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دانلود کتاب Clinical Laboratory Management
دانلود کتاب مدیریت آزمایشگاه بالینی
مشخصات کتاب
Clinical Laboratory Management
ویرایش: نویسندگان: Shakti Kumar Yadav (editor), Ruchika Gupta (editor), Sompal Singh (editor) سری: ISBN (شابک) : 3031464192, 9783031464195 ناشر: Springer سال نشر: 2024 تعداد صفحات: 309 [276] زبان: English فرمت فایل : PDF (درصورت درخواست کاربر به PDF، EPUB یا AZW3 تبدیل می شود) حجم فایل: 20 Mb
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فهرست مطالب
Foreword Preface Acknowledgments Contents Editors and Contributors About the Editors Contributors Abbreviations Part I: Introduction to Laboratory Management 1: Role of Medical Laboratory Technology in Health Care Background Screening Diagnosis Disease Prognosis Guidance for Treatment Follow-Up Evaluation of Substance Abuse Investigation and Surveillance of an Epidemic Teaching and Training Suggested Reading 2: Overview of Laboratory Management Background Workforce Machines/Equipment Money Finance Accounts Infrastructure Physical Location Layout and Design Processes Materials Information System Document Control and Record Keeping Ethical and Legal Aspect Laboratory Hazards Supporting Services Suggested Reading 3: General Principles of Management An Organization and Its Need for Management Principles of Management Specialization/Division of Labor Authority with Corresponding Responsibility Discipline Unity in Command Unity of Direction Subordination of Individual Interest to the General Interest Remuneration of Staff Centralization Scalar Chain/Line of Authority Order Equity Stability of Tenure Initiative Esprit de Corps Management Skills Technical Skills Human Skill Concept Skill Design Skill Suggested Reading Part II: Human Resource Management 4: Strategic Human Resource Management Human Resources as an Asset Basic Human Resource Activities Induction Suggested Reading 5: Job Analysis and Job Evaluation Definition and Terminology Job Analysis and Job Evaluation—Are They the Same? Job Analysis Questionnaires Interviews Observations Computer-Based System Recent Advances in Job Analysis Job Evaluation Job Evaluation Process Job Evaluation Methods Factor Comparison or Key Job Method Point Method Ranking Method Job Grading or Job Classification Method Job Evaluation Committee Suggested Reading 6: Recruitment and Selection Background Recruitment Sources of Recruitment Internal to the Organization External to the Organization Novel Approaches to Recruitment Selection Employment Interview Unstructured Interview Structured Interview Staffing Suggested Reading 7: Performance Management Background Process of Performance Management Step 1: Goal Setting Step 2: Establishment of Evaluation Criteria Step 3: Source of Appraisal Step 4: Methods of Performance Appraisal Step 5: Communication of Appraisal Tell and Sell Approach Tell and Listen Approach Mutual Problem-Solving Methods of Performance Appraisal Trait-Based Methods Graphic Rating Scale Forced Choice Method Essay Method Ranking Method Forced Distribution Method Behavior-Based Methods Critical Incident Method Checklist Method Weighted Checklist Method Behavior-Anchored Rating Scale (BARS) Result-Based Methods Productivity-Based Approach Management by Objectives (MBO) Competence Assessment Issues and Problems in Performance Management Suggested Reading 8: Staff Scheduling Background Scheduling Methods Full-Time Part-Time Shift-Based Seasonal Rotating On-Call Pre-requisites of a Good Schedule How to Prepare a Good Schedule? Scheduling Approach Heuristic Approach First Come First Serve Approach Linear Programming Approach Legal Aspects of Staff Scheduling Work Hours Compensatory Leave Women Safety at Workplace Suggested Reading 9: Conflict Management and Industrial Relations Background Theoretical Perspectives of Industrial Relations Other Approaches of Industrial Relations Systems Approach Social Action Theory How to Manage Industrial Relations? Industrial Disputes at the Workplace Conflict Management Stages of Conflict Methods of Conflict Management Consultation Dialogue Negotiation Mediation Suggested Reading Part III: Accounting and Finance 10: Financial Decision-Making Background Financing Decision Investment Decision Operating (or Dividend) Decisions Suggested Reading 11: General Accounting Principles Background Economic Entity Principle Monetary Unit Principle Going Concern Principle Time Period Principle Accrual Principle Matching Principle Revenue Recognition Principle Dual Concept Principle Cost Principle Objectivity (Verifiable) Principle Consistency Principle Conservatism Principle Full Disclosure Principle Materiality Principle Reliability Principle Generally Accepted Accounting Principles Suggested Reading Part IV: Organization and Operations 12: Introduction to Hospital Organization and Operations Introduction Hospital Organization Hospital Operations Suggested Reading 13: Basics of Laboratory Organization and Operations Laboratory Organization Laboratory Operations Advisory Services by a Clinical Laboratory Suggested Reading 14: Location Decision, Facility Layout, and Facility Control Location Decision Statistical Methods for location Decision for a Standalone Laboratory Cost–Volume–Profit Analysis Factor Rating Method Center of Gravity Method Hospital Integrated Laboratory Other Factors in Location Decision for a Standalone Laboratory Laboratory Facility Layout Design Laboratory Workflow Facility Control Suggested Reading 15: Designing a Safe Facility for Persons with Disabilities Background Guidelines for the Buildings to Provide Safe Access Waiting Area Accessible Examination Rooms Accessible Route Entry and Exit Equipment Floor Space Toilet Facility Staff Training Accessibility for Staff Members with Disabilities Suggested Reading 16: Equipment Management Background Equipment Life Cycle Assessment of the Need for Equipment Procurement of Equipment in a Laboratory Usage and Maintenance of Equipment Disposal After the End of Useful Life Steps of Procurement of Equipment General Information Regarding Handling of Equipment Some Common Instruments Used in a Clinical Laboratory Microbiology Incubators Function Check Door Gasket Cleaning AMC/CMC Laboratory Refrigerators Functional Check Door Gasket Cleaning AMC/CMC Laboratory Centrifuges Function Check Cleaning Rotor Balance Brushes and Bearings Lubrication Gaskets, Seals, Mounts AMC/CMC Micropipette Calibration Precautions AMC/CMC Cytocentrifuge Function Check Cleaning Spill Management AMC/CMC Grossing Station Maintenance Cleaning AMC/CMC Tissue Processor Cleaning AMC/CMC Tissue Embedding Station Cleaning Tissue Holding Tank Work Stage Paraffin Reservoir Cold Plate Microtome Function Check Cleaning AMC/CMC Hematology Analyzer Function Check Maintenance Cleaning AMC/CMC Suggested Reading 17: Inventory Management Background Methods of Laboratory Inventory Management Aggregate Inventory Management Item Inventory Management Inventory Classification Anticipation Inventory Fluctuation Inventory Lot-Size Inventory Hedge Inventory Inventory Cost Calculations Item Inventory Management Inventory Ordering Lot-for-Lot Fixed Order Quantity Fixed Time Method Economic Order Quantity (EOQ) Model Suggested Reading 18: Selection of Reference Laboratory Services Background In-House Testing Versus Outsourcing Benefits of Outsourcing Reference Laboratory Services Suggested Reading Untitled 19: Supply Chain Management Background Supply Chain Strategy Demand-Driven Supply Chain Strategy Agile Supply Chain Strategy Collaborative Supply Chain Strategy Collaborative Planning, Forecasting, and Replenishment Strategy (CPFR) Vertically Integrated Supply Chain Strategic Vendor Relationship and Cross-Docking Decentralized Manufacturing and Distribution Supply Chain Views Cycle View Pull–Push View Role of Information System in the Supply Chain Management Demand Management Supply Chain Management in a Clinical Laboratory Suggested Reading 20: Remote Sample Collection Facility and Sample Logistics Background Guidelines for SCF Clinical Sample Logistics Coagulation Tests Tissue for Histopathology Microbiological Samples Samples for DNA/RNA-Based Analysis Suggested Reading 21: Point-of-Care Testing Background Benefits of POCT Mechanisms Used by POCT Devices Qualitative Strip-Based POCT Methods Unit-Use Analyzers Bench-Top POCT Analyzers Hemostaseological Coagulation Analyzers Continuous Measurement POCT Molecular Biology-Based POCT Challenges in Implementation of POCT Quality Control and Data Management Analytical Errors Suggested Reading Part V: Quality Control 22: Quality Control: General Aspects Background Measurements Standard Deviation Co-efficient of Variance Accuracy Precision Traceability Measurement Uncertainty Materials Reference Material Calibrator Control Material Methods Reference Method Standardized Method Routine Working Method Classification of Quality Control in a Laboratory Alternatives of IQC Alternative of EQA Critical Result Handling Suggested Reading 23: Quality Control in Hematology and Biochemistry Laboratories Background Internal Quality Control (IQC) IQC Using Control Material Westgard Rules Types of Error CUSUM (CUmulative SUM) Chart IQC by Repeated Measurements on the Patients’ Samples Average of Normals (AON) Moving Averages Method (MA QC) IQC in Hematology Laboratory IQC in Coagulation Laboratory IQC in Biochemistry Laboratory External Quality Assessment (EQA) Process of EQA Computation of EQA Result Statistical Measures of EQA Deviation Index (DI) U Score Out-with Consensus Method En Number Bias Estimation Youden Plot Yundt Chart Regression Line Analysis Overall Laboratory Performance Measure Laboratory Performance over Time EQA for Qualitative Results Suggested Reading 24: Quality Control in Histopathology Background Pre-Analytical Phase QC in Histopathology Analytic Phase Intra-Departmental Consultation Frozen Section Review (FSR) Surgical Pathology Random Case Review Autopsy Pathology Random Case Review Anatomical Pathology Clinical Indicator Intradepartmental and Interdepartmental Conferences Inter-Institutional Review (IIR) Specimen Adequacy Report Lost Specimen Record Single Event Report Histology Slide Delivery Quality Control to Histology Quality Control from Histology Turn around Time (TAT) External Quality Assessment in Histopathology Suggested Reading 25: Quality Control Pertaining to Cytology Background Pre-Analytical Phase Analytical Phase Internal Quality Control in Cytopathology Cyto-Histological Correlation External Quality Assurance in Cytopathology Suggested Reading 26: Quality Control in Clinical Pathology Laboratory Background Quality Control in Urine Analysis Quality Indicators Preanalytical Factors Analytical Factors Equipment Reagents Test Method Microscopic Examination Internal Quality Control in Urinalysis External Quality Assessment and Proficiency Testing in Urinalysis Quality Control in Semen Analysis Quality Control Indicators Pre-Analytic Factors Analytic Factors Internal Quality Control IQC for Sperm Count IQC for Percentage Values Between Technician Variability External Quality Assessment Quality Control in Body Fluid Analysis Suggested Reading 27: Quality Control in a Microbiology Laboratory Background Internal Quality Control Pre-Analytical Phase QC QC in Analytical Phase in a Microbiology Laboratory Quality Control of Culture Media Commercially Prepared Media In-House Prepared Media pH Testing Checking the Sterility of the Culture Media Performance Testing Quality Control of Stains Processing of Samples for Culture QC of Bacteriological Techniques QC for Antimicrobial Susceptibility Testing (AST) QC in Serology QC in sterilization and Disinfection Maintenance of Reference QC Stocks Bacteriology Mycology Mycobacteriology Virology Parasitology QC in the Post-Analytical Phase in a Microbiology Laboratory External Quality Assurance in a Microbiology Laboratory Suggested Reading Untitled 28: Quality Control in Molecular Diagnostics Background Quality Control in Diagnostic Molecular Laboratory Molecular Assays—Steps Requiring QC Selection of Molecular Assay Primer Design Use of Appropriate Enzyme Reagents Validation of Assay Selection of Samples for Validation Parameters for Validation Measure of Uncertainty of Molecular Assays QC of Reagents in Molecular Laboratory QC of Equipment Controls Used in Molecular Lab External Quality Assurance Molecular Tests in HIV Testing Retention of Records Future of QC in Molecular Laboratories Suggested Reading 29: Quality Control in Blood Transfusion Services Background Quality Control in Donor Selection and Donation Procedure Quality Control for Reagents and Solutions in Blood Bank Quality Control of Bovine Serum Albumin, Enzyme Reagents, Normal Saline Quality Control of Reagent Red Cells Preparation of Red Cell Reagents Quality Control Measures Quality Control of Blood and Blood Components Factors Influencing the Quality of Blood Components Parameters to Be Tested in QC of Blood Components Equipment Calibration Quality Control in TTI Testing Document Control Measures to Be Undertaken in an Event of transfusion Reaction External Quality Assurance in Transfusion Services Suggested Reading 30: Benchmarking and Key Performance Indicators Benchmarking Objectives of Benchmarking Benchmarking Process Classification, Advantages, and Disadvantages of Benchmarking Key Performance Indicators (KPIs) Classification of KPIs Advantages and Limitations of KPIs KPIs for Clinical Laboratory Dashboard for KPIs Suggested Reading Part VI: Documentation and Information Systems 31: Document Control Background Document Control Creation and Approval Unique Identification Periodic Review and Update Revision and Amendment Availability Authorization Removal of Obsolete Document Standard Operating Procedures (SOPs) Body of SOP Types of SOPs Test Procedure SOP Equipment SOP Sample Handling SOP Reagent and Consumable SOP Quality Control SOP Personnel SOP Facility SOP SOP for Handling Complaints Document Control SOP Quality Manual Suggested Reading 32: Statistical Methods in a Clinical Laboratory Background Screening Test Diagnostic Test Validity of a Test Sensitivity Specificity Predictive Value of the Test Result Positive Predictive Value (PPV) Negative Predictive Value (NPV) Receiver Operating Characteristic Curve (ROC) Analysis Inter-Rate Agreement (Cohen’s Kappa Statistics) Bland and Altman Plot Suggested Reading 33: Role of Information Technology Background Need for Information Technology in Healthcare Laboratory Information Systems (LIS) Features of LIS Test Ordering Specimen Accessioning, and Processing Analytic Phase Result Entry and Validation Notifications Data Management Data Security in LIS Validation and Verification Documentation Protection Safeguarding Operation Maintenance Compliance Authorities and Responsibilities Minimizing Risks to and from Laboratory Information Systems Risk Analysis Risk Evaluation Risk Control Continuity Plan Disaster Management Plan Recovery Plan Suggested Reading 34: Electronic Health Record Management Background Types of Electronic Health Record Systems Transition from Physical Records to EHR Stage I Preparation for the EHR Implementation Step 1 Step 2 Step 3 Step 4 Stage II Implementation of EHR System Step 5 Step 6 Stage III Post-Implementation Management Step 7 Step 8 Standards for Electronic Health Records Suggested Reading Part VII: Laboratory Hazards and Safety 35: Laboratory Hazards Background Biological Hazards Mechanical Hazards Chemical Hazards Fire Hazard Class of Fire Response to Fire Incident Control of Fire Electrical Hazard Spill Management Classification of Spill Standard Cleaning Kit Management of Chemical Spills Management of Biological Spills Small Spills of Biological Material Large Blood Spills in a “Wet” Area Large Blood Spills in a “Dry” Area Biological Spill in a Biological Safety Cabinet Biological Spill in Centrifuge Radioactive Material Spills Documentation Suggested Reading 36: Biomedical Waste Management Background Biomedical Waste Management Procedures Segregation Classification of BMW and Specified Container for Segregation Bio-Waste Bag Sharps Container Color-Coded Containers Handling of BMW BMW Storage BMW Transport General Waste Management at Laboratory Suggested Reading Part VIII: Legal and Ethical Aspects 37: Introduction to Ethical and Legal Aspects Background Principle of Medical Ethics Informed Consent Genetic Testing Equity and Access to Laboratory Tests Incidental Findings Direct-to-Consumer Testing Ethical Issues in Transfusion Medicine Disclosure of Laboratory Errors Collection of Information and Specimen Special Procedures Performance of Test and Reporting of Results Retention of Medical Records and Specimen Financial Arrangements Research Confidentiality Legal Issues and Clinical Laboratory Suggested Reading 38: Role of Consent in Laboratory Practice Background Implied Consent Expressed Consent Informed Consent Written Consent Informed Written Consent Consent for Specific Procedures Suggested Reading 39: Negligence and Malpractice Background Medical Negligence Negligence in Laboratory Practice Indemnity Insurance Suggested Reading Part IX: Planning, Accreditation and Licensing 40: Planning and Designing a Clinical Laboratory Background Location of a Laboratory Laboratory Services Provided Laboratory Design Considerations Corridors and Doors Other Facilities Storage Space Specimen Storage Biomedical Waste Space Requirements in a Laboratory Patient Corridor Administrative Area Laboratory Area Patient Area Service Area Record and Storage Biosafety Levels in a Laboratory Suggested Reading 41: Clinical Laboratory Accreditation What Is Accreditation? Accreditation Bodies Laboratory Accreditation in India Quality Management System Standards ISO 15189 Standard for Medical Laboratories Suggested Reading 42: Planning and Designing a Blood Bank Background Space for a Blood Bank Functional Areas in a Blood Bank Reception and Donor Waiting Area Donor/Blood Collection Blood Processing Area and Laboratory Component Preparation Room Records Personnel and Competencies Equipment and Reagents Donor Room For Hemoglobin Estimation Emergency Equipment/Items Laboratory Equipment Reagents Equipment for Blood Components Suggested Reading 43: Licensing of a Blood Bank Background Blood Bank Licensing in India Blood Bank Licensing in the United States of America Blood Bank Licensing in United Kingdom Suggested Reading Part X: Other Management Activities 44: Market Basket Analysis Background Laboratory Market Basket Suggested Reading 45: Brief of Promotional Activities Background Marketing Communication Promotion Planning and Strategy Situational Analysis Establishing the Marketing Objectives Budget Allocation Specification and Management of Program Elements Coordinate and Integrate the Efforts Measurement of Effectiveness Evaluation and Follow-Up Health Check-Up Camps Suggested Reading 46: Corporate Social Responsibility Background Theories of Corporate Social Responsibility Components of Corporate Social Responsibility Environmental Responsibility Ethical Responsibility Philanthropic Responsibility Economic Responsibility Why Should Organizations or Businesses Engage in CSR? CSR Guidelines United Nations Global Compact Global Reporting Initiative World Business Council for Sustainable Development International Standards Organization Suggested Reading 47: Customer Feedback Analysis and Customer Complaint Management Background Customer Feedback Focus Group Meetings Customer Complaint Management (CCM) Ask the Right Questions from the Complaining Customer Identify Customer Type Respond Quickly Suggest Solution Maintain Complaint Logs Customer Feedback Data Analysis Customer Satisfaction Score (CSAT) Net Promoter Score (NPS) Suggested Reading 48: Risk Management Background Risk Management Risk Identification and Analysis Failure Mode Effect Analysis (FMEA) Failure Reporting Analysis and Corrective Action System (FRACAS) Suggested Reading 49: Internal Audit and Continual Improvement Internal Audit Advantages of Internal Audit Internal Audit Process Nonconformities Continual Improvement Types of Improvement Sources of Insight for Continual Improvement Steps for Continual Improvement Suggested Reading 50: Management Review Meeting Background Objectives and Agenda of an MRM Conduct of the MRM Minutes of the Meeting (MoM) for MRM Suggested Reading Index
