scholarly journals COMPETENCIES OF MEDICAL LABORATORY PERSONNEL

2021 ◽  
Author(s):  
Christine Guerrero
Keyword(s):  
Quality Management ◽  
Professional Ethics ◽  
Quality Management System ◽  
Clinical Work ◽  
Medical Laboratory ◽  
Survey Method ◽  
Laboratory Safety ◽  
Practical Judgment ◽  
Laboratory Personnel ◽  
Management And Leadership

Competence is defined as the quality or state of having sufficientknowledge, judgment, skill, or strength for a particular duty or in a particularrespect.Thus, for medical technologists to be considered “competent” they haveto possess sufficient medical knowledge, practical judgment, skill in the laboratory,or demonstrable attributes necessary to the performance of being a medicallaboratory scientist.This study seeks to answer the problem of an observed competency gap in some areas in health care knowledge, literacy, and skills among medical laboratory personnel. This study used a self-rated survey questionnaireas the descriptive survey method of researchtoassessed the level of competencies in the area of clinical work and fieldexpertise of selected medical laboratory personnel in Metro Manila in terms ofResearch, Quality Management Systems, General Laboratory Practices,Communication, Management and Leadership, Professional Ethics, WorkForceTraining, Emergency Management and Response, and Laboratory Safety. Based on the result of the self-rated survey,the respondents are “moderately competent” inthe following areas:Research, Communication, WorkForce Training skills, and Laboratory Safety. In response, aproposed health matrix program was created inthese competencyareasthat showeda need for continuing education and training. Although the respondents scored “highly competent” in Quality Management System, General Laboratory Practice, Management and Leadership, and Professional Ethics, the researcher still suggests further training in these areas to become more proficient and expert.

scholarly journals Pengaruh Implementasi Sistem Manajemen Mutu ISO 9001:2008 Dan Kemampuan Mengajar Widyaiswara Terhadap Kompetensi Lulusan Diklat

2016 ◽  
Vol 4 (3) ◽  
pp. 37
Author(s):  
Dewi Setiawati
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Research Problem ◽  
Teaching Quality ◽  
Iso 9001 ◽  
Survey Method ◽  
Main Research ◽  
Independent Variables

This research mainly aims to explore competencies of training graduated which focuses on factors that influence competencies of training graduates, such as the implementation of quality management system ISO 9001:2008 and teaching quality of Widyaiswara. The main research problem addressed in this study is how the implementation of quality management system ISO 9001:2008 and teaching quality of Widyaiswara contribute to competencies of training graduates, both partially and altogether. I conducting this research, explanatory survey method is used with questionairres using likert and interval scales as the data collection techniques, that are distributed to 51 graduates of training at PPPPTK Penjas dan BK. To analyse the data, the study employs PPM (Pearson Product Moment), to investigate the direct and non-direct correlations of dependent and independent variables. Significance tests are administered using F-test and t-test. The results show that (1) the impelementation of quality management system ISO 9001:2008 significantly influences competencies of training graduates; (2) teaching quality of Widyaiswara significantly influences competencies of training graduates; and (3) both the implementation of quality management system ISO 9001:2008 and teaching quality of Widyaiswara significantly influence competencies of training graduates.

scholarly journals Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research

2019 ◽  
Vol 3 ◽  
pp. 137 ◽  
Author(s):  
Horace Gumba ◽  
Joseph Waichungo ◽  
Brett Lowe ◽  
Alfred Mwanzu ◽  
Robert Musyimi ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
Research Programme ◽  
Good Clinical Practice ◽  
Laboratory Practice ◽  
Laboratory Personnel ◽  
Middle Income

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of GCLP at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

scholarly journals ISO 15189:2003: A practical tool for the management of quality in the medical laboratory

2005 ◽  
Vol 24 (3) ◽  
pp. 193-200 ◽  
Author(s):  
David Burnett
Keyword(s):  
Quality Management ◽  
Quality Management System ◽  
Internal Audit ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
External Assessment ◽  
Process And Outcome ◽  
Quality Management Model ◽  
Practical Tool ◽  
And Control

The requirements of ISO 15189:2003 are discussed in the context of a process and outcome based quality management model in which the user?s needs are the central focus. The requirements of ISO 15189:2003 are examined in terms of organization and a quality management system and stress the importance of evidence, document control and control of records and clinical material. Examples are provided from the areas of resource management, pre examination, examination and post examination processes. In the final section the importance of evaluation and continual improvement is presented in relation to internal audit and external assessment, non-conformity, corrective and preventative action and management review.

Development of quality management system documents of medical laboratory in accordance with the requirements of ISO 15189:2012

2016 ◽  
pp. 14-17
Author(s):  
A.V. Emanuel ◽  
A.V. Kalenskaya ◽  
G.A. Ivanov ◽  
A.V. Avramenko ◽  
N.A. Zimakova ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Medical Laboratory ◽  
Iso 15189

scholarly journals Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research

2018 ◽  
Vol 3 ◽  
pp. 137 ◽  
Author(s):  
Horace Gumba ◽  
Joseph Waichungo ◽  
Brett Lowe ◽  
Alfred Mwanzu ◽  
Robert Musyimi ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
Research Programme ◽  
Good Clinical Practice ◽  
Laboratory Practice ◽  
Laboratory Personnel ◽  
Middle Income

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of Good Clinical Laboratory Practice (GCLP) at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

scholarly journals CE lebel and harmonisation of quality systems in medical laboratories

2004 ◽  
Vol 23 (1) ◽  
pp. 77-83
Author(s):  
Nada Majkic-Singh
Keyword(s):  
European Union ◽  
Quality Management ◽  
Quality Management System ◽  
Clinical Chemistry ◽  
Common Interest ◽  
Medical Laboratory ◽  
Total Quality ◽  
Quality Systems ◽  
Laboratory Practice ◽  
Medical Laboratories

During the past ten years many activities have taken place in medical laboratories to harmonized the quality systems and accreditation activates. At that time, different approaches were followed in European countries concerning the demands for a quality system in a medical laboratory, and for the choice between certification or accreditation. Also, the working group on accreditation, of the European Communities Confederation of Clinical Chemistry (EC4) with as official name WG on Harmonization of Quality Systems and Accreditation was formed. From the start, the European Diagnostic Manufacturers Association (EDMA) was invited to participate, because harmonisation of quality systems and accreditation is of common interest. A crucial point in the quality revolution in medical laboratories is broad-based awareness of total quality management throughout the diagnostic business from manufacturers to laboratories to physicians and patients. In fact, the quality of laboratory tests largely depends on the products supplied (industry) and on quality management (laboratory management). Manufacturers recognize that accreditation gives high value to medical laboratories. However, while clinical laboratory practice is the responsibility of laboratory professionals, the in vitro diagnostics industry has a major role to play as the supplier of high quality goods and services, as training, scientific services, etc. On the other hand, the IVD industry is directly affected by accreditation schemes, and by the changes in laboratory practice and requirements that they initiate. The IVD Directive is a new example of legislative regulation that obliges the manufacturer (those who are not ISO 9000) to implement a quality management system. At the same time, the IVD Directive includes validation of products by competent laboratories, for ?sensitive? products. In fact, clinical laboratories should be assisted by manufacturers that provide reliable documentation, standard information for use, calibration procedure, performance checks and guide for preventive maintenance. The IVD Directive (EC 98/79) is released on December 1998, it is effective since June 2000 and final implementation is obliged from December 2003. IVDD shall ensure that only one safe and effective products will be sold in the European Union (EU), and just a single product approval is required to sell the products throughout the entire European Union. Official mark for products in conformity with the IVD Directive is CE label.

scholarly journals Pengaruh Implementasi Sistem Manajemen Mutu ISO 9001:2008 Terhadap Efektivitas Guru

2019 ◽  
Vol 4 (2) ◽  
pp. 208
Author(s):  
Syifa Nuraprilia ◽  
Nani Sutarni
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Iso 9001 ◽  
Scale Model ◽  
Survey Method ◽  
Simple Linear Regression ◽  
Analysis Technique ◽  
Data Collection Technique ◽  
High Condition

The study aimed to reveal the figure of the levels of the implementation of quality management system and teachers’ performance efectivity. On the other hand, it was also intended to uncover the effect of the Implementation of quality management system of ISO 9001:2008 on the teachers’ performance efectivity in SMK Negeri 3 Bandung. It employed a survey method. The data collection technique covered interval scale model. The data analysis technique employed simple linear regression. The respondent of the study were ninety teachers of SMK Negeri 3 Bandung by 90 of respondents. Based on the analysis results, the figure of the implementation of quality management system of ISO 9001:2008 is in the effective category; and the teachers’ performance efectivity is in the high condition. The result of hypothesis testing shows that the Implementation of quality management system of ISO 9001:2008 (X) affects the teachers’ performance efectivity (Y) positvely and significantly.ABSTRAKTujuan dari penelitian ini adalah untuk mengetahui gambaran tingkat implementasi sistem manajemen mutu, dan efektivitas kerja guru. Selain itu, tujuan dari penelitian ini adalah untuk mengetahui pengaruh implementasi sistem manajemen mutu ISO 9001:2008 terhadap efektivitas kerja guru di SMK Negeri 3 Bandung. Metode yang digunakan dalam penelitian ini adalah metode penelitian survey. Teknik pengumpulan data menggunakan angket dengan skala interval. Teknik analisis data menggunakan regresi linier sederhana. Responden penelitian ini adalah guru SMK Negeri 3 Bandung sebanyak 90 responden. Berdasarkan hasil analisis ditemukan gambaran implementasi sistem manajemen mutu ISO 9001:2008 berada pada kategori efektif, dan gambaran efektivitas kerja guru berada pada kategori tinggi. Hasil uji hipotesis diperoleh bahwa implementasi sistem manajemen mutu ISO 9001:2008 (X) berpengaruh secara signifikan dan positif terhadap efektivitas kerja guru (Y).

scholarly journals PENGARUH MOTIF INTERNAL DALAM PENGIMPLEMENTASIAN SISTEM MANAJEMEN MUTU (ISO 9001:2008) TERHADAP KINERJA OPERASIONAL SEKOLAH DI SMK NEGERI 1 BANDUNG

2018 ◽  
Vol 3 (1) ◽  
pp. 266
Author(s):  
Sylvia Sysca Angela ◽  
Edi Suryadi
Keyword(s):  
Quality Management ◽  
Management System ◽  
Rating Scale ◽  
Quality Management System ◽  
Iso 9001 ◽  
Operational Performance ◽  
Survey Method ◽  
Analysis Techniques ◽  
Education Personnel ◽  
Simple Regression

This study aims to analyze the internal motives of the implementation of quality management system on school operational performance. The research method used survey method. Data collection techniques used a rating scale scale questionnaire with scores ranging from 1 to 5. Respondents are educators and education personnel at SMK Negeri 1 Bandung. Data analysis techniques use simple regression. The result of the research shows that the internal motive in implementing the quality management system has a positive and significant effect on the operational performance of the school. Thus the operational performance of the school can be improved through the improvement of intenal motif in the implementation of quality management system.ABSTRAKPenelitian ini bertujuan untuk menganalisis motif internal implementasi sistem manajemen mutu terhadap kinerja operasional sekolah. Metode penelitian menggunakan metode survey. Teknik pengumpulan data menggunakan angket model rating scale dengan skor yang terentang antara 1 sampai dengan 5. Responden adalah pendidik dan tenaga kependidikan di SMK Negeri 1 Bandung. Teknik analisis data menggunakan regresi sederhana. Hasil penelitian menunjukkan motif internal dalam pengimplementasiasn sistem manajemen mutu berpengaruh positif dan signifikan terhadap kinerja operasional sekolah. Dengan demikian kinerja operasional sekolah dapat ditingkatkan melalui peningkatan motif intenal dalam pengimplementasian sistem menejemen mutu. 

scholarly journals Patients’ (Clients) Satisfaction with Medical Laboratory Services Contributes to Health and Quality Improvement

2021 ◽  
Author(s):  
Nkereuwem S. Etukudoh ◽  
Uchejeso M. Obeta
Keyword(s):  
Quality Improvement ◽  
Quality Management ◽  
Quality Management System ◽  
Heart Beat ◽  
Iso 9001 ◽  
Medical Laboratory ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Laboratory Services ◽  
Customer Services

Patients’ (clients/customer) services and satisfaction in Medical Laboratory Services and general healthcare is one of the twelve (12) quality essentials of Total Quality Management System (TQMS) emphasized by quality standards as seen in ISO 17025, ISO 15189 and ISO 9001. The patients otherwise referred to as customers or clients to Medical Laboratory and healthcare in general, is the heart-beat and kings to the healthcare system. This chapter looks into the quality aspect of medical laboratory services from the patients’ angle towards thorough satisfaction or dissatisfaction index and otherwise creates room for improvement in the services and healthcare in general. The chapter therefore, identified medical laboratory clients to include patients and patients’ relations, physicians and other healthcare workers, public health and government, communities and interested parties, and medical laboratory profession. There is a need to administer services satisfaction survey developed by Director of Medical Laboratory Services or human resources/quality officers in line with the ISO 15189, ISO 17075 and ISO 9001 to customers/clients from time to time so the outcome can be used to correct services errors and cause quality improvement. It is believed that patients’ satisfaction causes improvement in healthcare, quick recovery of patients and willingness of the patient to return to the healthcare facility in future. Patients’ and customers’ in medical laboratory feedback contributes to quality management and improvement to Medical Laboratory services and healthcare as an ingredient of TQMS.

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