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System Procedure Manual TABLE OF CONTENTS TABLE OF CONTENTS i Table of Contents Foreword Procedure Manual Overview iii Introduction Overview of a Quality Assurance Program iv
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System Procedure Manual TABLE OF CONTENTS TABLE OF CONTENTS i Table of Contents Foreword Procedure Manual Overview iii Introduction Overview of a Quality Assurance Program iv 1.0 Setup and Maintenance 1.1 Introduction Cholestech LDX Optics Check Cassette Optics Check Cassette Test Procedure Environmental Requirements Laboratory Temperature Records Instrument History Record Cholestech LDX System Initial Setup Maintenance and Cleaning of the Cholestech LDX System Course of Action If System Becomes Inoperable Procedure Sign-Off Reference(s) and Bibliography Specimen Collection and Handling 2.1 Introduction Fingerstick Procedure Procedure Sign-Off Venipuncture Procedure Procedure Sign-Off Reporting Results Properly Procedure Sign-Off Proper Specimen Storage Procedure to Properly Remove a Rubber Stopper from an Evacuated Tube Reference(s) and Bibliography Quality Control 3.1 Introduction Quality Control Materials Frequency of Testing Establishing and Calculating a Control Range Cholestech LDX System Quality Control Log When Results Are Outside Acceptable Control Limits Quality Control Remedial Action Procedure Sign-Off Reporting a Complaint Procedure Sign-Off Cholestech LDX System Calibration Verification and Linearity Testing Reference(s) and Bibliography Safety 4.1 Introduction Reference(s) and Bibliography Training 5.1 Introduction Cholestech LDX Training Checklist Certificate of Training Fingerstick Blood Collection Online Training TABLE OF CONTENTS ii TABLE OF CONTENTS 6.0 Material Safety Data Sheets Proficiency Testing 7.1 Overview of Proficiency Testing Proficiency Testing Agencies Reference(s) and Bibliography Glossary of Terms Reference(s) and Bibliography Master Forms Optics Check Log Temperature Chart Instrument History Record Information and Service Log Initial Setup Checklist Equipment Maintenance/Cleaning Log Instruments In-Use Record Patient Result Log Patient Result Label Log No. 1 Patient Result Label Log No. 2 Quality Control Log Quality Assurance Record Control Range Calculation Form Accuracy Study Data Precision Calculation Form Training Checklist Certificate of Training for Fingerstick Blood Collection Test Cassette Inserts Test Procedure Lipid Profile GLU Test Procedure ALT FOREWORD iii Foreword Procedure Manual Overview This procedure manual has been designed to instruct Cholestech LDX users in how to comply with good laboratory practices and assist in complying with applicable regulations. The covers: Setup and Maintenance: Procedure to properly run an optics check and record the values for the Cholestech LDX System. In addition, the section provides specific information about recording laboratory environmental conditions. Specimen Collection and Handling: General procedures that are applicable to obtaining a suitable specimen and running a test on the Cholestech LDX System. Quality Control: Discusses laboratory activities designed to ensure that each test system is working properly and that the test results satisfy quality standards. Safety: Allows you to file your safety guidelines as recommended by OSHA. Training: A checklist as a guideline to train personnel on the Cholestech LDX System. After the training is completed, you may use the Certificate of Training for the Cholestech LDX System and the Certificate of Training for Fingerstick Blood Collection to document training. Material Safety Data Sheets: A copy of Cholestech Corporation s MSDS for the Cholestech LDX test cassettes. You can add additional MSDSs as required. Proficiency Testing Guidance: Discusses the importance of proficiency testing, how testing is performed and lists agencies offering proficiency testing. Glossary of Terms: An alphabetical list of common laboratory terms. Master Forms: Master forms are provided for you to print as needed. An icon, characterized as a letter within a shape, will appear at the beginning of each section. These icons indicate the following: I R O The information in the following section is For Information Only. The information in the following section is Recommended by the Manufacturer. The information in the following section is recommended to comply with OSHA and CLIA 88 Moderately Complex Laboratory Regulations, as well as regulations that apply to users in certain states. If you need assistance using the manual, please call us at Please Note: The following procedures are outlined as a guide, not a substitute for complying with state or federal regulations relevant to your site. Cholestech Corporation does not guarantee that following this guide will result in certification or meeting state or federal regulations. For further information regarding regulations, please refer to your state or federal agencies. iv INTRODUCTION 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. Quality assurance in a point-of-care laboratory covers nine basic areas: 1. Policies and standards that govern the laboratory cover elements that affect test quality before (patient preparation, sample collection, etc.), during and after (data transcription errors, etc.) the testing process. 2. Training: All personnel conducting tests should be properly trained and their training documented. 3. Safety policies should be adhered to and a safe working environment provided. 4. Procedure manuals should contain operating protocols that are complete, up to date and available to laboratory personnel. 5. Record keeping: All aspects of the quality assurance program should be documented in writing as appropriate. 6. Calibration and instrument maintenance should be performed as needed. 7. Quality control may include initial verification of the test method, routine testing of quality control materials and a written procedure for responding to out of control test results. All quality control procedures and follow-up actions should be documented. 8. Participation in proficiency testing programs is optional for CLIA-waived tests. Proficiency testing may be performed and documented when required by local or state regulations. 9. Laboratory inspections may be conducted by the appropriate organization to assess quality assurance and suggest possible improvements. A successful QA program assures that: 1. Policies and procedures are established in writing and followed by all personnel involved in the testing process. 2. The test system performs properly at the time patient results are produced. 3. Written records are available to demonstrate that uniform procedures have been established and are followed. The material in this procedure manual can assist in assuring that the quality of test results in the laboratory or at a testing site is satisfactory over time. 1.0 Setup and Maintenance 2 SETUP AND MAINTENANCE Setup and Maintenance I 1.1 Introduction This section contains the procedure to properly run an optics check and specific information about proper maintenance. A sample copy of each form referred to is included in the Master Forms section of this manual. R 1.2 Cholestech LDX Optics Check Cassette A Cholestech LDX Optics Check Cassette with known reflectance values is supplied with each Analyzer. It should be used to check the optical system of the Analyzer. Store the Cholestech LDX Optics Check Cassette at room temperature in the case provided. Do not touch the reaction bar or allow it to become wet, dirty or scratched. Do not use a damaged or expired Cholestech LDX Optics Check Cassette. Run a Cholestech LDX Optics Check Cassette: Once each day before patient samples are tested. After the Cholestech LDX System has been moved or serviced. R 1.3 Optics Check Cassette Test Procedure Do not use a Cholestech LDX Optics Check Cassette that is expired, damaged or altered in any way. 1. Press the RUN button. After verifying the Selftest OK message, the drawer will open, and the screen will display: Load cassette and press RUN 2. Place the Optics Check Cassette into the cassette drawer. Do not place any blood sample on the cassette. 3. Press the RUN button again and the Analyzer will automatically perform the optics check. The words Optics Check and four numbers will appear on the screen, one for each optical channel in the Analyzer. Optics Check ##-##-##-## ch#1-ch#2-ch#3-ch#4 4. If the numbers for all four channels fall within the ranges printed on the Optics Check Cassette label, the system is ready for use. I R O For Information Only Recommended Optional Information SETUP AND MAINTENANCE 3 5. If the numbers for any of the four channels fall outside the ranges printed on the Optics Check Cassette label, the Analyzer will shut down. The Analyzer will be disabled until another optics check has been run that falls within range. Try running an optics check with a different Optics Check Cassette. If the numbers are still outside the range, call Cholestech Technical Service at Record the results in the Optics Check Log each day. R 1.4 Environmental Requirements Use your Cholestech LDX System in a location that has: Temperature F (20 31 C) A stable work surface No direct heat (oven or room heater) No bright light (sunlight or a spotlight) If the temperature or light requirements are not acceptable, the Analyzer will shut down until they are met. R 1.5 Laboratory Temperature Records Forms are included in this manual (see Master Forms section) to record the temperature of the laboratory room and refrigerator. Each form is designed for a daily record to be made. There is space for the site identification, the acceptable temperature range and daily temperature records. Record the temperature and your initials in the allocated spaces. R 1.6 Instrument History Record Proper, continuing care for a laboratory instrument has primary importance, as it minimizes breakdowns and ensures proper results. The Instrument History Record allows lab personnel to communicate effectively with Cholestech Technical Service. You should have a record for your Cholestech LDX System as well as records for any other instruments in the lab. Several general guidelines are helpful in ensuring satisfactory preventive maintenance: Select one person to have principal responsibility for a given instrument. Make sure that this person is familiar with the user manual, the procedure manual, and the package inserts for each test system. Perform all required preventive maintenance called for in the Cholestech LDX System User Manual and keep a record of it. Record the date, type of maintenance done, and the name or initials of the person doing the maintenance. Keep all spare parts recommended by the manufacturer on hand. I R O For Information Only Recommended Optional Information 4 SETUP AND MAINTENANCE R 1.7 Cholestech LDX System Initial Setup The Initial Setup Checklist is provided to assure that all of the environmental conditions are met and that the Cholestech LDX System runs properly during the initial setup in the laboratory. The Instrument History Record can be used to record any service performed on the Cholestech LDX System or other instruments in your laboratory. Both forms can be found in the Master Forms section of this manual. Cholestech Corporation will provide technical support to each Cholestech LDX System user. Any questions regarding the operation of the Cholestech LDX System may be directed to: Cholestech Corporation Technical Service Department 3347 Investment Boulevard Hayward, CA U.S.A. Tel Fax R 1.8 Maintenance and Cleaning of the Cholestech LDX System No maintenance is required other than routine cleaning when necessary. Clean the outside of the Cholestech LDX Analyzer case with a clean, damp, nonabrasive cloth. Most spills and stains will be removed with water or a mild detergent. A solution of 70% isopropyl alcohol, or 5% bleach, or any nonstaining, commercially available disinfectant are all appropriate cleaning agents. Do not immerse the instrument in water or other cleaning fluid. Do not use any abrasive cleanser. When necessary, clean the cassette drawer with a cotton swab moistened with water, a 70% isopropyl alcohol solution, 5% bleach or disinfectant. Dry with a second cotton swab. You can record maintenance and cleaning performed on the Cholestech LDX System and other instruments in your laboratory on the Equipment Maintenance/Cleaning Log in the Master Forms section of this manual. I R O For Information Only Recommended Optional Information SETUP AND MAINTENANCE 5 O 1.9 Course of Action If System Becomes Inoperable Course of Action for the Cholestech LDX System If the Cholestech LDX System becomes inoperable, call Cholestech Technical Service at or Until the instrument becomes operable, venous specimens will be drawn and sent to the following reference laboratory. Laboratory Name Laboratory Address Laboratory Phone No. or An alternative Cholestech LDX Analyzer will be used. Course of Action for Other Instruments in the Lab Name of Instrument Technical Service Phone Number Written Procedure If the Instrument Fails Course of Action for Other Instruments in the Lab Name of Instrument Technical Service Phone Number Written Procedure If the Instrument Fails I R O For Information Only Recommended Optional Information 6 SETUP AND MAINTENANCE O 1.10 Procedure Sign-Off Approved Adopted Revised Discontinued Director s Signature Director s Signature Director s Signature Director s Signature Date Date Date Date The procedure is not applicable to this laboratory: Director s Signature Date I 1.11 Reference(s) and Bibliography 1. National Committee for Clinical Laboratory Standards. Physician s Office Laboratory Procedure Manual; Tentative Guideline. Villanova, Pa.: NCCLS; NCCLS publication POL2-T, Vol. 12, No. 5. I R O For Information Only Recommended Optional Information 2.0 Specimen Collection and Handling 8 SPECIMEN COLLECTION AND HANDLING Specimen Collection and Handling I 2.1 Introduction Since the collection of the patient s specimen is the beginning of the analytical process, the use of proper collection techniques is essential to obtaining accurate results. It is imperative that laboratories follow appropriate biohazard and safety procedures. Many laboratory errors can be traced to such nonanalytical factors as misidentifying or mishandling specimens. Nonanalytical error can be prevented by using careful collection and processing procedures. Several factors can influence a result so that it does not reflect the patient s usual cholesterol level. Many of these variations are due to things that occur before or during blood collection, or during the time the blood is stored or shipped to the laboratory. It is important to understand and control these factors as much as possible to get accurate results. Factors that contribute to the patient s usual cholesterol level include: Age and gender Within-day variation Seasonal variation Diet and alcohol Exercise Drugs Fasting Posture Venous occlusion Recent heart attack or stroke Trauma and acute infection Pregnancy For more information on patient variables, please contact Cholestech Technical Service at R 2.2 Fingerstick Procedure Precautions When handling patient samples, appropriate biohazard precautions should be taken. A warm hand and good blood flow from the puncture site are essential to draw a good capillary sample. 1. The patient should sit quietly for five minutes before the blood sample is collected. 2. Put a capillary plunger into a Cholestech capillary tube at the end with the red mark. Set it aside. I R O For Information Only Recommended Optional Information SPECIMEN COLLECTION AND HANDLING 9 3. Choose a spot on the side of one of the center fingers of either hand. The fingers and hands should be warm to the touch. To warm the hand, you can: a. Wash the patient s hand with warm water, or... b. Apply a warm (not hot) compress to the hand for several minutes, or... c. Gently massage the finger from the base to the tip several times to bring the blood to the fingertip. 4. Clean the site with an alcohol swab. Dry thoroughly before pricking the finger. 5. Firmly prick the selected site with a lancet. 6. Squeeze the finger gently to obtain a large drop of blood. Wipe away this first drop of blood as it may contain tissue fluid. 7. Squeeze the finger gently again while holding it downward until a second large drop of blood forms. Do not milk the finger. The puncture should provide a free-flowing drop of blood. 8. Hold the capillary tube horizontally by the end with the plunger. Touch it to the drop of blood without touching the skin. The tube will fill by capillary action up to the black mark. Do not collect air bubbles. If it is necessary to collect another drop of blood, wipe the finger with gauze then massage again from base to tip until a large drop of blood forms. 9. Wipe off any excess blood and have the patient apply pressure to the puncture until the bleeding stops. O 2.3 Procedure Sign-Off Approved Adopted Revised Discontinued Director s Signature Director s Signature Director s Signature Director s Signature Date Date Date Date The procedure is not applicable to this laboratory: Director s Signature Date I R O For Information Only Recommended Optional Information 10 SPECIMEN COLLECTION AND HANDLING O 2.4 Venipuncture Procedure Precautions This procedure should be conducted only by a qualified phlebotomist. When handling patient samples, follow appropriate biohazard precautions. Venipuncture Setup 1. Identify appropriate specimen type/types for the tests you are performing: Whole blood Anticoagulated whole blood containing white blood cells, red blood cells, platelets, and plasma. Serum The liquid part of the blood obtained after the blood has been allowed to coagulate and then spun down in a centrifuge. Red blood cells and fibrin are separated from the rest of the liquid. Plasma The liquid part of the blood obtained after the specimen has been mixed with an anticoagulant and then spun down in a centrifuge. Cellular components are separated from the rest of the liquid. 2. Select appropriate tubes and needles needed for the tests. COLOR-CODED TUBES Color Use Additive Gray Plasma or Whole Blood Oxalate/fluoride (glycolysis inhibition) Green* Plasma or Whole Blood Heparin Blue Plasma or Whole Blood Citrate Lavender Plasma or Whole Blood EDTA Red Serum None Red or Red/Black Serum Serum separator gel 3. When collecting several samples during a venipuncture, start with the tubes that have no additive, or a serum separator tube. * This is the appropriate tube for use with the Cholestech LDX System. Performing the Venipuncture 1. Identify the patient by asking the patient to state his/her full name. 2. Label the tube with the patient s name or identification number. 3. Reassure the patient to make him or her comfortable. 4. Have the patient make a fist to increase blood flow. 5. Apply the tourniquet. Do not stop blood flowing in the veins for more than a minute before the blood is drawn as it causes venous occlusion. If necessary, release the tourniquet and reapply. Leaving the tourniquet on for more than three minutes may cause erroneous results. I R O For Information Only Recommended Optional Information SPECIMEN COLLECTION AND HANDLING Select the venipuncture site. 7. Clean the venipuncture site with a 70% isopropyl alcohol pad, making one smooth circular pass of the venipuncture site. 8. Allow the skin to dry to prevent hemolysis of the specimen and to prevent the patient from having a burning sensation when the venipuncture is performed. Do not touch the venipuncture site after cleaning it. 9. Perform the following procedure: Grasp the patient s arm near the venipuncture site using your thumb to draw the skin tight. With the needle bevel facing up, line up the needle with the vein. Penetrate the skin and enter the vein at an angle of appr
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