Laboratory Management PDF
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This document provides an overview of laboratory management, including planning, organizing, directing, and controlling resources. It also discusses key functions in management, such as planning and organizing, and principles in management, such as quality assurance and regulatory compliance.
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Lab Man Lec / First Semester - Prelims ~ Directing the resources to achieve the WEEK 1 & 2 goal (most important resource:...
Lab Man Lec / First Semester - Prelims ~ Directing the resources to achieve the WEEK 1 & 2 goal (most important resource: human resources) Defining Management ~ Also, designing physical space, it ~ Management is the process of planning, should be open to all organizing, directing, and controlling resources Ex: investing to test kits to achieve (including personnel, finances, equipment, and high accuracy results data) to achieve specific goals and objectives effectively and efficiently. ¨ Controlling ~ Fayol, H. (1916) in his book "General ~ Monitoring and evaluating performance and Industrial Management against set standards. ~ 1916, people are focusing in ~ To know if your activities are still in the manufacturing, industrial revolution right path towards your goal (machines & instruments are invented) ~ If not, redesign your plan, organize ~ We have been engage in the practice of resources, and think of how you can re- management ever since (ex: dealing w/ align those to achieve your goals courses or schedules, choosing clothes or ~ In laboratories, this involves quality control games) measures to ensure accurate and reliable ~ In other books, (1) planning, (2) organizing, (3) results. directing & controlling comes together, (4) leading Principles in Management ¨ Quality Assurance (under controlling Key Functions in Management but we should look at it as a principle) ¨ Planning ~ Ensuring that processes and procedures meet ~ The process of setting goals, defining high-quality standards. strategies, and outlining tasks to achieve ~ Continuous monitoring and improvement to objectives. enhance accuracy and reliability. ~ Why are you planning? (define & o Accurate – getting the true value / exact of the identify the goal) Next, strategized (how analyte to accomplish your goal) o Reliability – consistency of the values ~ In laboratory management, this involves ¨ Regulatory Compliance establishing clear objectives for accurate ~ Adherence to laws and regulations governing testing, resource allocation, and quality laboratory operations. standards. ~ Compliance with organizations like DOH and ~ Setting objectives to maintain and CAP/JCIA. College of American Pathologists & achieve accurate results, properly Joint Commission International Accreditation allocating the resources as well as the ~ Regulatory: DOH & PRC (you can’t human resources practice as MT without license) ¨ Organizing ~ Accreditation org – CAP & JCIA ~ Structuring resources and tasks to optimize o Principle governing management than a efficiency and productivity. function ~ It is not efficient / effective if you don’t ¨ Resource Management have organization (ex: organizing ~ Efficient allocation of resources, including staffs) personnel, finances, equipment, and materials. ~ In a laboratory, this means organizing ~ Individual staffs are all involve in R.M personnel, equipment, and materials for (ex: how many test kits are available / seamless operations. missing, what instruments are needed) ¨ Directing (or leading) ~ Section head – collect all the data from ~ Guiding and motivating employees to achieve individual MT goals. ~ Ensuring cost-effectiveness and sustainability. ~ In laboratory management, it's about leading o Cost-effectiveness – it is a risk benefit ratio ( and supervising laboratory staff to ensure if the benefits outweigh its cost) smooth workflows NINGNING 1 Lab Man Lec / First Semester - Prelims ¨ Data Management PHASE II: Budget Assumptions ~ Proper handling, storage, and interpretation of ~ The organization provides a forecast of data. available money based on past earnings, cash ~ Use of information systems for data flow, and changes in state or federal laws organization and reporting. affecting reimbursement. o Don’t release sensitive info to public ~ Health insurance o Digital data should be secured and not prone ~ Phil Health to hacking (all health data are centralized) ~ The laboratory formulates budget ¨ Interdisciplinary Collaboration assumptions based on annual test volume and ~ Working cooperatively with healthcare teams revenue generated. to provide accurate diagnostic information. PHASE III: Forecast of Expenses ~ All should work together to deliver ~ CAPITAL EXPENSE: Capital expenditures are holistic approach & to provide the best most often calculated for a three-year cycle. quality care ~ Items that may fall into this category include ~ Effective communication and teamwork. ~ Request for new space or space o Lab staffs get more participation in health care changes ¨ Safety Measures ~ Replacement equipment ~ Ensuring the safety of personnel, patients, and ~ Purchase or lease of new equipment the environment. ~ Information Technology; interfaces, ~ Handling biohazards and chemicals with care. hardware, licensing fees o Safety measures: proper waste disposal, waste categorization, chemical disposal to ~ Capital expenditure is an investment. ensure that lab is protected ~ Its rate of return must be evaluated ¨ Adaptability and Innovation and used as a criterion for budgeting decisions. ~ Being open to new technologies and practices. ¨ Suggested Categories of Capital ~ Embracing automation, AI, and emerging trends in laboratory management. Expenditure Justification: ~ Automation is an integral part of lab ~ Replacement operation ~ New Equipment o Don’t stop learning for continuous professional ~ Cost-reduction development ¨ Suggested Categories of Capital Expenditure Priority: WEEK 3: LABORATORY ~ Essential: needed immediately to maintain quality patient care BUDGETING & FINANCE ~ Necessary: also “essential” but greater PHASE I: Development of Goals leeway with regard to time of ~ Lab develops goals based on the acquisition. organization’s mission statement and ~ Desirable: means of reducing cost strategic objectives. ~ Other means of improving general ~ Lab goals must be in line with those of the working conditions organization and must be achievable. --------------------------- ~ SMART Rule (Based on Peter Drucker’s ~ Prior to any capital purchase, it is wise to do Management by Objective Concept; Term cost analysis coined by George T. Doran, appearing in the ~ Some items to consider in the analysis are: Nov 1982 issue of Management Review) ~ Equipment cost ~ Specific ~ Cost of service contract ~ Measurable ~ Reagent cost ~ Attainable ~ Technologist time ~ Realistic ~ Cost to the patient ~ Time-Bound ~ Insurance coverage of the lab test NINGNING 2 Lab Man Lec / First Semester - Prelims ~ OPERATIONAL EXPENSES: most commonly Organizational Structure encompass a twelve-month cycle. ~ Gives insight into how we act and react to our ~ Requires careful identification of all own system categories of expenditures and the most ~ Optimizes the technical and social aspect prudent allocation of funds for each category ~ Organization chart helps to understand the ~ Charts of Accounts: the grouping of levels of authority and lines of communication expense categories ~ Give physical structure of the system ¨ Example of a hospital laboratory ~ Organization chart with boxes and lines charts of account: describe the structural plan. ~ Salaries including cost of benefits ~ Helps to answer the question “how do we ~ Reference lab fees divide the work” ~ Education and travel ¨ “We cannot solve the problems we ~ Chemistry have created with the same thinking ~ Hematology that created them”. ~ Microbiology - Albert Einstein ~ Transfusion service ~ Organizations are like individuals, must ~ Operating costs learn from past successes and failures and ~ Blood supply cost look for creative ways to find solutions for the ~ Purchased service and maintenance future. ~ Other direct expenses ~ Organizations perform best were information flows rapidly ~ Information must flow both internally & WEEK 4: ORGANIZATION AS A externally to permit accurate decisions to be MANAGEMENT FUNCTION made ~ Organization: is a collection of people working Organizational Charts together under a defined structure for the ~ Organizational Charts explain: How do we purpose of achieving predetermined outcomes divide up the work?” through the use of financial, human and ~ Ex: different levels of healthcare material resources (primary, secondary, tertiary clinical lab) ~ Organization provides a vision and focus ~ No. increases = complexity of the ~ Management structure depends on factors structure increases such as size, content, complexity and ~ Charts simplify the responsibilities / distribution of work in the laboratory functions of the oganization ~ If you understand the structure of the Functions of Organization organization, communication and ¨ Provide understanding will become simpler. ~ Provide society with products and Organization of the Clinical Lab services ~ The clinical lab is typically an organization ¨ Offer within an organization. It functions as part of ~ Offer employment and economic the larger health system and provides specific exchange for members services that are vital to the overall mission of ¨ Give providing ~ Give a framework for a social system ~ patient care (central activity) ~ Ex: healthcare system – make a ~ Specialized services framework based on their functions ~ Center of excellence (distribute nurses, MTs, physicians, etc) ~ Understanding the concept of organization ¨ Learn structure and function can lead to optimizing ~ Organizations must learn from past the technical and social aspects of the successes or failures organization and enhance performance and outcome o Freestanding / private labs are still part of the healthcare system NINGNING 3 Lab Man Lec / First Semester - Prelims Historical Aspect of ~ Mechanistic structure – works in an environment of slow change and Organization relative stability ~ A review of different models of organization ~ Organic structure – preferred in Recent invention (19th century) environment of high change ~ Concepts were derived from military ~ The system: Features decentralized decision organization (Bureaucratic approach) – making and fluid design, which facilitates CLOSED SYSTEM flexibility and adaptation and encourages a ~ Bureaucratic management is wide sharing of responsibility an approach for providing a Open System Perspective clearly defined set of rules followed by ~ Biologic systems are generally thought of as a clear organizational structure exactly open systems that function as “input- quoted as 'hierarchy' by Max Weber. throughput-output mechanisms” This approach defines a clear chain ~ Dr Margaret Wheatley of command and a state where there is ~ “our concept of organizations is a clearly defined set of rules to be moving away from the mechanistic followed by each level of hierarchy creations that flourished in the age of ~ Max Weber introduced the concept of bureaucracy. We now speak in earnest bureaucracy /rational of more fluid, organic structures, of ~ Legal system boundary less and seamless ~ Rigid system organizations. We are beginning to ~ Businesses involving routine tasks recognize organizations as a whole Scientific Management systems, constructing them as ‘learning organizations’ or ‘organic’ ~ Frederick Taylor in 20th century – Principles and noticing that people exhibit self- of scientific management organizing capacity” ~ Division of labor between ~ Where members grow and progress management (thinking) and worker (not stagnant) (doing) – to produce products ~ Taylor introduced the discipline of ¨ The Clinical lab as an Open system scientific management as a mean of organize work. ~ In the past man has been first, in the future the system must be first” ~ Dealt with the problem of how to get more productivity out of workers ~ “the manager’s job to understand the task and plan a method of executing it and then coerce the worker to do it, by motivating the worker with pay” ¨ Open- and Closed-system of ~ Just doing the job left the workers Organization alienated and dispirited Inclusion of human element continued in 1960: Sociotechnical Theory ~ The development & application of behavioral and social sciences in combination with advancement in industrial and information technology ---- created new questions about the work environment” ~ Burns and Stalker – Organization as mechanistic to organic structures NINGNING 4 Lab Man Lec / First Semester - Prelims ¨ Characteristics of an Open-system ¨ Nadler-Tushman Congruence Model Organizational Model o Goal or purpose – primary mission or task determines its distinct nature ~ Production of timely meaningful delivery of report o External environment drives significant changes ~ The requirements of external environment directs & defines the purpose o Systems have clearly defined boundaries ~ Work: the tasks performed to provide the ~ The members of the clinical laboratory products or service are recognized by the boundaries of the departments ~ People: including skills, knowledge, and o Seek to maintain a state of stability and workforce expectations equilibrium ~ Formal organization: formal structure, ~ all labs have similar purpose of policies, and procedures for performing the generating quality reports, but each lab work has its unique way to accomplish it. ~ Informal organization: culture and informal o As a system grows it becomes more rules and understanding about how the system complex-it forms specialized components works or sub-systems ~ Constitutes of the system must be considered ~ labs function as sub-system of and must be congruent with each other to hospitals obtain maximum efficiency in transforming ~ labs in turns are differentiated into the strategies to performance departments (ex: hematology is ~ The lack of fit between any component of different from clinical chem) the operation organization compromises the o Feedback is important to the alignment system and can produce huge problems e.g. and performance of systems miscommunication, tension among personal, operational inefficiencies Congruence ~ The Congruence Model was developed in the ¨ Application of Nadler-Tushman early 1980s by organizational theorists David Congruence Model A. Nadler and Michael L. Tushman. It's a powerful tool for identifying the root causes of organizational performance issues and how you might fix them. ~ It is a challenge for the lab manger to recognize inconsistences and implement changes to improve organizations ~ Way to approach the change is look closely to what must happen within an open system to support a state of equilibrium (delivery of quality laboratory results to the patients) ~ The congruence model described by David Nadler shows the elements of an organization as an OPEN SYSTEM and some of the dynamics involved. ~ Used to analyse the external elements of a system together with the internal interdependence of its parts ~ Depend on work, people, formal organisation and informal organisation NINGNING 5 Lab Man Lec / First Semester - Prelims Organizational Design ~ But, can lead to duplication of resources and ~ Organization designs effect the efficiencies, expertise in specific areas and ability to meet productivity, cost containment and personal changing conditions quickly needs: ¨ Example of a self-contained unit ¨ Five factors influencing the design & organization structure 1. Goals & directions 2. Technologic capabilities including IT 3. Size (the laboratory subsystem/ patient needs) 4. Environment-Client & patient needs 5. Leadership style, member behaviors and organization culture Matrix Organization ~ Takes advantage of skills and functions Structural Models ~ Formation of multi-use areas to maximized 1. Functional staff skills and resources 2. Self-contained units 3. Matrix ~ Works well when the demands of the 4. Network structures environment are changing ~ However, roles and reporting structures can be Functional Model confusing ~ Hierarchical, rigid, bureaucratic ~ A matrix org chart is one of the most ~ Report in upward chain of command complicated org charts a company can adopt ~ Stable controlled, works well for small & dept. but as well as the most useful one. engaged in repetitive work ~ It is formed with grid or matrix. ~ Disadvantage – communication among the ~ Besides hierarchy, employees are groups is compromised divided into teams by projects, which ~ Upward Communication is the process means workers have dual reporting of information flowing from the lower levels of relationship-a functional manager and a hierarchy to the upper levels. This type a project manager. of communication is becoming more popular in ~ Outside lines indicates formal direct organizations as traditional forms of reporting communication are becoming less popular. ~ Inside lines indicate informal reporting The more traditional organization types such ~ Circles represent functional teams or as a hierarchy, places people into separate departments ranks. ~ Upward communication keeps managers ¨ Example of Matrix Organization aware of how employees feel about their jobs, policies and procedures, and the business in general. It consists of methods like Feedback from employees, helps in bringing Mutual Trust and helps the organization to determine, implement or decide upon new policies. It keeps the organization updated or prone to upcoming challenges. Self-Contained Units ~ Organized around a common basis (e.g. discipline, location, customer group or Network Structure technology) ~ Evolving due to IT systems allowing instant ~ Each unit has all the necessary skills to access and distribution of data and information function successfully ~ Reflects information technology models with ~ Can have sub-units ‘hot labs’ customers focus and information sharing ~ Works well if resources are shared for the ~ Consists of specialized units: internal or common good plus good communication external to the organization and sharing of information NINGNING 6 Lab Man Lec / First Semester - Prelims ~ Internal / external units are linked together departments (not hierarchical unlike by formal or informal agreements before) ~ May take a variety of forms as they run from ¨ Key Reminders the customer/patient back, not from the top ~ Look for new and creative designs to meet the down need of the environment, especially patients ~ Example of this type of system is the ~ No ‘right way’ browser-server network organisation ~ Evaluation of own situation and anticipate ¨ Example of Network Structure future trends ~ Front line employees – serve client needs & ~ ‘we have always done it this way’ make critical decisions ~ Should be replaced by change with strategic ~ Backline employees – support the front line plans which reflect the organisational goals ~ Network organizations have a center not a and vision top ~ Role of the management is to facilitate and WEEK 4: CLINICAL LAB serve ORGANIZATION Management ~ An ongoing process that seeks to achieve the objectives of an organisation in the most efficient ways possible”. ~ It may be also defined as “the attainment of objectives”. ¨ Network Structure in the Lab ~ It has been also simply defined as “controlling ~ Front line – closet to patients -point of care and organising an organisation and testing (employees serve client needs and leading” make critical decisions) ~ Next line represents less urgent batch testing Medical Laboratory Management ~ Backline – specialized technical areas offering ~ An ongoing process that seeks to efficiently complex tests achieve the objectives of a medical laboratory. ~ Central management provides necessary ~ The objectives of a medical laboratory are services & resources (e.g information systems, providing its customers (physicians on behalf facilities and personnel) of patients) accurate answers which contribute to clinical treatment ~ Network system depends on strong collaborative leadership, and efficient IT ¨ Rationale for Studying Lab system, appropriate clinical instrumentation Management and flexible staffing ~ In order for lab managers to be effective on the job 21st Century Organizational ~ Technically competent in specific areas of lab medicine and also, Trends ~ Non-technical side of management ~ Some trends in organisations prompted by ¨ Every achievement of management is requirements for efficiency, speed, cost the achievement of a manager, and effectiveness, and customer/patient focus every failure is the failure of a manager ~ Technology advancements ~ A good manager studies management as a ~ Diversity in the workforce daily practice. The high-performance manager ~ Flexibility required to respond to is: demands of patients and healthcare ~ A strategist: one who looks to the providers future. ~ Flattening of organizations – fewer ~ A Problem solver: one who uses his management levels and empowerment factors under his or her control to of employees to make decisions redirect the course of action to achieve ~ Strategic alliances, partnerships, the organization objectives mergers and information sharing - ~ A teacher: One who guides and helps Internet and intranet (increase in direct others to identify and solves problems communication across units and NINGNING 7 Lab Man Lec / First Semester - Prelims Medical Laboratory Managers ~ Optimizing the technical and social aspects of ~ Challenged to become business, as well as the organization can enhance and maximize technical specialists. performance and outcomes ~ There are many pressures on the modern ~ Organization structure describes structural medical laboratories and managers may be plan. forced to not only keep up to date but to move ¨ The Principles of Good Management ahead in preparation for the needs of the Practice – Development of the future. strategic plan ~ The work environment has changed with the 1. The strategic plan is consistent with the development of new technology. Laboratories mission of the organisation have always seen the need for change and 2. The strategic plan is developed using development, there has been increased both internal and external contributions and pressure to improve performance, tighten information. The development process margins, improve quality and reduce costs provides the opportunity for the organisation to learn from its own Organization performance and from external developments ~ are systems made up of individuals who share 3. The development of the strategic plan is the common purpose and perform tasks in an iterative(=repetitious) process whereby service of that purpose. different elements of the plan – direction, ~ Organizations provide vision and focus, facilities and services, staffing, finance, ~ They consist of technical and social IT – are brought together to form a components consistent and coherent plan Functions of Organization 4. Mechanisms are in place to ensure that ¨ Provide any decision which has significant resource ~ Provide society with products and implications (for revenue, expenditures and services capital) is only incorporated in the strategy after those implications have been ¨ Offer identified, estimated and built into future ~ Offer employment and economic plans exchange for members 5. There is a mechanism to facilitate the ¨ Give 'ownership' of the strategic plan and ~ Give a framework for a social system supporting operational plans through use of ¨ Learn the management structure ~ Organizations must learn from past Resource allocation successes or failures ~ There is a clear mechanism and criteria to Organization of Clinical determine priorities for resource allocation – Laboratories the criteria follow from the strategy and inform the planning process. ~ The organization depends on the site (public health hospital, physician office laboratory, or ~ Mechanisms and formulae, if any, for independent laboratory, etc.) and the allocating resources (for example, complexity of testing. performance-based formulae) are understood and transparent. ~ Microbiology Laboratory ~ There are agreed ways of allocating resources ~ Chemical & Biomedical Laboratory on an ad hoc basis as necessary. ~ Haematology Laboratory ~ The resource allocation process provides ~ Histopathology Laboratory incentives for increased value for money in all ~ Molecular Biology laboratory functions ~ Clinical Laboratory is an organization within Implementation of plans an organization. ~ Operational plans are developed from the ~ It functions as part of larger health system and strategic plan and include milestones and provides specific services that are vital to the performance measures for regular monitoring. overall mission of providing patient care. ~ It is clear who is responsible for the implementation of each plan component and how that responsibility is to be discharged. NINGNING 8 Lab Man Lec / First Semester - Prelims ~ Appropriate action is taken as a result of the Management information and outcomes of monitoring the implementation of systems the operational plans ~ In producing management information, both Roles, responsibilities and training financial and non-financial – the differing needs in an Organization of different users are established, assessed ~ There is a clear management structure, with and reflected in the information provided to the managerial responsibilities, reporting lines users. and means of accountability well defined and ~ There is a procedure in place to ensure that all accepted by all concerned; the scope of any management information used in decision delegated authorities is clear to both parties making and monitoring is adequately reliable, ~ The responsibilities of each member of staff valid and consistent and that the level of detail is defined and included in a job description; given to users is appropriate to their needs. which are aligned to the process for ~ Systems in place support administrative and assessing performance of individuals. management processes across the ~ For each committee, its terms of reference organisation. Systems are developed and are clear, unambiguous and accepted by its operated on the basis of user need. members; in particular it is clear whether a ~ Systems are reviewed on a regular basis committee is consultative, advisory or decision taking full account of user feedback and other making; each is subject to periodic review benchmark information. explicitly to consider its continuing usefulness ~ Disaster recovery plans exist for all systems ~ The competencies of committee members and staff are appropriate to their roles, with WEEK 5 : EQUIPMENT training available relevant to their needs, especially for those with new managerial MANAGEMENT responsibilities (e.g. financial responsibilities Overview of Equipment ~ There is clarity in roles and responsibilities Management with respect to committees and individual staff ~ Importance: Proper equipment members, especially in relation to the roles of management extends instrument life, reduces professional staff service interruptions, enhances worker safety, Service delivery in an Organization and boosts customer satisfaction. ~ There is a process to ensure that the ~ Key Responsibilities: The laboratory organisation is meeting the administrative director is responsible for overseeing and operational needs of its clients, staff equipment management, ensuring personnel and external constituencies – this includes are trained, and monitoring equipment mechanisms whereby service users can activities. comment on the level of service, priorities and Elements of Equipment related performance improvement plans and mechanisms to ensure that the plans are acted Management upon. ¨ Selection and Purchasing ~ There is a regular review processes (or ~ Criteria for selecting equipment (needs to audits) in place to assess and improve the set-up) include its intended use, performance performance and structure of all administrative characteristics, facility requirements, budget and committee functions and services (e.g. to considerations, and availability of reagents. ensure that there are no unnecessary steps, ~ Decisions about purchasing versus leasing duplication of activities or levels of should factor in repair costs and maintenance management). needs. ~ There is appropriate means to respond to ~ Ex: 1 lab will rent the machine then the external and internal audits or reviews of other lab will offer their reagents functions with structures and processes such ¨ Installation that change is possible within reasonable ~ Installation requirements must be confirmed, timescales including physical space, utilities, and vendor responsibilities. NINGNING 9 Lab Man Lec / First Semester - Prelims ~ A checklist for performance specifications W5: SUPPLY MANAGEMENT IN should be developed to verify equipment functionality post-installation. THE CLINICAL LABORATORY ¨ Calibration and Performance Introduction to Purchasing and Evaluation Inventory in Clinical Labs ~ Calibration protocols should be established, ~ Purchasing and inventory management are and equipment performance must be regularly essential components of the quality verified against manufacturer specifications. management system in clinical laboratories ~ Validation procedures are essential for new The Importance of Efficient and equipment to ensure expected results are achieved. Cost-effective Operations ~ Efficient laboratory operations require the ¨ Maintenance uninterrupted availability of reagents, supplies, ~ A preventive maintenance program is and services crucial, including systematic cleaning and ~ Shortages can significantly disrupt clinical scheduled part replacements to prevent care, prevention activities, and public health equipment failure and ensure optimal programs performance. ~ How can you test HIV w/o HIV test kits? ~ An inventory log of all equipment and spare parts should be maintained to track usage and Benefits of Careful Inventory status. (you should have records / log books) Management ¨ Troubleshooting and Repair ~ Proper management of inventory prevents ~ Operators should be trained to identify and waste from improper storage or use of troubleshoot equipment issues promptly. outdated reagents ~ Procedures for service and repair, including ~ Ensures that supplies and high-quality manufacturer assistance and in-house reagents are always available when needed capabilities, must be established. and at an appropriate cost ¨ Retirement and Disposal of Variability in Procurement Methods Equipment ~ Procurement methods vary between ~ A clear policy for retiring non-functional or laboratories outdated equipment is necessary to prevent Challenges of Inventory accumulation and ensure safe disposal. Management ~ You should have to document ~ Balancing supply availability with expiration everything before you throw something dates is a key challenge ¨ Documentation and Record Keeping ~ Continuous monitoring is necessary to avoid ~ Maintaining detailed records of equipment overstocking and ensure reagents are not used management is essential. This includes: beyond expiration Equipment maintenance documents with instructions for operation, maintenance Key Components for Successful schedules, and troubleshooting guides. Management ~ Logs for preventive maintenance, function ~ Successful purchasing and inventory checks, and any repairs performed. management require established policies and ¨ Summary of Benefits procedures for managing all critical materials ~ A well-organized equipment management and services program leads to: High laboratory ~ Key components include performance and reliability of test results. ~ Vendor/manufacturer qualifications ~ Fewer interruptions in testing, reduced repair ~ Purchase agreements costs, and extended equipment lifespan. ~ Processes for receiving, inspecting, ~ Enhanced safety for laboratory personnel testing, storing, and handling materials through well-maintained instruments. ~ Tracking materials to individual patients ~ Assessing and maintaining inventory ~ Controlling expiration periods ~ Dispatching supplies to satellite laboratories NINGNING 10 Lab Man Lec / First Semester - Prelims Selecting Vendors and Setting ~ Quality of Work: Laboratory work quality is Expectations directly linked to the quality of the samples used for testing ~ Building relationships with providers and ~ Key Areas: Emphasizes the importance of carefully evaluating vendor qualifications are organization, personnel, equipment, important purchasing, inventory, process control, ~ Selection criteria include cost, quality, information management, document and reliability, and compliance with specifications record keeping, occurrence management, Implementing an Inventory process improvement, customer service, Management Program facilities, and safety in sample management ~ Key steps in establishing an inventory Sample vs. Specimen control program include ~ Definitions: ISO defines a 'sample' as a part ~ Assigning responsibility for the program taken from a system to provide information on ~ Analyzing the needs of the laboratory that system ~ Establishing the minimum stock ~ Terminology Usage: 'Sample' and needed for an appropriate time period 'specimen' are interchangeable in certain ISO ~ Developing necessary forms and logs documents and in this context ~ Establishing a system for receiving, ~ Regulatory Note: The term 'specimen' is still inspecting, and storing supplies used in some transport regulations ~ Maintaining an inventory system in all Components of Sample storage areas and for all reagents and Management supplies used in the laboratory ~ Policies and Procedures: Importance of Quantification in Inventory written policies reflected in the Laboratory Management Handbook ~ Quantification is crucial for calculating the ~ Key Components: Requisitions or forms, required amount of each item for a given handling urgent requests, collection, labeling, period, forming an essential part of a preservation, transport, safety practices, successful inventory management program processing, tracking, storage, retention, and ~ Accurate quantification ensures essential disposal of samples supplies are available when needed and The Laboratory Handbook prevents overstocking and wastage ~ Purpose and Distribution: Provides ~ It provides information for estimating annual necessary information for sample budget requirements, better planning, and management, available at all collection areas making decisions ~ Essential Content: Contact information, ~ The two frequently used methods are operation hours, test lists, collection consumption-based and morbidity-based requirements, transport requirements, quantification turnaround times, and urgent request handling Summary and Key Messages ~ Staff Training: Importance of laboratory staff ~ A well-managed inventory system is being familiar with the handbook significant in a clinical laboratory Collection and Preservation ~ The focus is on increasing efficiency, ensuring ~ Laboratory Responsibilities: Ensuring the product availability, and meeting patient and collection of optimal samples clinical needs ~ Test Requisition: Essential information on the test request form, including patient W5: SAMPLE MANAGEMENT IN identification, tests requested, sample collection details, and contact information for THE CLINICAL LABORATORY the healthcare provider Overview of Sample Management ~ Collection Requirements: Patient ~ Role in Quality Management System: preparation, identification, sample type, Sample management as a part of process container type, labeling, and special handling control within the quality management system NINGNING 11 Lab Man Lec / First Semester - Prelims Sample Labeling and Tracking ~ Labeling Best Practices: Including patient name, unique ID, test requested, collection time and date, and collector’s initials ~ Tracking System: Keeping a register or log of samples, including collection and receipt times, sample type, patient details, and tests to be performed ~ Outcome of Collection Errors: Potential issues like delays in reporting, re-tests, decreased customer satisfaction, increased costs, incorrect diagnosis or treatment, injury, or death Processing and Quality Verification ~ Pre-examination Steps: Verifying sample labels, condition, adequacy, and appropriateness for the requested test ~ Sample Rejection Criteria: Establishing and following rejection criteria for poor samples ~ Sample Management Review: Regular review of rejected samples, training, and revising written procedures Storage, Retention, and Disposal ~ Policy Development: For sample storage, including conditions and organization ~ Retention Time: Monitoring stored samples, avoiding unnecessary long storage Sample Disposal: Developing policies for safe disposal, complying with regulations Sample Transport and Safety ~ Transport Requirements: Managing sample integrity during transport, adherence to temperature, preservation needs, and safety ~ Regulations and Compliance: Adherence to national and international transport regulations ~ Packaging and Labeling: Following specific packaging instructions based on the sample classification Summary and Key Takeaways ~ Recap: Emphasize the importance of a comprehensive laboratory handbook, efficient tracking system, and robust policies for storage, disposal, and transport of samples ~ Impact on Patient Care and Laboratory Efficiency: Highlight how effective sample management directly affects patient outcomes and laboratory efficiency ~ Continuous Improvement: Encourage ongoing assessment and improvement in sample management practices for enhanced laboratory performance NINGNING 12