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  • Revised: 09/27/2007

    COMMISSION ON LABORATORY ACCREDITATION

    Laboratory Accreditation Program

    HEMATOLOGY - COAGULATION CHECKLIST

    Disclaimer and Copyright Notice The College of American Pathologists (CAP) Checklists are posted on the CAP's Web site for information only. If you are enrolled in the CAP's Laboratory Accreditation Program and are preparing for an inspection, you must use the Checklists that were mailed in your application or reapplication packet, not those posted on the Web site. The Checklists undergo regular revision and Checklists may be revised after you receive your packet. If a Checklist has been updated since receiving your packet, you will be inspected based upon the Checklists that were mailed. If you have any questions about the use of Checklists in the inspection process, please e-mail the CAP (accred@cap.org), or call (800) 323-4040, ext. 6065. All Checklists are ©2007. College of American Pathologists. All rights reserved.

  • College of American Pathologists Revised: 09/27/2007

    HEMATOLOGY – COAGULATION (Web File) Page 2 of 132

    HEMATOLOGY - COAGULATION

    OUTLINE

    SUMMARY OF CHANGES ...............................................................................................................................................4 INSPECTION TECHNIQUES – KEY POINTS..................................................................................................................7 LABORATORY SAFETY...................................................................................................................................................9 PROFICIENCY TESTING ..................................................................................................................................................9 QUALITY MANAGEMENT AND QUALITY CONTROL.............................................................................................15

    WAIVED TESTS ..........................................................................................................................................................15 GENERAL ISSUES ......................................................................................................................................................16 PROCEDURE MANUAL.............................................................................................................................................22 SPECIMEN COLLECTION AND HANDLING - HEMATOLOGY...........................................................................25 SPECIMEN COLLECTION AND HANDLING - COAGULATION..........................................................................29 RESULTS REPORTING - GENERAL.........................................................................................................................33 RESULTS REPORTING - COAGULATION ..............................................................................................................37 REAGENTS ..................................................................................................................................................................43 INSTRUMENTS AND EQUIPMENT..........................................................................................................................45 COMPLETE BLOOD COUNT (CBC) INSTRUMENTS ............................................................................................47

    CALIBRATION .......................................................................................................................................................47 Fresh Whole Blood ..............................................................................................................................................48 Commercial Calibrators .......................................................................................................................................51

    CBC INSTRUMENT QUALITY CONTROL .........................................................................................................52 Stabilized Controls ...............................................................................................................................................53 Moving Averages.................................................................................................................................................54 Retained Patient Specimens .................................................................................................................................56 Interinstrument Comparisons ...............................................................................................................................57

    ERROR DETECTION AND VERIFICATION .......................................................................................................58 GENERAL INSTRUMENT ISSUES............................................................................................................................63 MANUAL HEMATOCRIT (MICROHEMATOCRIT, PACKED CELL VOLUME) .................................................64 MANUAL (HEMOCYTOMETER) LEUKOCYTE (WBC) AND PLATELET (PLT) COUNTS (BLOOD) .............65 AUTOMATED DIFFERENTIAL COUNTERS...........................................................................................................67 MANUAL BLOOD FILM EXAMINATION (DIFFERENTIAL COUNT).................................................................70

    Blood Films for Malaria and Other Parasites............................................................................................................73 AUTOMATED RETICULOCYTES.............................................................................................................................75 MANUAL RETICULOCYTES ....................................................................................................................................78 BODY FLUIDS.............................................................................................................................................................79

    Body Fluid Cell Counting - Manual .........................................................................................................................79 Body Fluid Cell Counting - Instrumental..................................................................................................................81 Body Fluid Nucleated Cell Differentials...................................................................................................................83 Semen Analysis.........................................................................................................................................................86

    Requisitions, Specimen Receipt and Results Reporting.......................................................................................86 Sperm Motility .....................................................................................................................................................89 Stained Smear - Sperm Differential .....................................................................................................................92 Biochemical Tests ................................................................................................................................................95 Anti-sperm Antibody (ASA) Tests ......................................................................................................................96 Automated Semen Analysis Instruments .............................................................................................................97 Calibration and Quality Control...........................................................................................................................97

    ABNORMAL HEMOGLOBIN DETECTION ...........................................................................................................102 BONE MARROW PREPARATIONS ........................................................................................................................105 BLOOD COAGULATION STUDIES ........................................................................................................................109

    Interinstrument Comparisons (Coagulation)...........................................................................................................111 Photo-Optical Coagulation Systems .......................................................................................................................112 Electromechanical Coagulation Systems ................................................................................................................113

  • College of American Pathologists Revised: 09/27/2007

    HEMATOLOGY – COAGULATION (Web File) Page 3 of 132

    Manual Coagulation Systems .................................................................................................................................114 Coagulation Studies by Electrophoresis..................................................................................................................116 D-Dimer Studies .....................................................................................................................................................116 Coagulation Factor Assays (including fibrinogen) .................................................................................................120 Mixing Studies........................................................................................................................................................122 Coagulation Tests Based on Direct Measurement of Analytes ......................................

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