{"product_id":"cytogenetic-laboratory-management-9781119069744","title":"Cytogenetic Laboratory Management","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cb\u003eCytogenetic Laboratory Management\u003c\/b\u003e \u003cp\u003e \u003cb\u003e Cytogenetic Laboratory Management  \u003c\/b\u003e\u003c\/p\u003e\u003cp\u003e Chromosomal, FISH and Microarray-Based Best Practices and Procedures  \u003c\/p\u003e\u003cp\u003e\u003ci\u003eCytogenetic Laboratory Management: Chromosomal, FISH and Microarray-Based Best Practices and Procedures\u003c\/i\u003e is a practical guide that describes how to develop and implement best practice processes and procedures in the genetic laboratory setting. The text first describes good laboratory practices, including quality management, design control of tests, and FDA guidelines for laboratory-developed tests, and preclinical validation study designs. The second focus of the book is on best practices for staffing and training, including cost of testing, staffing requirements, process improvement using Six Sigma techniques, training and competency guidelines, and complete training programs for cytogenetic and molecular genetic technologists. The third part of the text provides stepwise standard operating procedures for chromosomal\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\"From beginning to end, this book provides relevant concepts, procedures and strategies that give the reader a complete overview of good laboratory practices. In addition to providing an excellent guide for setting up a new clinical lab, Zneimer's book should be considered as a useful guide for any laboratory because it provides a wealth of practical information that can be used on a daily basis. All of the spreadsheets, guides, examples and templates in the book are useful bonus features and represent a valuable legacy of the author's extensive experience.\" (\u003ci\u003ePhenotype\u003c\/i\u003e June 2017)\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eDedication xiii\u003c\/p\u003e \u003cp\u003ePreface xvii\u003c\/p\u003e \u003cp\u003eAcknowledgments xix\u003c\/p\u003e \u003cp\u003eAbout the Companion Website v\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection I: Best Practices for Laboratory Operations 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Guidelines for Good Clinical Laboratory Practice 3\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Physical Facilities 4\u003c\/p\u003e \u003cp\u003e1.2 Specimen Transport and Management 5\u003c\/p\u003e \u003cp\u003e1.3 Personnel Safety 6\u003c\/p\u003e \u003cp\u003e1.4 Laboratory Information System (LIS) 7\u003c\/p\u003e \u003cp\u003e1.5 Quality Management 7\u003c\/p\u003e \u003cp\u003e1.6 Organization and Personnel 10\u003c\/p\u003e \u003cp\u003e1.7 Laboratory Equipment 10\u003c\/p\u003e \u003cp\u003e1.8 Testing Operating Procedures 11\u003c\/p\u003e \u003cp\u003e1.9 Safety Plan 12\u003c\/p\u003e \u003cp\u003e1.10 Biosafety Plan 22\u003c\/p\u003e \u003cp\u003e1.11 Chemical Hygiene Plan 31\u003c\/p\u003e \u003cp\u003e1.12 Health Insurance Portability and Accountability Act (HIPAA) Incident Plan 55\u003c\/p\u003e \u003cp\u003eAppendix 1.A: OSHA’s Form 300 60\u003c\/p\u003e \u003cp\u003eAppendix 1.B: OSHA’s Form 300A 61\u003c\/p\u003e \u003cp\u003eAppendix 1.C: Information on HMIS and NFPA Labeling Systems used in Laboratories 62\u003c\/p\u003e \u003cp\u003eFurther Reading 66\u003c\/p\u003e \u003cp\u003eMore Resources 69\u003c\/p\u003e \u003cp\u003eHIPAA Reference 70\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Quality Management 71\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 QC Program 74\u003c\/p\u003e \u003cp\u003e2.2 Individualized QC Plan (IQCP) 80\u003c\/p\u003e \u003cp\u003e2.3 Standards for Test Records and Reporting 81\u003c\/p\u003e \u003cp\u003e2.4 Overview of General Culturing Issues 83\u003c\/p\u003e \u003cp\u003e2.5 QI Program 95\u003c\/p\u003e \u003cp\u003e2.6 Proficiency Testing 101\u003c\/p\u003e \u003cp\u003e2.7 Inspection Preparation 110\u003c\/p\u003e \u003cp\u003e2.8 Calibration Verification 112\u003c\/p\u003e \u003cp\u003eFurther Reading 121\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Design Control of Tests and FDA Guidelines for Laboratory Developed Tests (LDTs) 125\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Design Control of Tests 125\u003c\/p\u003e \u003cp\u003e3.2 FDA Guideline Summary for LDTs 139\u003c\/p\u003e \u003cp\u003eFurther Reading 157\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Preclinical Validation Studies 159\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Validation Plans and Protocols 159\u003c\/p\u003e \u003cp\u003e4.2 Validation Reports 179\u003c\/p\u003e \u003cp\u003e4.3 Example Validation Plan and Report—Analysis of FISH Probes for Chromosome 5 Deletion and Monosomy 181\u003c\/p\u003e \u003cp\u003e4.4 Example Validation Plan and Report for the FDA‐Approved Vysis ALK FISH Probe 192\u003c\/p\u003e \u003cp\u003eFurther Reading 206\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Reagents, Instruments, and Equipment 209\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Reagents 209\u003c\/p\u003e \u003cp\u003e5.2 Instruments and Equipment 227\u003c\/p\u003e \u003cp\u003e5.3 IQ, OQ, and PQ Procedures 237\u003c\/p\u003e \u003cp\u003e5.4 Example Equipment Process Validation Protocol 245\u003c\/p\u003e \u003cp\u003eFurther Reading 250\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection II: Best Practices for Staffing and Training 253\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Cost of Testing and Staffing Requirements 255\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Labor Costs 256\u003c\/p\u003e \u003cp\u003e6.2 Time and Cost Assessment 260\u003c\/p\u003e \u003cp\u003e6.3 Staffing Hiring Needs 260\u003c\/p\u003e \u003cp\u003e6.4 Staff Task Requirements 262\u003c\/p\u003e \u003cp\u003eFurther Reading 267\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Process Improvement: Six Sigma Approach to Laboratory Improvement 269\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 269\u003c\/p\u003e \u003cp\u003e7.2 DMAIIC Tools 273\u003c\/p\u003e \u003cp\u003e7.3 Defining the Project 274\u003c\/p\u003e \u003cp\u003e7.4 Measuring Variables 279\u003c\/p\u003e \u003cp\u003e7.5 Analyze Data for the Project 282\u003c\/p\u003e \u003cp\u003e7.6 Innovate and Improve the Project 287\u003c\/p\u003e \u003cp\u003e7.7 Controlling the Results of the Project 289\u003c\/p\u003e \u003cp\u003eAppendix 7.A Raw Baseline Data 295\u003c\/p\u003e \u003cp\u003eAppendix 7.B Raw Control Data 295\u003c\/p\u003e \u003cp\u003eFurther Reading 296\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Staff Training and Competency for a Cytogenetics Laboratory 299\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Technician (Nonlicensed\/Certified Lab Personnel) Training and Competency 300\u003c\/p\u003e \u003cp\u003e8.2 Technologist (Licensed\/ASCP‐Certified) Training and Competency 303\u003c\/p\u003e \u003cp\u003e8.3 General Supervisor\/Manager Training and Competency 307\u003c\/p\u003e \u003cp\u003e8.4 Cytogenetic Technical Supervisor\/Director Training and Competency 310\u003c\/p\u003e \u003cp\u003eFurther Reading 316\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Training Program for Cytogenetic and FISH Technologists 319\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Training Program Overview and Objectives 320\u003c\/p\u003e \u003cp\u003e9.2 Program Content 323\u003c\/p\u003e \u003cp\u003e9.3 Practical Component 332\u003c\/p\u003e \u003cp\u003e9.4 Lectures, Quizzes, and Assignments 335\u003c\/p\u003e \u003cp\u003e9.5 Trainee Competency and Completion of the Program 335\u003c\/p\u003e \u003cp\u003e9.6 Trainee Handbook 336\u003c\/p\u003e \u003cp\u003e9.7 Logs, Competency Forms, and Evaluation Forms 344\u003c\/p\u003e \u003cp\u003eFurther Reading 356\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Training Program for Molecular Genetic Technologists 357\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Training Overview and Objectives 358\u003c\/p\u003e \u003cp\u003e10.2 Program Content 361\u003c\/p\u003e \u003cp\u003e10.3 Practical Component 367\u003c\/p\u003e \u003cp\u003e10.4 Lectures, Quizzes, and Assignments 370\u003c\/p\u003e \u003cp\u003e10.5 Trainee Competency and Completion of the Training Program 370\u003c\/p\u003e \u003cp\u003e10.6 Trainee Handbook 371\u003c\/p\u003e \u003cp\u003e10.7 Logs, Competency Forms, and Evaluations Forms 379\u003c\/p\u003e \u003cp\u003eFurther Reading 383\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection III: Standard Operating Procedures 385\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 General SOP Information by Test and Preanalytic Procedures 387\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Definition of an SOP 387\u003c\/p\u003e \u003cp\u003e11.2 Example Template for Writing an SOP 390\u003c\/p\u003e \u003cp\u003e11.3 CAP and ACMG Guidelines for Writing SOPs 393\u003c\/p\u003e \u003cp\u003e11.4 Preanalytic Procedures: Accessioning Specimens for all Specimen Types 396\u003c\/p\u003e \u003cp\u003eFurther Reading 402\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Analytic Procedures: Chromosome Analysis 405\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Peripheral Blood and Percutaneous Umbilical Blood Specimen for Constitutional Disorders 410\u003c\/p\u003e \u003cp\u003e12.2 Amniotic Fluid Specimens 440\u003c\/p\u003e \u003cp\u003e12.3 Chorionic Villus Sampling 479\u003c\/p\u003e \u003cp\u003e12.4 Solid Tissue Samples: Tissue Biopsies and Products of Conception 505\u003c\/p\u003e \u003cp\u003e12.5 Bone Marrow and Blood for Hematologic Malignancies 534\u003c\/p\u003e \u003cp\u003e12.6 Lymph Nodes and Solid Tumors 565\u003c\/p\u003e \u003cp\u003e12.7 Breakage Syndromes 592\u003c\/p\u003e \u003cp\u003eAppendix 12.A Cytogenetics Blood Culture and Harvest Worksheet 597\u003c\/p\u003e \u003cp\u003eAppendix 12.B Daily Harvest Log 598\u003c\/p\u003e \u003cp\u003eAppendix 12.C Test Slide Banding Log 599\u003c\/p\u003e \u003cp\u003eAppendix 12.D Batch Banding Log 600\u003c\/p\u003e \u003cp\u003eAppendix 12.E Analysis Sheet 601\u003c\/p\u003e \u003cp\u003eAppendix 12.F Prenatal Culture and Harvest Worksheet 602\u003c\/p\u003e \u003cp\u003eAppendix 12.G Culture Failure Log 603\u003c\/p\u003e \u003cp\u003eAppendix 12.H Amniotic Fluid Count Guidelines—for Normal and Extended Studies 604\u003c\/p\u003e \u003cp\u003eAppendix 12.I Hematologic Culture Log 605\u003c\/p\u003e \u003cp\u003eAppendix 12.J Specimen Setup—Hematologic Malignancies 606\u003c\/p\u003e \u003cp\u003eAppendix 12.K Solid Tumor Culture Worksheet 607\u003c\/p\u003e \u003cp\u003eFurther Reading 608\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Analytic Procedures: Fluorescence in situ Hybridization (FISH) Analysis 613\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 General Information 613\u003c\/p\u003e \u003cp\u003e13.2 CAP and ACMG Guidelines for Performing FISH Analyses 617\u003c\/p\u003e \u003cp\u003e13.3 Cell Sorting for Plasma Cell Disorders for FISH Analysis 619\u003c\/p\u003e \u003cp\u003e13.4 General Procedure for Direct Labeling of FISH Probes 624\u003c\/p\u003e \u003cp\u003e13.5 Prenatal Multicolor Probes 641\u003c\/p\u003e \u003cp\u003e13.6 ToTelVysion™ Multicolor DNA Probe Mixtures 654\u003c\/p\u003e \u003cp\u003e13.7 Multicolor: Telomere, Centromere, and Paint Probes (Cytocell) 666\u003c\/p\u003e \u003cp\u003e13.8 Microscope Analysis for Metaphase Scoring 680\u003c\/p\u003e \u003cp\u003e13.9 Microscope Analysis for Interphase Scoring 685\u003c\/p\u003e \u003cp\u003e13.10 Formalin‐Fixed Paraffin‐Embedded Procedure for FISH Analysis 693\u003c\/p\u003e \u003cp\u003e13.11 HER2\/ERBB2 FISH Analysis 700\u003c\/p\u003e \u003cp\u003e13.12 UroVysion (Vysis) Bladder Cancer FISH Analysis 711\u003c\/p\u003e \u003cp\u003eAppendix 13.Aa Constitutional FISH Probes 722\u003c\/p\u003e \u003cp\u003eAppendix 13.Ab Hematologic FISH Assays 723\u003c\/p\u003e \u003cp\u003eAppendix 13.B Probe Chart: Panels of Probes 724\u003c\/p\u003e \u003cp\u003eAppendix 13.C FISH Direct Harvest Log 725\u003c\/p\u003e \u003cp\u003eAppendix 13.D Batch Hybridization Log 726\u003c\/p\u003e \u003cp\u003eAppendix 13.E General FISH Probe Analysis Sheet 727\u003c\/p\u003e \u003cp\u003eAppendix 13.F FISH Probe Analysis Sheet—AML Panel 728\u003c\/p\u003e \u003cp\u003eAppendix 13.G FISH Probe Analysis Sheet—MDS Panel 729\u003c\/p\u003e \u003cp\u003eAppendix 13.H FISH Probe Analysis Sheet—CLL Panel 730\u003c\/p\u003e \u003cp\u003eAppendix 13.I FISH Probe Analysis Sheet—NHL Panel 731\u003c\/p\u003e \u003cp\u003eAppendix 13.J FISH Probe Analysis Sheet—MM Panel 732\u003c\/p\u003e \u003cp\u003eAppendix 13.K FISH Probe Analysis Sheet—ALL Panel 733\u003c\/p\u003e \u003cp\u003eAppendix 13.L FISH Analysis Sheet—BCR\/ABL\/ASS Triple Fusion 734\u003c\/p\u003e \u003cp\u003eAppendix 13.M HER2 Analysis Sheet 735\u003c\/p\u003e \u003cp\u003eAppendix 13.N UroVysion Analysis Sheet 736\u003c\/p\u003e \u003cp\u003eFurther Reading 736\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Analytic Procedures: Chromosomal Microarray Analysis (CMA) 739\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 Test Principle 739\u003c\/p\u003e \u003cp\u003e14.2 Comparing Conventional Chromosome Analysis, FISH Analysis and Chromosomal Microarray Analysis 741\u003c\/p\u003e \u003cp\u003e14.3 Interpretation 745\u003c\/p\u003e \u003cp\u003e14.4 Procedure Overview 747\u003c\/p\u003e \u003cp\u003eFurther Reading 752\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Postanalytic Procedures 755\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15.1 Reviewing and Reporting Cases for Chromosome Analysis 756\u003c\/p\u003e \u003cp\u003e15.2 Reviewing and Reporting Cases for FISH Analysis 762\u003c\/p\u003e \u003cp\u003e15.3 Reviewing and Reporting Cases for Microarray Analysis 765\u003c\/p\u003e \u003cp\u003e15.4 Procedure for Avoidance and Detection of Clerical Errors Post Reporting 772\u003c\/p\u003e \u003cp\u003e15.5 Specimen, Material and Record Retention, and Specimen Disposal 774\u003c\/p\u003e \u003cp\u003eAppendix 15.A Record of Results Correspondence Log 778\u003c\/p\u003e \u003cp\u003eFurther Reading 779\u003c\/p\u003e \u003cp\u003eGlossary 781\u003c\/p\u003e \u003cp\u003eIndex 811\u003c\/p\u003e","brand":"John Wiley and Sons Ltd","offers":[{"title":"Default Title","offer_id":52084556890455,"sku":"9781119069744","price":103.5,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781119069744.jpg?v=1762206793","url":"https:\/\/bookcurl.com\/products\/cytogenetic-laboratory-management-9781119069744","provider":"Book Curl","version":"1.0","type":"link"}