Laboratory Quality Management System (LQMS) PDF

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 decide...

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 management management system. Proper system management of the equipment in the laboratory is necessary to ensure accurate, reliable and timely testing. Purchasing Process Information and The benefits of a good equipment inventory control management management programme are many:  helps to maintain a high level of boratory performance; Documents Occurrence and Assessment  reduces variation in test results, records management nd improves the technologist’s confidence in the accuracy of testing results; Process Customer Facilities  lowers repair costs, as fewer repairs improvement service and safety will be needed for a well-maintained instrument;  lengthens instrument life;  reduces interruption of services due to breakdowns and failures;  increases safety for workers;  produces greater customer satisfaction. Program A great deal of thought and planning should go into equipment management. As considerations the laboratory puts an equipment management programme in place, the following elements should be considered.  Selection and purchasing—When obtaining new equipment, what criteria should be used to select equipment? Should equipment be purchased or would it be better to lease?  Installation—For new equipment, what are the installation requirements and who will install the new instrument?  Calibration and performance evaluation—What is needed to calibrate the equipment and validate that it is operating correctly? How will these important procedures be conducted for both old and new instruments?  Maintenance—What maintenance schedule is recommended by the manufacturer? Will the laboratory need additional preventive maintenance procedures? Are current maintenance procedures being conducted properly?  Troubleshooting—Is there a clear procedure for troubleshooting for each instrument?  Service and repair—What is the cost? Can the laboratory obtain the necessary service and repair in its geographical area?  Retiring and disposing of equipment—What must be done to dispose of old equipment when it needs to be replaced? 34 Laboratory Quality Management System  3-1: Overview Oversight It is the responsibility of the laboratory director to:  oversee all the equipment management systems in the laboratory;  ensure that all persons who will be using the instruments have been appropriately trained and understand how to both properly operate the instrument and perform all necessary routine maintenance procedures. Equipment management responsibility may be specifically assigned to a technologist in the laboratory. In many laboratories, there is a person who has good skills with equipment maintenance and troubleshooting. Giving this person the role of oversight of all equipment is recommended. Oversight of an equipment management programme includes:  assigning responsibilities for all activities  ensuring that all personnel are trained in operation and maintenance  monitoring the equipment management activities, including - reviewing all equipment records routinely - updating maintenance procedures as necessary - ensuring that all procedures are followed. Note: day-to-day maintenance should be the responsibility of the technical operator. Everyone who uses the equipment should be trained in calibration and daily maintenance. Laboratory Quality Management System 35  3-2: Selecting and acquiring equipment Selecting Selecting the best instrument for the laboratory is a very important part of equipment equipment management. Some criteria to consider when selecting laboratory equipment are listed below.  Why and how will the equipment be used? The instrument should be matched against the service the laboratory provides.  What are the performance characteristics of the instrument? Is it sufficiently accurate and reproducible to suit the needs of the testing to be done?  What are the facility requirements, including the requirements for physical space?  Will the cost of the equipment be within the laboratory’s budget?  Will reagents be readily available?  Will reagents be provided free of charge for a limited period of time? If so, for how long?  How easy will it be for staff to operate?  Will instructions be available in a language that is understood?  Is there a retailer for the equipment in the country, with available services?  Does the equipment have a warranty?  Are there any safety issues to consider? If the decisions about purchasing are made outside the laboratory (e.g. by a central purchasing body), the laboratory manager should provide information that will support selecting equipment that will best serve the needs of the laboratory. In areas where there are national programmes for purchasing standard equipment, the laboratories of the country should have some input to decisions. In addition, in areas where donors are likely to provide some of the equipment that is used, laboratory management should have input into the choice of equipment. If this is not possible, management should consider declining equipment if it is inappropriate for laboratory needs. Acquiring Is it better to purchase or lease equipment? When making this decision, it is a equipment good idea to factor in repair costs. The manufacturer should provide all of the necessary information to operate and maintain equipment. The initial cost of an instrument may seem reasonable, but it may be expensive to repair. Also consider savings that could be negotiated if the laboratory needs more than one piece of equipment. Before purchasing ask if:  wiring diagrams, computer software information, a list of parts needed, and an operator’s manual are provided;  the manufacturer will install the equipment and train staff (covering travel expenses as necessary) as part of the purchase price; 36 Laboratory Quality Management System  3-2: Selecting and acquiring equipment  the warranty includes a trial period to verify that the instrument performs as expected;  the manufacturer’s maintenance can be included in the contract and, if so, whether maintenance is provided on a regular basis. Determine if the laboratory can provide all the necessary physical requirements, such as electricity, water, and space. There must be adequate room to move the equipment into the laboratory; consider door openings and elevator access. Installing Before equipment is installed, verify that all physical requirements (electrical, equipment space, doors, ventilation and water supply) have been met. Other things to consider are:  The vendor’s responsibilities for installation should be confirmed in writing prior to beginning the installation process.  A checklist of the expected performance specifications should be developed, so that performance can be quickly verified as soon as the equipment is installed. Whenever possible, it is best to have the manufacturer install laboratory equipment; this will likely improve the conditions of the warranty, and also may ensure that the installation is done properly and quickly. If equipment is installed by the laboratory:  check that the package contents contain all of the parts;  make a copy of any software that is part of the system;  do not allow the equipment to be used before it is completely installed, performance is verified and testing personnel are trained. Laboratory Quality Management System 37  3-3: Getting equipment ready for service After installation After equipment has been installed, the following details need to be addressed before putting the equipment into service.  Assign responsibility for performing the maintenance and operation programmes.  Develop a system for recording the use of parts and supplies (see Chapter 4).  Implement a written plan for calibration, performance verification, and proper operation of the equipment.  Establish a scheduled maintenance programme that includes daily, weekly and monthly maintenance tasks.  Provide training for all operators; only personnel who have been trained specifically to properly use the equipment should be authorized as operators. Designate those authorized to use the equipment and when it is to be used. Inventory record Operating Calibration 3Verification 3procedures 3Maintenance program Train all operators Equipment Follow the manufacturer’s directions carefully when performing the initial calibration calibration of the instrument. It is a good idea to calibrate the instrument with each test run, when first putting it into service. Determine how often the instrument will need to be recalibrated, based on its stability and the manufacturer’s recommendation. It may be advantageous to use calibrators provided by or purchased from the manufacturer. 38 Laboratory Quality Management System  3-3: Getting equipment ready for service Performance Prior to testing patient specimens, it is important to evaluate the performance evaluation of new equipment to ensure it is working correctly with respect to accuracy and precision. In addition, test methods using kits or laboratory instruments need to be evaluated for the ability to detect disease (sensitivity, specificity, positive and negative predictive value) and to determine normal and reportable ranges. Verification of manufacturers’ performance claims—Manufacturers provide performance evaluations for testing methods using their kits or instruments, and include the information in the package inserts or operator's manuals. However, laboratories need to verify the manufacturer's performance claims, and demonstrate they can get the same results using the kits or equipment in their laboratory, with their personnel. Some of the steps that should be followed to verify performance include:  testing samples with known values and comparing the results to the expected or certified value;  if equipment is temperature controlled, establishing the stability and uniformity of the temperature. Validation of new equipment and associated techniques—If the equipment and associated techniques are new, validation processes will be important. Validation can be carried out by running samples in parallel using both old and new equipment and methods for a period of time to determine that the expected results can be obtained. These validation procedures should be completely recorded. Function In order to verify that equipment is working according to the manufacturer’s checks specifications, it is necessary to monitor instrument parameters by performing periodic function checks.This should be done before using the instrument initially, then with the frequency recommended by the manufacturer. These function checks should also be done following any instrument repairs. Some examples of function checks are daily monitoring of temperatures and checking the accuracy of wavelength calibration. Laboratory Quality Management System 39  3-4: Implementing an equipment maintenance programme Preventive Preventive maintenance includes measures such as systematic and routine maintenance cleaning, adjustment and replacement of equipment parts at scheduled intervals. Manufacturers generally recommend a set of equipment maintenance tasks that should be performed at regular intervals: daily, weekly, monthly or yearly. Following these recommendations will ensure that the equipment performs at maximum efficiency and will increase the lifespan of the equipment. This will also help to prevent:  inaccurate test results due to equipment failure  delays in reporting results  low productivity  large repair costs. Maintenance plan A maintenance plan will include preventive maintenance procedures as well as provision for inventory, troubleshooting and repair of equipment. When implementing an equipment maintenance program, some of the initial steps will include:  assigning responsibility for providing oversight;  developing written policies and procedures for maintaining equipment, including routine maintenance plans for each piece of equipment that specify the frequency with which all maintenance tasks should be performed;  developing the format for records, creating logs and forms, and establishing the processes to maintain records;  training staff on the use and maintenance of the equipment, and ensuring that all staff understand their specific responsibilities. It is recommended that a label is attached to the instrument indicating when the next maintenance or service should be performed. Equipment The laboratory should keep an inventory log of all equipment in the laboratory. inventory The log should be updated with information on new equipment and include documentation of when old equipment is retired. For each piece of equipment, the equipment inventory log should have a record of:  instrument type, make and model number, and serial number so that any problems can be discussed with the manufacturer;  date the equipment was purchased, and whether it was purchased new, used or reconditioned;  manufacturer/vendor contact information;  presence or absence of documentation, spare parts and maintenance contract;  warranty’s expiration date;  specific inventory number indicating the year of acquisition (this is especially useful for larger laboratories); for example, use the style “YY-number” (04- 001, 04-002, etc.) where “YY-number” equals the last two numbers of the year followed by a number attributed in the year. 40 Laboratory Quality Management System  3-4: Implementing an equipment maintenance programme An inventory process must be conducted if the laboratory does not have an existing inventory system for equipment. This could be conveniently organized following a model grid, room by room; for example, conduct an inventory of equipment in the reception area, then the sample collection area, the serology testing area, and the parasitology testing area. During the inventory, the condition of the equipment should be documented as functional, partially functional or nonfunctional. Equipment that is not functioning needs to be evaluated as to whether or not it can be repaired. Nonrepairable equipment should be retired, and work should be scheduled for equipment needing repair. Inventory of To ensure that the laboratory does not run out of spare parts, an inventory spare parts record of those used most frequently should be kept for each piece of equipment. The record should include:  part name and number;  average use of the part, and the minimum to keep on hand;  cost;  date when the part is placed into storage and when it is used (in and out stock log);  quantity of each part remaining in inventory. Laboratory Quality Management System 41  3-5: Troubleshooting, service repair and retiring equipment What is the Problems with equipment may present in many ways. The operator may notice source of the subtle changes such as drift in quality control or calibrator values, or obvious flaws problem? in equipment function. Sometimes, the equipment fails to operate. It is important to teach operators to troubleshoot equipment problems in order to quickly get the equipment functioning and resume testing as rapidly as possible. When an operator observes instrument drift, it is important to repeat the preventive maintenance procedures as a first step to resolve the problem. If this does not work, proceed with troubleshooting processes. Troubleshooting Manufacturers frequently provide a flowchart that can help determine the source of problems. Some of the questions to consider are listed below.  Is the problem related to a poor sample? Has the sample been collected and stored properly? Are factors such as turbidity or coagulation affecting instrument performance?  Is there a problem with the reagents? Have they been stored properly, and are they still in date? Have new lot numbers been introduced without updating instrument calibration?  Is there a problem with the water or electrical supply?  Is there a problem with the equipment? Make one change at a time based on symptoms. If the equipment is the problem, review the manufacturer’s instructions to verify that all procedures are being followed correctly. When problems If problems cannot be identified and corrected in-house, attempt to find a way to cannot be continue testing until the equipment can be repaired. Some ways to achieve this corrected are as follows.  Arrange to have access to backup instruments. It is often too costly for the laboratory to have its own backup instruments, but sometimes a central stores agency can maintain backup instruments to be shared throughout the local area or country.  Ask the manufacturer to provide a replacement instrument during repairs.  Send the samples to a nearby laboratory for testing. Be sure to notify the appropriate providers that there are problems and that there will probably be delays in completing the testing. 42 Laboratory Quality Management System  3-5: Troubleshooting, service, repair and retiring equipment Do not use faulty equipment! Seek help from the manufacturer or other technical expert. Place a note on the equipment so all staff are aware that it is not in use. Service and Manufacturers may provide service and repair of equipment that is purchased repair from them. Be sure to set up a procedure for scheduling service that must be periodically performed by the manufacturer. When instruments need repair, remember that some warranties require that repairs be handled only by the manufacturer. Large facilities sometimes have biomedical service technicians in- house who perform equipment maintenance and repair. Routine service should be scheduled so as not to interrupt the flow of work. It is very important to have a policy and procedure for retiring older laboratory Retiring and equipment. This will usually occur when it is clear that the instrument is not disposing of functioning and is not repairable, or when it is outmoded and should be replaced equipment with new equipment. Once a piece of equipment is fully retired and it has been determined that it has no further use, it should be disposed of in an appropriate manner. This last step is often neglected in laboratories and old equipment accumulates, taking up valuable space and sometimes creating a hazard. When disposing of equipment, salvage any usable parts, particularl