational processes and conditions under which non-clinical safety studies for human health and the environment are planned, developed, monitored, recorded, archived, and reported. The objective of this work was to analyze the market to guide decision-making regarding the implementation of GLP at CIMATEC's ISI-SAS, following NIT-Dicla-035, with a focus on achieving Conformity with the Principles of Good Laboratory Practices recognized by Cgcre of Inmetro. This study showed that the prevalence of Test Facilities in Braz
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Nasim, Sadia, Anjum Shahid, Muhammad Ayaz Mustufa, et al. "Biosafety perspective of clinical laboratory workers: a profile of Pakistan." Journal of Infection in Developing Countries 6, no. 08 (2012): 611–19. http://dx.doi.org/10.3855/jidc.2236.

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Introduction: 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. Methodology: A total of 1,782 laboratory technicians were interviewed from major public sector hospitals and a few private hospital laboratories throughout Pakistan. Results: A total of 1,
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16

James, Christopher A., and Howard M. Hill. "Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices studies and regulated clinical studies." AAPS Journal 9, no. 2 (2007): E123—E127. http://dx.doi.org/10.1208/aapsj0902014.

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17

Shahangian, Shahram, and Bin Chen. "CDC Recommendations: Good Laboratory Practices for Biochemical Genetic Testing and Newborn Screening for Inherited Metabolic Disorders." Clinical Chemistry 58, no. 12 (2012): 1728. http://dx.doi.org/10.1373/clinchem.2012.195362.

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18

Kline, Rande. "Expiration Dating Of Chemicals And Reagents." Microscopy Today 8, no. 6 (2000): 42–43. http://dx.doi.org/10.1017/s155192950005286x.

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With today's requirements for chemicals and reagents in research and clinical laboratory environments, questions often arise concerning expiration dating. Why are not all chemicals and reagents expiration dated by the manufacturer when they are made? How should expiration of chemicals and reagents not dated by the manufacturer be determined? How would a laboratory establish expiration of solutions and reagents prepared in-house?To assure good manufacturing practices, many manufacturers comply with guidelines set for them by agencies such as the International Organization for Standardization (I
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19

Shamim, Akhtar, and Mahore Sadhana. "Learnings for Best Practices of Critical Value Alert in Laboratory Quality Management System." PJSR 14, no. 1 (2020): 1–4. https://doi.org/10.5281/zenodo.8224516.

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A cross-sectional study was conducted at a tertiary health care centre in India during year 2018 to 2019 to provide a  standard for good laboratory practice, to increase the clinical effectiveness, patient safety and operational efficiency and  designing better and more evidence-based systems for timely notification of laboratory results. The entire data was obtained  from reports generated by hematology and clinical pathology laboratory recorded in critical call back log register. These  laboratories reported 86727 critical values out of 394213 performed test. The majority
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20

Naqvi, M. "Assessing good clinical practices in a clinical laboratory of a tertiary healthcare institute by evaluating key performance indicators of pre-analytical phase." Clinica Chimica Acta 558 (May 2024): 118722. http://dx.doi.org/10.1016/j.cca.2024.118722.

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21

Loen, Harry Van, Diana Arango, Hanne Landuyt, Christophe Burm, and Yven Van Herrewege. "PO 8490 PROMOTING GOOD DATA MANAGEMENT PRACTICES IN CLINICAL RESEARCH IN RESOURCE-POOR SETTINGS." BMJ Global Health 4, Suppl 3 (2019): A45.1—A45. http://dx.doi.org/10.1136/bmjgh-2019-edc.118.

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BackgroundAccurate and timely data management (DM) is of key importance in clinical research to generate high-quality and GCP-compliant data for analysis and/or sharing. Our objective is to strengthen the capacity for DM in clinical research in resource-poor settings by organising several teaching initiatives.MethodsOur teaching initiatives have a twofold approach. First, a generic and comprehensive approach with capacity building on various thematical modules. These include a research component (overviewing the research data management procedures) and a technological component (introducing da
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22

Steindel, Steven J., Sharon Granade, Jason Lee, et al. "Practice Patterns of Testing Waived Under the Clinical Laboratory Improvement Amendments." Archives of Pathology & Laboratory Medicine 126, no. 12 (2002): 1471–79. http://dx.doi.org/10.5858/2002-126-1471-ppotwu.

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Abstract Objectives.—To determine operational practices in laboratories operating under a Certificate of Wavier (waived laboratories), or equivalent, under the Clinical Laboratory Improvements Amendments (CLIA) of 1988 when performing tests designated as having an insignificant risk of an erroneous result (ie, waived tests). Methods.—Waived laboratories that were part of the Centers for Disease Control and Prevention Laboratory Sentinel Monitoring Network project in the states of Arkansas, New York, and Washington were surveyed about their quality control (QC) and quality assurances (QA) pract
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23

Simei, João Luís Q., José Diogo R. Souza, João Francisco Pedrazzi, et al. "Research and Clinical Practice Involving the Use of Cannabis Products, with Emphasis on Cannabidiol: A Narrative Review." Pharmaceuticals 17, no. 12 (2024): 1644. https://doi.org/10.3390/ph17121644.

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Background: Emerging evidence supports cannabidiol (CBD) as a promising therapeutic compound for various health conditions, despite its approval as a medication (product for medical purposes) remaining restricted to a limited range of clinical indications. Simultaneously, the regulation of cannabis-derived products for medicinal and recreational use has expanded their global market availability to meet local community demands. This scenario presents a complex challenge for clinicians, researchers, and industry, as the global appeal of therapeutic uses of CBD is growing more rapidly than the sc
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24

Kamaryanti, Ni Putu, Ni Luh Putu Dina Susanti, and Anak Agung Ayu Yuliati Darmini. "LEARNING MODEL OF HOSPITAL CLINICAL PRACTICE FROM STUDENT AND CLINICAL EDUCATOR POINT OF VIEW: A QUALITATIVE STUDY." INDONESIAN NURSING JOURNAL OF EDUCATION AND CLINIC (INJEC) 2, no. 1 (2017): 47. http://dx.doi.org/10.24990/injec.v2i1.135.

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Background and Purpose: Qualified education is characterized by qualified teaching and learning in the classroom, laboratory, and clinical practice. Producing nurses who are able to provide professional nursing care for patients requires learning process in practice by using learning models. The purpose of this study was to explore the experience and expectation of students and clinical instructors on practices learning model in Ners Program of STIKES Bali.Method: This study used qualitative design with phenomenology approach. There were 8 participants from students and clinical instructors se
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25

Khabour, Omar Falah, Khalil H. Al Ali, Jamal N. Aljuhani, Mousa A. Alrashedi, Fuaad H. Alharbe, and Ahmed Sanyowr. "Assessment of biosafety measures in clinical laboratories of Al-Madinah city, Saudi Arabia." Journal of Infection in Developing Countries 12, no. 09 (2018): 755–61. http://dx.doi.org/10.3855/jidc.10081.

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Introduction: Workers in clinical laboratories are exposed to occupational hazards on a daily basis and their health and safety may be threatened if appropriate protective standards are not implemented. The aim of this study was to assess the knowledge and practices of clinical laboratory workers towards biosafety measures, in Al-Madinah city, Saudi Arabia.
 Methodology: Clinical laboratory staff was recruited from both the public and private sectors. A structured self-administered questionnaire was used to achieve the aim of the study.
 Results: A total of 208 workers participated i
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Mattsson, Joel L., Pamela J. Spencer, and Ralph R. Albee. "A Performance Standard for Clinical and Functional Observational Battery Examinations of Rats." Journal of the American College of Toxicology 15, no. 3 (1996): 239–54. http://dx.doi.org/10.3109/10915819609008716.

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Clinical examinations are a key component of all toxicology studies and are a major component of the functional observational battery (FOB). The FOB is a core feature of the USEPA neurotoxicity screening guideline of 1991. The need for well-trained technicians is recognized, but technician competency is virtually always judged subjectively by their supervisors. Although subjective evaluation of performance cannot be replaced, what constitutes satisfactory performance is nebulous and therefore difficult to communicate to trainees and difficult to document. Consequently, a laboratory performance
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Mera, Carlos E., Jean P. Sanclemente, and Ivón Howland. "Pre-analytical criteria in blood culture sample collection." Journal of Advances in Education, Sciences and Humanities 1, no. 1 (2023): 27–31. https://doi.org/10.5281/zenodo.14601930.

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The pre-analytical process in blood culture sample collection is essential to ensure the accuracy in detecting pathogenic microorganisms in blood, which is crucial in diagnosing bacteremia and fungemia. This article reviews the main pre-analytical criteria associated with sample collection, considering aspects such as proper puncture site selection, strict aseptic techniques, blood volume collected, timing with febrile episodes, and the optimal number of samples. Sample contamination remains a significant challenge, impacting both the validity of results and the patient's clinical management.
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Mera, Carlos E., Jean P. Sanclemente, and Ivón Howland. "Preanalytical criteria for collecting blood culture samples in the Microbiology area at Portoviejo General Hospital." Journal of Advances in Education, Sciences and Humanities 2, no. 1 (2024): 11–18. https://doi.org/10.5281/zenodo.14602285.

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The General Hospital of Portoviejo serves a high demand of patients with suspected infections, bacteremia, or sepsis, highlighting the importance of performing high-quality blood cultures. This study characterized errors in the preanalytical sample collection phase for the microbiological diagnosis of bacteremia through blood cultures. Existing laboratory protocols were analyzed and compared with national and international standards, focusing on asepsis, blood volume, biosafety, and techniques. Information was gathered through surveys conducted with healthcare personnel involved in sample coll
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Newman-Gage, Helen. "Application of Quality Assurance Practices in Processing Cells and Tissues for Transplantation." Cell Transplantation 4, no. 5 (1995): 447–54. http://dx.doi.org/10.1177/096368979500400506.

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Attention to issues of quality assurance from the early stages of development of experimental cell therapies provides a margin of safety for recipients. Adherence to minimum standards of practice at acquisition, processing, storage, and implantation ensures not only this baseline safety factor for patients, but also provides a baseline for comparative evaluations between different studies or different banks. This paper describes the basic components of a quality assurance program tailored to laboratories and facilities that collect, process, or distribute human cells and tissues for transplant
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Porru, Stefano, Marco Chiappin, and Nicolò Sfriso. "[Bio-hazard in research laboratories]." Giornale Italiano di Medicina del Lavoro ed Ergonomia 41, no. 4 (2019): 359–64. https://doi.org/10.4081/gimle.523.

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Objectives. To deal with biohazards in research laboratories (RL), identify exposure features, types and incidence of laboratory-acquired infections/diseases (LAI), and prevention strategies.Methods. Literature search and appraisal, non-systematic, last 40 years; legislation, guidelines and good practices evaluation. Results. Biohazards are relevant in RL, in various biomedical, agri-food and industrials sectors, with a variety of LAI (especially viruses and bacteria), modes of exposure and transmission; LAI decrease after preventive measures, vaccinations and clinical treatments; LAl underest
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Khalki, Hanane, Chaimae Errabhi, Maryam Aabida, and Hicham Sbai. "Role of a Simulation Workshop Training in the Preanalytical Phase in Medical Biology: Experience of the Biochemistry Laboratory of the University Hospital of Tangier – Morocco." Saudi Journal of Pathology and Microbiology 7, no. 7 (2022): 276–79. http://dx.doi.org/10.36348/sjpm.2022.v07i07.005.

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Introduction: In order to fight against preanalytical errors, a simulation workshop around the requirements of this phase was carried out by the team of the biochemistry laboratory of the university hospital of Tangier Tetouan Alhoceima. Newly recruited nurses in oncology, hematology and the sampling center benefited from this training. Material and Methods: The course of this workshop took place in the premises of the center of clinical simulation and educational innovation in health sciences of the faculty of medicine and pharmacy of Tangier (Tangier'Sim Center). The beneficiaries were 19 nu
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32

Sturgeon, Catharine M., Barry R. Hoffman, Daniel W. Chan, et al. "National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for Use of Tumor Markers in Clinical Practice: Quality Requirements1." Clinical Chemistry 54, no. 8 (2008): e1-e10. http://dx.doi.org/10.1373/clinchem.2007.094144.

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Abstract Background: This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers. Methods: One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor markers in current clinical practice. Two other subcommittees formulated recommendations particularly relevant to the developing technologies of microarrays and mass spectrometry. Results: Prerequisites for optimal use of tumor markers in routine practice include formulation of the correct cli
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Gulab Kanwar, Shivprakash Rathore, Arpit Khandelwal, et al. "A study of “rational use of investigations” in a tertiary hospital." Asian Journal of Medical Sciences 13, no. 10 (2022): 121–25. http://dx.doi.org/10.3126/ajms.v13i10.45449.

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Background: Rational laboratory use is defined as effective and correct laboratory use by providing the most appropriate test selection with the right clinical approach in line with the evidence-based data and considering the cost and patient safety. The present study was thus conducted for the prevalence and features associated with rational use of investigations in a tertiary hospital. Aims and Objectives: The objectives of the study were to estimate prevalence of rational use of investigations and its associated confounding factors; to explain the educational approach underlying the study;
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Raghavendra Rao M.V, Srilatha Bashetti, A. Rekha, et al. "Candor in medical laboratory management “Quality is doing the right thing and making things right”." World Journal of Biology Pharmacy and Health Sciences 13, no. 3 (2023): 210–20. http://dx.doi.org/10.30574/wjbphs.2023.13.3.0139.

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The practice of medicine in the modern era is exclusively evidence based, focuses on justifiable laboratory reports contributing effective and opportune patient management. For many years, clinical laboratories have picked up astounding significance in medical care services. Laboratory investigations are essential for medical diagnosis in patient care as well as medical research. Reliability of laboratory data/report is therefore of paramount importance. Good Clinical Laboratory Practices (GCLP) is essential to be implemented in the field of medical research and health care services to ensure
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Timoteo, Margareth O., Ana Carolina Batista Brochado, Daniela Costa-Silva, José Mauro Granjeiro, Beni Olej, and Gutemberg Gomes Alves. "The impact of online management systems: a qualitative assessment of staff perception at a clinical research laboratory." Research, Society and Development 9, no. 10 (2020): e9239109188. http://dx.doi.org/10.33448/rsd-v9i10.9188.

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Good Clinical Laboratory Practices (GCLP) increase the quality and traceability of results in clinical research. However, high turnover of staff, insufficient resources, and lack of training in lab management may limit its implementation at Academic Health Centers (AHCs). This work aimed to qualitatively assess the staff perception of the implementation of a freeware Online Management System (OMS) on the workflow of an academic clinical research laboratory. A free online OMS (Quartzy, Quartzy Inc., USA) was selected and implemented from 2012-2016. After training interventions, a qualitative an
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Raghavendra, Rao M.V, Bashetti Srilatha, Rekha A., et al. "Candor in medical laboratory management "Quality is doing the right thing and making things right"." World Journal of Biology Pharmacy and Health Sciences 13, no. 3 (2023): 210–20. https://doi.org/10.5281/zenodo.8035914.

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The practice of medicine in the modern era is exclusively evidence based, focuses on justifiable laboratory reports contributing effective and opportune patient management. For many years, clinical laboratories have picked up astounding significance in medical care services. Laboratory investigations are essential for medical diagnosis in patient care as well as medical research. Reliability of laboratory data/report is therefore of paramount importance. Good Clinical Laboratory Practices (GCLP) is essential to be implemented in the field of medical research and health care services to en
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37

Fearon, Margaret. "The Laboratory Diagnosis of HIV Infections." Canadian Journal of Infectious Diseases and Medical Microbiology 16, no. 1 (2005): 26–30. http://dx.doi.org/10.1155/2005/515063.

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HIV diagnostic testing has come a long way since its inception in the early 1980s. Current enzyme immunoassays are sensitive enough to detect antibody as early as one to two weeks after infection. A variety of other assays are essential to confirm positive antibody screens (Western blot, polymerase chain reaction [PCR]), provide an adjunct to antibody testing (p24 antigen, PCR), or provide additional information for the clinician treating HIV-positive patients (qualitative and quantitative PCR, and genotyping). Most diagnostic laboratories have complex testing algorithms to ensure accuracy of
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Tassé, Anne Marie, Élodie Petit, and Béatrice Godard. "Differences in Regulatory Frameworks Governing Genetic Laboratories in Four Countries." Journal of Law, Medicine & Ethics 37, no. 2 (2009): 351–57. http://dx.doi.org/10.1111/j.1748-720x.2009.00378.x.

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A recent Organisation for Economic Co-Operation and Development (OECD) survey demonstrated that an internationalization of genetic laboratory services currently emerged from the rarity of certain genetic abnormalities and from the small of laboratories performing specialized testing. When DNA samples cross national boundaries for genetic testing services to be performed in another country, the heterogeneity of national legal frameworks raises important questions regarding quality of genetic services available internationally.Some aspects of the genetic laboratories’ services are abundantly dis
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Gebo, James E. T., Amanda D. East, and Anna F. Lau. "A Side-by-Side Comparison of Clinical versus Current Good Manufacturing Practices (cGMP) Microbiology Laboratory Requirements for Sterility Testing of Cellular and Gene Therapy Products." Clinical Microbiology Newsletter 43, no. 21 (2021): 181–91. http://dx.doi.org/10.1016/j.clinmicnews.2021.10.001.

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40

Gaydos, C. A., P. A. Rizzo-Price, P. Balakrishnan, et al. "Impact of international laboratory partnerships on the performance of HIV/sexually transmitted infection testing in five resource-constrained countries." International Journal of STD & AIDS 22, no. 11 (2011): 645–52. http://dx.doi.org/10.1258/ijsa.2011.010527.

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To review a quality control and quality assurance (QC/QA) model established to ensure the validity and reliability of collection, storage and analysis of biological outcome data, and to promote good laboratory practices (GLPs) and sustained operational improvements in international clinical laboratories, we conducted a two-arm randomized community-level HIV behavioural intervention trial in five countries: China, India, Peru, Russia and Zimbabwe. The trial was based on diffusion theory utilizing a Community Popular Opinion Leaders (CPOLs) intervention model with behavioural and biological outc
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41

Ferreira, José Ricardo Muniz, and Anna Paula Greck. "Adult mesenchymal stem cells and their possibilities for Dentistry: what to expect?" Dental Press Journal of Orthodontics 25, no. 3 (2020): 85–92. http://dx.doi.org/10.1590/2177-6709.25.3.085-092.sar.

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ABSTRACT Introduction: Stem cells obtained from the pulp of human deciduous teeth are highly proliferative and plastic multipotent cells, which makes them a relevant model of stem cells, applied in several biomedical areas, with different purposes. Objective: Based on a brief review of the literature, the present work intends to present from conceptual aspects about stem cells, classifications, potential (in vitro and in vivo) applications in dental practice, cell culture, cryopreservation and its importance, ethical and regulatory aspects, as well as the role of the dental surgeon as the endo
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42

Hall, J. R. "Critical-care medicine and the acute-care laboratory." Clinical Chemistry 36, no. 8 (1990): 1552–56. http://dx.doi.org/10.1093/clinchem/36.8.1552.

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Abstract Critical-care medicine today is practiced by anesthesiologists, internists, pediatricians, and surgeons. Outcome from today's management of critically ill patients is very good, yet associated costs are very high. Over one-half of the hospital costs of critically ill patients emanates from the intensive-care unit (ICU), although the ICU stay accounts for less than 20% of their time in the hospital. Outside of the operating room, the ICU is the most expensive location for patient care in the hospital, and laboratory tests are the most expensive single item. Plans for cost containment s
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Yeung, Eugene Y. H. "A Review of Laboratory Biosafety and Infection Prevention and Control Guidelines on the Management of High-Risk Pathogens in Canada." Acta Microbiologica Hellenica 70, no. 1 (2025): 2. https://doi.org/10.3390/amh70010002.

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The safety precautions required for certain pathogens are different in clinical laboratories and patient-facing healthcare settings, causing confusion for laboratorians and infection preventionists. The current review aims to summarize information from reputable Government of Canada guidance commonly used in clinical laboratories in Canada, including the Government of Canada Human Pathogens and Toxins Act and Regulations, the ePATHogen—Risk Group Database, biosafety directives and advisories, Transportation of Dangerous Goods Regulations, and the Canadian Biosafety Standard (2022). Guidelines
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Chung, William L., Bryan N. Brown, and Alejandro J. Almarza. "Decellularized small intestine submucosa device for temporomandibular joint meniscus repair: Acute timepoint safety study." PLOS ONE 17, no. 8 (2022): e0273336. http://dx.doi.org/10.1371/journal.pone.0273336.

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Temporomandibular joint (TMJ) Meniscus removal is an option for the patient to regain full range of motion if the disc is irreversibly damaged or unable to be reduced. However, this procedure leaves the joint vulnerable to condylar remodeling and degeneration. We have shown that extracellular matrix (ECM) scaffolds remodel into a tissue with near native TMJ meniscus in previous studies. The next step towards clinical translation is to manufacture the ECM scaffold as a device under good manufacturing practices (GMP) and test it in a pre-clinical animal study under good laboratory practices (GLP
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45

Gaspar, Jeric Vincent, and Benlene Llantero. "The Correlation between Psychology Laboratory and Practicum Performance of FAITH BS Psychology for the S. Y 2022 – 2023: Basis for Curriculum Enhancement Plan." Psychology and Education: A Multidisciplinary Journal 29, no. 1 (2024): 46–50. https://doi.org/10.5281/zenodo.14523961.

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This study examines the relationship between psychology laboratory performance and practicum performance among FAITH BS Psychology students for the school year 2022-2023, using a quantitative approach. The entire population of students completing psychological assessments and practicum in a clinical setting was analyzed, employing the Grade Weighted Average (GWA) as the instrument for measuring performance in both areas. Permission was obtained from relevant administrative authorities, and a structured data collection process was implemented to ensure confidentiality and data integrity. Result
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Creane, Michael, Mary McElroy, Aoife Duffy, Chaansha Shaik Dawood, and Timothy O’Brien. "A 3-month Safety Assessment of Human Bone Marrow Derived Mesenchymal Stromal Cells Administered Once by the Intramuscular Route to Immunodeficient Mice." Toxicologic Pathology 46, no. 3 (2018): 290–301. http://dx.doi.org/10.1177/0192623318760516.

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Critical limb ischemia (CLI) represents the severest manifestation of peripheral arterial disease and is a major unmet medical need. This disease occurs when the arterial blood supply within the limb fails to meet the metabolic demands of the resting muscle or tissue, resulting in chronic ischemic rest pain and/or tissue necrosis. Human mesenchymal stromal cells, termed hMSCs, represent an exciting therapeutic modality for the treatment of this disease due to their immunomodulatory and tissue reparative functions. The aim of the study was to assess the preclinical toxicity profile of human bon
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Jeremiah, Igunma A., Bob-Manuel Mienye, and Ejime Ebeigbe. "Determination of Perception and Knowledge of Specimen Rejection Criteria in the Laboratory among Medical Doctors in Southern Nigeria." South Asian Journal of Research in Microbiology 18, no. 1 (2024): 35–43. http://dx.doi.org/10.9734/sajrm/2024/v18i1341.

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Background: Laboratory diagnosis plays a major role in the clinical management of patients, as such, specimen handling errors should be avoided at all costs. Laboratory results are largely dependent on the quality and conditions of the specimens received for analysis. Every laboratory has a set of standard rejection criteria for samples.
 Since the pre-analytical stage of specimen handling lies in the purview of the medical practitioners who make the request, the aim of this study was to assess the knowledge of medical doctors regarding specimen appropriateness and their perception of spe
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48

Pyatigorskaya, N. V., M. A. Tulina, Zh I. Aladysheva, and V. V. Beregovykh. "INTERNATIONAL APPROACHES TO THE REGULATION OF CELL THERAPY PRODUCTS." Annals of the Russian academy of medical sciences 68, no. 8 (2013): 4–8. http://dx.doi.org/10.15690/vramn.v68i8.715.

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This article is a review of the main methods and approaches used in regulation of cell therapy products in the United States of America, Canada, European Union, Australia, Japan and South Korea. Intensive developments of scientific and technological aspects in stem cell and tissue engineering have led to the wide use of human cells and tissues for the treatment of various diseases and injuries of organs and tissues. Drug regulatory agencies of different countries are working on implementation of a risk-based legal framework with some common features. In many countries there is a multilevel con
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Bolon, Brad, Wallace Baze, Christopher J. Shilling, Kendy L. Keatley, Daniel J. Patrick, and Kenneth A. Schafer. "Good Laboratory Practice in the Academic Setting: Fundamental Principles for Nonclinical Safety Assessment and GLP-Compliant Pathology Support When Developing Innovative Biomedical Products." ILAR Journal 59, no. 1 (2018): 18–28. http://dx.doi.org/10.1093/ilar/ily008.

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AbstractDevelopment of new biomedical products necessitates nonclinical safety assessment in animals as a means of assessing potential risk to human patients. Pivotal nonclinical safety studies that support human clinical trials are performed according to Good Laboratory Practice (GLP) guidelines, which are designed to ensure that the study was conducted under carefully controlled conditions using standardized and validated procedures that will yield a reliable, reproducible, and traceable data set. The GLP guidelines established by different regulatory agencies address organizational structur
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Movva, Naimisha, Mina Suh, Lauren C. Bylsma, Jon P. Fryzek, and Christopher B. Nelson. "Systematic Literature Review of Respiratory Syncytial Virus Laboratory Testing Practices and Incidence in United States Infants and Children <5 Years of Age." Journal of Infectious Diseases 226, Supplement_2 (2022): S213—S224. http://dx.doi.org/10.1093/infdis/jiac203.

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Abstract Background Respiratory syncytial virus (RSV) can cause serious illness in those aged <5 years in the United States, but uncertainty remains around which populations receive RSV testing. We conducted a systematic literature review of RSV testing patterns in studies published from 2000 to 2021. Methods Studies of RSV, medically attended RSV lower respiratory tract infections (LRTIs), and bronchiolitis were identified using standard methodology. Outcomes were clinical decisions to test for RSV, testing frequency, and testing incidence proportions in inpatient (IP), emergency depar
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