Laboratory Quality Management System Handbook (PDF)

Laboratory Quality Management System Handbook WHO Library Cataloguing-in-Publication Data Laboratory quality management system: handbook. 1.Laboratories — organization and administration. 2. Laboratories — handbooks. 3.Laboratories techniques and procedures — standards. 4.Quality contr...

Laboratory Quality Management System Handbook WHO Library Cataloguing-in-Publication Data Laboratory quality management system: handbook. 1.Laboratories — organization and administration. 2. Laboratories — handbooks. 3.Laboratories techniques and procedures — standards. 4.Quality control. 5.Manuals. I.World Health Organization. ISBN 978 92 4 154827 4 (NLM classification: QY 25) © World Health Organization 2011 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed in France Contacts WHO Lyon Office – International Health Regulations Coordination 58 avenue Debourg – 69007 Lyon – France [email protected] CDC – National Center for Preparedness, Detection and Control of Infectious Diseases (NCPDCID) 1600 Clifton Road – Atlanta, GA – USA [email protected] Clinical and Laboratory Standards Institute 940 West Valley Road, Suite 1400 Wayne, PA 19087 – USA [email protected] Laboratory Quality Management System Table of contents Acknowledgements........................................................................................................p 4 Foreword...........................................................................................................................p 5 Key words..........................................................................................................................p 6 1. Introduction to quality................................................................................................p 7 1-1: The importance of laboratory quality...............................................................................................p 8 1-2: Overview of the quality management system...............................................................................p 9 1-3: The quality management system model.........................................................................................p 11 1-4: History of laboratory quality management..................................................................................p 14 1-5: International laboratory standards..................................................................................................p 15 1-6: Summary...............................................................................................................................................p 16 2. Facilities and safety................................................................................................... p 17 2-1: Overview..............................................................................................................................................p 18 2-2: Laboratory design..............................................................................................................................p 20 2-3: Geographic or spatial organization................................................................................................p 21 2-4: Physical aspects of premises and rooms........................................................................................p 22 2-5: Safety management programme.....................................................................................................p 23 2-6: Identification of risks.........................................................................................................................p 25 2-7: Personal protective equipment........................................................................................................p 29 2-8: Emergency management and first aid.............................................................................................p 30 2-9: Summary...............................................................................................................................................p 32 3. Equipment................................................................................................................... p 33 3-1: Overview.............................................................................................................................................p 34 3-2: Selecting and acquiring equipment.................................................................................................p 36 3-3: Getting equipment ready for service............................................................................................p 38 3-4: Implementing an equipment maintenance programme..............................................................p 40 3-5: Troubleshooting, service, repair and retiring equipment...........................................................p 42 3-6: Equipment maintenance documentation......................................................................................p 44 3-7: Summary...............................................................................................................................................p 46 4. Purchasing and inventory.................................................................................. p 47 4-1: Overview.............................................................................................................................................p 48 4-2: Purchasing............................................................................................................................................p 50 4-3: Implementing an inventory management programme...............................................................p 51 4-4: Quantification......................................................................................................................................p 52 4-5: Forms and logs...................................................................................................................................p 54 4-6: Receipt and storage of supplies.......................................................................................................p 55 4-7: Monitoring inventory........................................................................................................................p 57 4-8: Summary...............................................................................................................................................p 58 5. Process control—sample management.............................................................. p 59 5-1: Overview..............................................................................................................................................p 60 5-2: The laboratory handbook..................................................................................................................p 61 5-3: Collection and preservation............................................................................................................p 62 5-4: Sample processing...............................................................................................................................p 64 5-5: Sample storage, retention and disposal.........................................................................................p 66 5-6: Sample transport................................................................................................................................p 67 5-7: Summary...............................................................................................................................................p 70 Laboratory Quality Management System 1  6. Process control—introduction to quality control............................................. p 71 6-1: Introduction........................................................................................................................................p 72 7. Process control—quality control for quantitative tests................................... p 75 7-1: Overview.............................................................................................................................................p 76 7-2: Control materials...............................................................................................................................p 77 7-3: Establishing the value range for the control material.................................................................p 79 7-4: Graphically representing control ranges........................................................................................p 84 7-5: Interpreting quality control data....................................................................................................p 85 7-6: Using quality control information..................................................................................................p 87 7-7: Summary...............................................................................................................................................p 88 8. Process control—quality control for qualitative and semiquantitative procedures.................................................................................. p 89 8-1: Overview..............................................................................................................................................p 90 8-2: Quality control materials.................................................................................................................p 92 8-3: Quality control of stains....................................................................................................................p 94 8-4: Quality control of microbiological media......................................................................................p 96 8-5: Summary...............................................................................................................................................p 98 9. Assessment—audits.................................................................................................. p 99 9-1: Overview.......................................................................................................................................... p 100 9-2: External audit.................................................................................................................................... p 103 9-3: Internal audit..................................................................................................................................... p 105 9-4: Internal audit programme.............................................................................................................. p 106 9-5: Actions as result of audit............................................................................................................... p 108 9-6: Summary........................................................................................................................................... p 109 10. Assessment—external quality assessment..................................................... p 111 10-1: Overview......................................................................................................................................... p 112 10-2: Proficiency testing.......................................................................................................................... p 115 10-3: Other external quality assessment methods......................................................................... p 117 10-4: Comparison of external quality assessment methods........................................................... p 119 10-5: Managing external quality assessment in the laboratory..................................................... p 120 10-6: Summary.......................................................................................................................................... p 122 11. Assessment—norms and accreditation........................................................... p 123 11-1: Overview......................................................................................................................................... p 124 11-2: International standards and standardization bodies............................................................. p 125 11-3: National standards and technical guidelines........................................................................... p 127 11-4: Certification and accreditation................................................................................................... p 129 11-5: Process of accreditation............................................................................................................... p 132 11-6: Benefits of accreditation............................................................................................................. p 133 11-7: Summary.......................................................................................................................................... p 134 12. Personnel............................................................................................................... p 135 12-1: Overview........................................................................................................................................ p 136 12-2: Recruitment and orientation..................................................................................................... p 138 12-3: Competency and competency assessment............................................................................. p 140 12-4: Training and continuing education.............................................................................................. p 143 12-5: Employee performance appraisal.............................................................................................. p 145 12-6: Personnel records.......................................................................................................................... p 147 12-7: Summary.......................................................................................................................................... p 148 2 Laboratory Quality Management System 13. Customer service................................................................................................. p 149 13-1: Overview........................................................................................................................................ p 150 13-2: The laboratory clients—the customers................................................................................... p 152 13-3: Assessing and monitoring customer satisfaction................................................................... p 155 13-4: Customer satisfaction surveys.................................................................................................... p 156 13-5: Summary.......................................................................................................................................... p 158 14. Occurrence management.................................................................................. p 159 14-1: Overview......................................................................................................................................... p 160 14-2: Sources and consequences of laboratory error..................................................................... p 161 14-3: Investigation of occurrences........................................................................................................ p 163 14-4: Rectifying and managing occurrences........................................................................................ p 164 14-5: Summary.......................................................................................................................................... p 166 15. Process improvement......................................................................................... p 167 15-1: Continual improvement concept............................................................................................... p 168 15-2: Tools for process improvement.................................................................................................. p 170 15-3: Quality indicators.......................................................................................................................... p 172 15-4: Selecting quality indicators.......................................................................................................... p 173 15-5: Implementing process improvement......................................................................................... p 176 15-6: Summary......................................................................................................................................... p 178 16. Documents and records..................................................................................... p 179 16-1: Introduction.................................................................................................................................... p 180 16-2: Overview of documents............................................................................................................... p 181 16-3: The quality manual......................................................................................................................... p 184 16-4: Standard operating procedures (SOPs).................................................................................... p 185 16-5: Document control......................................................................................................................... p 188 16-6: Overview of records..................................................................................................................... p 191 16-7: Storing documents and records................................................................................................. p 193 16-8: Summary.......................................................................................................................................... p 194 17. Information management.................................................................................... p 195 17-1: Overview......................................................................................................................................... p 196 17-2: Elements of information management...................................................................................... p 197 17-3: Manual paper-based systems....................................................................................................... p 200 17-4: Computerized laboratory information systems..................................................................... p 202 17-5: Summary.......................................................................................................................................... p 205 18. Organization.......................................................................................................... p 207 18-1: Organizational requirements for a quality management system......................................... p 208 18-2: Management role........................................................................................................................... p 210 18-3: Organizational structure.............................................................................................................. p 212 18-4: Organizational functions: planning.............................................................................................. p 214 18-5: Organizational functions: implementation................................................................................ p 216 18-6: The laboratory quality manual.................................................................................................... p 218 18-7: Summary.......................................................................................................................................... p 220 Glossary....................................................................................................................... p 221 Acronyms...................................................................................................................... p 233 References and resources by chapter.................................................................... p 235 Notes............................................................................................................................. p 243 Laboratory Quality Management System 3  Acknowledgements This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. WHO, the CDC and the CLSI would like to acknowledge with thanks all those who contributed to the development and review of this training package, more specifically: Adilya Albetkova Robin Barteluk Anouk Berger Sébastien Cognat Carlyn Collins Philippe Dubois Christelle Estran Glen Fine Sharon Granade Stacy Howard Devery Howerton Kazunobu Kojima Xin Liu Jennifer McGeary Robert Martin Sylvio Menna Michael Noble Antoine Pierson Anne Pollock Mark Rayfield John Ridderhof Eunice Rosner Joanna Zwetyenga 4 Laboratory Quality Management System Foreword Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the “12 Quality System Essentials”. A diagram representing these 12 essentials is shown below. Organization Personnel Equipment Purchasing Process Information and control management inventory Documents Occurrence and Assessment management records Facilities Process Customer and improvement service safety Laboratory Quality Management System 5  Note: Health laboratories, in this handbook, is a term that is meant to be inclusive of clinical laboratories, diagnostic laboratories, medical laboratories, public health laboratories, animal and environmental health laboratories or any other laboratories performing testing for the purpose of disease diagnosis, screening, prevention, medical treatment decisions, surveillance or public health. Because all these terms for laboratories are frequently used interchangeably, the terms may likewise be used interchangeably in this handbook. Key words Laboratory quality management system, laboratory quality, laboratory quality systems, laboratory information management, laboratory information system, laboratory documents and records, laboratory quality manual, quality control, laboratory facilities and safety, laboratory equipment, laboratory sample management, laboratory sample transport, laboratory purchasing and inventory, laboratory assessment, laboratory customer service, occurrence management, process improvement, quality essentials, laboratory process control, clinical laboratory, ISO 15189. 6 Laboratory Quality Management System 1. Introduction to quality  1-1: The importance of laboratory quality Definition of Laboratory quality can be defined as accuracy, reliability and timeliness of reported quality test results. The laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely in order to be useful in a clinical or public health setting. Level of accuracy When making measurements, there is always some level of inaccuracy. The required challenge is to reduce the level of inaccuracy as much as possible, given the limitations of our testing systems. An accuracy level of 99% may at first glance appear acceptable, but the resulting 1% error can become quite large in a system where many events occur, such as laboratory testing. Negative Laboratories produce test results that are widely used in clinical and public consequences of health settings, and health outcomes depend on the accuracy of the testing laboratory error and reporting. If inaccurate results are provided, the consequences can be very significant, including:  unnecessary treatment  treatment complications  failure to provide the proper treatment  delay in correct diagnosis  additional and unnecessary diagnostic testing. These consequences result in increased cost in time and personnel effort, and often in poor patient outcomes. Minimizing In order to achieve the highest level of accuracy and reliability, it is essential laboratory error to perform all processes and procedures in the laboratory in the best possible way. The laboratory is a complex system, involving many steps of activity and many people. The complexity of the system requires that many processes and procedures be performed properly. Therefore, the quality management system model, which looks at the entire system, is very important for achieving good laboratory performance. 8 Laboratory Quality Management System  1-2: Overview of the quality management system Definition of A quality management system can be defined as “coordinated activities to direct quality and control an organization with regard to quality”. This definition is used by management the International Organization for Standardization (ISO) and by the Clinical and system Laboratory Standards Institute (CLSI). Both groups are internationally recognized laboratory standards organizations, and will be discussed later in this handbook. In a quality management system, all aspects of the laboratory operation, including the organizational structure, processes and procedures, need to be addressed to assure quality. Patient client prep Sample collection Pre- exa m i na Reporting tio n on xaminati Personnel competency test evaluations HIGH Sample receipt and accessioning Post-e LOW Record keeping Sample transport Quality control Ex testing amin ation Complexity There are many procedures and processes that are performed in the laboratory, of laboratory and each of these must be carried out correctly in order to assure accuracy processes and reliability of testing. An error in any part of the cycle can produce a poor laboratory result. A method of detecting errors at each phase of testing is needed if quality is to be assured. Laboratory Quality Management System 9  1-2: Overview of the quality management system ISO standards group laboratory processes into pre-examination, examination and post-examination categories. Comparable terms in current laboratory use include: pre-analytic, analytic and post-analytic processes; or pre-test, test and post-test processes. Path of workflow The entire set of operations that occur in testing is called the path of workflow. The path of workflow begins with the patient and ends in reporting and results interpretation, as shown in the figure below. The concept of the path of workflow is a key to the quality model or the quality management system, and must be considered when developing quality practices. For example, a sample that is damaged or altered as a result of improper collection or transport cannot provide a reliable result. A medical report that is delayed or lost, or poorly written, can negate all the effort of performing the test well. Test The patient selection Sample collection Pr e e xa mi na t i o n ph ase Sample transport Laboratory analysis Examination phase t io n p a s e h Report i na creation am Report transport ex st Po ti on R e s ult int e r p r e t a Quality The complexity of the laboratory system requires that many factors must be management addressed to assure quality in the laboratory. Some of these factors include: system addresses  the laboratory environment all processes  quality control procedures  communications  record keeping  competent and knowledgeable staff  good-quality reagents and equipment. 10 Laboratory Quality Management System  1-3: The quality management system model Overview of When all of the laboratory procedures the quality and processes are organized into Organization Personnel Equipment management an understandable and workable system model structure, the opportunity to ensure that all are appropriately managed Purchasing is increased. The quality model used and Process Information control management here organizes all of the laboratory inventory activities into 12 quality system Path of workflow essentials. These quality system Documents essentials are a set of coordinated and Occurrence Assessment management activities that serve as building blocks records for quality management. Each must be addressed if overall laboratory quality improvement is to be achieved. This Process Customer Facilities and quality management system model improvement service safety was developed by CLSI,1 and is fully compatible with ISO standards.2,3 Assuring accuracy and reliability throughout the path of workflow depends on good management of all of the quality essentials. Organization In order to have a functioning quality management system, the structure and management of the laboratory must be organized so that quality policies can be established and implemented. There must be a strong supporting organizational structure—management commitment is crucial—and there must be a mechanism for implementation and monitoring. Personnel The most important laboratory resource is competent, motivated staff.The quality management system addresses many elements of personnel management and oversight, and reminds us of the importance of encouragement and motivation. Equipment Many kinds of equipment are used in the laboratory, and each piece of equipment must be functioning properly. Choosing the right equipment, installing it correctly, ensuring that new equipment works properly, and having a system for maintenance are all part of the equipment management programme in a quality management system. 1 CLSI/NCCLS. A quality management system model for health care; approved guideline—second edition, CLSI/NCCLS document HS1-A2. Wayne, PA, NCCLS, 2004. 2 ISO 15189:2007. Medical laboratories–particular requirements for quality and competence. Geneva: International Organization for Standardization, 2007. 3 ISO 9001:2000. Quality management systems–requirements. Geneva: International Organization for Standardization, 2000. Laboratory Quality Management System 11  1-3: The quality management system model Purchasing and The management of reagents and supplies in the laboratory is often a challenging inventory task. However, proper management of purchasing and inventory can produce cost savings in addition to ensuring supplies and reagents are available when needed. The procedures that are a part of management of purchasing and inventory are designed to ensure that all reagents and supplies are of good quality, and that they are used and stored in a manner that preserves integrity and reliability. Process control Process control is comprised of several factors that are important in ensuring the quality of the laboratory testing processes.These factors include quality control for testing, appropriate management of the sample, including collection and handling, and method verification and validation. The elements of process control are very familiar to laboratorians; quality control was one of the first quality practices to be used in the laboratory and continues to play a vital role in ensuring accuracy of testing. Information The product of the laboratory is information, primarily in the form of test management reporting. Information (data) needs to be carefully managed to ensure accuracy and confidentiality, as well as accessibility to the laboratory staff and to the health care providers. Information may be managed and conveyed with either paper systems or with computers; both will be discussed in the section on information management. Many of the 12 quality system essentials overlap. A good example is the close Documents and relationship between "Documents and records" and "Information management". records Documents are needed in the laboratory to inform how to do things, and laboratories always have many documents. Records must be meticulously maintained so as to be accurate and accessible. Occurrence An “occurrence” is an error or an event that should not have happened. A system management is needed to detect these problems or occurrences, to handle them properly, and to learn from mistakes and take action so that they do not happen again. Assessment The process of assessment is a tool for examining laboratory performance and comparing it to standards, benchmarks or the performance of other laboratories. Assessment may be internal (performed within the laboratory using its own staff) or it may be external (conducted by a group or agency outside the laboratory). Laboratory quality standards are an important part of the assessment process, serving as benchmarks for the laboratory. 12 Laboratory Quality Management System  1-3: The quality management system model Process The primary goal in a quality management system is continuous improvement of improvement the laboratory processes, and this must be done in a systematic manner.There are a number of tools that are useful for process improvement. Customer The concept of customer service has often been overlooked in laboratory practice. service However, it is important to note that the laboratory is a service organization; therefore, it is essential that clients of the laboratory receive what they need. The laboratory should understand who the customers are, and should assess their needs and use customer feedback for making improvements. Facilities and Many factors must be a part of the quality management of facilities and safety. safety These include:  Security—which is the process of preventing unwanted risks and hazards from entering the laboratory space.  Containment—which seeks to minimize risks and prevent hazards from leaving the laboratory space and causing harm to the community.  Safety—which includes policies and procedures to prevent harm to workers, visitors and the community.  Ergonomics—which addresses facility and equipment adaptation to allow safe and healthy working conditions at the laboratory site. Quality In the quality management system model, all 12 quality system essentials must management be addressed to ensure accurate, reliable and timely laboratory results, and to system model have quality throughout the laboratory operations. It is important to note that the 12 quality system essentials may be implemented in the order that best suits the laboratory. Approaches to implementation will vary with the local situation. Laboratories not implementing a good quality management system are guaranteed that there will be many errors and problems occurring that may go undetected. Implementing a quality management system may not guarantee an error-free laboratory, but it does yield a high-quality laboratory that detects errors and prevents them from recurring. Laboratory Quality Management System 13  1-4: History of laboratory quality management Definition ISO 9000 defines quality management as “coordinated activities to direct and of quality control an organization with regard to quality”. This is intimately related to the management definition of a quality system—“organizational structure, resources, processes and procedures needed to implement quality management”. Quality management concepts in use today had their onset in the 20th century, and are primarily an outgrowth of manufacturing and shop processes. Principal One of the earliest concepts of the quality management movement was that innovators of quality control of the product. Shewhart developed a method for statistical and their process control in the 1920s, forming the basis for quality control procedures in contributions the laboratory. Quality control methods were not applied in the laboratory until the 1940s. Other critical thinkers and innovators, including Arman Feigenbaum, Kaoru Ishikawa and Genichi Taguchi, added to the concepts. The most recent method that is of importance to the laboratory is Galvin’s work on micro-scale error reduction. Quality management is not new. 14 Laboratory Quality Management System  1-5: International laboratory standards Need for international A part of quality management is assessment, measuring performance against laboratory standards a standard or benchmark. The concept of quality management requires that standards be set, and again industry has been in the lead. Important laboratory Using a set of standards established by the United States of America military for standards organizations the manufacture and production of equipment, the ISO established standards for industrial manufacturing; we know these standards as ISO standards. The ISO 9000 documents provide guidance for quality in manufacturing and ISO service industries, and can be broadly applied to many other kinds of organizations. ISO 9001:2000 addresses general quality management system requirements and applies to laboratories. There are two ISO standards that are specific to laboratories:  ISO 15189:2007. Medical laboratories—particular requirements for quality and competence. Geneva: International Organization for Standardization, 2007.  ISO/IEC 17025:2005. General requirements for the competence of testing and calibration laboratories. Geneva: International Organization for Standardization, 2005. Another important international standards organization for laboratories is the CLSI Clinical and Laboratory Standards Institute, or CLSI, formerly known as the National Committee for Clinical Laboratory Standards (NCCLS). CLSI uses a consensus process involving many stakeholders for developing standards. CLSI developed the quality management system model used in this handbook. This model is based on 12 quality system essentials, and is fully compatible with ISO laboratory standards. CLSI has two documents that are very important in the clinical laboratory:  A quality management system model for health care; approved guideline—second edition. CLSI/NCCLS document HS1-A2. Wayne, PA, NCCLS, 2004.  Application of a quality management system model for laboratory services; approved guideline—third edition. CLSI/NCCLS document GP26-A3. Wayne, PA, NCCLS, 2004. The information in this handbook is based on the CLSI quality management system model and the ISO 15189 standard. There are many other standards organizations, and many examples of laboratory Other standards. Some countries have established national laboratory quality standards standards that apply specifically to laboratories within the country. Some laboratory standards apply only to specific areas in the laboratory or only to specific tests. The World Health Organization has established standards for some specific programmes and areas. Laboratory Quality Management System 15  1-6: Summary Quality Quality management is not new; it grew from the work of innovators who defined management quality over a span of 80 years. Quality management is as applicable for the medical laboratory as it is for manufacturing and industry. Key messages  A laboratory is a complex system and all aspects must function properly to achieve quality.  Approaches to implementation will vary with the local situation.  Start with changes that can be easily accomplished and have the biggest impact.  Implement in a stepwise process but ultimately, all quality essentials must be addressed. 16 Laboratory Quality Management System 2. Facilities and safety  2-1: Overview Role in quality The laboratory work space and facilities management must be such that the workload can Organization Personnel Equipment system be performed without compromising the quality of work and the safety of the laboratory staff, other health care personnel, patients and the community. Purchasing Process Information and control management inventory This chapter will describe essential elements for laboratory design and safety that prevent and control Documents Occurrence exposure to physical, chemical and and management Assessment records biological hazards. This chapter addresses pathogens Facilities Process Customer and chemicals of moderate or low- improvement service and safety level risk, rather than highly dangerous substances. As a general rule, all diagnostic laboratories should be designed and organized for biosafety level 2 or above. Importance of A laboratory safety programme is important in order to protect the lives of safety employees and patients, to protect laboratory equipment and facilities, and to protect the environment. Neglecting laboratory safety is very costly. Secondary effects of a laboratory accident are:  loss of reputation  loss of customers / loss of income  negative effect on staff retention  increased costs—litigation, insurance. Responsibilities Ensuring quality and safety during laboratory processes is a major concern for laboratory managers. Often, the laboratories they manage are designed by architects and/or administrators who have little knowledge of specific laboratory needs, making the job of the manager more difficult. As a laboratory director, it is important to:  actively participate in the design and planning stages of new laboratory facilities;  assess all potential risks and apply basic concepts of organization in order to provide a proper and safe environment for conducting laboratory activities, including services to patients;  consider the organization of the laboratory when developing new activities or new diagnostic techniques in the laboratory. 18 Laboratory Quality Management System 2-1: Overview As a quality manager (or designated safety officer), it is necessary to:  develop a complete and thorough description of basic safety rules and organization, and ensure that personnel are trained in their specific duties when new activities or techniques are introduced into the laboratory;  know the basics of safety and biosafety management issues when working with chemicals and pathogens of moderate or low level of risk;  know how to perform an extensive risk assessment when developing new activities in the laboratory;  conduct laboratory safety audits. As a laboratorian, it is important to:  be aware of basic safety rules and processes;  understand the basics of safety and biosafety management issues when working with toxic chemicals, biological samples and physical hazards, and when interacting with patients. Everyone in the laboratory is responsible for quality and safety. Laboratory Quality Management System 19  2-2: Laboratory design Access When designing a laboratory or organizing workflow, ensure that patients and patient samples do not have common pathways. Circulation paths should be designed in such a way that contact between the public and biological materials can occur only in the rooms where patient samples are collected. The reception desk where incoming patients register should be located as close as possible to the entry door. Access to rooms where manipulation or analysis of samples takes place, or where hazardous chemicals or other materials are stored, must be restricted to authorized persons, usually laboratory technical staff and maintenance staff. Restriction of access may be accomplished using signs on doors, locks when appropriate and staff identification badges. Circulation To identify where improvements in laboratory design may be needed in order pathways to prevent or reduce risks of cross-contamination, follow the path of the sample as it moves through the laboratory during the pre-examination, examination and post-examination phases of testing. Pathways to assess include:  Sample collection areas—a laboratory layout with both the reception and the sample collection room located at the entrance saves time and energy.  Sample processing areas—here, samples are centrifuged as needed, allocated for different examinations and dispersed to the appropriate sections of the laboratory for analysis. If possible, the sample processing area should be separated from, but nearby, the testing areas.  Start with changes that can be easily accomplished and have the biggest impact.  Circulation pathways of biological samples between different sections of the laboratory—These pathways should be assessed for the purpose of minimizing contamination risks. If possible, circulation pathways of clean and dirty laboratory materials should never cross, and circulation pathways of contaminated waste should be isolated.  Post-examination pathways—After the analysis of the samples, the results must be accurately recorded, properly filed, and delivered on time to the right person. Communication systems appropriate to the size and complexity of the laboratory, including the efficient and reliable transferring of messages, should be part of the laboratory design. For the most efficient design, all related services should be located in close proximity. 20 Laboratory Quality Management System  2-3: Geographic or spatial organization Distribution of When organizing laboratory work space, divide the laboratory into areas with activities different access control in order to separate patients from biological samples. Where samples are actually processed, plan for spatial organization that ensures the best service. For optimal organization of the laboratory, consider:  Delineation of laboratory activities—Care should be taken to either group related activities in a single room, or to clearly delineate bench space for specific activities. Measures must be taken to prevent cross-contamination of samples.  Location of service rooms—Service rooms to accommodate autoclaves, sinks for cleaning glassware, preparation and sterilization of culture media, and so on, should be located in a central area to minimize distances and facilitate circulation paths of materials, samples and goods. A responsible staff member should be designated to oversee cleaning and maintenance of the service rooms.  Location of activities with specific requirements, such as: - molecular biology—needs to be located in a separate space, with at least two rooms, so that preparation of DNA extracts is not performed in the same room as where the subsequent steps (preparation of reagent mixes and DNA amplification) are performed; - fluorescence microscopy—requires a dark room with proper ventilation which must not be used for storage of stock materials and other chemicals; - ultraviolet illumination systems for DNA gel photography—requires a dark room and appropriate eye protection equipment. Spatial The laboratory director and safety officer must consider special needs for equipment provision for when designing laboratory space. Some things to consider are: equipment  Access to equipment for entry and maintenance—Make sure that there are no physical restrictions for access, such as door and elevator size, that could pose a problem for the delivery and maintenance of new machines and equipment.  Power supply—Consider the need for a stable power supply for sensitive equipment and a backup power supply or emergency generator for times when the laboratory’s primary power source is down.  Managing disposal of liquids from equipment—Disposal of liquid reagents, by- products and wastes from laboratory equipment and procedures is a major concern for laboratories. When placing equipment in the laboratory, be sure to consider how liquid wastes will be handled. It is important to be aware of, and comply with, local and national requirements for liquid waste disposal, in order to prevent contamination of community sewage systems with pathogens or toxic chemicals. Laboratory Quality Management System 21  2-4: Physical aspects of premises and rooms Facilities The laboratory must be designed to ensure proper ventilation throughout, with an active ventilation system and adequate space for circulation of people, laboratory carts and trolleys. Rooms should have a high ceiling to ensure proper ventilation, and walls and ceilings should be painted with washable, glossy paint or coated with a material suitable for cleaning and disinfection.The floor must also be easy to clean and disinfect, and have no edges between the walls and floor. Work benches Laboratory work benches should be constructed of materials that are durable and easy to disinfect. If the laboratory’s budget allows, ceramic tiles are good materials to use for benchtops, as they are easy to clean and are resistant to deterioration from harsh disinfectants and aggressive cleaning products. However, be aware that the grout between them can sometimes harbour contaminating microorganisms, so must be disinfected regularly. Wood should not be used, as it is not easy to clean or disinfect, and will deteriorate over time when repeatedly exposed to disinfectants and detergents. Wood also support the growth of contaminants when wet or damaged. The disadvantage of using steel for benchtops is that steel will rust when washed with chlorine. It is advisable to organize work benches according to the type of analysis that is performed, with adequate space for benchtop equipment and enough space to place a standard operating procedure while in use and display job aids. In areas where microbiology procedures are performed, work benches should be separated according to the different types of samples or pathogens that are analyzed, in order to minimize risks of cross-contamination. Cleaning It is very important that all areas of the laboratory are cleaned and maintained on a regular basis. Examples of areas that need daily attention are:  Benchtops—clean and disinfect benchtops after completing examinations, and after any spills of samples or reagents.This responsibility is generally assigned to the technical staff performing the tests.  Floors—these are usually cleaned by cleaning staff, unless restricted access allows only technical staff to disinfect the floors at the end of the day. Other areas of the laboratory should be scheduled for cleaning on a weekly or monthly basis, depending on laboratory conditions. For example, ceilings and walls may require cleaning weekly, whereas items such as refrigerators and storage areas might be scheduled for a monthly cleaning. Cleaning and disinfection of laboratory areas should be recorded, including the date and name of the person performing the maintenance. 22 Laboratory Quality Management System  2-5: Safety management programme Developing a Often, the responsibility for developing a safety programme and organizing laboratory safety appropriate safety measures for the laboratory is assigned to a laboratory safety programme officer. In smaller laboratories, the responsibility for laboratory safety may fall to the laboratory manager or even to the quality officer. The steps for designing a safety management programme include:  developing a manual to provide written procedures for safety and biosafety in the laboratory;  organizing safety training and exercises that teach staff to be aware of potential hazards and how to apply safety practices and techniques—training should include information about universal precautions, infection control, chemical and radiation safety, how to use personal protective equipment (PPE), how to dispose of hazardous waste, and what to do in case of emergencies;  setting up a process to conduct risk assessments—this process should include initial risk assessments, as well as ongoing laboratory safety audits to look for potential safety problems. General safety The safety officer should be assigned responsibility for ensuring that there is an equipment adequate supply of appropriate equipment for safety and biosafety, such as:  PPE  fire extinguishers and fire blankets  appropriate storage and cabinets for flammable and toxic chemicals  eye washers and emergency shower  waste disposal supplies and equipment  first aid equipment. Standard safety Policies should be put in place that outline the safety practices to be followed in practices the laboratory. Standard laboratory safety practices include:  limiting or restricting access to the laboratory;  washing hands after handling infectious or hazardous materials and animals, after removing gloves, and before leaving the laboratory;  prohibiting eating, drinking, smoking, handling contact lenses, and applying cosmetics in work areas;  prohibiting mouth pipetting;  using techniques that minimize aerosol or splash production when performing procedures—biosafety cabinets should be used whenever there is a potential for aerosol or splash creation, or when high concentrations or large volumes of infectious agents are used; Laboratory Quality Management System 23  2-5: Safety management programme  preventing inhalation exposure by using chemical fume hoods or other containment devices for vapours, gases, aerosols, fumes, dusts or powders;  properly storing chemicals according to recognized compatibilities—chemicals posing special hazards or risks should be limited to the minimum quantities required to meet short-term needs and stored under appropriately safe conditions (i.e. flammables in flammable storage cabinets)—chemicals should not be stored on the floor or in chemical fume hoods;  securing compressed gas cylinders at all times;  decontaminating work surfaces daily;  decontaminating all cultures, stocks and other regulated wastes before disposal via autoclave, chemical disinfection, incinerator or other approved method;  implementing and maintaining an insect and rodent control programme;  using PPE such as gloves, masks, goggles, face shields and laboratory coats when working in the laboratory;  prohibiting sandals and open-toed shoes to be worn while working in the laboratory;  disposing of chemical, biological and other wastes according to laboratory policies. Procedures and Monthly and yearly exercises must be organized for fire drills and laboratory exercises evacuation procedures. This is an occasion for the safety officer to emphasize risks to laboratory staff and to review with them the specific procedures for evacuation, handling of incidents and basic security precautions. Waste Laboratory waste management is a critical issue. All potentially harmful and management dangerous materials (including liquids and radioactive materials) must be treated in a specific way before disposing. Separate waste containers should be used depending on the nature of the waste, and must be clearly identified by a colour code. Specific attention should be given to the management of potentially harmful contaminated waste such as sharps, needles or broken glassware. Sharps containers must be available on work benches so they are conveniently accessible to staff. Internationally Many labels that give warnings and instructions for safety precautions are recognized labels internationally recognized. A list of websites that provide these labels can be found in the references and resources section. 24 Laboratory Quality Management System  2-6: Identification of risks Laboratories Laboratory workers encounter a significant number of risks, which vary with the are hazardous types of activities and analyses that are performed. environments Risk assessment is compulsory in order for the laboratory director to manage and reduce risks to laboratory employees. Assistance from a safety officer is needed to appreciate potential risks and incorporate appropriate preventive measures. It is important to develop safety procedures that describe what to do in case of accidents, injuries or contamination. In addition, it is important to keep a record of staff exposures to hazards, actions taken when this occurs, and procedures put into place to prevent future occurrences. The outcome of a study of physical Laceration 32% risks encountered by Bruise, sprain, strain, fracture 21% laboratory staff that Chemical exposure 11% was conducted by the Howard Hughes Eye injury 10% Medical Institute Repetitive stress 8% Office of Laboratory Needle puncture 7% Safety is shown in the Animal bite, scratch 4% chart.This study only Burn 3% addressed physical risks, but personnel Other 3% contamination and Allergy 1% infection have been reported in many instances, and recent reports on laboratory-acquired infection leading to severe acute respiratory syndrome (SARS) show that the risks are never reduced to zero, even in high-confinement facilities. Physical Laboratory equipment is a significant source of potential injury to laboratory hazards staff, thus making training in specific safety procedures imperative. Examples of equipment in which safety training and precautions are important include autoclaves, centrifuges, compressed gas cylinders and fume hoods. Many laboratory instruments pose a danger of electrical shock, and some equipment can emit dangerous microwaves or radiation if not properly used or maintained. Storage of compressed gases in the laboratory requires precautions unique to the unusual containers in which these materials are kept, and the high pressures they are subject to. Cylinders are kept chained to the wall so that they cannot fall over. The safety cap must be secured over the valve of the cylinder whenever it is moved or taken out of service. Laboratory Quality Management System 25  2-6: Identification of risks Needles and Needles, broken glass and other sharps need to be handled and disposed of sharps appropriately to prevent risks of infection to laboratory and housekeeping (custodial) staff. Instructions for proper disposal of sharps are:  Avoid needle recapping. If recapping is crucial, the correct procedure is for the person doing the recapping to keep one hand behind the back of the needle, and use the other hand to scoop the cover onto the needle.  Put sharps in a puncture-resistant, leak-proof sharps container. Label the container "Sharps". If the sharps are not biohazardous, deface any biohazard markings or symbols. Seal the container tightly. Laboratory glassware and plasticware are not considered to be sharps for disposal purposes. Laboratory glassware and plasticware include any item that could puncture regular waste bags and therefore endanger waste handlers. Laboratory glass must be placed in cardboard boxes for safety during transport through the building. Any cardboard box may be used, provided it is sturdy and of a size that will not weigh more than 40 pounds when full. Contaminated laboratory glass must be appropriately decontaminated prior to disposal. Never use boxes for the disposal of:  sharps  biohazardous materials that have not been autoclaved  liquid wastes  chemically contaminated laboratory glassware or plasticware  chemical containers that cannot be disposed of as regular solid waste. Chemical hazards Exposure to toxic chemicals poses a real threat to the health and safety of laboratory staff. There are three main routes by which chemicals enter the body.  Inhalation—this is the major route of entry when working with solvents; there is great rapidity of absorption when fumes are inhaled.  Absorption through skin—this may produce systemic poisoning; the condition of the skin determines the rate of absorption. Examples of chemicals with these risks are organic lead, solvents such as xylene and methylene chloride, organophosphate, pesticides and cyanides.  Ingestion—accidental ingestion is generally due to poor hygiene practices, such as eating or smoking in the laboratory. To prevent or reduce incidents caused by exposure to toxic chemicals, all chemicals, including solutions and chemicals transferred from their original containers, should be labelled with their common names, concentrations and hazards. Additional information, such as the date received, date opened and date of expiration, should also be recorded. It is crucial that chemicals are stored properly. Store corrosive, toxic and highly reactive chemicals in a well-ventilated area, and store chemicals that can ignite at room temperature in a flammables cabinet. 26 Laboratory Quality Management System  2-6: Identification of risks Radiochemicals require special precautions, and dedicated benches with specific bench covers for manipulation of radiolabelled elements are needed. Specific storage areas for radioactive materials are needed.These must provide appropriate protection (Plexiglas™, lead) and specific waste containers, depending on the chemical nature of waste and radioactive elements. Material safety The material safety data sheet (MSDS) is a technical bulletin providing detailed data sheet hazard and precautionary information.1 Businesses are required to provide to their customers the MSDS for all chemicals they manufacture or distribute. Laboratories need to heed precautions listed in the MSDS in order to ensure the chemicals they use are handled and stored safely. The MSDS provides: 0  product information;  fire and explosion precautions; FLAMMABILITY  toxicology; 0 0  health effects;  recommended PPE; HEALTH REACTIVITY  storage recommendations; 0  leaks and spills—recommended actions; PROTECTIVE  waste disposal recommendations; EQUIPEMENT  first aid. The MSDS should be:  available to all employees prior to use of hazardous materials;  kept close to where the hazardous material is used and located. Biological hazards Laboratory-acquired infections are not infrequent in medical laboratories. The following tables show the most frequently reported infections acquired in laboratories in the United States of America from 1979 to 1999.2 1 ISO 15190:2003. Medical laboratories—requirements for safety. Geneva: International Organization for Standardization, 2003. 2 Harding AL, Brandt Byers K. Epidemiology of laboratory-associated infections. In: Fleming, DO, Hunt DL, eds. Biological safety: principles and practices. Washington, DC, ASM Press, 2000, 35–54. Laboratory Quality Management System 27  2-6: Identification of risks Disease or agent No. of cases Mycobacterium tuberculosis 223 Q fever 176 Hantavirus 169 Hepatitis B 84 Brucella sp. 81 Salmonella sp. 66 Shigella sp. 56 Hepatitis non-A, non-B 28 Cryptosporidium sp. 27 Total 910 Maximum distance No. Disease Probable source from source infected Brucellosis Centrifugation Basement to 3rd 94 floor Coccidioidomycosis Culture transfer, solid media 2 building floors 13 Coxsackie Spilled tube of infected 5 feet estimated 2 virus infection mouse tissue on floor Murine typhus Intranasal inoculation of mice 6 feet estimated 6 Tularemia 20 petri plates dropped 70 feet 5 Venezuelan 9 lyophilized 4th floor stairs to 24 encephalitis ampoules dropped 3rd or 5th floor Aerosols are the main sources of contamination within diagnostic laboratories; contamination can occur over very long distances. This is why the major target of containment systems is the blockage of aerosol diffusion inside and outside the laboratory. Diagnostic laboratories of physical containment level 2, where activities concern only pathogens of moderate risks, must have appropriate ventilation. Higher containment level laboratories or working cabinets must ensure a continuous inward airflow, as well as absolute filtration of exhausted air, to avoid aerosol dissemination outside the working area or the whole laboratory.1 1 Reitman M, Wedum AG. Microbiological safety. Public Health Reports, 1956, 71(7):659–665. 28 Laboratory Quality Management System  2-7: Personal protective equipment Basic The major routes by which laboratory staff acquire work-related infections are: information  percutaneous inoculation  contact between mucous membranes and contaminated material  accidental ingestion. To reduce the risk of these occurrences, it is imperative that staff have access to PPE, be trained in how to properly use it, and habitually use the PPE while working in the laboratory. Approved goggles, face shields, splatter guards, masks, or other eye and face protection should be worn when handling infectious or other hazardous materials outside the biosafety cabinet. Hand Gloves should be worn in all instances, and should be available to laboratory staff on a protection routine basis. Effective use of gloves relies on two simple practices. 1. Remove gloves when leaving the working area to prevent contamination of other areas such as the telephone, door handles and pens. 2. Never reuse gloves. Do not attempt to wash or decontaminate gloves—they will develop microcracks, become more porous and lose their protective properties.After use, gloves must be disposed of in the contaminated waste. Face Goggles—The projection of droplets is a frequent occurrence when opening patient protection sample containers. Protection of eyes with goggles is strongly recommended as a routine procedure to prevent contact with these droplets. Another way to protect eyes and other mucous membranes from projection is to manipulate the specimen tubes behind a screen (glass or Plexiglas™) or face shield.This equipment should be compulsory when manipulating dangerous liquids, such as liquid nitrogen or some solvents. Contact lenses do not offer protection from splashes.Additional eye protection must be worn with contact lenses. Masks—Masks serve as a barrier when splashes or sprays occur. Furthermore, in order to reduce laboratory workers' respiratory exposure to airborne highly dangerous pathogens, it is recommended to use fit-tested particulate respirators with adequate filtering (e.g. EU FFP2, US NIOSH-certified N95) during specimen collection or handling. Body protection Laboratory coats are compulsory in all instances in the physical containment level 2 laboratory. Be aware of the composition of fabrics, as some might be highly flammable. A disposable laboratory coat is compulsory in physical containment level 3 laboratories or in specific instances such as sample collection when highly dangerous pathogens can be involved, such as suspected cases of H5N1 avian influenza or SARS. Laboratory Quality Management System 29  2-8: Emergency management and first aid Emergencies Laboratories need to have procedures in place for how staff should deal with accidents and emergencies. General written procedures for first aid should be developed and made available to all staff so they know the first things to do, and who to call or notify in case of minor cuts and bruises, major wounds or skin contamination. Chemical spills A chemical spill is considered to be minor only if the person who spilled it is familiar with the chemical, knows the associated hazards and knows how to clean up the spill safely. The recommended steps for dealing with a minor spill include:  alert coworkers, then clean up spill;  follow procedures for disposal of materials used to clean up spill;  absorb free liquids with an appropriate absorbent, as follows - caustic liquids—use polypropylene pads or diatomaceous earth - oxidizing acids—use diatomaceous earth - mineral acids—use baking soda or polypropylene pads - flammable liquids—use polypropylene pads;  neutralize residues and decontaminate the area. Anything beyond a minor spill and that requires help from outside of the laboratory group constitutes a major spill. Steps to deal with major spills include alerting coworkers, moving to a safe location and calling authorities to report the situation. Biological spills When surfaces are contaminated by biological spills, the appropriate actions to take are: 1. Define/isolate the contaminated area. 2. Alert coworkers. 3. Put on appropriate PPE. 4. Remove glass/lumps with forceps or scoop. 5. Apply absorbent towel(s) to the spill; remove bulk and reapply if needed. 6. Apply disinfectant to towel surface. 7. Allow adequate contact time (20 minutes). 8. Remove towel, mop up, and clean the surface with alcohol or soap and water. 9. Properly dispose of materials. 10. Notify the supervisor, safety officer, and other appropriate authorities. Disinfectant: For most spills, use a 1:50 solution (1 g/l chlorine) of household bleach (sodium hypochlorite solution containing 50 g/l chlorine). 30 Laboratory Quality Management System  2-8: Emergency management and first aid For spills containing large amounts of organic material, use a 1:10 solution (5 g/l chlorine) of household bleach, or an approved mycobactericidal.1 Suggested sources of mycobactericidals are registered with the United States of America Environmental Protection Agency (http://www.epa.gov/oppad001/chemregindex. htm). Alcohols are not recommended as surface decontaminating agents because they evaporate quickly, thus decreasing contact time. If laboratory personnel become contaminated with biological hazards due to splashes or spills, immediate steps to take include: 1. Clean exposed skin or body surface with soap and water, eyewash (for eye exposures) or saline (for mouth exposures). 2. Apply first aid and treat as an emergency. 3. Notify supervisor, safety officer, or security desk (after hours). 4. Follow appropriate reporting procedures. 5. Report to physician for treatment or counselling. Laboratory fires Laboratory personnel need to be alert for conditions that might pose a risk for fires. Keep in mind that liquids with low flash points may ignite if they are near heat sources such as hotplates, steam lines or equipment that might produce a spark or heat. A small laboratory fire is considered to be one that is extinguishable within 1–2 minutes. The appropriate action to take is to cover the fire with an inverted beaker or wet paper towels. If this fails, use a fire extinguisher. For large fires, call the appropriate local authorities, usually the fire department and the police department. Laboratories should have the appropriate class of extinguisher for the fire hazards in the laboratory. In general, a class BC or class ABC extinguisher is appropriate. Fire extinguishers must be inspected annually and replaced as needed. Laboratory personnel should be trained in the various classes of fires and basic fire extinguisher use in annual laboratory safety and hazardous waste management training. All laboratory personnel must learn how to operate a portable fire extinguisher. 1 See World Health Organization. Laboratory biosafety manual, 3rd ed. Geneva, WHO, 2004 Laboratory Quality Management System 31  2-9: Summary Summary When designing a laboratory or organizing workflow, ensure that patients and patient samples do not have common pathways. To identify where improvements in laboratory design may be needed in order to prevent or reduce risks of cross- contamination, follow the path of the sample as it moves through the laboratory during the pre-examination, examination and post-examination phases of testing. The design of laboratory work areas should ensure proper ventilation and surfaces that can be cleaned and disinfected. In establishing a safety management programme, it is important to appoint a responsible supervisor.The laboratory should have a safety manual that establishes policy and describes standard procedures for handling safety and emergency issues. Personnel need to be trained in how to apply safety practices and techniques, and to be aware of potential hazards. Key message Neglecting laboratory safety is costly. It jeopardizes the lives and health of employees and patients, laboratory reputation, equipment and facilities. 32 Laboratory Quality Management System 3. Equipment  3-1: Overview Role in Equipment management is one of quality the essential elements of a quality Organization Personnel Equipment