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General Laboratory Concepts and workflow

QuestionAnswer
Key elements of Laboratory Organization Strategic planning, marketing, human resource management, and quality management
Most laboratory errors occur in which phases of testing the pre-analytic and post-analytic stages
Which tools can be used to reduce laboratory errors and increase productivity Six Sigma and Lean
Physicians use Laboratory information for what purposes (1) detect disease or predisposition to disease; (2) confirm or reject a diagnosis; (3) establish prognosis; (4) guide patient management; and (5) monitor efficacy of therapy
What are the four primary management functions (1) planning and prompt decision-making, (2) organizing, (3) leading, and (4) controlling.
Four key leadership styles are supporting, directing, delegating, and coaching. A leader may adopt any behavior style periodically to suit a situation, but in general, one style usually dominates
Supportive leader Provides physical and personal resources so that an individual can accomplish his or her duties. This approach offers flexibility and encourages creative problem-solving
Directive leader Presents rules, orders, or other defined instructions to the individual. This approach offers concise and detailed instructions on how to complete a task.
Delegating leader Provides low support and direction
Coaching leader Provides high support and direction.
What are the roles played by different categories of Managers Top-level managers concentrate on strategizing and planning for the next 1–5 years, while first-line managers are more concerned about completing the day’s work. Middle managers may straddle both areas to some degree.
Strategic Planning Process by which high level decisions are made (1) deciding on the objectives of the organisation and the need to modify them (2) allocating resources to attain objectives (3) making policies for acquisition, use, and disposition of these resources.
Standard approaches to quality leadership and management for over 30 years Total quality management (TQM) and continuous quality improvement (CQI)
TQM Systems approach that focuses on teams, processes, statistics, and delivery of services/products that meet or exceed customer expectations. TQM thinking strives to continually look for ways to reduce errors (“defect prevention”) by empowering employees
CQI Element of TQM that strives to continually improve practices and not just meet established quality standards.
Two other quality tools other than TQM and CQI Six Sigma and Lean
Six Sigma Process improvement program that is a hands-on process for improved performance, improved quality, improved bottom line, improved customer satisfaction, and improved employee satisfaction.
Most organizations operate at what sigma level At or near four sigma (6210 DPMO).
12 QSEs created by CLSI based on ISO standards are Organization, Personnel, Documents and records, Facilities and safety, Equipment, Purchasing and inventory, Information management, Occurrence management, Assessments—internal/external, Process improvement, Customer service, Process control
What is the intent of Lean To reduce costs by identifying activities that do not directly add to the delivery of laboratory services in the most efficient or cost-effective ways. A Lean lab utilizes fewer resources, reduces costs, enhances productivity, promotes staff morale
Goal of Six Sigma The goal of Six Sigma is to reduce the number of defects to near zero. One sigma represents 691,463 DPMO, or a yield (i.e., percentage of products without defects) of only 30.854%, whereas the goal of Six Sigma is to reach 3.4 DPMO, or a 99.9997% yield
Evolution of functional design of a laboratory and its relationship to other testing sites within a facility Has evolved from one with discrete hematology, chemistry, microbiology, and blood bank sections to one where boundaries have been obscured - highly automated “core” facilities and distributed testing at peripheral stat laboratories and/or POCT sites.
Based on current technology, tests that once were performed in separate laboratory sections are now performed in which manner On a single testing platform (single analyzer), on a workcell (two or more linked instruments), or with the use of total laboratory automation (workcell with preanalytic and postanalytic processing).
Regionalization Grand scale Consolidation process -“hub and spoke” model, a single core laboratory serves as the hub, providing high volume, routine testing - other laboratories act as the spokes,thus consolidating certain functions into one highly specialized laboratory
The clinical laboratory exposes staff, and potentially the public, to a variety of hazards which are Biological Hazards (Infectious patients, infectious patient specimens), Chemical Hazards (hazardous chemicals), Ergonomic Hazards (equipment & layout)
What are the laboratory Hazard Prevention Strategies Workplace Controls (general procedures/policies that mandate measures to reduce or eliminate exposure to hazard), Engineering controls (safety features built into the overall design of a product), Personal Protective Equipment (PPE)
Among laboratory personnel what are the workplace ERGONOMIC hazards In laboratory cumulative trauma disorders are usually related to repetitive pipetting, keyboard use, or resting their wrists/arms on sharp edges, such as a laboratory counter.
What are the prevention steps for Ergonomic hazards in a laboratory Awareness and prevention are essential in managing these disorders. Work practice and engineering controls, in addition to various hand, arm, leg, back, and neck exercises, may reduce these problems
An effective testing process requires integration of preanalytic, analytic, and postanalytic steps
Fundamental prerequisite to any performance optimization strategy in Laboratory Understanding of laboratory workflow
Techniques to be used to collect workflow data in laboratory Sample and test mapping, tube analysis, workstation analysis, staff interviews, and task (process) mapping.
Issues to consider when auditing Laboratory Operations Test Ordering, Sample Collection, Transportation, Sample receipt, Sample processing, Testing and Reporting
Sample and Test Mapping Analyzing the distribution of samples and tests over time - time interval can be a day (e.g., hour increments for frequently ordered tests like those in general chemistry) or a week (e.g., daily increments for tests batched several times a week).
Tube Analysis Part of the laboratory’s daily work is related to processing collection tubes or containers. “Tube labor” includes sorting and centrifuging; aliquoting; racking, unracking, loading, and unloading samples on analyzers; retrieving tubes for add-on tests; pe
Workstation Analysis A workstation is one physical location (e.g., a fully automated analyzer or group of analyzers such as hematology cell counters or a chemistry workcell). Regardless of how a laboratory is organized, it is important to understand where, when, and how the w
Workflow Analysis Workflow analysis assimilates all data from Sample and test mapping, tube analysis, workstation analysis, staff interviews, task (process) mapping and transforms them into valuable information. This step can be done manu ally or using commercially availab
Workflow Modelling By using sophisticated workflow modeling software, one can analyze these complex interrelation- ships to better predict the outcome of a given workflow design. Workflow modeling can help identify bottlenecks and the impact of staffing changes or different
Laboratory technology refers largely to three functional areas Testing equipment (i.e., analyzers), preanalytic processors, and information technology (IT).
Key strategies that can optimize workflow using concepts such as Six Sigma to achieve Lean processes Consolidation, standardization, and integration. Managing test utilization may also change overall operational needs and workflow patterns.
Assessment of excess capacity is useful in Establishing the feasibility of increasing testing workload, especially in outreach programs.
What are the factors are involved in the assessment of whether a laboratory has excess capacity that will allow it to accept additional specimens for testing Philosophy and mission, Physical resources, Personnel and activities & Economy of scale
Key elements of Laboratory Organization Strategic planning, marketing, human resource management, and quality management
Most laboratory errors occur in which phases of testing the pre-analytic and post-analytic stages
Which tools can be used to reduce laboratory errors and increase productivity Six Sigma and Lean
Physicians use Laboratory information for what purposes (1) detect disease or predisposition to disease; (2) confirm or reject a diagnosis; (3) establish prognosis; (4) guide patient management; and (5) monitor efficacy of therapy
What are the four primary management functions (1) planning and prompt decision-making, (2) organizing, (3) leading, and (4) controlling.
Four key leadership styles are supporting, directing, delegating, and coaching. A leader may adopt any behavior style periodically to suit a situation, but in general, one style usually dominates
Supportive leader Provides physical and personal resources so that an individual can accomplish his or her duties. This approach offers flexibility and encourages creative problem-solving
Directive leader Presents rules, orders, or other defined instructions to the individual. This approach offers concise and detailed instructions on how to complete a task.
Delegating leader Provides low support and direction
Coaching leader Provides high support and direction.
What are the roles played by different categories of Managers Top-level managers concentrate on strategizing and planning for the next 1–5 years, while first-line managers are more concerned about completing the day’s work. Middle managers may straddle both areas to some degree.
Strategic Planning Process by which high level decisions are made (1) deciding on the objectives of the organisation and the need to modify them (2) allocating resources to attain objectives (3) making policies for acquisition, use, and disposition of these resources.
Standard approaches to quality leadership and management for over 30 years Total quality management (TQM) and continuous quality improvement (CQI)
TQM Systems approach that focuses on teams, processes, statistics, and delivery of services/products that meet or exceed customer expectations. TQM thinking strives to continually look for ways to reduce errors (“defect prevention”) by empowering employees
CQI Element of TQM that strives to continually improve practices and not just meet established quality standards.
Two other quality tools other than TQM and CQI Six Sigma and Lean
Six Sigma Process improvement program is a hands-on process for improved performance, improved quality, improved bottom line, improved customer satisfaction, and improved employee satisfaction.
Most organizations operate at what sigma level At or near four sigma (6210 DPMO).
12 QSEs created by CLSI based on ISO standards are Organization, Personnel, Documents and records, Facilities and safety, Equipment, Purchasing and inventory, Information management, Occurrence management, Assessments—internal/external, Process improvement, Customer service, Process control
What is the intent of Lean To reduce costs by identifying daily work activities that do not directly add to the delivery of laboratory services in the most efficient or cost-effective ways. A Lean laboratory utilizes fewer resources, reduces costs, enhances productivity and morale
Goal of Six Sigma The goal of Six Sigma is to reduce the number of defects to near zero. One sigma represents 691,463 DPMO, or a yield (i.e., percentage of products without defects) of only 30.854%, whereas the goal of Six Sigma is to reach 3.4 DPMO, or a 99.9997% yield
Evolution of functional design of a laboratory and its relationship to other testing sites within a facility This has evolved from one with discrete hematology, chemistry, microbiology, and blood bank sections to one where boundaries have been obscured - highly automated “core” facilities and distributed testing at peripheral POCT sites.
Based on current technology, tests that once were performed in separate laboratory sections are now performed in which manner On a single testing platform (single analyzer), on a workcell (two or more linked instruments), or with the use of total laboratory automation (workcell with preanalytic and postanalytic processing). In conjunction with improved preanalytic sample handlin
Regionalization This is a consolidation process on a grand scale. In the “hub and spoke” model, a single, core laboratory serves as the hub, providing high volume, routine testing. One or more other laboratories act as the spokes, thus consolidating certain functions int
The clinical laboratory exposes staff, and potentially the public, to a variety of hazards which are Biological Hazards (Infectious patients, infectious patient specimens), Chemical Hazards (hazardous chemicals), Ergonomic Hazards (equipment & layout)
What are the laboratory Hazard Prevention Strategies Workplace Controls (general procedures/policies that mandate measures to reduce or eliminate exposure to hazard), Engineering controls (safety features built into the overall design of a product), Personal Protective Equipment (PPE)
Among laboratory personnel what are the workplace ERGONOMIC hazards In laboratory cumulative trauma disorders are usually related to repetitive pipetting, keyboard use, or resting their wrists/arms on sharp edges, such as a laboratory counter.
What are the prevention steps for Ergonomic hazards in a laboratory Awareness and prevention are essential in managing these disorders. Work practice and engineering controls, in addition to various hand, arm, leg, back, and neck exercises, may reduce these problems
An effective testing process requires integration of preanalytic, analytic, and postanalytic steps
Fundamental prerequisite to any performance optimization strategy in Laboratory Understanding of laboratory workflow
Techniques to be used to collect workflow data in laboratory Sample and test mapping, tube analysis, workstation analysis, staff interviews, and task (process) mapping.
Issues to consider when auditing Laboratory Operations Test Ordering, Sample Collection, Transportation, Sample receipt, Sample processing, Testing and Reporting
Sample and Test Mapping Analyzing the distribution of samples and tests over time. Depending on what is mapped, the time interval can be a day (e.g., hour increments for frequently ordered tests) or a week (e.g., daily increments for tests batched several times a week).
Tube Analysis Part of the laboratory’s daily work is related to processing collection tubes or containers. “Tube labor” includes sorting and centrifuging; aliquoting; racking, unracking, loading, and unloading samples on analyzers; retrieving tubes for add-on tests etc
Workstation Analysis A workstation is one physical location (e.g., a fully automated analyzer or group of analyzers) - Instrument Audit, Test Menu, Processing Mode and Load Balancing, Staff interviews and task mapping
Workflow Analysis Workflow analysis assimilates all data from Sample and test mapping, tube analysis, workstation analysis, staff interviews, task (process) mapping and transforms them into valuable information
Workflow Modelling By using sophisticated workflow modeling software, one can analyze these complex interrelation- ships to better predict the outcome of a given workflow design.
Laboratory technology refers largely to three functional areas Testing equipment (i.e., analyzers), preanalytic processors, and information technology (IT).
Key strategies that can optimize workflow using concepts such as Six Sigma to achieve Lean processes Consolidation, standardization, and integration. Managing test utilization may also change overall operational needs and workflow patterns.
Assessment of excess capacity is useful in Establishing the feasibility of increasing testing workload, especially in outreach programs.
What are the factors are involved in the assessment of whether a laboratory has excess capacity that will allow it to accept additional specimens for testing Philosophy and mission, Physical resources, Personnel and activities & Economy of scale
Created by: docamrish