Medical Lab Management & QA 2024 PDF

Medical Laboratory Management and Quality Control I Prof. Dr. Khaled Abdulla Zain Al-Sakkaf, DrPH 2024 II  MEDICAL LABORATORY MANAGEMENT AND QUALITY CONTROL CHAPTER O...

Medical Laboratory Management and Quality Control I Prof. Dr. Khaled Abdulla Zain Al-Sakkaf, DrPH 2024 II  MEDICAL LABORATORY MANAGEMENT AND QUALITY CONTROL CHAPTER ONE: INTRODUCTION TO MANAGEMENT DEFINITION OF MANAGEMENT “Management is art of getting things done through people.” Many definitions exist to indicate what management is. It is clear that management is partly the process of getting things done through people; and partly the creative and energetic combination of scarce resources into effective and profitable activities and the combination of the skills and talents of the individuals concerned with doing this. So, management can be defined as: An interactive set of social/technical processes occurring within a formal organizational setting with the purpose of accomplishing predetermined objectives through the utilization of human and physical resources Is that field of human behavior in which managers plan, organize, staff, direct, and control human, financial resources in an organized group effort in order to achieve desired individual and group objectives with optimum efficiency and effectiveness. IMPORTANCE OF MANAGEMENT: 1) Acquisition and utilization of resources. 2) Environmental adaptation. Adopts organization to changing environmental forces. 3) Goal achievement. Achieves goals by balancing the requirement of jobs and people. 4) Problem solving. Identifies and evaluates various alternatives and choose appropriate course of action to solve organizational problems. 5) Performance control. Measures and evaluates the actual performance. III  6) Social responsibility. Anticipates and acts beforehand to social expectations PRINCIPLES OF MANAGEMENT: There are a number of principles of management and the following 15 are the commonest ones. 1. Principle of management by objective (MBO) Every activity of a given organization must have an objective, which could be qualitative or quantitative. Clear statement of the objective speaks it possible to evaluate how effective one is in approaching and reaching the objective. There are five important characteristics of objective and are known as SMART. 1. Simple: Objective should be clear and understandable to the health team. 2. Measurable: In terms of quality and quantity for two important reasons: i. To monitor the day-to-day activity (assessment of performance) ii. To help evaluate the activities (for the future course of action) 3. Achievable: Feasibility is an important criterion for good planning. Objective should be something that can be reached at; it should be realistic. 4. Relevant: All action plans should be directed to the major problems of that community (felt or real). The objective should address the real problems of the community. 5. Time bound: Time should be a common denominator for all objectives. Effectiveness is the degree to which a stated objective is being achieved; it is something that management tries to improve. At the end of all the activities achievement is compared with the objective, i.e., evaluation is done. This helps us to judge how effective our management was and to plan for the future course of action. 2. Learning from Experience It is directly or indirectly dependent on MBO. When a gap occurs between objective and achievement or result, management makes analysis of how the observed results are achieved and discovers what causes the gap. In this process learning can take place. This process is sometimes called feedback of information from experience to decision IV for action. 3. Division of Labor This is the principle of specialization that maintains that work should be distributed among members of a group. Where there is specialization and division of labor, each kind of manpower exercises its own knowledge and skill towards achieving the set objectives. 4. Authority and responsibility Authority is the power to give orders and get it obeyed or in other words it is the power to take decisions, and responsibility means state of being accountable or answerable for any obligation, trust, debt or something or in other words it means obligation to complete a job assigned on time and in best way (the reward or penalty accompanying the use of this power). Authority and responsibility are closely related and this principle states that these two must go hand in hand. It means that proper authority should be delegated to meet the responsibilities. Authority and responsibility go together or co-existing. Both authority and responsibility are the two sides of a coin. In this way, if anybody is made responsible for any job, he should also have the concerned authority. 5. Discipline Means sincerity about the work, carrying out orders and instructions of superiors and to have faith in the policies and programs of the business enterprise. The essence of discipline is obedient, diligence, energy, correct attitude and outward marks of respect, within the limits fixed by the agreement between an employer and his employees. A well-disciplined working force is essential for improving the quality and quantity of the production. 6. Efficient utilization of Resources Management is the efficient use of resources. Resources are the inputs that will be needed or consumed to achieve an objective. Efficiency is the degree to which our resources are utilized in a balanced way. This balance must be maintained between the different resources, through economic utilization of resources, substitution of resource, V etc. 7. Unity of Command This principle of management states that every member of the health team should receive orders, instructions, commands, etc. only from one supervisor. 8. Unity of management. One manager and one plan for all operations having the same objectives. 9. Span of Control The average number of people who are under the direct control of a given supervisor is determined by the nature of the work, i.e., complexity, simplicity, contiguity, etc. On average, one supervisor can effectively supervise not more than six subordinates (a maximum of ten subordinates). 10. Principle of Management by Exception (MBE) Health Managers at district and regional level should concentrate only on strategic and highly important tasks and leave the routine and standardized tasks to operating personnel. 11. Principle of Delegation Delegation is the process whereby somebody’s authority is lent to another person, conditionally or not so that to enable that person to take responsibility when the occasion arises. It is the most forward-thinking principle whereby as many operating tasks as possible are granted to the subordinate. The principle “Never do yourself that another can do for you as well as you would ” applies for delegation of authority and responsibility. 12. The principle of Convergence of Work Work activities should be designed and directed so as to support each other towards achievement of objectives. It also implies that working relations should continue to the success of each activity and so to general effectiveness. VI 13. Scalar Chain Hierarchy This refers to an interconnected chain of relationships extending from top of an organization to the bottom. This shows graded chain of authority from top to bottom through which all decisions flow. 14. Structures determine function A major concern in working relation is to enable decisions to be made where and when necessary, by the most suitable person. In a health team any person might be called to make decisions at one time or another. Decisions should be made by the right person and be channeled down or in any other appropriate direction and the flow of decision is alongside the organizational structure. 15. Subordination of individual interest's public interests Hereby the public interests are superior and precede the interests of individuals. There are also other principles of management such as the principle of centralization, decentralization, coordination, equity, etc. FUNCTIONS OF MANAGEMENT VII Function is a broad area of responsibility composed of many activities aimed at achieving a predetermined objective. It explains managerial performance or the activities done by a manager. The specific processes that constitute management “function of management” are: 1- Decision-making process 2- Planning process 3- Organizing process 4- Executing process 5- Controlling process These processes are interactive in nature: ØAffect each other ØOccur simultaneously ØThey are continuous Ø Resulting in the conversion of inputs to outputs. VIII  I. DECISION MAKING Decision making is the mental process resulting in the selection of a course of action among several alternatives. Every decision-making process produces a final choice in an action or an opinion of choice. If a person neither takes an action nor gives an opinion, this is also decision. Difference between Problem Solving and Decision Making Traditionally, it is argued that problem analysis must be done first, so that the information gathered in that process may be used towards decision making. A problem is a deviation from performance standards - that is, what occurred is different from what was expected to have occurred. In decision making, the objective(s) are first established, and a choice is made among alternatives for action or for an opinion. Steps in Decision Making Decision making can be broken down into the following steps: 1. Become aware that a decision must be made.2The problem must be defined.3Relevant information must be gathered 4. Objectives must first be established 5. Objectives must be classified and placed in order of importance 6. Alternative actions must be developed 7. The alternative must be evaluated against all the objectives 8. The alternative that is able to achieve all the objectives is the tentative decision 9. The tentative decision is evaluated for more possible consequences 10. The decision is implemented. A major part of decision making involves the analysis of a finite set of alternatives using some set of criteria. These criteria may be benefit or cost oriented. IX  II. PLANNING Planning is the process of setting goals and deciding how best to achieve them. Planning is predetermining future. Planning is deciding in advance about what to do how to do it when to do it and who is to do it. Planning involves: 1. Evaluating the situation. 2. Developing incident objectives. 3. Selecting a strategy. 4. Deciding which resources should be used to achieve the objectives in the safest, most efficient and cost-effective manner. Importance of planning: The combination of a good strategic framework (arrived at through strategic planning and a good operational plan or action plan) 1. Provides a clear understanding of what you need to do in order to achieve your development goals; 2. Guides you in prioritizing and making decisions; 3. Allows you to focus possibly limited resources on the actions that will benefit your work the most; 4. Keeps you in touch with your context – global, national and local; 5. Provides a tool to help you communicate your intentions to others; 6. Provides a coherent guide for day-to-day implementation. Different kinds of planning: Planning is a big term that includes a number of different kinds of activities. It is possible to plan at the strategic level, at the activity or operation level, to plan for an organization, or for a program or for a project. The two main kinds of planning are: X  1. Strategic planning and 2. Business/action/operational planning 1. Strategic planning is more than ensuring your association will remain financially sound and be able to maintain its reserves—it’s projecting where your association expects to be in five, ten, or fifteen years—and how your association will get there. It is a systematic planning process involving a number of steps that identify the current status of the association, including its mission, vision for the future, operating values, needs (strengths, weaknesses, opportunities, and threats), goals, prioritized actions and strategies, action plans, and monitoring plans. 2. Operational (Action) planning is the process that guides the day-to-day activities of an organization or project. It is the process of planning what needs to be done, when it needs to be done, by whom it needs to be done, and what resources or inputs are needed to do it. It is the process of operationalizing your strategic objectives. That is why it is also called operational planning. Operational plans should contain: 1. clear objectives 2. activities to be delivered 3. quality standards 4. desired outcomes 5. staffing and resource requirements 6. implementation timetables 7. a process for monitoring progress III. ORGANIZING PROCESS It is a function in which the synchronization and combination of human, physical and financial resources take place. Organizing is a function by which the concern is able to define the role positions, the jobs related and the coordination between authority and XI responsibility. Hence, a manager always has to organize in order to get results. A manager performs organizing function with the help of following steps: - 1. Identification of activities All the activities which have to be performed in a concern have to be identified first. All these activities have to be grouped and classified into units. 2. Departmentally organizing the activities - In this step, the manager tries to combine and group similar and related activities into units or departments. This organization of dividing the whole concern into independent units and departments is called departmentalization. 3. Classifying the authority - Once the departments are made, the manager likes to classify the powers and its extent to the managers. This activity of giving a rank in order to the managerial positions is called hierarchy. The top management is into formulation of policies, the middle level management into departmental supervision and lower-level management into supervision of foremen. 4. Co-ordination between authority and responsibility - Relationships are established among various groups to enable smooth interaction toward the achievement of the organizational goal. Each individual is made aware of his authority and he/she knows whom they have to take orders from and to whom they are accountable and to whom they have to report. A clear organizational structure is drawn and all the employees are made aware of it. Importance of Organizing Function 1. Specialization - Organizational structure is a network of relationships in which the work is divided into units and departments. 2. Well defined jobs - Organizational structure helps in putting right men on right job which can be done by selecting people for various departments according to their qualifications, skills and experience. 3. Clarifies authority - Organizational structure helps in clarifying the role positions to every manager. This can be done by clarifying the powers to every manager and the way he has to exercise those powers should be clarified so that misuse of XII  powers does not take place. 4. Coordination - Organization is a means of creating coordination among different departments of the enterprise. It creates clear cut relationships among positions and ensures mutual cooperation among individuals. 5. Authority responsibility relationships can be fruitful only when there is a formal relationship between the two. Clarity should be made for having an ultimate responsibility attached to every authority. 6. Effective administration - The organization structure is helpful in defining the jobs positions. The roles to be performed by different managers are clarified. Specialization is achieved through division of work. 7. Growth and diversification - A company’s growth is totally dependent on how efficiently and smoothly a concern works. This is possible through a set of formal structure. 8. Sense of security - Organizational structure clarifies the job positions. The roles assigned to every manager are clear. Therefore, clarity of powers helps automatically in increasing mental satisfaction and thereby a sense of security in a concern. This is very important for job- satisfaction. 9. Scope for new changes - Where the roles and activities to be performed are clear and every person gets independence in his working, this provides enough space to a manager to develop his talents and flourish his knowledge. Principles of Organizing The organizing process can be done efficiently if the managers have certain guidelines so that they can take decisions and can act. To organize in an effective manner, the following principles of organization can be used by a manager. 1. Principle of Specialization The whole work of a concern should be divided amongst the subordinates on the XIII  basis of qualifications, abilities and skills. It is through division of work specialization can be achieved which results in effective organization 2. Principle of Functional Definition According to this principle, all the functions in a concern should be completely and clearly defined to the managers and subordinates. This can be done by clearly defining the duties, responsibilities, authority and relationships of people towards each other. 3. Principles of Span of Control/Supervision There are two types of span of control: - A. Wide span of control- It is one in which a manager can supervise and control effectively a large group of persons at one time. The features of this span are: - a. less overhead cost of supervision. b. prompt response from the employees. c. better communication. d. better supervision. e. better coordination. f. suitable for repetitive jobs. B. Narrow span of control- According to this span, the work and authority is divided amongst many subordinates and a manager doesn't supervises and control a very big group of people under him. The manager according to a narrow span supervises a selected number of employees at one time. The features of this span are: - a. Work which requires tight control and supervision, for example, handicrafts, ivory work, etc. which requires craftsmanship, there narrow span is more helpful. b. Co-ordination is difficult to be achieved. c. Communication gaps can come. d. Messages can be distorted. e. Specialization work can be achieved. XIV Factors influencing Span of Control i. Managerial abilities ii. Competence of subordinates iii. Nature of work iv. Delegation of authority v. Degree of decentralization 4. Principle of Scalar Chain With a chain of authority available, wastages of resources are minimized, communication is affected, overlapping of work is avoided and easy organization takes place 5. Principle of Unity of Command It implies one subordinate-one superior relationship. Every subordinate is answerable and accountable to one boss at one time. This helps in avoiding communication gaps and feedback and response is prompt. Classification of Organizations Organizations are basically classified on the basis of relationships. There are two types of organizations formed on the basis of relationships in an organization. 1. Formal Organization - This is one which refers to a structure of well-defined jobs each bearing a measure of authority and responsibility. 2. Informal Organization - It refers to a network of personal and social relationships which spontaneously originates within the formal set up. Relationship between formal and informal organizations For an efficient organization, both formal and informal organizations are required. Formal organization can work independently. But informal organization depends totally upon the formal organization. Formal and informal organization helps in bringing efficient working organization and smoothness in a concern. Implementation (or deployment) of a system, plan or method is commonly viewed XV as the execution of a series of related activities, each activity termed an implementation stage. A number of broad steps can be used to guide an implementation process, including: 1. Initiation – Determine the key strategic objectives of the implementation plan. 2. Key Processes or Activities - Identify the key processes or activities required. A. Identify Tasks- Under each process identify the tasks that need to be completed in order to achieve the strategic objectives B.Action Steps – Each task may be subdivided into further individual sub-tasks or action steps. allows focus and therefore easier implementation. C. Assign Responsibility - assign responsibility for each sub-task to a specific human resource. The assignment of the task should reflect the best person able to complete or deliver the task. The composition of the team is important for successful implementation. D. Prioritize – Activities or tasks need to be prioritized to reflect the most important tasks that need to be completed, or specific tasks that need to be actioned before other tasks can begin. Some tasks can be scheduled in parallel to reduce the overall time. E.Timeline – The time required to complete each task must be estimated in advance. The forecast will need to be as realistic as possible, but allow some flexibility F.Cost & Budget – The costs to complete each task must be calculated in advance and an overall budget should be assigned for the implementation plan G. Do It! – The key to successful implementation is taking action and executing the assigned tasks as outlined in the implementation plan. This step is always crucial for successful implementation. H. Review and evaluate require continuous monitoring and review to evaluate progress. V. CONTROLLING PROCESS XVI Controlling is maintaining, comparing and correcting organizational performance toward goal achievement. It is a process of monitoring performance and taking action to ensure desired results. It sees to it that the right things happen, in the right ways, and at the right time. Controlling is regarded as one of the most important management functions. In fact, without the presence of a control function, the entire management function will become obsolete. The management will not be able to determine if the plan is working properly or not, or if it is properly implemented or not. The main objective of the control process is to make sure that the activities within an organization are going as per the planning. Control process helps the managers in determining the level of performance of their respective organizations. Steps involved in Control Process The following are the steps involved in the control process: 1. Establishing standards and methods or ways to measure performance The control process begins with planning and the establishment of performance objectives. Performance objectives are defined and the standards for measuring them are set. There are two types of standards: a. Output Standards – measures performance results in terms of quantity, quality, cost, or time. b. Input Standards - measures work efforts that go into a performance task. 2. Measuring actual performance Measurements must be accurate enough to spot deviations or variances between what really occurs and what is most desired. Without measurement, effective control is not possible. 3. Determining if the performance matches with the standard Checking if the performance matches with the standards is very important. It is an important step in controlling. In this step, the results are measured with the XVII  already set standards. The comparison of actual performance with desired performance establishes the need for action. 4. Taking corrective action and re-evaluating the standard Corrective measures need to be taken when there is a discrepancy. Correct actions provide protection against loss and stop them from reappearing in future. XVIII  CHAPTER TWO: HEALTH LABORATORY MANAGEMENT Definition and Principles The first step in a systematic approach to the management and organization of a health laboratory begins with the establishment of general goals and specific objectives by the laboratory staff. The use of such objectives for the purpose of management is known as management by objectives (MBO). In order to achieve these objectives, the laboratory must have adequate facilities, equipment & supplies, and an adequate number of qualified personnel. As used here, goals are those general and qualitative statements of overall philosophy of the organization. An example of a goal is “a commitment by the hospital laboratories to be a vital component of the hospital goal to: provide a patient care environment of excellence, serve the community and serve as a setting for clinical teaching. The goal should be consistent with: - the organizational structure, - the management style of the laboratory director, and - the available resources. In turn, such goals should influence the future programs of the laboratory and the activities of the director and the lab staff. As a tool of management, MBO encourages discussion; interaction; and consensus decision making among all organizational levels of the laboratory. Good management means getting work done through a well-organized, efficient, laboratory service, and producing work of high standards in a safe and pleasant working environment. The main steps to good management are: - Setting up the main working room - Arranging stocks of laboratory items - Establishing routine procedures for disinfection and waste disposal. XIX  - Establishing good communication with clinicians - Organizing patient flow - Keeping laboratory records - Ordering laboratory supplies - Organizing staff activities - Establishing a reliable quality control system - Setting planned program for lab personnel training to the highest possible qualification. - Setting plans for enhancing the lab activities to the highest possible technical level. Role of Laboratory in Health Care The laboratory is an integral part of a nation’s health service. It gives the service a scientific foundation by providing accurate information to clinicians and to other responsible bodies for: - Treating patients - Deciding health priorities and allocating resources. - Monitoring the development and spread of infections pathogens as well as status of non-infectious acute or chronic diseases or their markers: tumor markers, hormones, cancer cells, etc. - Investigating preventable premature loss of life. - Deciding effective control measures against major prevalent diseases. Without reliable laboratory support: - Patients are less likely to receive the best possible care. - Resistance to essential drugs will continue to spread. - The sources of disease may not be identified correctly. - Epidemics and spread of major communicable diseases will not be checked reliably. - Valuable financial and human resources may be diverted to ineffective `control measures. XX Training of Laboratory Personnel Basic training should be undertaken nationally in accordance with a country’s health needs, available resources, and laboratory working environments. A trainee should be taught the technical skills, knowledge, and attitudes required to perform their functions reliably and confidently. Performance needs to be assessed during training and supervised adequately after training. Inappropriate or inadequate training is not only wasteful but also dangerous. Indicators of poor training The following are some of the indicators of poor training of laboratory personnel: a. Increase in the number of wrong test results b. Delay in the issuing of reports c. Frequent and serious complaints from those requesting lab tests and an increase in requests for repeat tests as confidence decreases. d. Increase in the damage to equipment e. Increase in the contamination of reagents and materials f. Greater incidence of lab acquired infections g. Poorly motivated staff and job dissatisfaction h. Lack of laboratory ethics such as not respecting confidentiality of lab results and informing a patient result directly which should have been dealt with by the concerned physician, etc. The better a person can do a job; the greater will be the effectiveness and satisfaction. Competency and job satisfaction are major factors in achieving and retaining quality of service. Code of Conduct A code of professional conduct for medical laboratory personnel should include those practices and attitudes which characterize a laboratory professional. Such code is necessary to ensure that technicians’ work is of recognized standards, so, that patients and those requesting the tests are confident of the results they receive. XXI Code of professional conduct for medical laboratory personnel - Be dedicated to the use of clinical laboratory science to benefit mankind. - Place the well-being and services of patients above your own interests. - Be accountable for the quality and integrity of clinical laboratory services. - Exercise professional judgment, skill, and care while meeting established standards. - Do not misuse your professional skills or knowledge for personal gain, and never take anything from your place of work that does not belong to you. - Be at all times courteous, and considerate to patients and their relatives. Safeguard the dignity and privacy of patients. - Do not disclose to a patient or any unauthorized person the results of your investigations and treat with strict confidentiality any personal information that you may learn about a patient. - Respect and work in harmony with other members of your hospital staff or health center team. - Promote health care and disease prevention and control. - Follow safe working practices and ensure that patients and others are not put at risk. - Do not consume alcohol or take non-prescribed drugs that could interfere with your work performance during laboratory working hours or when on emergency stand-by. - Use equipment and laboratory ware correctly and do not waste reagents or another laboratory supplies. - Strive to improve professional skills and knowledge and adopt scientific advances that benefit the patient and improve the delivery of test results. XXII  - Fulfill reliably and completely the terms and conditions of your employment. CHAPTER THREE: LABORATORY ORGANIZATION Introduction Organization by definition means a system that is an orderly structure, which puts things together into a working order and makes arrangements for undertakings which involve cooperation. Actually, the emphasis is on arrangements which enable people to work together and to accomplish common objectives in an efficient, planned, and economic manner. Efficient organization is the product of good ideas and good planning. In turn, these are dependent upon certain qualities of the director and his/her associates, which comprise leadership, experience, industry, enthusiasm, and a desire to do things well. In the clinical laboratory there are two interlocking components of organization. These are: 1. The overall management provided by the director, 2. The organization of units provided by section heads. The director and his/her associates must: - define goals, - set down policies, - analyze general problems and find solutions for them, - provide funds for the laboratories, - outline programs, - coordinate the work of sections, - set down personnel policies and interpret policies of the hospital board. XXIII In any section of the laboratory, the section’s head must work within the policies, rules, and regulations of the director. To be productive, he/she must: - utilize the skills of the staff members in the section; - supervise and systematize the use of space, equipment, and supplies; - streamline work flow; - develop systems to handle specimens and paper; and - design detailed responsibility to designated individuals. Structure and Function of Laboratory Service in Developing Countries Strengthening holistic and integrated national laboratory systems (NLSs) in the developing countries is critical to delivering reliable laboratory services to meet the Sustainable Development Goals (SDGs) for health, and to fight multiple existing, emerging, and reemerging diseases. Challenges of NLSs in developing countries Major challenges facing NLSs in developing countries include: - a shortage of skilled and trained personnel; - an inadequate infrastructure such as consistent supply of electricity, water, and physical infrastructure; - a lack of equipment; - inadequate supply-chain management for consumables and reagents; XXIV  - poor equipment maintenance; - lack of clear policies, and - insufficient leadership. Organization of Health Laboratory Services in Republic of Yemen. In Yemen, an attempt was made to standardize the functions of health laboratories at all levels. The tests, their methods, and the equipment needed at all levels of health laboratories in the country were listed in the publication: standard list of tests and basic laboratory materials for health services in Yemen. According to this publication, the functions of the laboratories are as follows: 1. Community Based PHC Laboratory In the Yemeni context these laboratories are called health center laboratories. Many of them are situated at the periphery of the country. The work of the community based primary health lab is to support the center of primary health care: - in investigating, controlling, and preventing major diseases in the community, and - in promoting health care by integrated health education. Staffing: A laboratory in a primary health care center will usually be staffed by a junior laboratory technician with certificate or a local community health worker trained to examine specimens microscopically, perform appropriate diagnostic and screening tests, collect and refer specimens for specialized tests, and participate in community health education. Depending on the workload of the health center, one or two laboratory aids may also be required. Function. Community based primary health lab is established to investigate by referral or testing on site important diseases and health problems affecting the local community. Such investigations usually include: - Bacterial diseases like tuberculosis, leprosy, meningitis, STDs, ARI, etc. - Parasitic diseases like malaria, schistosomiasis, intestinal parasitic infections, and locally important parasitic diseases. XXV  - Other causes of ill health like anemia, diabetes, etc. - To collect and refer all kinds of specimens for testing to the district laboratory - To screen pregnant women for anemia, proteinuria and malaria, etc. - To promote health care and assist in community health education by e.g., demonstrating microscopically the parasites of important local diseases - To keep records and send a simple informative monthly report to the district laboratory. The main equipment is a microscope, others include: manual centrifuge; materials for complete blood count tests; ESR racks and tubes… etc. 2. District Hospital Laboratory In Yemen these laboratories have an important role in supervising the work of the peripheral community-based laboratories, testing referred specimens, and performing a range of tests compatible with the work of the district hospital. Staffing: A district lab is usually staffed by at least one diploma holder senior laboratory technician and depending on work load, by two to four lab assistants and several lab aids. The staff of the district laboratory should also include a laboratory tutor to train and supervise the work of primary health laboratory workers. Function: The main functions of the district hospital laboratory are as follows: - To perform a range of tests relevant to the medical, surgical and public health activities of the district hospital. - All investigations listed above for primary health laboratories. - Basic hematology, serology, and urinalysis diagnostic services. - To support the work of the community-based laboratories by: a. Testing referred specimens b. Providing reagents, controls, standards, and other essential lab supplies c. Training community health laboratory workers - Referring specimens to the regional laboratory. - Finally, participating in the external quality assurance program organized by the regional lab. XXVI 3. Governorate Hospital Laboratory (Referral) The main role of the governorate laboratory is to assist and supervise the district laboratories, to test referred specimens and to perform a range of specialized and other tests required by the work of the regional hospital. Staffing: The governorate lab is usually staffed by one coordinating chief laboratory officer a medical lab technologist having a B.Sc. degree or an M.Sc., an experienced specialist lab technician and two or three technicians in each department, laboratory tutors, a safety officer, a store officer, clerical staff, and several lab aids according to the work load. Function: The main functions of the governorate laboratory are as follows: - To perform a range of tests as required by the medical and health needs of the region. - To operate a regional blood transfusion center. - To prepare reagents, culture media, controls, clinical chemistry standards, and specimen containers. - To investigate epidemics and perform tests of public health importance in the region. - To perform bacteriological and chemical analysis of food, water, beverages and other industrial products - To support the work of the district hospital labs in the governorate. - To send specimens that require specialized investigation to central and public health labs. - To participate in external quality assessment program organized by the central laboratory. 4. Central Public Health Laboratory This laboratory is responsible for the planning, expenditure, and co-ordination of the national laboratory services. It has equally important roles in ensuring the reliability of the service, the appropriateness of its technology, training and motivation of its XXVII workforce; as well as, ensuring that the service extends into areas of health needs and its facilities are made available to as many people as possible. Staffing: A central laboratory is staffed by a director (ideally pathologist, at the moment, it is mostly directed by a microbiologist, but no specification is of a limit) a senior coordinating officer, several research scientists of various disciplines with qualifications of B.Sc., M.Sc., M.D., MPH, PhD and several senior technologists and technicians, a senior safety officer, clerical staff, and several lab aids according to the size and workload of the laboratory. Function: This is the highest responsible body to provide technical support and advice for all regional laboratories or regional referral hospital laboratories. The main functions of a central and public health laboratory are as follows: - To formulate a professional Code of Conduct for medical laboratory personnel. - To perform with high tech methods and facilities a range of specialized tests not normally undertaken in the governorate laboratories, such as bacteriological, mycological, viral, histopathological, cytological, immunological, nutritional, hormonal, metabolic, forensic, molecular and genetic investigations, - To carry out appropriate research on important national health problems. - To organize a national blood transfusion service. - To evaluate new technologies, standardize techniques, and test the appropriateness of new equipment. - To purchase supplies and equipment for the national laboratory service and to organize an efficient system of requisition, distribution, and maintenance of equipment. - To prepare control sera, blood grouping antiserum, antihuman globulin, complex biochemical reagents and culture media that require standardization and are more economically prepared in the central laboratory. - To communicate and collaborate with International Organizations in promoting laboratory standards and a Code of Safety for indigenous medical laboratories. XXVIII  - To train specialist technicians and to organize laboratory teaching seminars. - To prepare, and where required, translate appropriate training manuals for the different laboratory training programs. - To prepare laboratory request forms, record sheets, order forms, and other essential stationery which require standardization. - To prepare and distribute an annual report on the activities of the country’s laboratory service. - To co-ordinate the work of the laboratory service within the national health program, and to prepare a budget for presentation to health authorities. - To support the work of the regional hospital laboratory by: · Providing control sera, certain standardized reagents, chemicals, bacteriological media constituents and ready-prepared complex media, blood collecting packs, standardized stationery, specimen containers, and other essential laboratory supplies. · Visiting each regional laboratory every six months to discuss with the medical and technical staff the work and needs of all the laboratories in the region, to check records and quality control measures, service major equipment, install and demonstrate any new complex equipment, and ensure that safety measures in each department are being followed. · Co-ordinate an external quality assessment program in parasitology, bacteriology, hematology, blood transfusion and clinical chemistry. Note: The above-mentioned functions of the Central Public Health Laboratory are the ideal functions in any Central Public Health Laboratory; these are and not necessarily practiced in Yemen at present. XXIX  CHAPTER FOUR: SAFETY IN THE LABORATORY 1. Importance of Safety Quite common hazards and accidents occur in the laboratory. The need and importance of laboratory safety should be the real concern of the laboratory. Laboratory accidents and hazards are controlled by the use of: - Simple precautions - Foresight (prudence) - Safety devices XXX Above all a ‘real concern’ or a ‘built in concern’ or ‘safety mindedness’ for oneself and the other fellow working at the next bench is very essential. Laboratory accidents range from minor injury, illness or loss of body parts to death. There are many factors that contribute to laboratory accidents. These include: - Poorly designed laboratory - Overcrowding of materials - Poor training - Lack of concentration - Noisy and untidy working environment - Carelessness and neglect - Overwork and fatigue - Hot and humid climatic conditions - Hurrying to finish work on time - Emergency condition (especially during night hours) 2. Source of Laboratory Hazards Physical Sources A. Poorly Designed Laboratory Buildings: Due attention should be given in the design of laboratories. The management, the laboratory personnel and the architecture should be involved in the standard design of the lab, (for more information, see chapter 3 under safe lab design). B. Burns: Burns may be caused by: - Flammable chemicals and stains, or by reagents catching alight. - Fires from spirit lamps, Bunsen burners, lighted tapers (e.g., when heating Ziehl-Neelsen stain), or from faulty electrical equipment or overloaded circuits. Spirit burners should not be used in direct sunlight because in bright light the flame can be difficult to see. - Corrosive chemicals being spilt on the skin or ingested when mouth –pipetting. C. Electric shock: Electric shock can be caused by: - Faulty electrical circuits. XXXI  - Incorrect installation of equipment. - Touching exposed live wires. D. Cuts: Cuts may be caused by: - Breakages. - Using glassware that is cracked or has damaged edges. - Walking on glass chippings. Chemical Sources A. Toxic harmful chemicals - Inhaling fumes from toxic chemicals - Ingesting toxic chemicals by mouth pipetting - Skin contact B. Explosive chemicals: Injury from explosions can be caused by: - Incompatible chemical exploding - Leaking gas C. Flammable chemicals causing fire - Burns D. Kinds of chemicals a. Corrosive (strong acids & alkalis) - Concentrated sulphuric acid - Nitric acid - Sodium hydroxide - Potassium Hydroxide b. Toxic irritating chemicals - cause death or serious ill health if swallowed, inhaled, and by skin contact. - Potassium cyanide - Chloroform - Barium chloride c. Flammable chemicals - Ether - Acetone - Romanowsky stains – Methanol XXXII  d. Explosive chemicals - Picric acid e. Carcinogens - Chemicals that cause cancer through ingestion, inhalation, skin contact - Proven carcinogen chemicals include benzidin, otoulidine, and Nitrophenol. - The risk is proportional to the length of exposure, frequency of exposure, and concentration of the chemical. Biological Sources A. Laboratory acquired infections: Infection can be caused by: - Pathogens being inhaled in aerosols (airborne droplets) when snap-closing specimen containers, dispensing or pipetting infectious fluids, or centrifuging infectious material in open buckets. Aerosols may also be formed and inhaled following breakages or after spilling infectious fluids. Breakages in centrifuges can be particularly hazardous if the centrifuge is opened before the aerosols have settled. - Pathogen being ingested from contaminated fingers, or in food that has been contaminated, e.g., by being stored in a laboratory refrigerator. Care should be taken to avoid the fingers or other parts of the body touching infected material. Mouth-pipetting specimens and cultures is one of the commonest ways of ingesting pathogens. - Pathogens entering the skin through needle punctures, cuts, scratches, insect bites, sores or other open skin lesions. Laboratory workers must always handle infected needles with great care. - Pathogens can also be acquired from unclean or non-disinfected room floors and walls, water taps and laboratory benches. - Pathogens are acquired directly through careless contacts with patients or carrier staff through breathing, hand contact, etc. B. Laboratory animals - are source of a biohazard and they might present physical injury like scratches or infection through inhalation of organisms or by skin XXXIII  contact. 3. Safety Measures Safely Designed and Organized Laboratory It is clear that a poorly designed laboratory and overcrowding can increase the risk of laboratory accidents. It is, therefore, important to know how the laboratory should be designed with regard to safety considerations. The following are some of the features, for further detail refer safe lab design in chapter three. A. Adequate floor, bench and storage space B. A floor that is well constructed with a surface that is nonslip, impermeable to liquids, and resistant to those chemicals used in the laboratory. C. Walls that are smooth, free from cracks, impermeable to liquids and easily washable. D. A door at each end of the lab so that lab staff will not be trapped should a firebreak out. E. Adequate ventilation with windows that can be opened. F. Sectioning of the laboratory into separate rooms with places for patients, visitors, and reception of specimens. G. Bench surface that are without cracks, impervious, washable, and resistant to disinfectants and chemicals. H. Suitable storage facilities that include a well ventilated, fire proof, locked store, for the storage of flammable chemicals. I. A good supply of gas, water, electric power & wall electric points J. Provision of protective safety cabinets, fire extinguishers at accessible points, and adequate waste disposal area, etc. Safe use of Laboratory Equipment A. Positioning - Suitable and ideal place for operation - Avoid overcrowding of a bench with equipment - Position equipment correctly that requires special facilities like ventilation, shield XXXIV  from sunlight, and great care. B. Installation - Should be carried out by the supplier or by the health unit electrician or trained lab equipment technician. - Important points to consider for safe installation: - Ensure that the voltage of the new equipment is the same as that of the electricity supply. - Check that the power required by the instrument does not exceed the power supply circuit of the lab. - Make sure that the equipment is wired correctly, and the wiring system have grounded conductor. Safe use of Electrical Equipment The supplier should demonstrate the use of an apparatus. If this is not possible, the operation and service manual should be carefully studied before the equipment is operated. Points to consider with regard to the safe use of electrical equipment: 1. Hands should be dry completely, and also the floor on which the operator is standing. 2. The electric supply must be disconnected when performing any maintenance and at the end of the day’s work. 3. If a fuse should blow, do not automatically put in a new one until the circuit is checked. Safe use and Storage of Chemicals and Reagents Even in the smallest lab, dangerous chemicals are used directly or incorporated into stains and reagents. These include highly flammable chemicals such as ether or methanol, highly corrosive chemicals such as phenol or sulphuric acid, or toxic and harmful chemicals such as formaldehyde solution. The correct handling and storage of hazardous chemicals is essential to prevent injury and damage. It is particularly important to keep chemicals out of direct sunlight and avoid overheating in chemical stores and the laboratory. Overheating can decompose XXXV many chemicals, cause explosions, or the formation of toxic fumes. - Labeling of dangerous chemicals and reagents To reduce accidents caused by chemicals, many countries have introduced legislation, requiring manufacturers to label dangerous chemicals with hazard symbols and to provide simple safety instructions. The six accepted danger symbols currently in use are toxic, corrosive, explosive, oxidizing, highly flammable, and harmful or irritant. Figure 7.1. Common symbols of hazards 4. Preventing Laboratory Infection All specimens received in the lab should be regarded as potentially pathogenic. For example, a blood specimen sent for measuring hemoglobin may contain highly infectious organisms. Laboratory acquired infections can be prevented by: - Practicing personal hygiene - Wearing of laboratory coat and protective gloves - Safe handling of specimens and infectious materials. - Avoiding mouth-pipetting - Disposing safely of specimens and contaminated material. - Being immunized against highly infectious pathogens Practice of Personal Hygiene This includes: - Washing of hands and arms with soap and water before and after work - Wearing protective clothing and gloves whenever possible. - Covering any cuts, insect bites open sores, or wounds with a water proof adhesive dressing. XXXVI  - Wearing closed shoes and not walking barefoot. - Not eating, drinking, chewing gum, smoking or applying cosmetics in any part of the lab. Safe Handling and Disposal of Specimens Special precautions should be taken when collecting specimens, especially blood specimens, and when testing specimens and handling infected material. Safety measures involved are: - Careful handling and disposal of materials used for collecting specimens. - Making contaminated materials non-infectious by using appropriate decontamination methods. - Wearing gloves and a plastic apron when collecting blood suspected of having a highly infectious disease like AIDS. - Avoid contamination of fingers, other body parts, and working surface. - Specimens suspected of having hepatitis, viral hemorrhagic fever, and AIDS must be labeled ‘HIGH RISK’. Strict Prohibition of Mouth Pipetting Pathogens may be ingested during mouth pipetting, either by direct aspiration or from the mouth ends of pipettes which have been contaminated from fingers or benches. Accidents caused by mouth pipetting include infection, poisoning, chemical burns, and other injuries from chemicals. There are many inexpensive and simple ways to measure and dispense safely without mouth pipetting. Miscellaneous - Immunization- protective inoculations against certain pathogenic organisms are necessary. - The use of signs- display suitable safety signs both prohibitive (don’t) and commands (do). - First aid- basic practical training in first aid helps to reduce suffering and consequences of serious accidents. 5. Elements of a Laboratory Safety Program XXXVII  - A successful laboratory safety program requires the participation of persons at every level of the laboratory staff. - Safety does not occur only with the appointment of safety officer or safety committee. - Safety does not occur by having employees solely perform their assigned duties in manner which they feel is most efficient. - Laboratory safety requires the full participation of every member of the staff. Management Responsibility - Establish a policy relative to the design and implementation of the safety program. - Delegate authority for implementing the program. - Provide a safe and healthful work place. - Provide fund for the implementation of the program. Safety Officer Responsibility - Technical advisor to the program - Assist in the development of safe work method - Advise management on safety issues - Assist safety committee - Provide a variety of communication, e.g., hazard notice, safety data - Review a variety of plans which include facility designs, special equipment purchases in relation to safety. Supervisor Responsibility - Train the staff in lab practices required for safe conduct of work. - Evaluate regularity of the laboratory facilities, equipment, personnel and work place. - Correct unsafe condition as fire hazards, physical hazards, and defective equipment. Employees’ Responsibility - Use of safe equipment - Report of malfunctioning of equipment XXXVIII - Report injuries or exposure - Report hazard or unsafe condition to supervisors. XXXIX