LABMAN Lesson 1

• Clinical and Laboratory Standard Institute (CLSI) created the 12 quality system essentials.
• Laboratories provide physicians and other healthcare professionals with information to detect disease or predisposition to disease, confirm or reject a diagnosis, establish prognosis, guide patient management, and monitor the efficacy of therapy.
• Government-operated laboratories are partially maintained by the national government, a local government unit.
• Private laboratories are privately owned, established, and operated with funds through donation, principal investment, or other means by an individual, corporation, association, or organization.
• Institution-based laboratories are located within the premises and operate as part of a DOH-licensed health facility, such as hospitals, clinics, schools, medical facilities, and department of pathology.
• Non-institution-based laboratories operate independently and are not attached to any DOH-licensed health facility.
• Clinical Pathology deals with the chemical and cellular analysis of blood and other body fluids, including Clinical Chemistry, Clinical Microscopy, Immunology and Serology, Hematology, Bacteriology, and Anatomic Pathology.
• Molecular Pathology deals with the analysis of certain genes, proteins, and other molecules, in samples from organs, tissues, or bodily fluids to diagnose disease and/or to guide the prevention and treatment of disease.
• Leadership provides direction where an organization is going and is a pattern of behaviors used to engage others to complete tasks in a timely and productive manner.
• Supportive Leader provides physical and personal resources, flexibility, encourages creative problem solving.
• Directive Leader presents rules, orders, and other defined instructions to the individual, is concise, detailed, and provides direction.
• Delegating Leader provides low support and low direction, also known as "delikado".
• Coaching Leader provides high support and high direction.
• Management provides the "road" to get here, the primary functions are planning & prompt decision making, organizing, leading, and controlling - effective utilization of resources.
• First-Line Managers complete tasks for the day, such as supervisors, team leaders, and CMT.
• Middle-Line Managers are engaged in strategic and tactical activities, such as operations managers and division heads.
• Every laboratory should strive for modern equipment, hire well-trained staff, ensure a well-designed and safe physical environment, create a good management team.
• The College of American Pathology (CAP) has adopted ISO (15189: 2007).
• Strategic planning involves deciding on the objectives of the organization and need to modify existing objectives.
• Continuous Quality Improvement (CQI) is an element of TQM that strives to continually improve practices and not just meet established quality standards.
• Six Sigma is a performance improvement program, the goal of which can be summarized by the mantra "improvement by eliminating process variation".
• Pre-planning, organization, well-defined goals, communication, firm belief are elements of strategic planning.
• Laboratory Directors, CEOs, CIOs are examples of Top-Liner Managers.
• Establishing policies that govern the acquisition, use, and disposition of these resources is based on long-term projections with a global view.
• The International Organization for Standardization (ISO) has established guidelines that would reflect the highest level of quality.
• Plan, Do, Check, Act (PDCA) is a methodology for continuous improvement.
• Top-Liner Managers concentrate on strategizing and planning for the next 1-5 years.
• Lean utilizes techniques that would determine the work activities that do not directly add to the laboratory services in the most cost effective ways.
• Lean Lab is an approach to laboratory management that utilizes Lean techniques.
• Tactical planning involves detailed day-to-day operations needed to meet the immediate need of the laboratory and works toward meeting the long-term strategic goals that have been set.
• DMAIC stands for Define, Measure, Analyze, Improve, Control.
• Allocating resources to attain these objectives is a process by which high-level decisions are made.
• The five "S" techniques are Sort, Set in order, Shine, Standardize, Sustain.
• Quality systems management is a key management goal to ensure that quality laboratory services are provided.
• Total Quality Management (TQM) is a system of approach that focuses on teams, processes, statistics, and delivery of products that meet customer expectations.