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Cholestech GDX Procedures Manual

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Summary of Contents for Cholestech GDX

  • Page 1 System Procedure Manual > TABLE OF CONTENTS...
  • Page 2 > TABLE OF CONTENTS...
  • Page 3 1.8 Cholestech GDX System Initial Setup ........4...
  • Page 4 6.2 Cholestech GDX Training Checklist ........32...
  • Page 5 Cholestech GDX System Procedure Manual Foreword Procedure Manual Overview This Procedure manual has been designed to instruct Cholestech GDX users in how to comply with good laboratory practices and assist in complying with applicable regulations. The Cholestech GDX System Procedure Manual covers: •...
  • Page 6 INTRODUCTION Cholestech GDX System Procedure Manual Introduction Overview of a Quality Assurance Program Quality assurance (QA) is a comprehensive set of policies, procedures and practices necessary to ensure the quality of laboratory tests. Its purpose is to ensure that over the long term, the laboratory provides reliable data that accurately reflect the patient’s status.

  • Page 7: Maintenance

    1.0 Setup and Maintenance < TABLE OF CONTENTS...

  • Page 8: Setup And Maintenance

    If you are concerned that your test result is incorrect, also run the quality control material. 1.4 Optics Check Cartridge Test Procedure Do not use a Cholestech GDX Optics Cartridge that is expired, damaged or altered in any way. Plug in the Analyzer and allow to warm up.
  • Page 9 Do not use the Optics Check Cartridge if it has been stored incorrectly and is scratched or damaged in any way. For technical help and troubleshooting, please refer to the Cholestech GDX A1C Test Cartridge package insert and the User Manual. If technical help is required, please contact Cholestech Technical Service at 800-733-0404.
  • Page 10 The Initial Setup Checklist is provided to assure that all of the environmental conditions are met and that the Cholestech GDX System runs properly during the initial setup in the laboratory. Refer to the Master Forms section of this manual.
  • Page 11 1.9 Maintenance and Cleaning of the Cholestech GDX System No maintenance is required other than routine cleaning when necessary. • Clean the outside of the Cholestech GDX Analyzer case with a clean, damp, nonabrasive cloth. Most spills and stains will be removed with water or a mild detergent.
  • Page 12 SETUP AND MAINTENANCE Cholestech GDX System Procedure Manual Course of Action for Other Instruments in the Lab Name of Instrument Technical Service Phone Number Written Procedure If the Instrument Fails 1.11 Procedure Sign-Off Approved Director’s Signature Date Adopted Director’s Signature...

  • Page 13: Specimen Collection

    2.0 Specimen Collection and Handling < TABLE OF CONTENTS...

  • Page 14: Specimen Collection And Handling

    When handling patient samples, appropriate biohazard precautions should be taken. The Cholestech GDX A1C test is carried out on a fingerstick blood sample. Choose a spot on the side of one of the center or ring fingers of either hand. The fingers and hands should be warm to the touch.
  • Page 15 Serum Serum separator gel When collecting several samples during a venipuncture, start with the tubes that have no additive, or a serum separator tube. *Appropriate for use with the Cholestech GDX System. < TABLE OF CONTENTS For Information Only Recommended...
  • Page 16 SPECIMEN COLLECTION AND HANDLING Cholestech GDX System Procedure Manual Performing the Venipuncture Identify the patient by asking the patient to state his/her full name. Label the tube with the patient’s name or identification number. Reassure the patient to make him or her comfortable.
  • Page 17 SPECIMEN COLLECTION AND HANDLING Cholestech GDX System Procedure Manual 10. Remove the needle and bandage the site. • After the tube has been withdrawn from the holder, gently remove the needle from the venipuncture site. Immediately apply a sterile gauze pad to the site, and tell the patient to keep pressure on the site for two minutes.
  • Page 18 The following space is available to record the laboratory procedure that will be used to report results from the Cholestech GDX System. Or you may use the A1C Result Log in the Master Forms section.
  • Page 19 SPECIMEN COLLECTION AND HANDLING Cholestech GDX System Procedure Manual 2.7 Procedure Sign-Off Approved Director’s Signature Date Adopted Director’s Signature Date Revised Director’s Signature Date Discontinued Director’s Signature Date The procedure is not applicable to this laboratory: Director’s Signature Date 2.8 Proper Specimen Storage Anticoagulated blood may be sampled directly from the tube after mixing.

  • Page 20: Reference(S) And Bibliography

    SPECIMEN COLLECTION AND HANDLING Cholestech GDX System Procedure Manual 2.10 Reference(s) and Bibliography National Committee for Clinical Laboratory Standards. Physician’s Office Laboratory Procedure Manual; Tentative Guideline. Villanova, Pa.: NCCLS; 1989. NCCLS publication POL2-T, Vol. 12, No. 5. National Committee for Clinical Laboratory Standards. Procedure for the Collection of Diagnostic Blood Specimens by Skin Puncture.
  • Page 21 3.0 Quality Control < TABLE OF CONTENTS...

  • Page 22: Quality Control

    • With each new lot of test cartridges. • As otherwise required by your laboratory’s standard quality control procedures. • If you are not running the Cholestech GDX under CLIA-waived status, or if your local or state regulations require more frequent testing of quality control material, then quality control must be performed in compliance with those regulations.
  • Page 23 QUALITY CONTROL Cholestech GDX System Procedure Manual 3.4 Control Range Results for Cholestech GDX A1C Controls must be within the ranges included with the controls before patient samples are tested. Results Within the Control Range QC results can be logged on the Quality Assurance Record template found in the Master Forms section.
  • Page 24 < TABLE OF CONTENTS...
  • Page 25 4.0 A1C Test Procedure < TABLE OF CONTENTS...
  • Page 26 A1C (hemoglobin A1C) in the sample. After a GDX test cartridge has been placed into the instrument, a small sample of blood is added to the first (red-capped) sample tube, which contains the boronate affinity resin. The red blood cells are instantly lysed to release the hemoglobin and the boronate affinity resin...
  • Page 27 Calibration The Cholestech GDX Analyzer and A1C Test Cartridges have been manufactured to deliver an A1C result. This is calibrated to the recommendations of the Diabetes Control and Complications Trial (DCCT). This result is traceable to the NGSP (National Glycohemoglobin Standardization Program), an internationally accepted method of standardization.
  • Page 28 For more information, see the test cartridge package inserts. The Quick Reference Guide gives a brief summary of the procedures. Note: If the Cholestech GDX Analyzer has not been plugged in and has not been stored at room temperature, a warm-up period will occur at initial setup. The maximum time required for warm-up is 10 minutes.
  • Page 29 A1C TEST PROCEDURE Cholestech GDX System Procedure Manual IMPORTANT: Gloves should be worn whenever working with samples that are potentially biohazardous. Hold the white rim of the test cartridge and rotate it clockwise through 90º to Position 1 (see Figure 3). The test cartridge will click into its new position. The first sample tube will rise from the cartridge.
  • Page 30 A1C TEST PROCEDURE Cholestech GDX System Procedure Manual Put everything that touched the blood sample or control in a biohazard waste container. The end of the countdown is indicated by a beep. The Insert/Mix and Pour Tube icons will appear on the display. Mix the contents of the tube by turning upside down 3 TIMES (see Figure 10).
  • Page 31 Analyzer displays the percentage A1C value for the sample. • Push the enter button to clear the display. Please call Cholestech Technical Service at 800-733-0404 if you have any questions about the operation of the Cholestech GDX System.
  • Page 32 Limitations Linearity and Temperature Effects The Cholestech GDX test has been shown to give a linear response from 4–15% A1C using patient samples. In addition, the theoretical performance of the test indicates a linear range of 2% to >25% A1C. Cholestech GDX results were shown not to be affected by operating temperatures of 63–86ºF (17–30º...
  • Page 33 Accuracy and Precision The Cholestech GDX has met the accuracy and precision requirements set by the NGSP in each year it has been tested. Cholestech GDX A1C results are certified as traceable to the DCCT. NGSP precision: <4% coefficient of variation (CV) by NCCLS EP5-A protocol.

  • Page 34: Reference(S) And Bibliography

    A1C TEST PROCEDURE Cholestech GDX System Procedure Manual 4.8 Reference(s) and Bibliography The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993; 329:977–986. United Kingdom Prospective Diabetes Study Group. Lancet 1998; 352:837–853. Sperling MA et al. Physicians Guide to Insulin-Dependent (Type 1) Diabetes: Diagnosis and Treatment.
  • Page 35 5.0 Safety < TABLE OF CONTENTS...
  • Page 36 SAFETY Cholestech GDX System Procedure Manual Safety 5.1 Introduction The Occupational Safety & Health Administration (OSHA) ruled that beginning March 6, 1992, all labs must undergo training to protect the workers from bloodborne pathogens. The new regulations outline in detail what employees must be taught about the hazards of working with potentially infectious materials and what precautions must be taken to prevent or minimize exposure.
  • Page 37 6.0 Training < TABLE OF CONTENTS...

  • Page 38: Online Training

    6.2 Cholestech GDX Training Checklist This checklist is designed to assist the trainer in training users of the Cholestech GDX System. There is room to date and sign each procedure as the task is completed. 6.3 Certificate of Training—Fingerstick Blood Collection This certificate can be used to document that fingerstick training has been completed and...

  • Page 39: Material Safety

    7.0 Material Safety Data Sheets < TABLE OF CONTENTS...

  • Page 40: Material Safety Data Sheets

    Identity Hazardous Ingredients Physical Data Fire & Explosion Data Health Information Reactivity Data Spill or Leak Procedures Personal Protection Information Special Precautions MSDSs for Cholestech GDX test cartridges, controls, and Optics Check Cartridges are included here. < TABLE OF CONTENTS...

  • Page 41: Section 1 - Identity

    MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET Cholestech GDX ™ A1C Test Cartridges SECTION 1 – IDENTITY NAME ADDRESS Cholestech GDX ™ System 3347 Investment Blvd., Hayward, CA 94545 TELEPHONE NUMBER FOR ADDITIONAL INFORMATION CONTACT...

  • Page 42: Section 5 - Health Information

    MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET CONTINUED SECTION 5 – HEALTH INFORMATION PRIMARY ROUTES OF EXPOSURE Skin, eye, ingestion SIGNS AND SYMPTOMS OF EXPOSURE (1) ACUTE OVEREXPOSURE – None (2) CHRONIC OVEREXPOSURE – None...
  • Page 43 MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET Cholestech GDX ™ A1C Controls SECTION 1 – IDENTITY NAME ADDRESS Cholestech GDX ™ System 3347 Investment Blvd., Hayward, CA 94545 TELEPHONE NUMBER FOR ADDITIONAL INFORMATION CONTACT...
  • Page 44 MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET CONTINUED SECTION 6 – REACTIVITY DATA STABILITY CONDITIONS TO AVOID Unstable ___ Stable ___ Not determined Non-reactive INCOMPATIBILITY (MATERIALS TO AVOID) Not determined HAZARDOUS DECOMPOSITION PRODUCTS Not determined...
  • Page 45 MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET Cholestech GDX ™ Optics Check Cartridge SECTION 1 – IDENTITY NAME ADDRESS Cholestech GDX ™ System 3347 Investment Blvd., Hayward, CA 94545 TELEPHONE NUMBER FOR ADDITIONAL INFORMATION CONTACT...
  • Page 46 MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET CONTINUED SECTION 6 – REACTIVITY DATA STABILITY CONDITIONS TO AVOID Unstable ___ Stable ___ Not determined INCOMPATIBILITY (MATERIALS TO AVOID) Not determined HAZARDOUS DECOMPOSITION PRODUCTS Not determined...
  • Page 47 8.0 Proficiency Testing < TABLE OF CONTENTS...

  • Page 48: Proficiency Testing

    Under CLIA ’88, proficiency testing is required three times per year, testing five samples each time for moderately complex and highly complex labs. The specimen of choice for the Cholestech GDX System is a specimen of human whole blood with no stabilizers.

  • Page 49: Proficiency Testing Agencies

    The director of a point-of- care laboratory will review all proficiency testing results and document the review and responses to unacceptable results. • Cholestech Technical Service can provide assistance in troubleshooting proficiency testing failures. 8.2 Proficiency Testing Agencies •...
  • Page 50 < TABLE OF CONTENTS...
  • Page 51 9.0 Troubleshooting < TABLE OF CONTENTS...

  • Page 52: Troubleshooting

    TROUBLESHOOTING Cholestech GDX System Procedure Manual Troubleshooting 9.1 Time / Sequence Errors It is essential to follow the operational sequence without extensive delays between steps. The Analyzer measures time intervals between steps at appropriate points and will give an error message if the time interval exceeds the stated limits.
  • Page 53 Cholestech GDX System Procedure Manual 9.2 Analyzer / Test Errors The Cholestech GDX Analyzer has been programmed to detect any Analyzer or test problems. An error message will appear on the display if any mistakes arise during the test. Look at the following table to see the cause of the error message and the possible correction.
  • Page 54 TROUBLESHOOTING Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err-4 A test cartridge is turned between Positions 1 Complete the rotation of the cartridge Cartridge in the wrong position and 2 before being prompted by the Analyzer.
  • Page 55 TROUBLESHOOTING Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err-8 The test cartridge has been damaged. Run the Optics Check Cartridge. If the Optics Position 1 blank reading out of range Check Cartridge fails, remove it from the...
  • Page 56 TROUBLESHOOTING Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err-13 User error. The user is unfamiliar with the Check blood sampling technique with user Absorbance 3 calculation too high blood collection pipette and has overfilled instructions. If necessary, practice using the the pipette.
  • Page 57 TROUBLESHOOTING Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err-18 (continued) A cartridge has been left “resting” in the Remove the cartridge, turn off the power Analyzer. supply and disconnect the Analyzer. Reconnect the analyzer, allow to warm up and insert an Optics Check Cartridge.
  • Page 58 TROUBLESHOOTING Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err-23 (continued) Analyzer failure. Power off the Analyzer and power it back on again. Try running the Optics Check Cartridge again. If the error message persists, call Technical Service.
  • Page 59 10.0 Glossary of Terms < TABLE OF CONTENTS...

  • Page 60: Glossary Of Terms

    GLOSSARY OF TERMS Cholestech GDX System Procedure Manual Glossary of Terms Acceptable Control Range – range of results that indicate adequate performance when analyzing a control sample. The range is shown in the control’s assay sheet. Accuracy – correctness; freedom from error. The accuracy of results can be measured by comparing them with those from another laboratory (this is “relative accuracy”).
  • Page 61 GLOSSARY OF TERMS Cholestech GDX System Procedure Manual Capillary (capillary action) – attraction between a liquid and a solid that causes the liquid to rise, as for example, into a capillary tube. Centrifuge – instrument that separates the lighter portions of a solution, mixture, or suspension from the heavier portions by centrifugal force.
  • Page 62 GLOSSARY OF TERMS Cholestech GDX System Procedure Manual Gravimetry – measurement of a substance by determining its weight or specific gravity. Hematoma – mass of blood, usually clotted, under the skin in an organ, space, or tissue caused by a break in the wall of a blood vessel.
  • Page 63 GLOSSARY OF TERMS Cholestech GDX System Procedure Manual Method – analytical method; the instructions including procedures, material, equipment, and everything else needed for an analyst to perform an analysis. Normal Values (Expected Values, Reference Values) – range of values established for each analyte, which includes the results expected when performing a test on a healthy person.
  • Page 64 GLOSSARY OF TERMS Cholestech GDX System Procedure Manual Quantitative – applied to tests that give results expressing the numerical amount of an analyte in a specimen. This is in contrast to qualitative tests that detect whether a particular analyte, constituent, or condition is present.
  • Page 65 GLOSSARY OF TERMS Cholestech GDX System Procedure Manual Standard, Secondary – reference material, the analyte concentration of which has been ascertained by reference to a primary standard. Standard Deviation – statistical measurement of the degree of variation from the mean of a series of measurements.
  • Page 66 < TABLE OF CONTENTS...

  • Page 67: Master Forms

    11.0 Master Forms < TABLE OF CONTENTS...

  • Page 68: A1C Result Log

    A1C RESULT LOG Cholestech GDX Serial No. Test Cartridge Lot No. Expiration Date Optics Check Cartridge Lot No. Expiration Date Range Control Lot No. Expiration Date Level 1 Range Level 2 Range SAMPLE DATE IDENTIFIER PATIENT OPTICS LEVEL 1 LEVEL 2...

  • Page 69: Temperature Chart

    TEMPERATURE CHART YEAR Record the temperature and initial the space provided. One sheet should be used per room, refrigerator, or freezer as your procedures dictate. Site ID Acceptable Temperature Range MARCH APRIL JUNE JULY SEPT < TABLE OF CONTENTS...

  • Page 70: Instrument History Record

    INSTRUMENT HISTORY RECORD GENERAL INFORMATION Instrument Model No. Serial No. Date Purchased Cost Manufacturer Address City State Telephone Contact Person Distributor Address City State Telephone Contact Person Warranty Contact Person Notes: Technical Service Representative Telephone SERVICE RECORD Date Comments < TABLE OF CONTENTS...

  • Page 71: Information And Service Log

    INFORMATION AND SERVICE LOG Instrument Serial No. Purchase Date Warranty Expires: Customer Service Representative Phone No. Technical Service Representative Phone No. Sales Representative Phone No. DATE PROBLEM ACTION TAKEN OPERATOR < TABLE OF CONTENTS...

  • Page 72: Initial Setup Checklist

    INITIAL SETUP CHECKLIST Cholestech GDX Serial No. Date of Setup Name of Lab Person Performing Initial Setup Signature Approval by Laboratory Director FACILITY SPECIFICATIONS OPERATOR DATE 1. Room temperature: 63–86°F (17–30°C) 2. Stable work surface free from vibrations 3. Isolation from direct heat and light sources (e.g., sunlight, ovens, room heater, etc.) 4.

  • Page 73: Equipment Maintenance / Cleaning Log

    EQUIPMENT MAINTENANCE / CLEANING LOG INSTRUMENT NAME MAINTENANCE NOTES (problems reported, dates, solutions) Serial No. Quarterly Cleaning Schedule Dates < TABLE OF CONTENTS...

  • Page 74: Instruments In-Use Record

    INSTRUMENTS IN-USE RECORD INSTRUMENT/ SERIAL MANUFACTURER DATE OPERATOR MODEL NUMBER INSTALLED < TABLE OF CONTENTS...

  • Page 75: Patient Result Label Log

    PATIENT RESULT LABEL LOG Cholestech GDX Serial No. Operator Cartridge Lot No. Expiration Date Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here <...

  • Page 76: Quality Assurance Record

    Expiration Date Cartridge Lot No. Expiration Date ROOM TEMP REFRIG TEMP RANGE Results Accept Reject Level 1 Level 1 CHOLESTECH GDX SERIAL NO. Level 2 Level 2 OPTICS CHECK Accept Reject OPTICS CHECK LOT NO. Result DATE Control Level 1 Lot No.

  • Page 77: Control Range Calculation Form

    CONTROL RANGE CALCULATION FORM Control Name Lot No. Analyte Cartridge Lot No. Cholestech GDX Serial No. Accept Reject Director Approval Approval Date 1. Record the date in Column 2 and the initials in Column 3. – – Date Init. Result Result –...

  • Page 78: Accuracy Study Data

    Cartridge Expiration Date REFERENCE METHOD CHOLESTECH GDX – Sample Date Reference Method % Difference Acceptable Accuracy Range is ± Cholestech GDX Result – Ref. Result % Difference = x 100 Ref. Result Test Disposition Accept Reject Director Approval Approval Date <...

  • Page 79: Precision Calculation Form (Within-Run)

    PRECISION CALCULATION FORM (WITHIN-RUN) Date Operator Specimen Identification Analyte Cartridge Lot No. Cholestech GDX Serial No. Accept Reject Director Approval Approval Date 1. Record the result of the quality control material in – – Column 2 – RESULT. Result Result – X (Result –...

  • Page 80: Training Checklist

    DATE 1. Has read User Manual. 2. Has read Procedure Manual. 3. Has viewed Cholestech GDX Training CD-ROM. 4. Has read Cholestech GDX package insert. 5. Understands room temperature storage procedures for test cartridges. 6. Has been properly trained in procedure for handling biohazardous waste.
  • Page 81 VxÜà|y|vtàx Éy gÜt|Ç|Çz for Fingerstick Blood Collection I, Dr. , certify that possesses the necessary skills and competencies to perform skin puncture for fingerstick blood collection. This person has properly demonstrated to me fingerstick blood collection in accordance with currently accepted laboratory standards and protocols.
  • Page 82 < TABLE OF CONTENTS...
  • Page 83 < TABLE OF CONTENTS...
  • Page 84 Procedure Manual 3347 Investment Blvd. Hayward, CA 94545 U.S.A. Tel 800 733.0404 Cholestech GDX is a trademark of Cholestech Corporation. MiniPet is a trademark of TriContinent Scientific, Inc. Fax 510 732.7227 MicroSafe is a trademark of Safe-Tec Clinical Products, Inc.

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