2021LaboratoryProcedures ManualFebruary 2022

Table of ContentsChapter12PageOverview and Laboratory Team Responsibilities .1- .The Laboratory Team.Tasks .Organization of the Laboratory .Tasks—Phlebotomy Room .Tasks—Lab Workstation 1 .Tasks—Lab Workstation 2 .Tasks—Lab Workstation 3 .Cross Training .1-11-21-21-21-41-41-51-71-8Laboratory Information Systems (ISIS) Functionality .2- Functionality .Laboratory Heads-Up Display .Laboratory Task Bar .Menu Bar Options -52-62-62- Menu Options .Utilities Menu Options .Quality Control Menu .Report Menu Options .Modules .Shipping .Informed Consent (IC) Exclusions .Set Session Utility .Container Map .Container Content Verification .Subsample Preview .Informed Consent Status .Access a Processing Module.Warning and Error Messages .2-82-92-112-122-182-192-202-“Not Filled” Requires a Comment .Labels Must Be Printed in Advance.2-222-22Coulter and Urine Scale Icons.2-23iiiLaboratory Procedures 2021

Contents (continued)Chapter3PageVenipuncture .3- .Equipment and Supplies .Overview .Gaining Cooperation ming the Venipuncture on SPs Who Do Not SpeakEnglish .Open the Exam and Log the SP in to the Exam .The Phlebotomy Interview .3-93-93- Shared Exclusion Question .Safety Exclusion Questions.3-143-16Administering the Fasting Questionnaire .Venipuncture Procedures .3-223-303. of the Puncture Site .Venipuncture Technique for the Nipro (19-, 21-,and 23-Gauge) .Concluding the Venipuncture .3-333-35Pediatric Venipuncture .3-373.10.1Age Specific Care and Phlebotomy.3-39Hand Venipuncture .Veinlite EMS.Buzzy .Recording the Results of the Venipuncture Procedure .Venipuncture Status.Repeat Blood Draw .Phlebotomy Quality Control .3-463-473-483-493-523-553-563.17.1Daily Quality Control .3-57Red Cross Procedures for Handling Fainting (Syncope) .How to Deal with System .173.183.19Rationale.Refusal Conversion .ivLaboratory Procedures 2021

Contents (continued)Chapter4PageReferences .3-68Urine Specimen Collection and Processing .4- .Equipment and Supplies .Using the Scale for Urine Collection.Document Urine Collection .4-14-24-34-54.4.14-94.5Manually Documenting Urine Collection ity Not Sufficient (QNS) Urines .Manually Document Urine Collection withBarcode Scanning .Manually Document Urine Collection WithoutBarcode Scanning .Manually Entering Adults Who Collect in 3- to5-Year-Old Container .Urine Specimen Assays .Urine Specimen Protocols .Labeling Urine Processing Vessels .Urine Specimen Processing .Record the Results of Urine Specimen Processing .Second and Third Urine Samples .Specimen Storage .How to Deal with System 294-30Urine Pregnancy Test .5- and Principle of the Test .Special Safety Precautions.Computerization: Integrated Survey Information System(ISIS) .Specimen Collection and Preparation .Reagents and Supplies .5-35-35- .Supplies .5-35-5Assay Procedure .Reportable Range of Results .5-55-6vLaboratory Procedures 2021

Contents (continued)ChapterPage5.85.95.10Quality Control (QC) .Interpretation of Results and Remedial Action .Record Results l Exams Requiring Repeat PregnancyTesting .Limitations of Method: Specimen Rejection, InterferingSubstances, and Conditions .Reference Ranges .Action Limits .Specimen Storage and Handling During Testing .Alternative Method for Performing the Test or StoringSpecimens if the Test System Fails.Test Results Reporting System Protocol for ReportingAction Limits .Specimen Accountability and Tracking .Quality Control Summary Statistics and Graphs .Further 45-245-25Complete Blood Count.6-16.16.2Introduction .Purpose and Principle of Test er Method .VCSn Technology.Dataplot Development .Parameter Measurement, Derivation, andCalculation .6-5Components of DxH 800 .6- Specimen Processing Module .The System Manager .Pneumatic Supply Module.6-66-76-7Special Safety Precautions.Digital Interface with the Integrated Survey InformationSystem (ISIS).6-7vi6-8Laboratory Procedures 2021

Contents (continued)ChapterPage6. Collection and Preparation .6- Collection .Specimen Preparation .6-86-8Procedure for Microscopic Examination .6- and Supplies .DxH 800 Supplies.6-96-12Shutdown of DxH 800 System .6- Shutdown.Shutdown at the Mobile Examination Center .Cancel Automatic Shutdown .Manual Shutdown of DxH Units .6-136-146-156-15Log On as User .6-166.9.1Entering New Operator.6-16Run Daily Checks.6- Checks Screen .Additional Tasks From the Daily Checks Screen .6-176-18Quality equency of Performing Quality Control .Setting Up a Control File.Setting Up a Latron Control File.Establishing Means and Standard Deviations(SDs) for Quality Control Material .6.11.5 To Change the Mean and Standard Deviation(SD) on the Coulter .6.11.6 What to do When a Control is Out of Range .6.11.7 Viewing Control Files – Data View(Menu QA QC) .6.11.8 Selecting a Control.6.11.9 Viewing Control Files Graphically(Menu QA QC View Graph) .6.11.10 Using and Interpreting the Levey-JenningsGraphs .vii6-216-226-236-246-316-316-32Laboratory Procedures 2021

Contents 6.11.11 Add, Modify, or Delete Comments to QCResults .6.11.12 View Control Files Under Error Conditions .6-336-34Sample Analysis .6-346. .Cassette Presentation .Single-Tube Presentation.Handling Alarms .6-346-356-356-36Data 396-40Flags .Codes .Messages.All Specimens .Laser Safety .Calibration of the DxH 15.7Perform Calibration.Verify the Calibration of Your Instrument .Coulter Pre-Startup Procedure .Initial DxH 800 Startup .Repeatability, Carryover Check, and Calibration .Carryover .Calibration .6-426-426-426-436-446-466-47Run Study Participant Samples .6-486. Data and Transmit .Daily Shutdown.Prolonged Shutdown.Beginning and End of Stand Operations .6-496-496-496-50Coulter Reportable Range of Results .Integrated Survey Information System .6-516-526. 6C Cell and Latron Lot Numbers inIntegrated Survey Information System.Interlaboratory Quality Assurance Program(IQAP).viii6-526-55Laboratory Procedures 2021

Contents (continued)ChapterPage6. Testing .Linearity for WBC, RBC, Hgb, and PltParameters .6-58Interpretation of Results and Remedial Action .6-586.19.1Sample Person Hemoglobin and HematocritReview and Remedial Actions .SP Parameter Value Review and RemedialActions .DxH 800 Suspect Messages .DxH 800 Histogram Interpretations .Clinician Review.6-596-886-896-94Limitations of Method: Specimen Rejection, InterferingSubstances, and Conditions en Rejection .Interfering Substances and Conditions .Reference Ranges .Action Limits .Specimen Storage and Handling During Testing .Alternative Method for Performing Test or StoringSpecimens if Test System Fails .Test Results Reporting System: Protocol for ReportingAction Limits .Quality Control Summary Statistics and Graphs .Troubleshooting .Setting Shift Times .Reference lood Processing .7- .Blood Processing Age-Specific Protocols .Labeling Vessels .Equipment.7-17-17-77- Centrifuges .Laminar Flow Biological Safety CabinetOperating Sequence .ix7-9Laboratory Procedures 2021

Contents (continued)ChapterPage7.5Blood-Processing Procedures 7.88Aliquoting Whole Blood and Serum.Process the 3 mL, 4 mL, and 7 mL EDTATubes .Process the 2 mL Gray Tube for Glucose .Process the 7 mL Gray Tube for VolatileOrganic Compounds (VOCs) .Process the 6 mL Lavender Tube for Genetics .Process the 7 mL, 10 mL, and 15 mL Red Topfor Pooled Sera.Ascorbic Acid Processing and Preparation.7-177-227-237-237-247-25Record the Results of Specimen Processing .Blood Specimen Storage .7-267-327.7.1Blood Specimen Storage Protocol .7-32How to Deal with System Failure.7-34Printing Labels and Specimen Shipment.8- .Equipment and Supplies .Print Vessel Labels and Label Blood Processing Racks .8.3.1Print Vessel Labels Using the Label PrintApplication .Main Printing Screen .Filter Options .Print Key .Print Options: Print Labels .Print Options: Group By .Print Options: Module Filter .Print Order .Print Display Options .Printing One SP’s Labels .Printing Individual Labels .Label Action .Label Printing Cheat Sheet reate New Container Labels .Close Containers . Procedures 2021

Contents (continued)ChapterPage8.6Trash or Reprint Container Labels . Container Labels for ExistingContainers .8-34Shipping Overview .Assign Containers to Shippers .Create Shipping Manifests .Informed Consent Exclusions .Packing Procedure for the Shippers .11.58.1298-33Pack the Boxed Specimens.Pack the Medium Shipping Containers forFrozen Shipment .Pack the Small Shipping Containers for FrozenShipment .Pack the Medium Shipping Containers forRefrigerated Shipment .Label the Shippers .Container Protocol and Weekly Shipping List .8-528-528-538-548-55Quality Control and Quality Assurance—Policies and Procedures .9-19.1Safety .9-19.1.1Introduction .9-1Specimen Submission and Handling .9- .Identification of Specimens .Questions on Specimen Submission andHandling.9-2Test n .Laboratory Tests .Human Subjects Review .xiLaboratory Procedures 2021

Contents (continued)ChapterPage9.49.59.6Test Records .9- .Components of Test Records .9-39-3Test Report .9- .Review, Approval, and Release of Test Results .List of Methods and Method Details.Format of the Test Report .Format for the Laboratory Report Cover Letter .Format for Listing of Laboratory Results .9-49-49-59-59-69-7Quality tion .Method-Specific QC Procedures.QC Definitions.Overview of the Relationship Between InternalQC, Proficiency Testing, and External QC .Internal (“Bench”) QC.Coulter Interlaboratory Quality AssuranceProgram (IQAP) .Calibration and Calibration Verification .Proficiency Testing .Calibration Verification.Linearity .Quality Control Records .9-149-189-199-239-249-25Test Methods, Equipment, Reagents, Supplies, andFacilities 9.7.2Introduction .Labeling of Reagents, Solutions, and OtherSupplies .Facilities.9-269-26Analytical Procedure ion .Contents of the Analytical ProcedureDocumentation .xii9-259-27Laboratory Procedures 2021

Contents l and Record Maintenance .Method Performance Specifications .9-279-28Equipment Maintenance and Function Checks .9- .Laboratory Equipment Calibration .Temperature Monitoring .Humidity Monitoring .9-289-299-299-31Troubleshooting .9-329.10.1Introduction .9-32Integrated Survey Information System (ISIS) .9-329.1

Laboratory Procedures Manual February 2022 . iii Laboratory Procedures 2021 Table of Contents Chapter Page . . 5.6 Assay Procedure . 5-5 . 5.7 Reportable Range of Results . 5-6 . vi Laboratory Procedures 2021 Contents (continued) Chapter Page .