LDX Procedures Manual
Contents
1. 23 Safety INTFOQUCUON corra eee AAT Sar eue on me 26 Reference s and Bibliography 26 Training guess EP 28 Cholestech LDX Training Checklist 28 Certificate of Training Fingerstick Blood Collection 28 Online xoi sec Sem pee e rmm ie emo adis 28 ii TABLE OF CONTENTS Cholestech LDX System Procedure Manual TABLE OF CONTENTS 6 0 1 0 71 7 2 7 3 8 0 8 1 9 0 Material Safety Data Sheets Proficiency Testing Overview Proficiency Testing Proficiency Testing Agencies Reference s and Bibliography Bl ssaryof Tels Sh ed 222 Reference s and Bibliography Master ouod cie ar Optics Check Log Temperature Chart nstrument History Record nformation and Service Log nitial Setup Checklist Equipment Maintenance Cleaning Log nstruments In Use Record Patient Result Log Patient Result Label Log No 1 Patient Result Label Log No 2 Quality Control Log No 1 Quality Control Log No 2 Quality Assurance Record Control Range Calculation Form Accuracy Study Data Precision Calculation Form Training Checklist Certif2. lt TABLE OF CONTENTS EQUIPMENT MAINTENANCE CLEANING LOG LDX LDX INSTRUMENT NAME MAINTENANCE NOTES problems reported dates solutions Serial No Quarterly Cleaning Schedule Dates TABLE OF CONTENTS INSTRUMENTS IN USE RECORD LDX LDX INSTRUMENT SERIAL MANUFACTURER DATE OPERATOR MODEL NUMBER INSTALLED lt TABLE OF CONTENTS PATIENT RESULT LOG Cassette Lot No Expiration Date LDX LDX Cholestech LDX Serial No DATE OPERATOR PATIENT NAME PATIENT ID TABLE OF CONTENTS PATIENT RESULT LABEL LOG 1 Cholestech LDX Serial No LDX LDX Cassette 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 Place Label Here Place Label Here Place Label Here TABLE OF CONTENTS PATIENT RESULT LABEL LOG NO 2 Cholestech LDX Serial No Operator LDX LDX Cassette Lot No Expiration Date Place Label Here Place Label Here Place L
3. 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 Reactivity ability of a reagent to produce its proper chemical reaction Reagents can lose their reactivity if they are misused mishandled or are too old Reagent substance that produces a chemical reaction in a sample that allows an analyte to be detected and measured Reconstitute to add a diluent to a freeze dried calibrator control or reagent Reference Interval see Normal Values Replicate to repeat an experiment and or analysis to check the accuracy of the results Each repeat is a replicate pronounced rep li kit test or measurement Reproducibility see Precision Result value obtained by analysis for a particular analyte in a particular sample Run analytical run group of measurements by a particular method over a period of time during which the accuracy and precision of the method are expected to be stable Sample part of a specimen used for an analysis Sensitivity ability of a test to give a positive result for patients who have the disease or condition they are tested for measured as the ratio of positive tests to the total number of tests in those who have the disease expressed as a percentage Serum liquid part of the blood after it has coagu
4. CHOLESTECH Table of Contents 1 0 11 12 1 3 14 1 5 1 6 L7 1 8 1 9 1 10 111 2 0 24 22 23 24 2 5 2 6 2 7 2 8 2 9 210 3 0 3 1 3 2 3 3 3 4 3 5 3 6 3 7 3 8 3 9 3 10 3 11 3 12 4 0 41 42 5 0 54 5 2 5 3 5 4 TABLE 5 gt 5 Cholestech LDX System Procedure Manual Foreword Procedure Manual Overview iii Introduction Overview of a Quality Assurance Program iv Setup and Maintenance OTFOQUCION EP 2 Cholestech LDX Optics Check 2 Optics Check Cassette Test Procedure 2 Environmental Requirements 3 Laboratory Temperature Records 3 nstrument History Record aas sausik nabari dare a REG RE Ru entree 3 Cholestech LDX System Initial 4 Maintenance and Cleaning of the Cholestech LDX System 4 Course of Action If System Becomes Inoperable 5 Procedure 5 1 6 Reference s and Bibliography 1 6 Specimen Collection and Handling augere bonor ETC 8 Firigerstick 4 44 444 at tu
5. NCCLS publication EP5 T National Committee for Clinical Laboratory Standards Meeting CLIA Quality Standards in the 90s Villanova Pa NCCLS 1992 amp For Information Only Li Recommended Optional Information 4 0 Safety 26 SAFETY Cholestech LDX System Procedure Manual Safety lt TABLE OF CONTENTS 4 1 4 2 Introduction The Occupational Safety amp 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 All biosafety training must documented with dates summary of content per each class names and qualifications of all instructors and the names and job titles of employees who attend OSHA has also required that as of May 5 1992 every employer will have a written plan designed to eliminate or minimize worker exposure This includes an outline of the employer s hepatitis B vaccination program Employers are required to offer at their expense a vaccine to any worker who may at any time be exposed to potential infectious materials Staff members may waive their right to the vaccine by signing a form but they are entitled to change their minds and receive the vaccine as soon as possible You may use this section to file a
6. 732 7227 www cholestech com techservice cholestech com Maintenance and Cleaning of the Cholestech LDX System No maintenance is required other than routine cleaning when necessary e Clean the outside of the Cholestech LDX Analyzer case with a clean damp non abrasive 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 e When necessary clean the cassette drawer with a cotton swab moistened with water 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 4 For Information Only Li Recommended Optional Information lt TABLE ONT SETUP AND MAINTENANCE Cholestech LDX System Procedure Manual 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 800 733 0404 or 510 732 7200 Until the instrument becomes operable venous specimens will be drawn and sent to the following reference laboratory Labora
7. 800 733 0404 fax 510 732 7227 We will perform the calculations for you and send the results and data calculations back to you 3 Your control range should be set as the mean value plus or minus two standard deviations rounded off to the nearest integer For example If you calculate the mean to be 175 mg dL and the standard deviation to be 3 9 mg dL your acceptable control range would be 175 mg dL 8 mg dL 167 183 mg dL 4 Record this control range on the Quality Control Log for that analyte level and lot number of control material For Information Only Li Recommended Optional Information 20 QUALITY CONTROL Cholestech LDX System Procedure Manual lt TABLE OF CONTENTS 3 5 3 6 3 1 5 When you run quality control samples the results you get should fall within this range If the value of the control is outside these limits then testing is considered to be out of control The quality control results must be in range before testing patient samples See the Cholestech LDX System User Manual if they are not 6 If results for all levels of quality control material are within established ranges patient samples may be tested and the results reported 7 When you change lot numbers of control materials you will need to repeat this procedure Cholestech LDX System Quality Control Log We have provided you with a log sheet that can be duplicated and used for your records when you test quality contr
8. The laboratory performs the required tests and returns the results to the agency The data are analyzed and a summary report is sent to the laboratory indicating the laboratory s performance Why Is Proficiency Testing Necessary Proficiency testing assures the user of quality results and measures the performance of the test system and operators relative to other laboratories using the same test system or a reference method Testing may identify bias in a test system which may not be apparent with an internal daily quality control program Proficiency testing may be necessary for compliance with state or federal law e g CLIA 88 How Does Proficiency Testing Work Proficiency testing is one aspect of a quality assurance program The method works in conjunction with a daily internal quality control program When properly controlled it indicates the laboratory s accuracy performance on the test system being evaluated A number of agencies offer proficiency testing surveys The surveys vary by the analytes offered for testing number of challenges per analyte number of mailings per year report format sample preparation and result evaluation 1 Surveys are offered for most routine tests performed 2 Under CLIA 88 proficiency testing is required three times per year testing five samples each time 4 For Information Only Li Recommended Optional Information PROFICIENCY TESTING 35 Cholestech LDX System Procedure Manual
9. at 4 F 20 C Glucose is stable in serum samples for up to 8 hours at 77 F 25 or up to 72 hours at 36 46 F 2 8 C when the serum separated from the blood cells is unhemolyzed and kept free of bacterial contamination Minimal loss of ALT and AST activity occurs when serum samples are stored up to 2 days at 36 46 F 2 8 C Serum samples should be stored frozen if they are to be kept more than 3 4 days Serum and plasma samples should be brought to room temperature before the test is performed Mix all samples thoroughly by gentle inversion 7 8 times before testing 4 For Information Only Li Recommended Optional Information SPECIMEN COLLECTION AND HANDLING 15 Cholestech LDX System Procedure Manual 29 Procedure to Properly Remove a Rubber Stopper from an Evacuated Tube 1 All blood samples and blood products are potentially biohazardous and should be treated as such Gloves goggles and a completely buttoned long sleeve lab coat should be worn when handling these materials When removing rubber stoppers from evacuated tubes cover the stopper with a piece of gauze or remove with an evacuated tube stopper remover Always point the tops of any sample tubes away from anyone when removing the caps Pipette tips are pointed away from people while the tips are being ejected For cleanup of spilled blood and blood products observe the safety policies in the lab and the Universal Precautions recommended by the Occu
10. blood flow ceases this assures the correct ratio of anticoagulant to blood volume Gently invert the tube five to ten times to mix the blood and anticoagulant Do not shake the tube vigorously e Insert the next tube into the holder and repeat the collection procedure If a blood sample cannot be obtained change the position of the needle If the needle has penetrated too far into the vein pull it back a hit If it has not penetrated far enough move it farther into the vein If this does not help try inserting another evacuated tube 10 Remove the needle apply pressure and bandage the site e 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 e Apply an adhesive or gauze bandage over the venipuncture site after the bleeding has stopped The patient should leave the bandage on for a minimum of 15 minutes 11 Dispose of the puncture unit To prevent injury and to be sure needles are not reused promptly dispose of the needle and the blood tube holder in an appropriate biohazard container Do not recap the needle lt TABLE OF CONTENTS For Information Only Recommended Optional Information 12 SPECIMEN COLLECTION AND HANDLING Cholestech LDX System Procedure Manual lt TABLE OF CONTENTS 2 5 2 6 Procedure Sign Off Approved Di
11. check with a different Optics Check Cassette If the numbers are still outside the range call Cholestech Technical Service at 800 733 0404 6 Record the results in the Optics Check Log each day Environmental Requirements Operating Voltage e 49 volt DC at 1 amp Environmental Conditions e Indoor use e Altitude up to 2000 meters e Temperature 20 C 31 C 68 F 87 F e Relative humidity 80 for temperature up to 31 C decreasing linearly to 50 relative humidity at 40 C e PollutionDegree Class Two If the temperature or light requirements are not acceptale the Analyzer will shut down until they are met 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 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 sa
12. e g a pipette graduated into appropriate units Calibration taking readings from an instrument or other measuring device and relating them to known concentrations of an analyte or true value Calibrator material solution or freeze dried preparation used in calibration The concentration of the analytes in a calibrator is known to be within a particular range Calibrators may be a primary or a secondary standard Capillary any one of the small vessels that form a network throughout the body for the interchange of substances between the blood and tissue fluid lt TABLE 5 GLOSSARY TERMS 39 Cholestech LDX 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 Coagulation how various coagulation factors in the blood interact to form a clot Coefficient of Variation statistical measure of the ratio of the standard deviation of a series of measurements to the mean of the measurements Expressed as a percentage the coefficient of variation CV shows the precision of measurements Colorimeter measurement and analysis of color by comparison with a standard in terms of brightness hue or purity Contaminant microorganism chemic
13. values Column 2 in the RESULT Column then divide by the number of results n Y Results MEAN Calculate the difference between each RESULT and the MEAN X and record in Column 3 RESULT X Square each value in Column 3 and record in Column 4 RESULT Add the values Column 4 Calculate the Standard Deviation SD using the formula Divide the sum of the values calculated in Column 4 by the number of values minus 1 Take the square root of this number SD Y Results X n 1 To calculate the coefficient of variation use the following formula CV 59 x 100 TRAINING CHECKLIST LDX Name Director Signature Date Approved Has read User Manual Has read Procedure Manual Has viewed Cholestech LDX Training Video Has read Cholestech product insert Understands refrigerated and room temperature storage procedures for test cassettes Has been properly trained in procedure for handling biohazardous waste THE CHOLESTECH LDX ANALYZER Correctly connects the Analyzer to the power supply Correctly connects the Analyzer to the printer if applicable Understands and demonstrates Analyzer functions RUN STOP DATA buttons Configuration Menu Risk Assessment Program 10 Demonstrates correct procedure for changing ROM Pack 11 Understands the meaning of all LCD display messages 12 Demonstrates how to clean Analyzer case
14. 3 specimen of choice for the Cholestech LDX System is specimen of human serum with no stabilizers The type of specimen provided presents a potential problem for some instruments and methodologies Lyophilized serum has been the most frequently used sample for clinical chemistry proficiency surveys But with some test systems including the Cholestech LDX lyophilized serum may not provide an adequate accuracy check due to matrix interference If you are unfamiliar with the concept of matrix effect please call Cholestech Technical Service for clarification In Section 7 2 of this manual a list of agencies offering CMS approved proficiency surveys is provided The agencies set in bold are the ones Cholestech has evaluated and found to demonstrate acceptable performance on the Cholestech LDX For testing other instruments in your laboratory it is important to contact the manufacturer and request the names of agencies that run compatible surveys with no matrix interferences on these instruments or system 4 The survey samples are mailed the participating laboratories according to a schedule set by the proficiency testing agency Within the time limit set by the agency the laboratory personnel perform the required tests on the survey specimens Only tests performed in the laboratory should be analyzed Survey specimens are handled and analyzed using the same procedure as that for patient specimens When you perform proficiency tests
15. 8 PERSONAL PROTECTION INFORMATION RESPIRATORY PROTECTION Not required under normal and intended uses VENTILATION General room ventilation PROTECTIVE GLOVES EYE PROTECTION Not required Not required OTHER PROTECTIVE CLOTHING OR EQUIPMENT None SECTION 9 SPECIAL PRECAUTIONS PRECAUTIONS TO BE TAKEN IN HANDLING amp STORING Store and handle according to packaged instructions OTHER PRECAUTIONS None lt TABLE OF CONTENTS 7 0 Proficiency Testing lt TABLE OF CONTENTS 34 PROFICIENCY TESTING Cholestech LDX System Procedure Manual Proficiency Testing 9 TABLE OF CONTENTS 1 1 Overview of Proficiency Testing Under CLIA 88 all laboratories conducting tests classified moderately complex and highly complex must participate in an approved proficiency testing PT program for each specialty they perform testing in The purpose of this section is to discuss the importance of proficiency testing and describe how proficiency testing is performed When choosing the appropriate agency for your testing it is important to ask the agency if it is certified by CMS Centers for Medicare and Medicaid Services to comply with CLIA 88 standard regulations What Is Proficiency Testing Although analyzing quality control specimens provides an internal check on the quality of a laboratory s results proficiency testing serves as an external check Outside agencies send unknown specimens to subscribing laboratories
16. A 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 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 Training personnel conducting tests should properly trained and their training documented Safety policies should be adhered to and a safe working environment provided Procedure manuals should contain operating protocols that are complete up to date and available to laboratory personnel Record keeping aspects of the quality assurance program should be documented in writing as appropriate Calibration and instrument maintenance should be performed as needed 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 quality control procedures and follow up actions should be documented Participation in proficiency testing programs is optional for CLIA waived tests Proficiency testing may be performed and documented when required by local o
17. AND ODOR White no odor SECTION 4 FIRE AND EXPLOSION DATA FLASH POINT FLAMMABLE LIMITS IN AIR by VOLUME Not determined LOWER Not determined UPPER Not determined EXTINGUISHING MEDIA AUTO IGNITION TEMPERATURE Use extinguishing media appropriate for surrounding fire Not determined UNUSUAL FIRE AND EXPLOSION HAZARDS Not determined SPECIAL FIRE FIGHTING PROCEDURES None Continued on next page lt TABLE OF CONTENTS 32 MATERIAL SAFETY DATA 5 5 Cholestech LDX System Procedure Manual MATERIAL SAFETY DATA SHEET CONTINUED CHOLESTECH SECTION 5 HEALTH INFORMATION PRIMARY ROUTES OF EXPOSURE Skin SIGNS AND SYMPTOMS OF EXPOSURE 1 ACUTE OVEREXPOSURE None 2 CHRONIC OVEREXPOSURE None MEDICAL CONDITIONS GENERALLY AGGRAVATED BY EXPOSURE None CHEMICAL COMPONENT LISTED AS CARCINOGEN OR POTENTIAL CARCINOGEN None OTHER EXPOSURE LIMITS None EMERGENCY amp FIRST AID PROCEDURES None SECTION 6 REACTIVITY DATA STABILITY CONDITIONS TO AVOID Unstable ___ Stable X Not determined INCOMPATIBILITY MATERIALS TO AVOID Not determined HAZARDOUS DECOMPOSITION PRODUCTS Not determined HAZARDOUS POLYMERIZATION CONDITIONS TO AVOID May Will Not Occur _X_ Not determined SECTION 7 SPILL OR LEAK PROCEDURES STEPS TO BE TAKEN IN CASE MATERIAL IS LEAKED OR SPILLED Not applicable WASTE DISPOSAL METHOD Dispose of wastes in accordance with federal state and local codes SECTION
18. OL RESULTS Level 1 DATE Level 2 Control Level 1 Lot No Expiration Date OPERATOR Control Level 2 Lot No Expiration Date ROOM TEMP Cassette Type CONTROL RANGES Expiration Date REFRIG TEMP Level 1 mg dL Level 2 mg dL CHOLESTECH LDX SERIAL CONTROL RESULTS Level 1 Level 2 DATE Control Level 1 Lot No Expiration Date OPERATOR Control Level 2 Lot No Expiration Date ROOM TEMP Cassette Type CONTROL RANGES Expiration Date REFRIG TEMP Level 1 mg dL Level 2 mg dL CHOLESTECH LDX SERIAL NO CONTROL RESULTS Level 1 Level 2 lt TABLE OF CONTENTS CONTROL RANGE CALCULATION FORM Control Name Lot No LDX LDX Analyte Cassette Lot No Cholestech LDX Serial No C Accept Reject Director Approval Approval Date 6 Result Result X 5 lt TABLE OF CONTENTS Record the date in Column 2 and the initials in Column 3 Record the results of the quality control material in Column 4 RESULT Calculate the MEAN X Add the values Column 4 in the RESULT Column then divide by the number of results n Y Results MEAN Calculate the difference between each RES
19. OR CODED TUBES Color Use Additive Green Plasma or Whole Blood Heparin Red Serum None Red or Red Black Serum Serum separator gel Please Note The Cholestech LDX System is CLIA waived for fingerstick or venous whole blood unprocessed samples only If you run serum or plasma on the Cholestech LDX you will be classified as moderately complex and will have to comply with the regulations for moderate complexity See the Cholestech LDX System User Manual for a summary of these regulations 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 l 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 amp For Information Only Li Recommended Optional Information SPECIMEN COLLECTION AND HANDLING 11 Cholestech LDX System Procedure Manual 6 Select the venipuncture site 7 Clean the venipunctu
20. S for the Cholestech LDX test cassettes You can add additional MSDSs as required e Proficiency Testing Guidance Discusses the importance of proficiency testing how testing is performed and lists agencies offering proficiency testing e Glossary of Terms An alphabetical list of common laboratory terms e 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 information in this section is For Information Only Li The information in this section is Recommended by the Manufacturer The information in this 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 800 33 0404 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 Cholestech LDX System Procedure Manual Introduction lt TABLE OF CONTENTS Overview of a Quality Assurance Program Quality assurance Q
21. ULT and the MEAN X and record in Column 5 RESULT X Square each value in Column 5 and record in Column 6 RESULT X Add the values Column 6 Calculate the standard deviation SD using the formula Divide the sum of the values calculated in Column 6 by the number of values minus 1 Take the square root of this number Y Results X n 1 SD The control range is the X 250 record above ACCURACY STUDY DATA Analyte LDX LDX Cholestech LDX Serial No Cassette Lot No Cassette Expiration Date REFERENCE METHOD Date Reference Method Sample CHOLESTECH LDX 1 2 X Difference Acceptable Accuracy Range is 26 Test Disposition Accept Reject Director Approval Approval Date TABLE OF CONTENTS Cholestech LDX Result Ref Result Difference Ker eut x 100 PRECISION CALCULATION FORM WITHIN RUN Date perator Specimen Identification LDX LDX Analyte Cassette Lot No Cholestech LDX Serial No E Reject Director Approval Approval Date 2 4 Result Result X lt TABLE OF CONTENTS Record the result of the quality control material in Column 2 RESULT Calculate the MEAN X Add the
22. abel Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here lt TABLE OF CONTENTS QUALITY CONTROL LOG 1 LDX Cholestech LDX Serial No Control Range TC H Control Lot TRG GLU Expiration Date ALT AST Control Level DATE CASSETTE LOT NO ANALYTE VALUE ACCEPT REJECT OPERATOR COMMENTS ACTION TAKEN lt TABLE OF CONTENTS QUALITY CONTROL LOG 2 LDX Cholestech LDX Serial No Level 1 Control Lot Level 2 Control 101 Optics Check Lot No Exp Date Exp Date Optics Check Exp Date Open Exp Date Open Exp Date Optics Check Range Level 1 Ranges TC HDL Level 2 Ranges TC HDL TRG LDL TRG LDL non HDL TC HDL non HDL TCeHDL GLU AST GLU AST ALT ASTeALT ALT ASTeALT OPTICS QUALITY CONTROL Performed Each Day of Use Test with each new shipment and or each new lot lt TABLE OF CONTENTS QUALITY ASSURANCE RECORD DATE Control Level 1 Lot No LDX LDX Expiration Date OPERATOR Control Level 2 Lot No Expiration Date ROOM TEMP Cassette Type CONTROL RANGES Expiration Date REFRIG TEMP Level 1 mg dL Level 2 mg dL CHOLESTECH LDX SERIAL CONTR
23. al or other material that makes something impure by contact or mixture with it Control material solution lyophilized preparation or pool of collected serum designed to be used in the process of quality control The concentrations of the analytes of the interest in the control material are known within limits ascertained during its preparation and confirmed in use Data numerical or quantitative results of a test that conclusions are made from Diagnostic Test laboratory test or measurement that helps determine the cause or nature of a disease Laboratory tests are often called in vitro diagnostic tests Diluent liquid usually distilled water used to reconstitute a freeze dried control or reagent Dilution mixing of a diluent and a calibrator or control or patient sample A serial dilution is the progressive dilution of a substance in a series of tubes in predetermined ratios ELISA enzyme linked immunosorbent assay a diagnostic test used to detect either antigens or antibodies in a patient s specimen Enzyme compound produced in a cell and capable of greatly increasing the rate of a chemical reaction Erythrocyte red blood cell one of the elements in peripheral blood Etiologic Agent agent that causes disease False Negative Result negative test result for a patient who is positive for the condition or constituent in question False Positive Result positive test resul
24. and cassette holder tray QUALITY ASSURANCE 13 Correctly performs the optics check procedure 14 Correctly performs the quality control procedure 15 Understands what actions are to be taken if the quality control results are outside acceptable limits 16 Understands Proficiency Testing 17 Understands appropriate record keeping QC patient logs temperature monitoring etc PERFORMING A TEST Allows test cassettes to come to room temperature prior to running test Properly prepares supplies for patient testing alcohol swabs gauze lancets capillary tubes plungers latex gloves biohazardous waste container Explains the procedure to the patient Handles cassette properly Performs fingerstick using correct techniques Performs test properly Records results TABLE OF CONTENTS Cholestech LDX System Procedure Manual CHOLESTECH 3347 Investment Blvd Hayward CA 94545 U S A Tel 800 733 0404 Cholestech LDX is a registered trademark of Cholestech Corporation MiniPet is a trademark of TriContinent Scientific Inc Fax 510 732 7227 2003 Cholestech Corporation 001 12517 Rev D www cholestech com lt TABLE OF CONTENTS
25. cation POL2 T Vol 12 No 5 9 0 Master Forms lt TABLE OF CONTENTS OPTICS CHECK LOG LDX Cholestech LDX Serial No Acceptable Range Optics Check Cassette Lot No Expiration Date RESULTS DATE chi one c3 M PERFORMED BY ACCEPT REJECT COMMENTS TABLE OF CONTENTS 20 21 22 23 24 25 26 21 28 29 30 31 TEMPERATURE CHART Record the temperature and initial the space provided One sheet should be used per room refrigerator or freezer as your procedures dictate Site ID YEAR Acceptable Temperature Range LDX LDX JAN FEB MARCH APRIL JUNE JULY AUG SEPT OCT NOV DEC lt TABLE OF CONT ENTS INSTRUMENT HISTORY RECORD LDX Instrument Model No Serial No Date Purchased Cost Manufacturer Address City Telephone Contact Person Distributor Address City Telephone Contact Person Warranty Contact Person Notes Technical Service Representative Telephone SERVICE RECORD Comments lt TABLE OF CONTENTS INFORMATION AND SERVICE LOG LDX LDX Instrument Serial No Purchase Date Warranty Expires Customer Service R
26. commercially available Each sample is tested in duplicate and the results averaged Results are evaluated by a regression analysis or the manufacturer of the calibration verification material may give acceptable ranges for results Contact Cholestech Technical Service at 800 33 0404 for recommended calibration verification material 4 For Information Only Li Recommended Optional Information QUALITY CONTROL 23 Cholestech LDX System Procedure Manual 3 12 Reference s and Bibliography lt TABLE OF CONTENTS 1 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 Westgard JO et al Concepts and practices in the evaluation of clinical chemistry methods II experimental procedures American Journal of Medical Technology 1978 44 420 30 National Committee for Clinical Laboratory Standards Physician s Office Laboratory Guidelines Tentative Guidelines Villanova Pa NCCLS 1989 NCCLS publication POL1 T National Committee for Clinical Laboratory Standards User Comparison of Quantitative Clinical Laboratory Methods Using Patient Samples Proposed Guideline Villanova NCCLS 1986 NCCLS publication EP9 P National Committee for Clinical Laboratory Standards User Evaluation of Precision Performance of Clinical Chemistry Devices Tentative Guideline Villanova Pa NCCLS 1984
27. control assay sheet for the correct sample setting for running controls Verify that the lot number on the control vial and the assay sheet are the same Frequency of Testing Liquid Level 1 and Level 2 Controls are available from Cholestech Controls must be tested e With each new shipment of cassettes even if cassettes are from the same lot previously received e With each new lot of cassettes As otherwise required by your laboratory s standard quality control procedures If you are not running the Cholestech LDX 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 For Information Only Li Recommended Optional Information lt TABLE 5 34 QUALITY CONTROL 19 Cholestech LDX System Procedure Manual Good laboratory practice principles suggest that external controls must be run whenever the laboratory director has any question about test system integrity or operator technique e g when reagents may have been stored or handled in a way that can degrade their performance or when operators have not performed a particular test in recent weeks If the controls do not perform as expected repeat the test or contact Cholestech Technical Service before testing patient samples The quality control results must be in range before testing patient samples See the Cholestec
28. epresentative Phone No Technical Service Representative Phone No Sales Representative Phone No PROBLEM ACTION TAKEN OPERATOR lt TABLE OF CONTENTS 5 CHECKLIST LDX Cholestech LDX Serial No Date of Setup Name of Lab Person Performing Initial Setup Signature Approval by Laboratory Director FACILITY SPECIFICATIONS OPERATOR DATE 1 Room temperature 68 87 F 20 31 C 2 Stable work surface free from vibrations 3 Isolation from direct heat and light sources e g sunlight ovens room heater etc 4 grounded wall outlet supplying 100 to 240 VAC with the appropriate power supply which will not be interrupted during use INSTALLATION 1 Verify that the wall outlet corresponds to the voltage requirements of the power supply 2 Connect the power cord to the inlet on the back of the instrument 3 Plug the power supply into the wall socket 4 Allow the instrument to warm up for five minutes 5 The Liquid Crystal Display LCD will give the message SELFTEST RUNNING 6 The LCD will give the message SELFTEST OK 7 Allow up to five minutes for initial warm up The LCD will give the message INITIAL WARM RATE 8 LCD screen is blank and the system is warmed up and ready for use 9 Set the Configuration Menu 10 Press RUN to begin testing
29. from a control sample or series of control samples are within the acceptable control range Infectious Agent any microorganism that can invade body tissue and multiply causing infection In Vitro Latin for in glass used to describe diagnostic tests that analyze processes occuring inside the body in vivo from samples of body fluids in glass test tubes or other controlled artificial environments Levey Jennings Chart quality control chart a graph or table that shows results of control tests over a period of time used in a quality control program Linearity measure of the range the inear range of concentration of an analyte over which a measure or test produces consistent e linear straight line and accurate results Lipemia adjective condition of too much fat or lipids in the blood A lipemic serum sample looks milky and turbid and may produce erroneous results Lyophilized freeze dried a lyophilized calibrator control or reagent has been specially dried to make its analytes more stable It must be refrigerated to maintain its stability and is reconstituted by adding an appropriate diluent Matrix physical and chemical properties that describe a fluid Often used to describe the effect of differences seen when lyophilized freeze dried samples such as control material behave differently than patient specimens when analyzed Mean average of the numerical results obtained fr
30. ge 1 Anticoagulated blood may be sampled directly from the tube after mixing This step should be performed within 30 minutes of collection Use MiniPet Pipette and tips or micropipetter calibrated to deliver 35 uL Do not use the Cholestech capillary tubes for transferring venous whole blood serum or plasma to a Cholestech LDX test cassette Glucose levels decrease due to glycolysis at the rate of 5 to 10 mg dL per hour in whole blood at room temperature Serum samples should be allowed to clot for 30 minutes and then centrifuged Serum should be separated from the blood cells and stored refrigerated in a tightly sealed sample tube at 36 46 F 2 8 C until a test is performed When plasma samples are used plasma should be separated from the blood cells within 30 minutes of collection and stored refrigerated in a tightly sealed sample tube at 36 46 F 2 8 C until the test is performed If using serum or plasma samples to evaluate or validate the Cholestech LDX System the following information should be considered Cholesterol levels are stable in serum or plasma for 4 days at 36 46 7 2 8 C or for months at 4 F 20 C HDL cholesterol levels are stable in serum or plasma samples for up to 24 hours when stored at 36 46 2 8 C or up to 2 weeks when stored at 4 F 20 C Triglyceride levels are stable in serum or plasma samples for 7 days when stored at 36 46 7 2 8 C or for months when stored
31. h LDX System User Manual if they are not Please call Cholestech Technical Service at 800 733 0404 if you have any questions regarding the manufacturer s instructions for quality control Establishing and Calculating a Control Range If the control materials you plan to use do not have ranges set for the Cholestech LDX or if you prefer to set your own ranges please follow this procedure Before you start order an adequate supply of control materials to last you several months Do not order more than you will use before the expiration date You will need to follow this procedure to set ranges for each level of control you use and for each analyte you test for 1 For each analyte test a minimum of 20 replicates for each level of control material on the Cholestech LDX Record each result on the form provided a Use one Control Range Calculation Form for each analyte and control level b Assure all information is completed at the top of the data collection form c If more than one Cholestech LDX Analyzer is in use in the laboratory they should all be used in determining the control range The total number of results included in the calculation should be at least 20 evenly run across the Analyzers 2 You may calculate the statistics manually using the form provided by Cholestech or you can use a statistical calculator computer program to do the calculations If you prefer you can send or fax your results to Cholestech Technical Service at
32. icate of Training for Fingerstick Blood Collection Test Cassette Inserts Test Procedure Lipid Profile GLU Test Procedure ALT Foreword lt TABLE OF CONTENTS FOREWORD iii Cholestech LDX System Procedure Manual 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 Cholestech LDX System Procedure Manual covers e 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 e Specimen Collection and Handling General procedures that are applicable to obtaining a suitable specimen and running a test on the Cholestech LDX System e Quality Control Discusses laboratory activities designed to ensure that each test system is working properly and that the test results satisfy quality standards e 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 e Material Safety Data Sheets A copy of Cholestech Corporation s MSD
33. igned to assist the trainer in training users of the Cholestech LDX System There is room to date and sign each procedure as the task is completed Certificate of Training Fingerstick Blood Collection This certificate can be used to document that fingerstick training has been completed and approved by a physician You can file the certificates in this section as proof of documented training if it is required by regulations in your area Online Training Training is available at the Cholestech Web site www cholestech com 4 For Information Only Li Recommended Optional Information 6 0 Material Safety Data Sheets lt TABLE OF CONTENTS 30 MATERIAL SAFETY DATA SHEETS Cholestech LDX System Procedure Manual Material Safety Data Sheets 9 TABLE OF CONTENTS OSHA requires all businesses that manufacture chemical based products and distribute them through interstate shipment to have a Material Safety Data Sheet MSDS The information contained on an MSDS describes any potential hazards and any special handling required for chemical products The standard format for an MSDS is as follows 1 2 Identity Hazardous Ingredients Physical Data Fire amp Explosion Data Health Information Reactivity Data Spill or Leak Procedures Personal Protection Information Special Precautions An MSDS for the Cholestech LDX test cassette product is included here 4 For Information Only Li Recommended Optional I
34. lated and then been spun down in a centrifuge Specificity ability of a test to give a negative result for patients who do not have the disease or condition they are tested for measured as the ratio of negative tests to the total number of tests in those who do not have the disease or condition expressed as a percentage Specimen portion of body fluid e g blood or urine collected from the patient Split Sample Testing dividing a sample in half and testing half in your laboratory and having the other half tested in another laboratory and then comparing the results This is a technique for testing accuracy Stability ability of a specimen reagent or control to maintain a constant concentration of the analyte Reagents and controls must be handled and stored properly and used before their expiration dates to maintain their stability Specimens must be collected handled and processed properly Standard Primary reference material of fixed and known chemical composition and capable of being prepared in essentially pure form Also any certified reference material generally accepted or officially recognized as the unique standard for the assay regardless of its level of purity of analyte content lt TABLE 5 8 1 GLOSSARY TERMS 43 Cholestech LDX System Procedure Manual Standard Secondary reference material the analyte concentration of which has been ascertained by reference to a pri
35. mary standard Standard Deviation statistical measurement of the degree of variation from the mean of a series of measurements It is a measure of precision or reproducibility Test procedure for detecting the presence or amount of an analyte Titer quantity of a substance required to produce a reaction with a particular amount of another substance The amount of one substance required to correspond with a particular amount of another substance Agglutination titer is the highest dilution of a serum that causes clumping of particulate antigens Throughput applied to analytical instruments specifying the number of tests that can be performed in a given time Toxicology study of the origin nature and effects of poison Toxicological analyses are used to detect the amount of a substance that can be poisonous at a particular concentration Turbidity adjective turbid cloudiness distribution of a substance in a solution making it unclear or cloudy Value number in units of the method obtained for an analyte in a particular sample See Result Venipuncture procedure for collecting a blood sample from a vein venous blood Whole Blood blood mixed with an anticoagulant but not spun down in a centrifuge Reference s and Bibliography 1 National Committee for Clinical Laboratory Standards Physician s Office Laboratory Procedure Manual Tentative Guideline Villanova Pa NCCLS 1989 NCCLS publi
36. nformation MATERIAL SAFETY DATA 5 5 31 Cholestech LDX System Procedure Manual MATERIAL SAFETY DATA SHEET SECTION 1 IDENTITY NAME ADDRESS Cholestech LDX System 3347 Investment Blvd Hayward 94545 TELEPHONE NUMBER FOR ADDITIONAL INFORMATION CONTACT DATE PREPARED 800 733 0404 Technical Service August 25 1995 COMMON NAME USED ON LABEL CHEMICAL FAMILY Cholestech LDX TC Cassette TC and HDL Panel Cassette Lipid Profile Cassette Does not apply TC HDL GLU Panel Cassette Lipid Profile plus Glucose Cassette TC and Glucose Cassette Cholestech LDX Alanine Aminotransferase and Aspartate Aminotransferase Test Cassette CHEMICAL NAME FORMULA Does not apply Does not apply TRADE NAME amp SYNONYMS Cholestech LDX9 Trademark of Cholestech Corporation SECTION 2 HAZARDOUS INGREDIENTS HAZARDOUS COMPONENT None PEL Permissible Exposure Limit established by the Occupational Safety amp Health Administration OSHA TLV Threshold Limit Value established by the American Conference of Governmental Industrial Hygienists 1987 88 SECTION 3 PHYSICAL DATA BOILING POINT SPECIFIC GRAVITY VAPOR PRESSURE Not determined H0 1 mm Hg Not determined Not determined PERCENT VOLATILE BY VOLUME VAPOR DENSITY AIR 1 EVAPORATION DATE Not determined Not determined Not determined SOLUBILITY IN WATER REACTIVITY IN WATER Some components are soluble Not determined APPEARANCE
37. nual 21 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 Reporting a Complaint Use this space if you wish to document the action taken when a patient complains of receiving erroneous test result s Procedure amp For Information Only Li Recommended Optional Information 22 QUALITY CONTROL Cholestech LDX System Procedure Manual 3 10 3 11 lt TABLE OF CONTENTS 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 Cholestech LDX System Calibration Verification and Linearity Testing This procedure meets requirements for calibration verification and linearity testing To verify calibration for the Cholestech LDX System a linearity test is performed with a minimum of three samples over the measuring range for each analyte to be tested on the instrument The samples can be sera collected by the user that have test values set by an accepted reference method Alternately materials to verify the instrument calibration and cassettes are
38. ny training material forms or guidelines regarding lab safety practices For further information or to obtain training material regarding these regulations contact OSHA Reprints of the final rule Occupational Exposures to Blood Borne Pathogens can be obtained by contacting this organization OSHA Office of Publications U S Department of Labor P O Box 37535 Washington DC 20013 7535 Web site www osha gov Another excellent source of reference is the National Committee for Clinical Laboratory Standards NCCLS The NCCLS is a U S organization developing standards for clinical laboratory testing For further information you may contact this organization National Committee for Clinical Laboratory Standards 940 West Valley Road Suite 1400 Wayne PA 19087 1898 610 688 0100 FAX 610 688 0700 e mail exoffice nccls org Web site www nccls org Reference s and Bibliography 1 Brown JW Blackwell H Complying with the new OSHA regs and HBV protection Medical Laboratory Observer June 1992 21 4 For Information Only Li Recommended Optional Information 5 0 Training lt TABLE OF CONTENTS 28 TRAINING Cholestech LDX System Procedure Manual Training lt TABLE OF CONTENTS 9 1 9 2 9 3 94 Introduction In the Master Forms section of this manual Cholestech has included various forms to support your training requirements Cholestech LDX Training Checklist This checklist is des
39. ocess 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 e Within day variation e Seasonal variation e Diet and alcohol e Exercise e Drugs e Fasting e Posture e Venous occlusion e Recent heart attack or stroke e and acute infection e Pregnancy For more information on patient variables please contact Cholestech Technical Service at 800 733 0404 22 Fingerstick Procedure TABLE OF CONTENTS 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 sam
40. ol materials on the Cholestech LDX System See Master Forms section When Results Are Outside Acceptable Control Limits If results of one or both levels of control tested are outside established ranges 1 Check that the expiration date for the test cassette and quality control materials have not passed 2 Verify that the lot number on the control vial and the assay sheet are the same 3 Retest the control level that is out of range using a new sample from the same control vial Pay careful attention to possible errors in technique a If the control is within acceptable limits patient samples may be tested and results reported b If the control is outside acceptable limits retest with a sample of control from a new vial e If results are in range continue testing patient samples e If the control is still outside acceptable limits contact Cholestech Technical Service at 800 33 0404 Do not use the Analyzer for testing patient samples until the problem is resolved Quality Control Remedial Action Use this space if you wish to document a course of remedial action should any erroneous results occur The action will be initiated if a patient has received test results during the time in which the instrument control results were out of range Procedure For Information Only Li Recommended Optional Information lt TABLE OF CONTENTS 3 8 3 9 Procedure Sign Off QUALITY CONTROL Cholestech LDX System Procedure Ma
41. om a series of analyses lt TABLE 5 GLOSSARY TERMS 4 Cholestech LDX 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 Out of Control in a testing procedure when the results from a control sample are outside the acceptable control range Pathogen adjective pathogenic microorganism that causes a disease Phlebotomy puncture of a vein to collect blood A phlebotomist collects blood by venipuncture venous blood Photometry measurement or analysis of light emitted by a substance Reflectance photometry is the principle used in most instruments that read dry reagent strips Pipette glass or transparent plastic tube used to measure small quantities of liquid A volumetric pipette is an extremely accurate single line pipette used to reconstitute calibrators and controls Plasma liquid part of blood after it has been mixed with an anticoagulant and spun down in a centrifuge Precision reproducibility measure of the closeness of the results obtained when analyzing the same sample more than once the measure of agreement between replicate measurements Procedure Manual laborator
42. on the Cholestech LDX using serum or plasma samples the Serum switch must be Refer to the Cholestech LDX System User Manual for instructions to reconfigure the menu from Whole Blood to Serum 5 Results on the survey specimens are entered on a preprinted form coded according to reagent instrument method and returned to the proficiency testing agency After evaluation statistics have been calculated a summary report of results is sent to all participating laboratories e Laboratories may also request that a proficiency testing agency send a copy of its results to state or federal regulatory agencies e n general regulatory agencies require documented evidence of corrective action taken when survey results fall outside acceptable limits The director of a point of care laboratory will review all proficiency testing results and document the review and responses to unacceptable results e Cholestech Technical Service can provide assistance in troubleshooting proficiency testing failures TABLE OF CONTENTS For Information Only Recommended Optional Information 36 PROFICIENCY TESTING Cholestech LDX System Procedure Manual lt TABLE OF CONTENTS 1 2 1 3 Proficiency Testing Agencies Wisconsin State Laboratory of Hygiene Proficiency Testing Program 465 Henry Room GCD Madison WI 53706 1578 800 462 5261 FAX 608 265 1111 The College of American Pathologists EXCEL Program 325 Waukegan Road Nor
43. oratory this is relative accuracy Additive chemical added to a blood collection tube usually to prevent the blood from clotting anticoagulant Aerosol fine mist that solid or liquid particles are dispersed in Agglutination clumping together of antigen bearing cells bacteria or particles in the presence of specific antibodies Also called clumping Aliquot small portion of a measured volume of a substance taken as a sample representing the whole Analysis laboratory procedure that enables measurement of the amount of an analyte in a specimen Analyte substance or constituent being measured e g cholesterol triglycerides glucose Antibody substance formed in the body in response to a foreign substance an antigen and that interacts only with that substance Anticoagulant chemical used to prevent blood from clotting Antigen any substance that injected into an organism causes the development of antibodies Antiserum serum that contains antibodies Aseptic free from infection or septic material sterile Assay measurement of the amount of an analyte in a specimen a test Autoclave instrument that sterilizes material by subjecting it to steam under pressure Bias inaccuracy measure of the departure from accuracy A numerical difference between the mean of a set of replicate measurements and the true value of the sample Calibrated of a measuring device
44. p 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 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 For Information Only Li Recommended Optional Information 10 SPECIMEN COLLECTION AND HANDLING Cholestech LDX System Procedure Manual lt TABLE OF CONTENTS 24 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 e 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 e 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 COL
45. pational Safety amp Health Administration OSHA 210 Reference s and Bibliography 1 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 2nd ed Approved Standards NCCLS Tietz NW ed Fundamentals of Clinical Chemistry Philadelphia Pa WB Saunders Co 1987 National Committee for Clinical Laboratory Standards Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue Tentative Guideline Villanova Pa NCCLS 1991 NCCLS document M29 T2 ISBN 1 56238 123 7 Davidsohn Henry JB eds Todd Sanford Clinical Diagnosis by Laboratory Methods Philadelphia Pa WB Saunders Co 1969 Burtis CA Ashwood ER eds Tietz Textbook of Clinical Chemistry 3rd ed Philadelphia Pa WB Saunders Co 1999 TABLE OF CONTENTS For Information Only Recommended Optional Information 3 0 Quality Control lt TABLE OF CONTENTS 18 QUALITY CONTROL Cholestech LDX System Procedure Manual Quality Control lt TABLE OF CONTENTS 3 1 3 2 3 3 Introduction Quality control is the specific set of laboratory activities designed to ensure that the test system is working properly and that test results
46. ple is collected 2 Puta capillary plunger into a Cholestech capillary tube at the end with the red mark Set it aside 4 For Information Only Li Recommended Optional Information lt TABLE 5 2 3 SPECIMEN COLLECTION AND HANDLING Cholestech LDX System Procedure Manual 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 9 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 ti
47. r state regulations Laboratory inspections may be conducted by the appropriate organization to assess quality assurance and suggest possible improvements successful program assures that 1 Policies and procedures established writing and followed all personnel involved in the testing process The test system performs properly at the time patient results are produced 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 Cholestech LDX System Procedure Manual Setup and Maintenance lt TABLE 5 1 1 1 2 1 3 Introduction This section contains the procedure to properly run an optics check and specific information about proper maintenance sample copy of each form referred to is included in the Master Forms section of this manual Cholestech LDX Optics Check Cassette 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
48. re site with 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 e Grasp the patient s arm near the venipuncture site using your thumb to draw the skin tight e With the needle bevel facing up line up the needle with the vein Penetrate the skin and enter the vein at an angle of approximately 45 e Holding the flange of the needle holder push the tube forward until the back end of the needle punctures the stopper While the needle is in the vein keep the tube below the puncture site e When the blood starts flowing into the tube release the tourniquet and open the patient s hand This allows circulation to return to normal and reduces bleeding at the venipuncture site When drawing multiple tubes keep the tourniquet in place until the last tube is being collected e Keep constant forward pressure on the tube in the direction of the needle this prevents the shutoff valve from closing and stopping the flow of blood e When the blood stops flowing remove the tube from the holder The needle s shutoff valve will stop the blood flow until the next tube is inserted Tubes containing an anticoagulant should be allowed to fill until the vacuum is exhausted and
49. rector 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 Reporting Results Properly You may wish to establish a procedure that will prevent any misidentification when giving the results to the physician or patient The following space is available to record the laboratory procedure that will be used to report results from the Cholestech LDX System Or you may use the Patient Result Log in the Master Forms section The additional space that follows is available to document the procedures for other instruments in the laboratory Cholestech LDX System Instrument Name Manufacturer 4 For Information Only Li Recommended O Optional Information SPECIMEN COLLECTION AND HANDLING 13 Cholestech LDX System Procedure Manual Instrument Name Manufacturer 2 1 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 TABLE OF CONTENTS amp For Information Only Recommended Optional Information 14 SPECIMEN COLLECTION AND HANDLING Cholestech LDX System Procedure Manual lt TABLE OF CONTENTS 2 8 Specimen Stora
50. s ee ee an do de 8 Procedure SIBD Off sss sew ddr E pur REGN eda vaa 9 Verilpuncture PrOCedUte 2224 unc Ex E REED 10 Procedure Sign Off ize edam ub RR REA ca RE Eg 12 Reporting Results 12 Procedure SEn O uses ad aer des dik detto e dere MN ee xia acentos ud 13 Proper Specimen Storage 14 Procedure to Properly Remove a Rubber Stopper from an Evacuated Tube 15 Reference s and Bibliography 15 Quality Control 5 se antic aa daa il Reese 18 Quality Control 5 18 Frequency Or Testing ui aa qe ral 18 Establishing and Calculating Control Range 19 Cholestech LDX System Quality Control Log 20 When Results Are Outside Acceptable Control Limits 20 Quality Control Remedial Action 2 1 20 Procedure SISTE s ua de lie dede S ed te o diia 21 Reporting a Complaint 21 Proc dure SIEN Off ous ib Edu demie 22 Cholestech LDX System Calibration Verification and Linearity Testing 22 Reference s and Bibliography
51. satisfy quality standards Quality control data must as permanent records to document the performance of laboratory testing Documentation includes written laboratory records that are a clear and up to date compilation of quality control data These records may be in the form of daily worksheets or logs The person performing the test should sign and date the log sheets We have provided you with a Quality Control Log that you can duplicate and use for recording quality control test results for the Cholestech LDX System As an alternative we have also supplied a Daily Quality Assurance Record that can be used to record all routine quality control documentation The originals are in the Master Forms section of this manual Quality Control Materials Control materials should be provided for at least two levels of total cholesterol HDL cholesterol triglycerides glucose ALT and AST Choice of Material The preferred quality control material for use with the Cholestech LDX System is Cholestech LDX Level 1 and Level 2 Control Materials If you choose to use an alternate quality control material see Section 3 4 Handling of Material e Follow the instructions for preparation handling and storage that accompany each lot of control material e Check the expiration date before use Do not use the control material beyond the expiration date e quality control material by gentle inversion 7 8 times before use e Check the
52. t for a patient who is negative for the constituent or condition in question Glycolysis lowering of glucose concentration in a blood sample by the action of enzymes in the red blood cells 40 GLOSSARY TERMS Cholestech LDX System Procedure Manual lt TABLE OF CONTENTS Gravimetry measurement of a substance by determining its weight or specific gravity Hematoma mass of blood usually clotted under the skin in organ space or tissue caused by a break in the wall of a blood vessel Hematocrit also called packed cell volume volume percentage of erythrocytes red blood cells in whole blood Hemolysis adjective hemolytic breakdown of red blood cells in serum or plasma freeing the hemoglobin from the cells When this happens the serum or plasma becomes reddish Hemolysis interferes with some laboratory tests Beta hemolysis is the production of a clear zone surrounding a bacterial colony on blood agar medium which is characteristic of certain pathogenic bacteria such as Group A Streptococcus Icterus adjective icteric condition in which there is too much bilirubin in the blood jaundice An icteric serum sample looks dark yellow it may even look greenish An icteric sample may produce erroneous test results Immunoassay diagnostic test that uses a specific antibody or antigen to detect the presence of an analyte Inaccuracy see Bias In Control in a testing procedure when the results
53. thfield IL 60093 2750 800 323 4040 American Proficiency Institute 1159 Business Park Drive Traverse City MI 49686 800 333 0958 FAX 231 941 7287 The American Academy of Family Physicians 11400 Tomahawk Creek Parkway Leawood KS 66211 2672 800 274 7911 Ask for AAFP PT FAX 816 361 8167 Some state health departments These laboratories have been shown to correlate with minimal matrix effects on the Cholestech LDX Reference s and Bibliography 1 National Committee for Clinical Laboratory Standards Physician s Office Laboratory Guidelines Tentative Guidelines Villanova Pa NCCLS 1989 NCCLS publication 1 Howanitz PJ Howanitz JH Laboratory Quality Assurance New York N Y McGraw Hill Book Co 1987 How to avoid dangerous mistakes in a physician s office laboratory Continuing Education Course No 328 American Academy of Family Physicians Scientific Assembly 1989 4 For Information Only Li Recommended Optional Information 8 0 Glossary of Terms lt TABLE OF CONTENTS 38 GLOSSARY TERMS Cholestech LDX System Procedure Manual Glossary of Terms 9 lt TABLE OF CONTENTS Acceptable Control Range range of results that indicate adequate performance when analyzing a control sample The range is shown in the control s product insert Accuracy correctness freedom from error The accuracy of results can be measured by comparing them with those from another lab
54. tisfactory preventive maintenance Select one person to have principal responsibility for a given instrument sure that this person is familiar with the user manual the procedure manual and the package inserts for each test system e 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 e Keep all spare parts recommended by the manufacturer hand For Information Only Li Recommended Optional Information 4 SETUP AND MAINTENANCE Cholestech LDX System Procedure Manual lt TABLE OF CONTENTS 1 7 1 8 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 94545 U S A Tel 800 733 0404 Fax 510
55. tory Name 5 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 amp For Information Only Li Recommended Optional Information 6 SETUP AND MAINTENANCE Cholestech LDX System Procedure Manual 110 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 111 5 and Bibliography 1 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 TABLE OF CONTENTS 4 For Information Only Recommended Optional Information 2 0 Specimen Collection and Handling 8 SPECIMEN COLLECTION AND HANDLING Cholestech LDX System Procedure Manual Specimen Collection and Handling 2 1 Introduction Since the collection of the patient s specimen is the beginning of the analytical pr
56. use a damaged or expired Cholestech LDX Optics Check Cassette Run a Cholestech LDX Optics Check Cassette e Once each day before patient samples are tested e After the Cholestech LDX System has been moved or serviced Optics Check Cassette Test Procedure Do not use a Cholestech LDX Optics Check Cassette that is expired damaged or altered in any way l Press the RUN button After verifying the Selftest OK message the drawer will open and the screen will display 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 Dehinc Check Lele iu id EH chiti chitz chitZ chit4 4 Ifthe numbers for all four channels fall within the ranges printed on the Optics Check Cassette label the system is ready for use 4 For Information Only Li Recommended Optional Information lt TABLE 5 1 4 SETUP AND MAINTENANCE 3 Cholestech LDX System Procedure Manual 5 Ifthe 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
57. y manual that contains the methods materials and other information needed to do a test Product Insert informational material that comes with instruments reagents and other laboratory products giving instructions for the use of the product and other information required of the manufacturer by the U S Food and Drug Administration Proficiency Samples analytes of unknown concentration that are sent to laboratories participating in proficiency testing programs Proficiency Testing program in which samples are sent to a group of laboratories for analysis The results are tabulated by the program s sponsor and a participating laboratory can compare its results with those of other laboratories that use the same method Protocol standard set of procedures for performing a procedure such as a test or an evaluation Quality Assurance comprehensive set of policies procedures and practices necessary to make sure that the laboratory s results are reliable QA includes record keeping calibration and maintenance of equipment quality control proficiency testing and training Quality Control set of laboratory procedures designed to ensure that the test method is working properly and that the results meet the diagnostic needs of the physician QC includes testing control samples charting the results and analyzing them statistically 42 GLOSSARY TERMS Cholestech LDX System Procedure Manual lt TABLE OF CONTENTS
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