Innovative and Efficient Laboratory Management

By Godswill Ntsomboh Ntsefong

Since most research activities involve laboratory work, there is need for efficient management of laboratory or test facilities to ensure quality-controlled research and cost-effective use of resources. It is obvious that good laboratory and research management skills are necessary for scientists and scholars involved directly or indirectly in industrial, clinical, or bioscience research and/or charged with management of laboratory facilities. The essence of this write-up is therefore to enhance good laboratory management practices that ensure stressless compliance with legal and regulatory frameworks for health and safety. The aim is to promote scientific excellence by highlighting the conditions and skills necessary for efficient and innovative management of laboratory facilities while enhancing consciousness and efficacy in cost-effective research management.

The issues addressed in the book include a proposal of the administrative setup of a laboratory or test facility, laboratory design considerations, which obviously have a significant impact on the quality of results generated. The principles of good laboratory practices and the importance of biosafety and biosecurity are specially addressed.

The author also reiterates the importance of a procurement strategy for each laboratory or test facility, whose aim should be to set out a planned approach for cost-effective purchasing of required goods and services, taking into account several factors such as the timeline for procurement, the funding and budget and the projected risks and opportunities. Here, the need for a defined and documented policy and procedures for selection and use of purchased external goods and services in addition to an inventory control system for laboratory supplies is highlighted. Laboratory operators need to have an overview of different categories and types of laboratory equipment at their disposal with good knowledge of their safe handling, operation, and maintenance following well-set schedules. Besides this concern, the book also dwells on laboratory information management system (LIMS), which is an important and integral part of laboratory operations relevant for efficient laboratory management.

A whole chapter is consecrated to quality control (QC), quality assurance (QA) and total quality management (TQM) as the three major elements of quality, which effectively sets the stage for laboratory accreditation, which demonstrates legitimacy and credibility of research results. In fact, laboratory accreditation is the process by which an independent and authorized agency certifies the quality system and competence of a laboratory on the basis of certain predefined standards. It is the formal recognition, authorization, and registration of a laboratory that has demonstrated its capability, competence and credibility to carry out the tasks it is claiming to be able to do. In this book, the reader will discover the whole process of laboratory accreditation with the various agencies involved as well as the benefits of laboratory accreditation.

The book closes up with ethical issues in research management. It is obvious that the consideration of ethics in research should enhance mature decision-making in harmony with changing technology. The chapter on this issue points out the fact that efficient research and laboratory management must be based on ethical principles that guarantee all stakeholders access to the benefits of new technologies with increased understanding of biological systems and responsible use of technology. Some basic guidelines are given at the end on how to implement knowledge gained from the book to efficiently run a modern laboratory or research facility.

• Language: English
• Publisher: Xlibris US
• Release date: Apr 29, 2015
• ISBN: 9781503564367

Godswill Ntsomboh Ntsefong

Godswill Ntsomboh Ntsefong currently serves as laboratory manager of the Lipids Analysis Laboratory of the Institute of Agricultural Research for Development, IRAD Dibamba, in Cameroon. He is also the chief of Seed Production and Phytopathology Units of the same institution. He was born to Fomenop Thomas Ntsefong and Monica Matang on February 11, 1976, in Bamenda-Cameroon and obtained the First School Leaving Certificate and Common entrance (list A) from G. S. Santa in 1987. He attended secondary school in Cameroon Protestant College (CPC) Bali, NCVHS Santa, and CCC Mankon Bamenda from where he obtained the GCE O-Level in 1992. By 1994, he obtained the GCE A-Level from GHS Santa and later obtained a BSc. degree in botany in 2001 from the University of Dschang (Cameroon). He then went through a master’s degree program in Botany in the same University, though without final certification, and later obtained an MSc. I (Maîtrise) in 2003 and MSc. II (Diplôme d’Etudes Approfondies, DEA) in 2007 both in plant biotechnology from the University of Yaounde I. While pursuing university studies, he served from 2003 to 2010 as teacher of science subjects, music, sports, and computer literacy in several schools in Cameroon. Godswill enrolled for an MBA in 2009, which he didn’t complete due to particular constraints! He is currently a doctorate/PhD fellow, and his research interests have so far been focused on integrated crop protection, breeding, and genetic improvement, with special regards on dietary oil quality improvement. As a laboratory manager, he has been more concerned recently with good laboratory practices and management principles. Godswill is father to four lovely children with Mrs. Dzeufouo Tapinfo Celestine, a plant biotechnologist.

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Copyright © 2015 by Godswill Ntsomboh Ntsefong.

ISBN:      Softcover      978-1-5035-6437-4

                eBook         978-1-5035-6436-7

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Rev. date: 04/23/2015

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Table of Contents

Dedication

Preface

Abbreviations

Acknowledgement

Introduction

Chapter 1 Laboratory or Test Facility management basics

SAFETY TRAINING

LABORATORY ADMINISTRATION

The Laboratory Organigramme

The Laboratory Manager

The Quality Manager

The IT Manager

Documentation Officer

Financial Officer

Chief Laboratory Technician

Chapter 2 Laboratory design considerations

OBJECTIVES AND PRECONDITIONS

Safety issues in Laboratory building design

Safe access

Sanitation considerations

Electrical and plumbing considerations

Chapter 3 Good Laboratory Practices

USE OF SOPS AND QUALITY MANUAL

USE OF MATERIAL SAFETY DATA SHEETS

LABELING AS A GLP

WORK PRACTICE AND ENGINEERING CONTROLS

USE OF PERSONAL PROTECTIVE EQUIPMENT

Establishing a PPE program

CATEGORIES OF PPE

Chapter 4 Biosafety and Biosecurity

THE RATIONALE FOR BIOSAFETY AND BIOSECURITY

RISK ASSESSMENT FOR BIOSAFETY AND BIOSECURITY

LABORATORY BIOSECURITY

Brief on the American Biosecurity experience

LABORATORY BIOSAFETY

Biosafety potentials for consideration as a separate academic discipline

Laboratory classification into Biosafety Levels

BSL-I Laboratory

BSL-II Laboratory

BSL-III Laboratory

BSL-IV Laboratory

Laboratory classification based on context and threat

The SARS-CoV experience

MANAGEMENT OF LABORATORY WASTE AS A GLP

Historical background of waste management

Laboratory waste management

Environmental impacts of Laboratory wastes and operations

Chapter 5 Procurement of Laboratory Supplies

LABORATORY GOODS AND SERVICES

LABORATORY SUPPLY CHAIN MANAGEMENT

Chapter 6 Laboratory equipment operation

CATEGORIES OF LABORATORY EQUIPMENT

LABORATORY EQUIPMENT MAINTENANCE

Chapter 7 Laboratory information management system

CORE FUNCTIONALITIES ASSOCIATED WITH LIMS

LIMS ARCHITECTURES

Thick-client LIMS

Thin-client LIMS

Hybrid LIMS architecture

Web-enabled LIMS architecture

Web-based LIMS architecture

Some limitations of LIMS

A case study of LIMS

Chapter 8 Quality Control and Quality Assurance

QUALITY CONTROL

QUALITY SYSTEM

QUALITY ASSURANCE

TOTAL QUALITY MANAGEMENT

Chapter 9 Laboratory Accreditation

ACCREDITATION PROCESS ESSENTIALS AND REQUIREMENTS

IMPLEMENTATION OF ACCREDITATION AT NATIONAL LEVEL

NATIONAL ACCREDITATION STANDARDS, A STEP TOWARDS CONFORMITY WITH INTERNATIONAL STANDARDS

INTERNATIONAL STANDARDS FOR LABORATORY ACCREDITATION

BENEFITS OF LABORATORY ACCREDITATION

Chapter 10 Ethical issues in research management

SOME STRATEGIES TO IMPLEMENT ETHICS

Material transfer and ethics

Conclusion

References

Dedication

I dedicate this work to my beloved father Nde Fomenop Thomas Ntsefong, whom I know would have been elated if still alive today, to see and appreciate the fruits of the precious moral and ethical education he gave me as heritage.

Preface

Within the last two decades, the phenomenon of management has acquired a remarkable visibility. The challenges of organizational management are directly related to economic growth, social development and the policy choices of societies. By developing this theme on the laboratory, a structure for research, diagnosis, prevention or production, the author recognizes it as a context where the future/wellbeing of people is designed and decided. Meanwhile, there are real gaps between technical knowhow and management, as well as between general management and laboratory management, the general objectives of laboratories must be attained for their activities to keep running smoothly and for their efficient contribution to the quality of life. The focus on the laboratory as an entity comprising all specialties is pertinent of this book.

Technologist, laboratory technician, operator, and laboratorian, are some designations of those who work day and night in various scientific domains. Usually considered as executors, their efficacy is limited when it comes to planning, organizing, directing and evaluating. The common perception is that such tasks are reserved for others and that being a technical specialist in the laboratory signifies no need of seeing beyond…the objectives of a microscope. Such duties are therefore trusted to others like trained managers or administrators whose basic training has nothing to do with the specified scientific domain. Such leaders find it difficult to make technical specialists understand the importance of putting in place and/or respect of policies, procedures and their application. This results to less implication of the latter, consequently leading to frustration, misunderstanding, wastage, supply shortages, equipment failures, erroneous or less authentic data or results, and bad reputation of laboratories.

The author has met these difficulties through his scientific journey. His interest in research is focused on Plant Biotechnology with a special objective of improving dietary oil quality. The high quality training he received on good laboratory practices and management principles has completely changed his vision on how to work as a laboratory manager. In this book, he puts together information that has been most useful for him to improve on his efficacy. His view is not limited on a precise type of laboratory but covers all scientific domains. Innovative and efficient laboratory management treats the laboratory from a global perspective: biosciences, industrial, and clinical research. The presentation is practical and can constitute a solution to all types of managers and laboratory personnel. From administrative organization to Good Laboratory Practices via Biosafety and Biosecurity and the notion of Quality Control, Quality Assurance and ethics in research, all is well set to give the reader a clear understanding of the importance of laboratory recognition through the process of accreditation.

The book is actually an innovative solution to the problem of laboratory efficiency and can constitute the basic competence of the laboratory. It can help to manage a laboratory project or develop a private or public career, while re-orientating or equiping in the jungle of laboratory careers. This document can valuably serve as course material for lectures in scientific programs of training institutions and universities, in order that the management culture is inculcated right at the foundation of scientific training.

Are you a manager, biologist, technician, trainer or lecturer? Discover the content of "Innovative and efficient laboratory management" and progressively ‘unveil the blind’ that has so far prevented you from being efficient in the administrative organization of your laboratory, or in Good Laboratory Practices, Biosafety and Biosecurity, management of equipment, reagents and supplies, or in putting in place of a Quality System and the practice of Quality Control. The content can equally lead to an engagement in a sure process towards accreditation as the ultimate formal recognition of the quality of services of your laboratory.

Georgette NDONGO NKENG épse EKANGA

Biologist/Specialist in Management of Health Services

Chief of Medico-Sanitary Techniques Services

University Teaching Hospital (CHU) Yaounde, Cameroon

Abbreviations

ABSA: American Biological Safety Association

AEL: Airborne Exposure Limits

AMR: Analytical Measurement Range

APLAC: Asia Pacific Laboratory Accreditation Cooperation

BATA: Biological Agents and Toxins Act (Singapore)

BBFC: Bioscience-Bioethics Friendship Co-operative

BecA-ILRI Hub, Nairobi – Kenya

BLQS: The Bureau of Laboratory Quality and Standards (Thailand)

BMBL: National Institutes of Health Biosafety in Microbiological and Biomedical Laboratories of the United States of America.

BSE: Bovine Spongiform Encephalopathy (mad cow disease)

BSL: Biosafety Level

BW: Biowarfare

CDC: Centers for Disease Control and Prevention (USA)

CEREPAH: CEntre specialisé de REcherche sur le PAlmier à Huile de La Dibamba

CFRs: Codes of Federal Regulations

CJD: Creutzfeldt Jakob disease

CRR: Clinically Reportable Range

CWM: Clinical Waste Management

DRID: Deliberately Reemerging Infectious Disease (bioterrorism)

EQAS: External Quality Assessment Schemes

GCLP: Good Clinical Laboratory Practice

GLP: Good Laboratory Practice

GMM: Genetically Modified Microorganism

GMP: Good Manufacturing Practices

HIV: Human Immunodeficiency Virus

IEC: International Electrotechnical Commission

ILAC: International Laboratory Accreditation Cooperation

IP: Intellectual Property

IQC: Internal Quality Control

IRAD: Institute of Agricultural Research for Development, Cameroon

ISO: International Standardization Organization

IT: Information Technology

KAN: National Accreditation Committee (Indonesia)

LAIs: Laboratory acquired infections (e.g. SARS, Ebola, vaccinia)

LIMS: Laboratory information management system

LIS: Laboratory Information System

LSDG: Laboratory Standard and Design Guide (Stanford)

MOHSW: Lesotho Ministry of Health and Social Welfare

MRA: Mutual Recognition of Accredited results

MSDS: Material Safety Data Sheets

MSW: Maintenance, Support, and Warranty

MTA: Material Transfer Agreements

NABL: National Accreditation Board for Testing and Calibration Laboratories (India)

NJDHSS: New Jersey Department of Health and Senior Services

OSHA: Occupational Safety and Health Administration of the U.S. Department of Labor

P&P: Laboratory process and procedure

PEL: Permissible Exposure Limit