Laboratory Procedures Manual

1 Laboratory Procedures Manual July 2009 National Health and Nutrition Examination Survey Laboratory Procedures Manual July 2009 \\cdc\project\NCHS_DHANES_IB\Data Council\Lab_Manual\ - 12/18/2012 - 5:23 PM - LA iii TABLE OF CONTENTS Chapter Page 1 OVERVIEW OF THE NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY .. 1- 1 History .. 1- 1 Goals of the 1- 4 NHANES Data Accomplishments .. 1- 4 National Center for Health Statistics .. 1- 6 Sample 1- 6 Field Organization for 1- 7 Exams and Interviews in the Mobile Examination Center (MEC) .. 1- 10 Exam Sessions .. 1- 11 Exam Team Responsibilities .. 1- 12 Examination Components.

2 1- 13 Sample Person Remuneration .. 1- 20 Report of Exam Findings .. 1- 20 Dry Run Day .. 1- 21 Integrated Survey Information System (ISIS) .. 1- 21 Confidentiality and Professional Ethics .. 1- 22 2 OVERVIEW AND Laboratory TEAM RESPONSIBILITIES .. 2- 1 Overview .. 2- 1 The Laboratory Team .. 2- 2 Tasks .. 2- 2 Organization of the Laboratory .. 2- 3 Tasks Phlebotomy Room .. 2- 5 Tasks Workstation 2 .. 2- 5 Tasks Workstation 1 .. 2- 7 Tasks Workstation 3 .. 2- 8 Cross 2- 9 3 Laboratory ISIS FUNCTIONALITY .. 3- 1 Laboratory -Specific Functionality .. 3- 1 Laboratory Heads-up Display .. 3- 1 Laboratory Task Bar.

3 3- 3 Menu Bar Options .. 3- 4 File Menu 3- 4 Utilities Menu Options .. 3- 6 Report Menu Options .. 3- 8 iv TABLE OF CONTENTS (CONTINUED) Chapter Page Modules .. 3- 9 Shipping .. 3- 10 Informed Consent Exclusions .. 3- 11 Set Session Utility .. 3- 14 Container Map .. 3- 16 Subsample Preview .. 3- 19 Informed Consent Status .. 3- 21 Access a Processing Module .. 3- 23 Warning and Error Messages .. 3- 24 Not Filled Require a Comment .. 3- 25 Labels Must be Printed in Advance .. 3- 25 Print an Ad Hoc Label .. 3- 27 Coulter, Urine Scale, and Osmolality Icons .. 3- 28 4 VENIPUNCTURE .. 4- 1 Introduction.

4 4- 1 Equipment and Supplies .. 4- 4 Overview .. 4- 6 Gaining Cooperation .. 4- 10 Refusal Conversion .. 4- 12 Performing the Venipuncture on SPs who do not Speak English .. 4- 12 Open the Exam and Log the SP into the Exam .. 4- 13 The Phlebotomy Interview .. 4- 17 Pregnancy Shared Exclusion Question .. 4- 18 Safety Exclusion Questions .. 4- 21 Administering the Fasting Questionnaire .. 4- 31 Venipuncture Procedures .. 4- 38 Preparation of the Puncture Site .. 4- 39 Venipuncture Technique for the BD Saf-T EZ Blood Collection Set (19 Gauge) .. 4- 41 Venipuncture Technique for the BD Safety-Lok Blood Collection Set (21 and 23 Gauge).

5 4- 43 Venipuncture Technique for the Eclipse Multisample Needle .. 4- 44 v TABLE OF CONTENTS (CONTINUED) Chapter Page Concluding the 4- 46 Pediatric Venipuncture .. 4- 48 Age-Specific Techniques in Phlebotomy Competency .. 4- 50 Hand Venipuncture .. 4- 64 Recording the Results of the Venipuncture Procedure .. 4- 65 Venipuncture Status .. 4- 69 Repeat Blood Draw .. 4- 73 Phlebotomy Quality Control .. 4- 75 Daily QC .. 4- 76 Supply Use Control Log .. 4- 78 Red Cross Procedures for Handling Fainting (Syncope) .. 4- 81 How to Deal With System Failure .. 4- 83 5 URINE SPECIMEN COLLECTION AND PROCESSING .. 5- 1 Introduction.

6 5- 1 Supplies .. 5- 2 Urine Flow Rate Background .. 5- 3 Using the Scale for Urine Collection .. 5- 4 Document Urine Collection .. 5- 6 Manually Documenting Urine Collection .. 5- 23 Manually Document Urine Collection With Barcode Scanning .. 5- 23 Manually Document Urine Collection Without Barcode 5- 24 Urine Specimen Assays .. 5- 27 Urine Specimen Protocols .. 5- 27 Labeling Urine Processing Vessels .. 5- 29 Urine Specimen Processing .. 5- 29 Record the Results of Urine Specimen Processing .. 5- 30 Second and Third Urine Samples .. 5- 40 Specimen Storage .. 5- 40 How to Deal With System Failure .. 5- 41 vi TABLE OF CONTENTS (continued) Chapter Page 6 URINE PREGNANCY TEST.

7 6- 3 I. Purpose and Principle of the Test .. 6- 3 II. Special Safety Precautions .. 6- 4 III. Computerization: Integrated Survey and Information System (ISIS) . 6- 5 IV. Specimen Collection and Preparation .. 6- 5 V. Procedure for Microscopic Examination .. 6- 5 VI. Reagents and Supplies .. 6- 6 A. Reagents .. 6- 6 B. Supplies .. 6- 7 VII. Calibration .. 6- 8 VIII. Assay Procedure .. 6- 8 IX. Reportable Range of Results .. 6- 9 X. Quality Control .. 6- 9 XI. Interpretation of Results and Remedial Action .. 6- 25 XII. Record Results .. 6- 28 XIII. Limitations of Method: Specimen Rejection, Interfering Substances, and Conditions.

8 6- 42 XIV. Reference Ranges .. 6- 46 XV. Action Limits .. 6- 46 XVI. Specimen Storage and Handling During Testing .. 6- 47 XVII. Alternative Method for Performing Test or Storing Specimens if Test System 6- 47 XVIII. Test Results Reporting System Protocol for Reporting Action Limits .. 6- 47 XIX. Specimen Accountability and Tracking .. 6- 47 XX. Quality Control Summary Statistics and Graphs .. 6- 47 XXI. References .. 6- 48 7 COMPLETE BLOOD COUNT (CBC) .. 7- 3 I. Purpose and Principle of Test .. 7- 3 A. Access 7- 10 B. Software Menu Tree .. 7- 11 C. Run Sample Screen Options .. 7- 12 D. Status Line .. 7- 13 II. Special Safety Precautions.

9 7- 14 III. Computerization: Integrated Survey and Information System (ISIS) .. 7- 14 vii TABLE OF CONTENTS (continued) Chapter Page IV. Specimen Collection and Preparation .. 7- 14 A. Specimen Collection .. 7- 14 B. Specimen Preparation .. 7- 15 V. Procedure for Microscopic Examination .. 7- 15 VI. Reagents and Supplies .. 7- 15 A. Reagents, Controls, and Calibrators .. 7- 15 B. Supplies .. 7- 18 C. Notes .. 7- 18 VII. Calibration .. 7- 19 A. Perform Calibration: .. 7- 19 B. Verify the Calibration of Your Instrument: .. 7- 19 C. Pre-calibration, Reproducibility, and Carryover Check .. 7- 21 D. CBC Calibration with S-CAL Calibrator.

10 7- 25 VIII. Assay Procedure .. 7- 30 A. Run Start Up at the Beginning of the First Session Each Operational Day.. 7- 30 B. Run Controls .. 7- 32 C. Run Sample Persons .. 7- 32 D. Daily Shut Down .. 7- 38 E. Clean Cycle .. 7- 38 F. Prolonged Shut Down .. 7- 39 G. Autopurge Cycle .. 7- 40 H. Beginning and End of Stand Operations .. 7- 41 IX. Coulter Reportable Range of Results .. 7- 54 X. Quality Control .. 7- 55 A. Latron Primer and Latex Controls .. 7- 55 B. 5C Cell Controls Tri Pack contains Normal, Abnormal I, Abnormal II .. 7- 58 C. Control Statistics and Graphs .. 7- 62 D. Record 5C Cell and Latron Lot Numbers in ISIS .. 7- 65 E.