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POLICY AND PROCEDURE MANUAL

1. 39 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX G Cholestech LDX Patient Result Log Cassette Lot Expiration Date LDX Serial Date Operator Patient Patient ID TR IT GL HD LD TC AL ACTIO Name G C IU L L HD IT N L TAKEN 40 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX H RISK ASSESSMENT ALGORITHM Patient s cholesterol level is between 200 239 Patient s HDL lt 40 Patient s HDL gt 40 It is important to see your physician within 2 months for further Patient has gt 2 risk factors evaluation and for a lipoprotein analysis Repeat measurements within 1 2 years and continue if not already started healthy eating patterns and regular physical activity An earlier repeat measurement by a physician within 1 year is appropriate if this is your first cholesterol screening Patient receives EVALUATION 3 form see Appendix K Patient receives EVALUATION 4 form see Appendix L 41 Patient s cholesterol level is gt 240 Patient s cholesterol level is lt 200 Patients HDL gt 40 See your physician within 2 months for further evaluation and for a lipoprotein analysis regardless of risk factors Repeat
2. 46 F Ifa temperature is read outside this range the materials will be moved to another refrigerator within the acceptable 17 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures temperature range immediately Acceptable room temperature for the machine is 68 95 F However for the cassettes kept at room temperature the maximum threshold is less than 86 F Therefore the acceptable room temperature range will be 68 86 F 9 INTERPRETATION i Cholesterol screening a Total Cholesterol The National Cholesterol Education Program NCEP Adult Treatment Panel ATP II of the National Heart Lung and Blood Institute NHLBI has recommended the following guidelines for total cholesterol in adults Desirable Less than 200 mg dL Borderline High 200 239 mg dL High Equal to or greater than 240 mg dL b HDL Cholesterol The Adult Treatment Panel HI ATP ID recognizes that an HDL cholesterol level below 40 mg dL is associated with risk of coronary heart disease CHD in men and women A desirable HDL cholesterol level is greater than 40 mg dL HDL level greater than 60 mg dL decreases CHD risk Studies have shown an inverse relationship between HDL cholesterol levels and the incidence of CHD c Triglyceride The ATP III of the NHLBI has recommended these guidelines for fasting triglyceride levels Normal Less than 150 mg dL Borderline High 150 199 mg dL High 200 499 mg dL Very High Equal to or greater than 50
3. Iam between 45 and 64 years of age Spts Opts 4 Iam 65 years or older Opts Opts 5 Tama woman who has had a baby lpt Opts Weighing more than nine pounds at birth 6 Ihave a sister or brother with diabetes lpt Opts 7 Ihave a parent with diabetes lpt Opts Total Points Scoring 3 9 pts You are at low risk for having diabetes now But don t just forget about it especially if you are Hispanic Latino African American American Indian Asian American or Pacific Islander You may be at higher risk in the future New guidelines recommend everyone age 45 and over consider being tested for the disease every 3 years However people at high risk should consider being tested at a younger age Keep your risk low by losing weight if you are overweight being active most days and eating low fat meals that are high in fruits and vegetables and whole grain foods Scoring 10 or more points You are at high risk for having diabetes Only your health care provider can determine if you have diabetes See your health care provider soon and find out for sure 55 Height Weight Feet inches Pounds Without Without shoes clothing 4 10 129 4 11 133 r 0 138 r 143 57 27 147 3S 3 152 5 4 157 5S 5 162 F 6 167 37 172 P 8 177 y 9 182 F 10 188 F 11 193 6 0 199 E 1 204 6 2 210 6 3 216 6 4 221 If you w
4. Offer each eligible faculty staff or student the Hepatitis B vaccine Each employee shall complete Appendix 2 Hepatitis B Declaration Form For those that accept the offer direct them to contact the designated health care facility for an appointment see below A copy of this form must be sent to Laboratory Safety Additional directions can be found in Appendix 2 PROGRAM COMPONENTS Universal Precautions 8CCR Sec 5193 defines universal precautions as an approach to infection control where all human non human primate blood and other body fluids tissues and cells are treated as 25 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures if they were infectious for Human Immunodeficiency Virus Hepatitis B Hepatitis C and other Bloodborne Pathogens BBPs Exposure Determination The Principal Investigator Supervisor will determine which faculty staff or students are involved in procedures that create a potential exposure to BBPs These procedures include but are not limited to the following Phlebotomy or venipuncture of humans or non human primates Injections into humans or animals using non human primate or human specimens Other use of needles with human or non human primate specimens Pipetting mixing or handling human or non human primate blood fluid or tissue Centrifuging human or non human primate blood fluid or tissue Handling human or non human primate tissue including preparation dissection cuttin
5. a 19 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures b Puta capillary plunger into the end of a capillary tube with the red mark Set it aside c Choose a spot that is on the side of one of the center fingers of either hand To help increase blood flow the fingers and hands should be warm to the touch To warm the hand you can iv Wash the patient s hand with warm water or v Apply a warm not hot compress to the hand for several minutes or ii Gently massage the finger from the base to the tip several times to bring the blood to the fingertip d Clean the site with an alcohol swab Dry thoroughly with a gauze pad before pricking the finger e Firmly prick the selected site with a lancet f Squeeze the finger gently to obtain a large drop of blood Wipe away this first drop of blood as it may contain tissue fluid g 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 h 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 i Wipe off any excess blood and hav
6. anti HCV Date ordered results 2 Obtain Risk Information If results of HIV HBV amp HCV are already known skip to 2B a For exposure to your patient Please indicate below the presence or absence of risk factors Note that your patient s cooperation in providing this information is voluntary under law If your patient refuses to cooperate please indicate so here circle Patient Refuses gt Receipt of blood product transfusion or organ tissue transplantation Yes No If yes Date Type and Place gt Use of injection drugs with sharing of needles works or drugs Yes No If yes Date Type and Place 12 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures USC Bloodborne Pathogen Exposure Protocol gt Sexual exposure please note the following risk factors O Sex with many partners i e not both virgins Yes No o Sex with exchange of blood semen or vaginal fluids i e no barriers used or barrier failed including penial vaginal anal and oral genital intercourse Circle applicable Yes No o Sex under the influence of any drugs or alcohol where safe sex may not have been adhered to Yes No o Prior unsafe sex as evidenced by history of STD s or unplanned Pregnancy Yes No o Sex with anyone having any of the above risk factors Yes No o If there are any other circumstances of risks that we should be aware of please indicate them here b If your patient is
7. LDL low density lipoprotein Shad chalactaral Name Age Sex What does my cholesterol level mean Total Blood Cholesterol Level Desirable lt 200 mg dl Borderline 200 239 mg dl High risk 2240 mg dl HDL Cholesterol Level Desirable gt 40 mg dl Risk lt 40 mg dl LDL Cholesterol Level Desirable lt 100 mg dl Borderline 130 159 mg dl High risk 2160 mg dl Triglyceride TG Level Normal lt 150 mg dl Borderline High 150 199m g dl High 200 499 mg dl Very High gt 500 mg dl What are my risk factors Q Male age 245 years or Female age 255 years Family history of premature coronary heart disease HDL level lt 40mg dL Smoking Hypertension Oooo Negative risk factor D HDL level gt 60mg dL Risk Factors What do I need to do now Your cholesterol level is between 200 239 mg dl and your HDL lt 40 or 22 risk factors Itis important to see your physician within 2 months for further evaluation and for a lipoprotein analysis USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX L EVALUATION 4 Patient Cholesterol Level Evaluation lipoprotein good cholesterol Triglycerides fat LDL low density lipoprotein Shad chalactaral Name Age Sex What does my cholesterol level mean Total Blood Cholesterol Level Desirable lt 200 mg dl Borderline 200 239 mg dl High risk 2240 mg dl HDL Cholesterol Level Desirable gt 40 mg dl Risk lt 40 mg dl LDL Cholestero
8. St CHP 148 Los Angeles CA 90033 9005 323 442 2200 36 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX D Quality Control Flow Diagram Begin Testing of Quality Control Material Are Results within Acceptable Limits Verify Expiration Date on eQuality Control Material e Cassette Retest with sample from Same Control vial using New Cassette Record Results on Quality Control Log Continue Testing Within Limits Patient Retest with Sample from a New Control Vial using a New Cassette Within Limits Call Cholestech Tech Service at 800 733 0404 37 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX E Optics Check Log Cholestech LDX Serial Optics Check Cassette Lot Acceptable Range Expiration Date Date Results Ch 1 Ch 2 Ch 3 Ch 4 Performed By Accept Reject Comments 38 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX F Cholestech LDX Quality Control Log Cholestech LDX Control Lot Expiration Date Control Level S N Control Range TRG TC GLU HDL ALT Date Cassette Lot Control Expiration Date opened Value Accept Reject Operator Comments Action taken
9. age of 18 Run the Quality Control if needed as delineated in the Quality Control section Insert correct MEMo Chip for the lot of strips in use Insert MEMo Chip with finger notch top side up lot number code facing down Press either button to turn CardioChek ON Analyzer will display lot code Make sure that the code matches the one on the test strip vial When INSERT STRIP is displayed insert the strip into the Test Strip Insert Opening as far as it will go Obtain a blood drop following a correct technique Please refer to Section B for Procedures for Drawing Blood When APPLY SAMPLE is displayed apply blood to the Test Strip with a capillary tube Fingerstick samples must be applied within five minutes after collection or the blood will clot Within one to two minutes the results will be displayed Record the results on the appropriate form Appendices I L If there is a problem with the test a message will appear on the screen See the Troubleshooting and Maintenance section for further instructions if any problems occur Appendix N Remove test strip and discard Put everything that came into direct contact with the blood sample into a biohazardous waste container The analyzer automatically shuts down after three minutes of idle time with no Test Strip inserted DO NOT leave a used Test Strip or Check Strip in the analyzer Test Strip Opening This prevents the analyzer from automatically shutting down and shortens
10. in a refrigerator 2 8 C 36 46 F or may be stored for up to 30 days at room temperature less than 30 C 86 F Once cassettes have been stored at room temperature they should not be returned to the refrigerator Additionally a cassette should not be used beyond the printed expiration date or if it has been stored at room temperature for more than 30 days Cassettes should not be reused and should sit at room temperature for 10 minutes before opening the pouch Use the cassette as soon as the pouch is opened c No maintenance is required other than routine cleaning if necessary Clean the outside of the Cholestech LDX Analyzer case with a clean damp non abrasive cloth Most spills and 10 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures 6 PROCEDURE stains will be removed with water or a mild detergent A solution of 70 isopropyl alcohol is an appropriate cleaning agent Do not immerse the instrument in water or other cleaning fluid Do not use any abrasive cleanser When necessary clean the cassette holder tray with a cotton swab moistened with water or a 70 isopropyl alcohol solution Dry with a second cotton swab i CardioChek Analyzer Gloves should be worn whenever working with blood or samples that are potentially biohazardous a Prior to performing a test all patients must sign a consent form Appendix A No assessment of any kind will be made on pregnant women or persons under the
11. instructions if any problems occur Appendix N When the drawer opens remove the cassette Put it in a biohazardous waste container Leave the Analyzer drawer empty when not in use Record the results on the appropriate form Appendices I L 7 CALCULATIONS Test results will be displayed on the screen and no additional calculations are necessary 8 QUALITY CONTROL i CardioChek a Da mo B Quality control on CardioChek should be performed with each new Test Strip lot or whenever there are questions about the results To perform a quality control test the following will be needed CardioChek Analyzer PTS PANELS Test Strips Quality Control Materials provided by PTS such as PTS PANELS Multi Chemistry Controls and PTS PANELS HDL Controls Quality Control Instructions and Quality Control Range Insert Do not use control solutions that have expired Check the expiration date printed on the control bottles Install correct MEMo Chip for the lot of strips that are being used Press either button to turn the analyzer ON Press Next until the display reads UTILITY Press Enter Press Next until RUN CONTROL is displayed Press Enter Insert the test strip into the analyzer The CardioChek will display APPLY SAMPLE This indicates the system is ready for a sample control to be applied a Immediately replace vial cap making sure the strip vial is closed tightly Remove cap from the Control Material and turn bottle upside dow
12. is red green Reprint test results stored in memory Labels paper were not See Section IV Set Up for instruc loaded in the printer tions on how to load labels paper into the printer 48 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures High or low results that are incorrect may have serious medical conse quences If the result reads gt greater than or lt less than or results are not as expected always repeat the test correctly with a new unused Test Strip If a test result is displayed that is not expected consult the following table PROBLEM PROBABLE SOLUTION CAUSE Results are not as Strips improperly A displayed result reads lt less than a value A displayed result reads gt greater than a value Display reads _ _ __ orN A stored Batteries are defective The analyzer was improperly stored Test Strip Insert Open ing is dirty MEMo Chip and Test Strips are not the same lot number Result is below the measuring range of the test Result is above the measuring range of the test Result is not available due to a missing value from a calculation Or a value is outside the measuring range 49 Repeat test using a different vial of strips Run controls confirm that results are in range Change batteries Make sure analyzer was not exposed to high or low tempera tures or humidity and repeat test Clean the Test Strip Insert Op
13. may not be accurate 5 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures b Hematocrit Hct range of 30 55 is needed to measure blood glucose Hematocrit readings outside this range may produce inaccurate blood glucose results 11 REFERENCES a American Diabetes Association Standards of Medical Care in Diabetes Position Statement Diabetes Care 2005 28 S4 36 b American Diabetes Associate Diagnosis and Classification of Diabetes Mellitus Position Statement Diabetes Care 2005 28 S37 42 c OneTouch Ultra System Owner s Booklet 2002 LifeScan Inc d University of Southern California Environmental Health and Safety Policies Safety Policy 16 Bloodborne Pathogens March 15 2004 available at http policies usc edu policies safety060108 pdf e University of Southern California Environmental Health and Safety Policies Safety Policy 007 Hazardous Waste Management March 15 2004 available at http policies usc edu policies safety060108 pdf 12 SIGNATURES Please refer to page 1 of Policy and Procedure Manual B PROCEDURE FOR DRAWING BLOOD 1 Fingerstick Procedure for blood glucose screening a A warm hand and good blood flow from the puncture site are essential in order to collect a good capillary sample Gloves should be worn when working with blood samples and should always be changed between each patient b Insert a test strip into the glucose meter c Choose a spot that is
14. on the side of one of the center fingers of either hand To help increase blood flow the fingers and hands should be warm to the touch To warm the hand you can i Wash the patient s hand with warm water or il Apply a warm not hot compress to the hand for several minutes or ii Gently massage the finger from the base to the tip several times to bring the blood to the fingertip d Clean the site with an alcohol swab Dry thoroughly with a gauze pad before pricking the finger or lancing the arm Firmly prick the selected site with a lancet e Touch one edge of the test strip to the drop of blood without touching the skin The test strip will automatically draw up the drop of blood through capillary action If it necessary to collect another drop of blood wipe the site with gauze then massage again from the base to tip until another drop of blood forms 6 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures f Wipe off any excess blood and have the patient apply pressure to the puncture until the bleeding stops g Apply a band aid to the puncture site SECTION 2 CHOLESTEROL SCREENING 2 PRINCIPLE a Test Reaction Taking Place i The Cholestech LDX System and CardioChek Analyzer use reflectance photometry the amount of light reflected from a solid surface to measure the amount of substances in blood The Analyzers measure color changes of the four reagent pads The amount of color formed is converte
15. personnel engaged in activities that may involve skin contact with potentially infectious fluids or tissues must wear gloves Gloves are also required for laboratory workers with skin conditions on the hands that may have direct or indirect contact with potentially infectious materials Hand washing with soap and water must be a routine practice performed immediately after removal of gloves Gloves should be removed before touching common equipment phone computer appropriate laboratory equipment to prevent the spread of contamination Personnel must wear gloves lab coat and safety glasses whenever handling human or non human primate blood fluids or tissue Gloves must be replaced frequently and immediately if they become contaminated or damaged in any way Hand Washing Personnel must wash their hands immediately upon removal of gloves and upon any contact with potential BBP materials Mouth Pipetting Mouth pipetting is prohibited No Eating Drinking or Smoking Eating drinking smoking applying cosmetics or lip balm and handling inhalers or contact lenses are not permitted in work areas Food and drink are not to be placed or stored in areas refrigerators microwaves etc where potential BBP are kept or may be present 28 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures Needles Sharps and Broken Glass Used needles and other sharps are not to be sheared bent broken recapped or resheathed
16. type use the Cholestech LDX capillary tube fingerstick or Mini Pet pipette control material to place sample into the test cassette sample well Fingerstick samples must be applied within five minutes after collection or the blood will clot j If the cassettes have been refrigerated allow them to come to room temperature for at least 10 minutes before opening Hold the cassettes by the short sides only Do not touch the black bar or the brown magnetic stripe Keep the cassette level after the sample has been applied Immediately place the cassette into the drawer of the Analyzer The black reaction bar must face toward the Analyzer The brown magnetic stripe must be on the right k Press RUN The drawer will close During the test the screen will display Test Name s Running L Put everything that came into direct contact with the blood sample or control material into a biohazardous waste container m When the test is complete the Analyzer will beep The screen willdi Test Name s units date warnings n Press DATA to view the calculated results o When results are outside the measuring range of the test the screen will display Test Name gt or Test Name lt 13 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures p r If there is a problem with the test a message will appear on the screen See the Troubleshooting and Maintenance section for further
17. water in the past 8 hours Yes No 3 Would you like us to contact your physician with the results of the assessment Yes No If YES please provide physician information Physician s Name Fax have read or have had explained the information provided about the cholesterol screening am to receive have had a chance to ask questions that were answered to my satisfaction believe understand the benefits and risks of cholesterol screening and ask that a finger stick be performed on me or on the person named above for whom am authorized to make this request Patient Signature 54 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX P ADA RISK ASSESSMENT FORM Diabetes Risk Test Sixteen million Americans have Diabetes and 1 out of 3 doesn t eve know it Take this test to see if you are at risk for having diabetes Diabetes is more common in African America Hispanics Native Americans Asian Americans and Pacific Islanders If you are a member of one of these ethnic groups you need to pay special attention to this test To find out if you are at risk circle the number of points next to each statement that is true for you If a statement is not true circle zero Add your circled numbers to get a total score YES NO 1 My weight is equal to or above that Spts Opts listed in the chart 2 Iam under 65 years of age and I get Spts Opts little or no exercise during the usual day 3
18. 0 mg dL d LDL Cholesterol The ATP III of the NHLBI has recommended the following guidelines for LDL cholesterol Optimal lt 100 mg dL Near Optimal 100 129 mg dL Boarderline High 130 159 mg dL High 160 189 mg dL Very High gt 190 mg dL e CHD and CHD risk equivalents Less than 100 mg dL e Multiple 2 risk factors Less than 130 mg dL e 0 1 risk factor Less than 160 mg dL CHD Risk Equivalent Diabetes Risk Factors Cigarette smoking hypertension low HDL cholesterol lt 40 mg dL family history of premature CHD age e TC HDL Ratio The TC HDL ratio can be a useful summary of CHD risk A ratio of 4 5 or less is desirable A ratio greater than 6 0 means a high risk of CHD 10 LIMITATIONS OF METHOD i Cholesterol screening 18 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures The measuring range for total cholesterol is 100 500 mg dL Results outside this range will appear as lt 100 mg dL or gt 500 mg dL The measuring range for HDL cholesterol is 15 100 mg dL Results outside this range will appear as lt 15 mg dL or gt 100 mg dL The measuring range for triglycerides is 45 650 mg dL Results outside this range will appear as lt 45 mg dL or gt 650 mg dL If the triglycerides are gt 400 mg dL the estimated LDL will not be calculated If the triglycerides are gt 650 mg dL the HDL result may not be accurate and will appear as N A Patients samples with total cholesterol HDL choles
19. 070 pe Ss Chief Waste Management Section 26 59 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX T Completion of Lipid Testing Training CHOLESTECH AND FINGERSTICK TRAINING USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX U CLIA Certificate 61 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX V Non Diagnostic General Health Assessment LA County Per event 62 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures USC Bloodborne Pathogen Exposure Protocol Initial Visit Baseline Data Patient Information exposed person Name DOB Institution of Employment Enrollment Medical History Current Past Kidney Dis Liver Dis Heme Dis LMP Pregnancy wks of gestation Breast feeding Medications Current Allergies Pre existing infection circle HIV infected Yes No HBV infected Yes No HCV infected Yes No Susceptibility Hepatitis B vaccine series completed Yes No HBV sAb titer Exposure Information Date amp Time of Exposure Location hospital clinic of Exposure Type of Exposure needlestick scalpel splash etc How Exposure Occurred suturing etc Type of Substance Exposed to blood CSF etc Area exposed finger eyes etc For Percutaneous exposure depth of injury and whether fluid injected 63 updated 3 19
20. 2010 USC Mobile CLIA Waived Testing Policy and Procedures For Mucocutaneous Exposure volume of material duration of contact amp condition of skin mucosa abraded chapped intact etc Exposure Source Name DOB Location facility amp room Medical Problems Infection Status circle HIV Pos Neg HBV sAg Pos Neg HBV eAg Pos Neg HCV Ab Pos Neg If known HIV HIV disease stage or symptoms past amp current antiretroviral therapy current DC4 amp viral load If unknown HIV status HIV risk factors in patient or prevalence in clinic population for unknown source e g sharps box Patient Name DOB MRN School Grad Year 64 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures USC Bloodborne Pathogen Exposure Protocol Initial Visit Assessment and Plan 1 HIV Post Exposure Prophylaxis PEP a Circle recommended PEP regimen based on Exposure type and source patient status Infection Status of Source Exposure Type HIV HIV Unknown Unknown HIV Low High HIV Patient Negative Titer Titer Solid 2 Drug 3 Drug 2 Drugs 2 Drugs No PEP Percutaneous Superficial Regimen Regimen PRN PRN Indicated Risks Risks Hollow 3 drug 3 drug 2 Drugs 2 Drugs No PEP Deep Regimen Regimen PRN PRN Indicated Bloody Risks Risks Small 2 Drug 2 Drug 2 Drugs 2 Drugs No PEP Mucocutaneous Volume Regimen Regimen PRN PRN Ind
21. 323 442 5631 Student Health Nurse on Call 323 442 5631 LAC USC HIV AIDS Clinic 323 343 8255 National Post Exposure Hotline 888 448 4911 Other 911 70 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures USC Bloodborne Pathogen Exposure Protocol Information Sheet for Attending Physician of Source Patient Page of 2 Dear Doctor We need your assistance for a fellow healthcare worker who has sustained an occupational bloodborne exposure with a patient at your facility under your care as detailed below e Date and time of exposure e Facility and room location of exposure e Source of exposure e g needlestick splash e Your Patients Name Date of Birth Medical Record Number e An unknown patient e g sharps containter In order to assist in the post exposure care of the health care worker we need for you to 1 order lab tests 2 obtain risk information and 3 have the results faxed to us ASAP as detailed below Your assistance in this matter is greatly appreciated If exposure was to an unknown patient please skip to 2C on the next page 1 Order Lab Tests or provide us known results note This is voluntary and must be with your patients consent a HIV antibodies by EIA Date ordered results 71 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures b HBV HBxAg HBeAg if known sAg Date ordered results c HCV
22. 9 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX C BLOOD BORNE PATHOGENS EXPOSURE CONTROL PLAN University of Southern California Bloodborne Pathogens Program Exposure Control Plan PI Supervisor Department___Jeff Goad Pharmacy Room Phone 323 442 1907 PROGRAM SCOPE The University of Southern California USC Exposure Control Plan describes how to eliminate or minimize exposure of all USC personnel to human non human primate blood or blood products that might contain bloodborne pathogens This Exposure Control Plan demonstrates compliance with the California OSHA Bloodborne Pathogens Standard 8CCR Sec 5193 http www dir ca gov title8 5193 html RESPONSIBILITIES Each Principal Investigator PI or Supervisor will 1 Print and review the Exposure Control Plan based on the nature of the research or clinical activities being performed in their facilities The plan shall be available to all personnel within the laboratory work place along with the other relevant USC safety documents 2 Determine which faculty students and staff are subject to the provisions of the standard using Appendix 1 Exposure Determination Keep a copy of the Exposure Determination with the printed Exposure Control Plan 3 Assure that these faculty staff and students are referred to Laboratory Safety http capsnet usc edu LabSafety index cfm to register for training at the time of initial assignment and annually thereafter 4
23. 9 2010 USC Mobile CLIA Waived Testing Policy and Procedures Principal Investigator Supervisor Departmental records and with the Laboratory Safety Department Post Exposure Evaluation and Follow up 5193 f 3 A Any exposure e g spill needlestick ingestion resulting in direct unprotected contact with human or non human primate blood fluids or tissue gives you the right to prompt medical evaluation and treatment with a qualified physician familiar with evaluations and treatment protocols as recommended by the Centers for Disease Control and Prevention These services will be provided to you at no cost See Appendix W for HSC student procedures What to do following an exposure After any direct exposure to BBP through a needlestick immediately wash the affected area with soap and water and NOTIFY YOUR SUPERVISOR For splashes with potential bloodborne pathogens rinse affected area for 15 minutes During Business Hours University Park Campus Health Science Campus Students and employees should go to Students should go to Student Health Center Eric Cohen Student Health Center 849 W 34 St 1 floor 1510 San Pablo St Suite 104 Los Angeles CA 90007 Los Angeles Ca 90033 213 740 6205 Tel 323 442 5631 or as directed by Workers Compensation or as directed by Workers Compensation After Hours Employees should go to one of the following medical facilities Employees must notify their supervisor of any injury or
24. A Waived Testing Policy and Procedures APPENDIX J EVALUATION 2 Patient Cholesterol Level Evaluation Y Y Triglycerides fat LDL low density lipoprotein Ehad cnhalactaral Name What does my cholesterol level mean Total Blood Cholesterol Level HDL Cholesterol Level LDL Cholesterol Level Triglyceride TG Level What are my risk factors a Oooo Negative risk factor a a What do I need to do now Your total cholesterol level is lt 200 and your HDL is 240 HDL high density lipoprotein good cholesterol Age Desirable lt 200 mg dl Borderline 200 239 mg dl High risk 2240 mg dl Desirable gt 40 mg dl Risk lt 40 mg dl Desirable lt 100 mg dl Borderline 130 159 mg dl High risk 2160 mg dl Normal lt 150 mg dl Borderline High 150 199 mg dl High 200 499 mg dl Very High gt 500 mg dl Male age 245 years or Female age 255 years Family history of premature coronary heart disease HDL level lt 40mg dL Smoking Hypertension HDL level gt 60mg dL Risk Factors Repeat your measurements within 5 years Continue with healthy eating patterns regular physical activity and weight reduction if overweight As a part of good healthcare see your physician regularly USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX K EVALUATION 3 Patient Cholesterol Level Evaluation lipoprotein good cholesterol Triglycerides fat
25. BC w Diff 6 week Labs HIV antibody HBV sAB Titer HCV RNA ALT RPR 3 Month Labs HIV antibody HCV antibody HCV RNA ALT 6 Month Labs HIV antibody HBV sAB Titer 67 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures HCV RNA ALT 12 Month Labs HIV antibody Notes 1 HBV sAB titer if not done in past or results not known Z Metabolic panel with liver function test and CBC w Diff if taking HIV PEP 3 Syphilis testing if indicated by source patient risk status 4 Pregnancy test if indicated by exposed patient risk status 5 Repeat HBV sAB titer if HBV vaccine booster or series has been given 6 6 week HCV RNA if early diagnostic evaluation indicated by symptoms of history 7 HCV RNA confirmatory test to be ordered when HCV antibody positive or HCV symptoms with negative antibody ALT baseline and subsequent screen for HCV antibody sometimes negative 9 Extended HIV testing indicated when concurrent HCV sero conversion or if possible delayed immune response love 68 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures USC Bloodborne Pathogen Exposure Protocol Information Sheet for Health Care Worker Exposed Person Tear off remaining 3 pages and give to Exposed Person Things that you the exposed person need to know and o
26. ING 2 PRINCIPLE a Test Reaction Taking Place i The OneTouch Ultra Glucose Meter measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement When glucose is applied to the test strip it is oxidized to gluconolactone via its reaction with glucose dehydrogenase GDH in the presence of a proprietary electron transfer mediator The reaction proceeds as follows 2 mediator oxidized glucose GDH 2 mediator reduced gluconolactone gt b Clinical Application i Glucose is the major energy source for the human body and is necessary for the growth development and maintenance of virtually all cells in the tissues and organs Blood glucose levels are maintained within a relatively narrow range Insulin is the principal hormone that regulates glucose and any defect in the production or action of insulin can lead to diabetes mellitus Patients with diabetes mellitus may develop various complications and some studies have shown that careful control of blood glucose levels may reduce the incidence or delay the onset of these complications 3 SPECIMEN REQUIREMENTS i OneTouch Ultra glucose meter requires al microliter uL blood sample from a finger stick or from the arm The blood sample will be collected and applied to the OneTouch Ultra Test strip that is specific for the glucose meter Blood from the fingerstick should flow freely If fasti
27. No maintenance is required other than routine cleaning when necessary If the surface of the meter becomes dirty clean it with a damp non abrasive cloth Most spills and stains will be removed with water or a mild detergent A solution of 70 isopropyl alcohol is an appropriate cleaning agent Do not immerse the instrument in water or other cleaning fluid and do not spray any solution directly onto the meter Do not attempt to clean the test port When not in use store the meter in the carrying case i OneTouch Ultra Glucose Meter Gloves should be worn whenever working with blood or samples that are potentially biohazardous a Prior to performing a test all patients must sign a consent form Appendix O No assessment of any kind will be made on pregnant women or persons under the age of 18 Each patient must complete the American Diabetes Risk Assessment Form Appendix P For each patient a Participant Assessment Form is used to record individual results and risk assessment scores Appendix Q Clean the site chosen for the test fingertip or arm with warm soapy water or an alcohol swab and dry thoroughly Check the vial expiration date before placing the any strip into the meter The meter will automatically be activated once a test strip is inserted 3 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures Before lancing the finger match the code numbers on the meter and the number on the via
28. Service for assistance at 1 877 870 5610 Toll free inside the United States or 1 317 870 5610 v A gray Instrument Check Strip included in the analyzer carrying case can be used to verify proper functioning of the CardioChek s electronic and optical systems The Instrument Check Strip provides a color standard read by the analyzer When the Check Strip in not in use it should be stored in the analyzer carrying case It is recommended that the analyzer be checked with the Instrument Check Strip when the analyzer is first received if the analyzer is dropped or when a result that is not expected is obtained To check the analyzer the follow the steps below a Turn the analyzer ON by pressing either button b When INSTALL MEMO CHIP or RUN TEST is displayed press Next until UTILITY is displayed Press Enter Press Enter when CK STRIP is displayed d Insert the Check Strip ribbed side up into the Test Strip Insert opening when INSERT STRIP is displayed e The analyzer should display PASSED i Remove the Check Strip and store it in the analyzer carrying case ii Press Next until EXIT is displayed Press Enter iii Press Next until RUN TEST is displayed iv Press Enter The analyzer is ready to run tests f Ifthe analyzer displays FAILED i Clean the CardioChek Test Strip Insert Opening where the strip is inserted into the analyzer O 15 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures wit
29. USC Mobile CLIA Waived Testing Policy and Procedures Policy CLIA EFRRECTIVE DATE Aug 2009 DATE REPLACES 1 30 2005 PLATA TAI ep per tie s e aa Authority A I f b 47375 Jeffery A Goad Pharm D MPH Lic Associate Professor USC SOP Ant Wome _ GASE Roscoe Atkinson MD Lic CLIA Waived Laboratory Director PAGE 1 OF 54 E aa a E AA PT Tf fy HERR em m SUBJECT and SCOPE Mobile CLIA Waived Testing MTABEAS boratory Technologist Lic The USC School of Pharmacy is committed to providing the highest quality patient care services USC pharmacists and intern pharmacists under the supervision of said pharmacists according to and in compliance with Article 3 of the B amp P code 4052 a 4 C and B amp P code 4052 a 5 A ii of the California Pharmacy Scope of Practice section will provide non diagnostic lipid panel and diabetes screening for a fee All individuals who request to receive a screening will be provided with this service at the USC Campus Pharmacies or at a suitable location in compliance with the USC School of Pharmacy Mobile CLIA license 05D0989993 in accordance with this policy and procedures and any applicable federal and state law All individuals who will receive the lipid panel or diabetes screening will sign a consent form and the USC School of Pharmacy will maintain a patient record of administration including but not limited
30. al Pharmacy USC School of Pharmacy 323 442 1907 21 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures I CLIA LABORTORY CERTIFICATE OF WAIVER a CLIA ID Number 05D0989993 b Expiration date 08 09 2011 Appendix U J LIMITED QUANTITY HAULING EXEMPTION a Limited Quantity Medical Waste Transporter Registration 19 1436 Expires December 17 2006 Appendix S b Small Quantity Medical Waste Generator Registration 19 11323 Expires December 17 2006 Appendix S K Non Diagnostic General Health Assessment NGHA Appendix V 22 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX A PATIENT CONSENT FORM PARTICIPANT CONSENT FORM USC School of Pharmacy Cholesterol Screening Patient s Name Today s Date Three Step Process 1 A finger prick on the middle or ring finger with a lancet will be used to obtain the blood specimen 2 The blood specimen will be taken up by a capillary tube inserted into a cassette or placed onto a PTS PANELS Test Strip and placed in the Cholestech LDX or CardioChek analyzer respectively 3 The machine will run and within 5 minutes a blood cholesterol level for HDL TG Total Cholesterol and calculated LDL will be obtained Have you consumed food or liquid other than water in the past 8 hours Yes No Are you currently on any cholesterol lowering medication Yes No Patient Address Please initial bel
31. all within the ranges printed on the Optics Check Cassette label the system is ready for use f 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 Try running an optics check with a different Optics Check Cassette If the numbers are still outside the range call Cholestech Technical Service at 1 800 733 0404 g Record the results in the Optics Check Log each day Appendix E 16 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures h Specific quality control materials should be provided for at least two levels of total cholesterol HDL cholesterol and triglycerides The preferred quality control material for use with the Cholestech LDX System is Cholestech LDX Level 1 and Level 2 control materials The expiration date should be checked before use Control material should not be used beyond the expiration date The quality control material should be mixed by gentle inversion 7 8 times before use Follow the same test procedures used for a fingerstick blood sample with the exception that a Mini Pet pipette should be used to apply the control sample to the test cassette in lieu of a capillary tube i A high and a low control for each analyte are preferred The results should be within range before testing patient samples Quality control material should be tested on each new shipment of cassettes on each lot of cassettes receive
32. als will be performed with appropriate consideration for the personnel involved in the handling of laboratory waste as well as federal state and local laws concerning the disposal of such materials In accordance with the California Medical Waste Management Act Health and Safety Code Chapter 6 1 medical waste includes but is not limited to e Human or animal specimens or infectious cultures 30 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures e Needles and syringes e Cultures and stocks of infectious agents e Wastes from the production of bacteria viruses or the use of spores discarded live and e attenuated vaccines and cultures e Waste which contains recognizable blood fluid blood products containers or equipment containing blood or blood from animals known to be infected with diseases which are communicable to humans Specific procedures for the disposal of biological materials are available from Laboratory Safety http capsnet usc edu LabSafety index cfm and can also be found in the Hazardous Materials Management Program binder REPORTING AND TESTING Reporting and Documenting Sharps Injuries All sharps related injuries will be reported immediately by completing a University of Southern California Employers Report of Occupational Injury or Illness They will notify Laboratory Safety who will initiate a review of the injury and enter the information into a Sharps Injury Log within 14 days
33. ature 47 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures PROBABLE INSTALL MEMO MEMo Chip is not Insert same or new MEMo Chip CHIP properly inserted or is properly defective MEMO CHIP MEMo Chip is defective Use another MEMo Chip from ERROR same lot of product EXPIRED LOT Test Strips are expired Check Test Strip expiration date wrong MEMo Chip is in and make sure correct MEMo Chip serted or analyzer Date is inserted Check analyzer Date is not set properly setting follow User Guide instruc tions CHANGE Batteries need to be Replace both batteries with new BATTERY replaced high quality AAA batteries The analyzer will not run tests until bat teries are replaced TEST Test Strip was not Test again with fresh Test Strip ABORTED properly inserted or was removed before test was complete TRIGS TOO HIGH Lipid Panel triglycerides No action needed LDL will not be LDL N A test result was 400 calculated on samples with triglyc mg dL 4 52 mmol L or erides of 400 mg dL 4 52 mmol L greater or greater PRINT ERROR Print function has been Print result in MEMORY or test interrupted again Results will not Communication Cable Check all connections Reprint test print was improperly con results stored in memory nected Printer cover is not Close printer cover correctly ensur closed properly Printer ing that the Printer indicator light is indicator light
34. battery life Test results are automatically stored in the analyzer s memory CardioChek can store up to 30 results of each chemistry and at least 10 results of each control test The analyzer allows review of the results in order from the most recent to the oldest Each 11 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures result is displayed with time and date Results stored in memory are not deleted when the batteries are changed n To review results stored in memory turn the analyzer ON by pressing either button If the display reads INSTALL MEMO CHIP go to the next step If the display reads INSERT STRIP press Enter Press Next until MEMORY is displayed Press Enter and CHEM will be displayed Press Enter then Next to select the desired chemistry Press Enter to view the test result including time and date a To recall Control results press Next until EXIT is displayed Press Enter Press Next until CONTROL is displayed b Press Enter when the desired Control test is displayed c For example to review Lipid Panel results from the CHEM display press NEXT until LIPIDS is displayed then ENTER The time and date will be displayed Press ENTER when the desired test time and date is displayed Press NEXT to scroll through the results s To clear results stored in memory press either button to turn analyzer ON Wait for the display to read either INSTALL MEMO CHIP or INSERT STRIP t Press Ent
35. by hand Disposable sharps must not be reused All sharps contaminated or not will be disposed of in a puncture resistant hard sided labeled sharps container The CAL OSHA BBP Standard requires any laboratory using human or non human primate blood blood products cell lines tissues or other potentially infectious materials to use needleless systems non needle sharps or engineered sharps Furthermore USC procedures requires laboratories using needles with animals to implement needleless systems or engineered sharps controls Needleless system means a device that does not use needles for 1 the withdrawal of body fluids 2 administration of medication or fluids and 3 performance of any other procedure involving the potential for an exposure incident Engineered sharp means either 1 a physical attribute built into a needle device or 2 a physical mechanism that effectively reduces the risk of an exposure incident If the Principal Investigator Supervisor decides that a non compliant sharp is necessary for a certain procedure the reason must be documented in Departmental files and on the Institutional Biosafety Committee protocol form Any broken glassware must not be directly handled with a gloved or bare hand Use of a mechanical tool tongs dustpan and broom to collect the pieces into a hard sided container labeled broken glass is enforced Contaminated broken glass must be placed in a puncture resistant hard sided sharps conta
36. d and if you think the cassettes may not have been stored properly and recorded on the Quality Control Log Appendix E Results for Cholestech controls should be within the ranges included with the control The expected ranges for each lot of controls are calculated using several LDX Analyzers and test cassette lots If results for all analytes are within the expected ranges patient samples may be tested and the results reported If results of one or both levels of control tested are outside the established ranges 1 Check that the expiration date for the test cassette and quality control materials have not passed 2 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 3 Ifthe control is within acceptable limits patient samples may be tested and results reported 4 Ifthe control is outside the acceptable limits retest with a sample of control from a new vial 5 If results are in range continue testing patient samples However if the control is still outside the acceptable limits contact Cholestech Technical Service at 1 800 733 0404 Do not use the Analyzer for testing patient samples until the problem is resolved j Temperature charts will be maintained on a daily basis for both the refrigerator temperature and the room temperature Acceptable refrigerator temperatures for storing cassettes and control solutions will be 2 8 C 36
37. d by the Analyzer to mg dL mmol L or U L depending on the cassette used and the results are shown on the liquid crystal display LCD screen The CardioChek test system consists of three main parts These include analyzer Polymer Technology Systems PTS Panels Test Strips and a MEMo Chip When a blood sample is applied to the Test Strip a chemical reaction occurs producing a color change The analyzer measures the color reaction and compares the information to the calibration curve stored in the MEMo chip The analyzer converts this color reading into a test result that is displayed on the screen The Cholestech LDX System combines enzymatic methodology and solid phase technology to measure total cholesterol HDL cholesterol triglycerides and glucose The sample is applied to a Cholestech LDX cassette and the cassette is placed into the Analyzer where the plasma is separated from the blood cells A portion of the plasma flows to the left side of the cassette where the low density lipoproteins LDL and VLDL are precipitated with dextran sulfate 50 000MW and magnesium acetate precipitating reagent The filtrate containing both glucose and HDL cholesterol is transferred to both reaction pads The enzymatic reactions that occur when using CardioChek and Cholestech LDX System to measure cholesterol and HDL are listed below Cholesterol esters H2O Cholesterol esterase Free Cholesterol Fatty acids Cholesterol O Choleste
38. e access door to the laboratory work area All human tissue body fluid or other potentially infectious materials must be stored in a container labeled with a biohazard symbol Equipment where BBPs or potentially infectious materials are stored or handled must also be labeled with the biohazard symbol All signs are available from Laboratory Safety Transportation on Campus Specimens of blood or other potentially infectious materials will be placed in a primary container that prevents leakage capped test tube centrifuge tube etc during collection handling and storage If the specimens are transported outside of the lab or work site the primary containers must be placed in a secondary container bucket beaker cooler etc which would contain the contents if the primary container if it were to leak or break Shipping of Samples Specimens of blood or other potentially infectious materials that will be shipped to or from University of Southern California must be clearly identified as human blood or blood products The material will be placed in a closed primary container and a leak proof secondary container prior to shipment Personnel involved with shipping of biohazardous agents or potential BBPs must have documented training prior to shipping Contact Laboratory Safety 323 442 2200 for additional information on training for shipping samples or specimens Biological Waste Disposal Disposal of potentially hazardous biological materi
39. e the patient apply pressure to the puncture until the bleeding stops C PROCEUDRE FOR HANDLING AND DISPOSAL OF BIOLOGICAL MATERIAL a Lancet Disposal Dispose lancets immediately after each use Lancets are to be placed in red puncture resistant sharps container marked with a biohazard symbol Lancets are not to be disposed in wastebaskets or regular trash containers b Materials contaminated with blood Items in contact with blood e g cotton balls gauze band aids are to be disposed of in red plastic bags marked with a biohazard symbol They are not to be placed in red sharps containers with the lancets c The University of Southern California Safety Policy 16 Bloodborne Pathogens and the University of Southern California School of Pharmacy Campus Pharmacies Policy 2 Blood Borne Pathogens Prevention Program procedures will be used Appendix C d In accordance with the University of Southern California Safety Policy 007 Hazardous Waste Management Career and Protective Services will remove and dispose of waste appropriately Appendix S 20 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures D PROCEDURE TO BE EMPOLYED IN HANGLING EXCESSIVE BLEEDING FAINTING OR OTHER MEDICAL EMERGENCY a Bleeding 1 ii ii iv Apply pressure over wound with wad of sterile gauze If bleeding continues and elevate wound until bleeding stops If bleeding still continues apply pressure to bl
40. egistered pursuant to the provisions of the Medical Waste Management Act 066 ILID Division 104 Part 14 Chapter 5 of oh sao Health and Safety Code Try eer and shall be subject to all applicable provisions gfthis law This permit is not transferable 608 Gee i a ee 280 Me es Date issued 01 06 2010 TRUR Chief Waste Management Secon 9 Sees t 2200 att eee rv ws we a o s wes e v o s 8 6 ee el se S Qu ese 2s ee ee es eseeeseesee eeeesenseeeeeee ese 2 256 Sesteeseeeesesescoaesvsesesoevesesees es easeeesen sre fe Sseeececeseoeocoeseeseooeseoseosseosseoeosege SOOO SSSHSSSSSSSOHSESEOSSHSESEHHOCOCHOCEOSESES 58 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures STATE OF CALIFORNIA Department of Public Health Sere Medical Waste Management PublicHealth e rogr 2080 Program con 09 USC Pharmacy 008 29 0 Registration No in the county of Treatment Permit No ra Se see 19 1436 Los Angeles None 00 is registered as a 2260 78 LIMITED QUANTITY MEDICAL WASTE TRANSPORTER cae Expiration Date 00 9 December 16 2010 e09 20 The facility named herein is registared pursuant to the provisions of the Medical Waste Management Act ed Division 104 Part 14 Chapter 6 of the Califomia Health and Safety Code 2086 and shall be subject to all applicable provisi ns of this law This certificate is not transferable 000 f cer 0 Date Issued 2 11 2
41. eigh the same or more than the amount listed for your height you may be at risk for diabetes This chart is based on a measure called the Body Mass Index BMI The chart shows unhealthy weights for men and women age 35 or older at the listed heights At risk weights are lower for individuals under age 35 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX Q PARTICIPANT ASSESSMENT FORM PATIENT ASSESSMENT FORM USC School of Pharmacy NAME DIABETES RISK SCORE BLOOD GLUCOSE LEVEL TYPE OF TEST i Non Fasting 56 updated 3 19 2010 ACTION PLAN USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX R INSTRUCTIONS ON USING THE GLUCOMETER Attach manual for CLIA Waived Glucometer 57 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX S Limited Quantity Medical Waste Transporter and Small Quantity Medical Waster Generator Certificate ee CS a Se ee 22s0 e e3 90 STATE OF CALIFORNIA AeA Department of Public Health 90 Medical Waste Management Program PublicHeatth ee see 00 3806 USC Pharmacy see See Registration No in the county of Treatment Permit No 000 09o 19 11323 None 6 pp Los Angeles 00 Qee l is registered as a o8 Ote c90 0 ee SMALL QUANTITY MEDICAL WASTE GENERATOR 16 ea Expiration Date 200 PA Docember 16 2010 coe TE 2e ees The facility named herein is r
42. en ing Use MEMo Chip and Test Strips with the same lot number If you or your patient have symptoms call healthcare professional immediately Re peat the test Run controls and confirm that controls are in range If you or your patient have symptoms call healthcare profes sional immediately Run test again Run controls and confirm that controls are in range Run test again Run controls and confirm that controls are in range updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures CHOLESTECH LDX SYSTEM Action to Take Mag Read Error See User Manual Unable to read magnetic stripe on the cassette 1 Wipe magnetic stripe with a soft tissue and restart test If second test fails repeat test using a new cassette 2 Check cassette position magnetic stripe must be on the right 3 If message reappears call Technical Service Run button pushed without cassette in drawer Place cassette in drawer before pushing Run Tray Timeout The cassette is jammed in the tray See User The microprocessor is confused Disconnect Reconnect Analyzer from Manual because the buttons were pressed too power supply Repeat test with a new quickly cassette If message reappears call Technical Service Calibration An electrical problem occurred or the Disconnect Reconnect Analyzer from Fail Call Tech Analyzer lost its optical calibration power supply If message reappears Service informati
43. er then press Next until UTILITY is displayed Press Enter u Press Next until CLEAR MEMORY is displayed Press Enter v Press Next until the display reads CLR YES Press Enter The display will read ERASE CLEARED and then CLEAR MEMORY w To exit press Enter until the display reads EXIT then press Enter Press Next until you return to RUN TEST ii Cholestech LDX Gloves should be worn whenever working with blood or samples that are potentially biohazardous a Prior to performing a test all patients must sign a consent form Appendix A No assessment of any kind will be made on pregnant women or persons under the age of 18 mao b If the cassette has been refrigerated allow it to come to room temperature at least ten minutes before opening Make sure the Analyzer is plugged in and has warmed up d Run Optics Check and or Quality Control as delineated on page 5 section A 6 Quality Control e Remove the cassette from its pouch Hold the cassette by the short sides only Do not touch the black bar or the brown magnetic stripe Place the cassette on a flat surface f Press RUN The Analyzer will do a self test The screen will display Selftest running 12 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures Testing memory g Then a message on the screen will appear Selftest OK h The cassette drawer will open The screen will read Load Cassette 1 Depending on sample
44. et usc edu LabSafety index cfm Written Exposure Control Plan 5193 c 1 The Principal Investigator Supervisor will print this laboratory specific plan and file it in the USC Hazardous Materials Management Program Binder in a central location within the laboratory for all personnel to access The plan will be reviewed and revised annually or whenever significant changes in procedure or personnel occur Additional copies of the uncompleted plan are available at the Laboratory Safety Department or on the web at http capsnet usc edu LabSafety index cfm Engineering and Work Practice Controls 5993 d 2 Engineering and work practice controls must be used to eliminate or minimize exposure to individuals The following engineering and work practice controls will be utilized Personal Protective Equipment 5193 d 3 Personal protective equipment PPE will be provided without cost to all individuals who are at risk of occupational exposure to bloodborne pathogens All PPE will be inspected cleaned or replaced as needed at no cost to personnel PPE will be chosen based on the anticipated exposure to blood or other potentially infectious materials The protective equipment will be considered appropriate only if it does not permit blood or other potentially infectious materials to pass through or reach the individual s clothing skin eyes mouth or other mucous membranes under normal conditions of use and for the duration of time that
45. fluids tissues cell lines or other potentially infectious material OPIM in the course of conducting their job responsibilities Federal regulations require that employers notify employees who are at risk that they have the right to be vaccinated Although vaccination is optional employers are required to confirm that they have been notified of this right The vaccination series is provided through the clinics listed below You must make an appointment to receive services USC Department of Family Medicine USC Department of Internal Student Health Services Health Care Consultation Center Medicine 849 W 34 St 1510 San Pablo St Health Care Consultation Center 213 740 9355 323 422 5807 Il 1520 San Pablo St 323 442 5100 Please check one of the following I am a student and understand that the USC Hepatitis B Program cannot provide the vaccine for me I have been advised to seek assistance through Student Health Services or my own medical insurance provider a I accept the offer of the hepatitis B vaccination I understand that it will be provided at no charge to me and that it is comprised of a series of three inoculations E I have previously completed the hepatitis B vaccination series and can show laboratory confirmation of immunity E I accept the offer of a hepatitis B antibody titer to check my immune status a I understand that due to my occupational exposure to blood or other potentially infectious materia
46. g Handling tubes or other container of human or non human primate blood fluid cultures or tissue Handling contaminated sharps or other contaminated waste Cleaning spills of human or non human primate blood or other body fluids Other procedures or tasks that would create risk of exposure to BBPs ALL classifications at risk for exposure include the following All health care and allied services classifications e Hospital attendants e Technologists e Nurses e Physicians and dentists e Pharmacists e Medical auxiliary services e Radiation physicists e Medical assistants e USC Social services e College of Medicine Psychologists e USC Therapeutic services physical therapists occupational therapists e USC facilities services Police Housekeeping Plumbers Environmental Health and Safety Laboratory Safety staff SOME Classifications at risk including Faculty principal investigator Senior or staff research associate Laboratory supervisor or assistant Veterinarian or animal health technician 26 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures e Others as defined by Principal Investigator Supervisor METHODS OF COMPLIANCE 5193 d i Information and Training 5193 g 2 All staff that have the potential for exposure to BBPs must have initial and annual training for bloodborne pathogens To sign up for a training session contact Laboratory Safety at 323 442 2200 or visit their website http capsn
47. h a soft lint free damp cloth See Storage and Handling section under EQUIPMENT ii Inspect the Check Strip to make sure it is not dirty or damaged Use the spare Check Strip and repeat iii See Troubleshooting section Appendix N ii Cholestech LDX a 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 The Cholestech LDX Optics Check Cassette should be stored at room temperature in the case provided The reaction bar should not be touched or allowed to become wet dirty or scratched A damaged or expired Cholestech LDX Optics Check Cassette should not be used The Cholestech Optics Check Cassette should be run once each day before patient samples are tested and anytime after the Analyzer has been moved or serviced b The Optics Check Cassette test procedure is as follows After verifying the Self Test OK message press the RUN button The drawer will open and the screen will display Load cassette And press RUN c Place the Optics Check Cassette into the cassette drawer Do not place any blood sample on the cassette d 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 HHH HE THE Ch 1 Ch 2 Ch 3 CH 4 e If the numbers for all four channels f
48. he test with anew cassette not linear Optics Test Fail A problem with the optical Repeat optics check with another See User Manual system of the analyzer or a faulty Optics Check Cassette optics check cassette If the message reappears call Cholestech Technical Service The Analyzer will now be deactivated Too Much Light See User Manual The analyzer is in an environment with excessively Move the Analyzer to a location with less light When light level 51 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures bright light is acceptable it will again become operable Temp Too High See User Manual The analyzer is in an environment outside its proper temperature range Move the Analyzer to another location When it reaches acceptable temperature it will again become operable Selftest Fail Analyzer has lost internal Disconnect Reconnect Analyzer memory temperature from power supply If message malfunction or hardware reappears call Cholestech problem Technical Service Bad Checksum Indicates a defective ROM Unplug the LDX Remove ROM pack pack and install a ROM pack from an LDX which is functional If the LDX is functional with thins ROM pack then the problem is the ROM pack and it will have to be replaced Call Cholestech Technical Service NOTE do not try to run a cassette if you have been troubleshooting a problem with it for m
49. icated Risks Risks Large 2 Drug 3 drug 2 Drugs 2 Drugs No PEP Volume Regimen Regimen PRN PRN Indicated Risks Risks b Circle Prescribed HIV PEP Regimen Note PEP regimen is for 4 weeks Medication Regimens Dosage Side Effects amp Comments 2 Drug Combivir AZT 3TC 300 150mg 1 PO Nausea HA Insomnia fatigue Inc BID LFT Dec Hgb Dec WBC Dec Plt peripheral neuropathy rare pancreatitis 3 Drug Combivir Plus Nelfinavir viracept 5 PO BID with Diarrhea PRN Tx food P450 drug interactions 65 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures or Indinavir Crixivan 400mg 2 PO Q 8hrs Nephrolithiasis must drink gt 1 5 on Empty Stomach H2O daily asymptomatic inc or with Nonfat bilirubin rare hemolytic anemia P450 snack drug interaction 2 Hepatitis B PEP Circle Fill In HBIG 0 06 ml kg IM Date s HBV Vaccine Booster Date HBV Vaccine Serie Date Due Scheduled Date Done Lot Number Initials 1 2 3 66 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures USC Bloodborne Pathogen Exposure Protocol Exposed Patient Testing Test Date Results Date reviewed Indicated Ordered Initials Follow Up Baseline labs HIV antibody HBV sAB Titer HCV antibody ALT CMP CBC w Diff RPR Pregnancy test 2 week Labs if on HIV PEP CMP CBC w Diff 4 week Labs if on HIV PEP CMP C
50. ilities or as directed by USC Workers Compensation If it is after hours follow the directions listed above Medical information will not be discussed or revealed to supervisors personnel representatives or other health care professionals who do not need the information RECORD KEEPING 5193 h The Principal Investigator Supervisor must maintain all training records as discussed above for at least three years and provide record keeping for advising staff of the offer of the Hepatitis B vaccination The medical provider maintains all medical records related to the provision of clinical services for thirty years To access these records call the provider directly 33 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures BBPECP APPENDIX 1 Exposure Determination PI SUPERVISOR DATE List of faculty staff and students who have been determined to be at risk for exposure to bloodborne pathogens or other potentially infectious materials NAME JOB TITLE TRAINING HEPATITIS B_ OFFER DATE S VACCINE DATE INITIAL ANNUAL 34 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures BBPECP APPENDIX 2 UNIVERSITY OF SOUTHERN CALIFORINA K HEPATITIS B VACCINATION AGREEMENT REFUSAL FORM The hepatitis B vaccination is provided free of charge to USC employees who are exposed to human material including blood blood products body
51. illness the following day or as soon as possible The supervisor should notify Workers Compensation Laboratory Safety by phone and then complete and forward the proper forms White Memorial Hospital Good Samaritan Hospital 1720 Cesar E Chavez Ave 1225 Wilshire Blvd Los Angeles CA 90033 Los Angeles CA 90017 323 268 5000 213 977 2121 Emergency Room Services are 24 hours per day 7 days a week These providers follow a protocol that is designed to provide the individual with the most appropriate medical procedures consultation and supportive therapy 32 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures The exposed employee or student will be provided with a written opinion that will include e HBV vaccination status and recommendation e Results of the post exposure evaluation and follow up e Discussion of any medical conditions resulting from exposure to blood or other potentially infectious materials which requires further evaluation or treatment e All other findings or diagnoses will remain confidential and will not be included in the e written report Exposure to animal bites and scratches It is important to immediately report all bite wounds and scratches to your supervisor Wounds must be cleansed immediately in your work area Your supervisor will give you instructions for the proper cleaning of wounds After you have cleansed the wound go immediately to one of the designated healthcare fac
52. iner and disposed of as biohazardous waste Minimization of Aerosols All procedures must be performed carefully to minimize the creation of aerosols Biological safety cabinets Class II or III or other physical containment devices must be used whenever possible while performing operations capable of creating aerosols These operations may include e Centrifugation e Blending e Homogenization e Opening pressurized containers If a biological safety cabinet is not available the most effective means of minimizing exposure is to use closed containers centrifuge tubes sealed centrifuge rotors capped test tubes etc Disinfection of Work Area and Spill Cleanups 29 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures Blood and blood products will be handled in an area that can be readily decontaminated The work area must be disinfected before and after handling microorganisms Non laboratory personnel should not handle equipment that has been used with potential BBPs until it has been decontaminated All spills must be cleaned up immediately and disinfected with a germicide by appropriate decontamination procedures determined by the laboratory supervisor The laboratory supervisor or other laboratory personnel must immediately report laboratory accidents to the Laboratory Safety Department at 323 442 2200 Labeling A biohazard warning sign incorporating the universal biohazard symbol will be posted on th
53. known to be HIV please provide the following HIV disease details e HIV disease stage or symptoms e Past and current antiretroviral therapy e Current CD4 and Viral Load e Other things that should be known about the patient c For Exposure to unknown patient e Are there any known likely HIV HBV or HCV patients treated at this site Yes No T2 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures If Yes pelase estimate the approximate percentage of the total patients seen which are known or likely to be so infected Write in the percentage e Are there any other contagious conditions to which the HCW may have been exposed to Please indicate the best way to contact you for lab results or questions Your Name Title Contact Numbers phone fax pager Address Please complete this form As Soon As Possible and send it to Eric Cohen Student Health Center 1510 San Pablo St Suite 104 Los Angeles Ca 90033 Tel 323 442 5631 Fax 323 442 6029 Thank you for your assistance 74 updated 3 19 2010
54. l I may be at risk of acquiring hepatitis B virus HBV infection I have been given the opportunity to be vaccinated with the hepatitis B vaccine at no charge However I decline the hepatitis B vaccination at this time I understand that by declining this vaccine I continue to be at risk of acquiring hepatitis B a serious disease If I continue to have occupational exposure to blood or OPIM and wish to be vaccinated with hepatitis B vaccine in the future I can receive the vaccination at no charge 35 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures Additional Attestations I understand that my acceptance or refusal to be vaccinated does not affect my USC health benefits or employment status I recognize that I will be required to follow established safety procedures regardless of my vaccination status I understand that the University of Southern California is not liable for pre existing infections that any employee has at the time of his or her employment with the University I understand that I also have the right to be tested for HIV if I am exposed to blood or bodily fluids However the HIV test will be conducted separately only upon my request and not as part of the hepatitis B screening process Employee Name Employee Identification Number Employee Signature Telephone Email Date Authorized by Signature Date BILL TO HEPATITIS B PROGRAM Laboratory Safety 1540 Alcazar
55. l Level Desirable lt 100 mg dl Borderline 130 159 mg dl High risk 2160 mg dl Triglyceride TG Level Normal lt 150 mg dl Borderline High 150 199 mg dl High 200 499 mg dl Very High 500 mg dl What are my risk factors Q Male age 245 years or Female age 255 years Family history of premature coronary heart disease HDL level lt 40mg dL Smoking Hypertension Oooo Negative risk factor D HDL level gt 60mg dL Risk Factors What do I need to do now Your cholesterol level is between 200 239 mg dl and your HDL is gt 40 with lt 2 risk factors Repeat measurements within 1 2 years and continue if not already started healthy eating patterns and regular physical activity An earlier repeat measurement by a physician within 1 year is appropriate if this is your first cholesterol screening USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX M NON DIAGNOSTIC LIPID PANEL SCREENING FLOW CHART PATIENT REQUESTS LIPID PANEL SCREENING QUALITY CONTROL PERFORMED WHEN NECESSARY SEE SECTION 3 PATIENT SIGNS CONSENT FORM SEE SECTION 1 OBTAIN BLOOD SAMPLE FROM PATIENT SEE SECTION 2 RUN THE LIPID PANEL SCREENING SEE SECTION 4 BASED ON LIPID PANEL LEVELS PROVIDE PATIENT WITH THE PROPER EVALUATION FORM SEE SECTION 5 46 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX N TROUBLESHOOTING CARDIOCHEK ANALYZER PROBABLE Desired language La
56. l of the test strips If the code does not match refer to the Owner s Manual for instructions on coding the meter Use a new single use disposable lancet to perform the fingerstick each time a test is done Gently massage and warm the hand or arm to bring fresh blood to the surface Refer to section B Procedure drawing blood for information on how to lance the finger When the prompt to apply the sample appears on the screen picture of a drop of blood lance the finger and obtain an adequate amount of blood Gently touch only the edge of the test strip to the blood sample A sample must be applied within 2 minutes after inserting the test strip The test strip will then automatically draw the blood into the meter via capillary action If an error message appears refer to the User s Manual If an adequate sample was applied results will be displayed in 5 seconds Record the results on the appropriate form Dispose everything that came into direct contact with the blood sample or control material into a biohazardous waste container 7 CALCULATIONS Test results will be displayed on the screen and no additional calculations are necessary 8 QUALITY CONTROL i OneTouch Ultra a The OneTouch Ultra control solution is used to check that the meter and test strips are working together as a system and the test is performed correctly Check the expiration date on the control solution vial Once opened the control solution expire
57. ly filled capillary tube or pipette 1 Repeat test with a new cassette and new fingerstick sample 2 Repeat test with a new pipette tip and cassette Be sure pipette tip is firmly in place Insufficient sample volume reached reaction pads due to high hematocrit or sample Repeat test with a new cassette and new fingerstick sample If message reappears test patient by alternate method Improper sample collection sample clotted because it was left in the capillary tube too long Repeat test with a new cassette and new fingerstick sample Pay close attention to proper technique Improper sample collection Finger was milked to obtain sample or capillary tube was filled too slowly Repeat test with a new cassette and new fingerstick sample Pay close attention to proper technique The cassette is malfunctioning Repeat test with a new cassette Low Battery Internal battery voltage is too low Call Technical Service Internal battery is not user serviceable WARN 1 The analyzer is in an environment outside its proper temperature range WARN 2 Cassette expiration date month Check calendar in the Analyzer to has been reached make sure it is set correctly Check expiration date on cassette pouch or box WARN 3 There is a large difference Repeat the test with anew cassette between two readings that are used to calculate a mean value WARN 7 Kinetic reaction for ALT was Repeat t
58. n a CONTROL MUST BE APPLIED TO THE TEST STRIP WITHIN 10 SECONDS OF REMOVING THE STRIP FROM THE VIAL Hold bottle directly over and perpendicular to the blood application window of the Test Strip Squeeze bottle so a small drop of solution is formed Allow the drop of control solution to fall onto the application window of the Test Strip Do not allow the tip of the bottle to touch the Test Strip Replace cap on the Control Material Results will be displayed within about one to two minutes Compare control results to the values on the Quality Control Range Insert included with control materials 14 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures p The control result s will also be stored in the analyzer s Memory q To exit the control testing menu press Enter twice RUN CONTROL will be displayed r Press Next until EXIT is displayed Press Enter Press Next until RUN TEST is displayed t If Quality Control Results are in Range continue testing patient samples u If Quality Control Results are not in Range do not use the Analyzer for testing patient samples until the problem is resolved The following may be tried a Ensure Test Strip insert opening area is clean b Make sure neither the Test Strips nor the controls are past the expiration date printed on the label c Make sure MEMo Chip matches the lot d Repeat the test again using fresh materials e Call CardioChek PTS Customer
59. n with no dust or fingerprints The glass must be completely dry before running a test The Cholestech LDX System includes Cholestech LDX Analyzer power supply optics check cassette test cassettes user manual procedure manual capillary tubes capillary plungers lancets Mini Pet pipette pipette tips and printer and cable assembly No calibration of the Analyzer is done by the user Test information is on the brown magnetic stripe of the cassette The brown stripe is read by the Cholestech LDX each time a cassette is run a The Cholestech LDX System should be used in a location that has a temperature between 20 C to 35 C 68 F to 95 F a stable work surface no direct heat oven or room heater and no bright light sunlight or a spot light If the temperature or light requirements are not acceptable the Analyzer will shut down until they are met b Each test cassette has two parts the main body and the reaction bar The main body contains a sample well where the blood sample is dispensed and a brown magnetic stripe The magnetic stripe contains the test names instructions to the Analyzer for running the tests on the cassette and calibration information for converting the color reading to analyte concentration The reaction bar holds the reagent pads which contain the chemicals for each test The test cassettes must be stored in the sealed foil pouches Cassettes may be used until the date printed on the pouch when stored
60. ng levels are to be obtained the patient should not eat or drink anything other than water for 8 to 12 hours prior to the test 4 REAGENTS 2 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures i No reagents are needed to perform a blood glucose or cholesterol test Please refer to Quality Control section A8 for information on materials used for quality control 5 EQUIPMENT 1 OneTouch Ultra includes meter logbook owner s booklet quick reference guide OneTouch UltraSoft Blood Sampler control solution 3 0V lithium battery and carrying case a 6 PROCEDURE The meter can be used to measure glucose levels from different areas of the body including the fingertips and arm The meter should be used in a location with a temperature between 43 111 F 6 44 C and relative humidity 10 90 a stable work surface no direct heat oven or room heater and no bright light sunlight or spotlight Test strips should be stored in their original container in a cool dry place below 86 F 30 C Keep away from direct sunlight and heat Do not refrigerate Do not use test strips beyond the expiration date printed on the package since it may cause inaccurate results Discard test strips after 3 months from the date a new vial of test strips is opened Replace the vial cap immediately after removing a test strip Do not bend cut or modify test strips Test strips are for single use only never reuse
61. nger The capillary tube should be completely filled in under 10 seconds to ensure proper mixing of blood and anticoagulant to prevent clotting The blood should be dispensed from the capillary tube within five minutes of collection after which time the blood will begin to clot in the capillary tube Blood from the finger stick should flow freely Too much squeezing of the finger may cause inaccurate test results For details on the finger stick procedure refer to Section B Procedure for Drawing Blood If fasting levels are to be obtained the patient should not eat for 9 to 12 hours prior to the test 4 REAGENTS i No reagents are needed to perform a blood glucose or cholesterol test Please refer to Quality Control section A8 for information on materials used for quality control 5 EQUIPMENT i The CardioChek Test System includes CardioChek Analyzer PTS Panels Test Strips MEMo Chip 2AAA 1 5 volt alkaline batteries user manual capillary tubes capillary plungers lancets 8 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures Mini Pet pipette and or pipette tips No calibration of the Analyzer is done by the user The information is on the MEMo Chip per Test Strip lot a The CardioChek Analyzer should be used in a location that has a temperature between 20 C to 25 C 68 F to 77 F a stable work surface no direct heat oven or room heater and no bright light sunlight or a spot light If
62. nguage has been set Turn analyzer OFF See Section IV is not displayed incorrectly Set Up How to Reset the Lan guage The wrong date Date and time have not See Section IV Set Up to set the and or time is been set correctly correct date and time displayed FAILED is dis Analyzer needs to be Wipe the Test Strip Insert Opening played during a cleaned with a clean damp and lint free Check Strip test cloth Check Strip is dirty or Use spare Check Strip If Check damaged Strip still fails call Customer Service TOO MUCH LIGHT Test is being performed Test inside away from windows in direct light or outside and away from direct lamp light MEMO ERR MEMo Chip is defective Use another MEMo Chip from the same lot TEST ERR Insufficient sample has__ Test again with a new Test Strip been added to Test and make sure the correct volume Strip of sample is used SET TIME AND Analyzer is new or Follow User Guide instructions to DATE language option has not set language been set Test selected by MEMo Check MEMo Chip and make sure Chip installed cannot be that the correct MEMo Chip is run on your analyzer inserted Call Customer Service LOW TEMP Analyzer is below Move to warmer environment and acceptable operating test after analyzer reaches proper temperature temperature HI TEMP Analyzer is above Move to acceptable environment acceptable operating and test after analyzer reaches temperature proper temper
63. of the injury The Sharps Injury Log is maintained for five years by Career and Protective Services The Biological Safety Specialist and the Occupational Safety and Health Specialist will review the log to identify trends and take corrective action Medical Surveillance Program 5193 f University of Southern California Laboratory Safety has made arrangements for all appropriate required medical services related to bloodborne pathogens Hepatitis B Vaccination A safe and effective vaccine is available for protection from Hepatitis B The University of Southern California encourages employees to be vaccinated The employee may decline the vaccination Accepting vaccination is not a condition of employment This vaccine is available at no cost to the employee Post vaccination serological testing to assure that antibodies to hepatitis B have developed is also provided at no cost following completion of the vaccination series The Principal Investigator Supervisor will assure that all personnel with potential for occupational exposure to bloodborne pathogens are offered the Hepatitis B HBV vaccination as soon as possible Students should be referred to Laboratory Safety for the appropriate forms If you decide not to be vaccinated but later change your mind you may still receive the vaccination at no cost Each employee who declines the HBV vaccination series is required to sign a declination form that will be filed in the 31 updated 3 1
64. on call Technical Service Used Cassette A previously used cassette has been placed in the Analyzer Repeat test with a new cassette Dispose of used cassette appropriately The cassette was placed incorrectly Repeat test with a new cassette Call technical service if message reappears The cassette is malfunctioning Repeat test with a new cassette Data file empty This is normal message which appears 1 When the optics Check has been run and DATA is pushed 2 A cassette has been run the power supply has been unplugged from the LDX and DATA is pushed 3 When an error message occurs i e Used Cassette and DATA is pushed End of data info This is a normal message which appears 1 Framingham risk is off and DATA button is pushed twice after results appear 2 Framingham risk is on and the STOP button is pushed when Risk Run yes STOP no appears A D Error Internal hardware problem Disconnect Reconnect Analyzer from power supply If message reappears call Technical Service 50 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures NOTE do not try to run a cassette if you have been troubleshooting a problem with it for more than 30 seconds Evaporation of sample may cause inaccurate results Action to Take Reaction Did Not Occur Insufficient sample volume was applied to the cassette due to air bubbles or incomplete
65. ood vessels leading to area in arm press just below armpit in leg press against groin where thigh and trunk join Use a tourniquet tight band that cuts off circulation only when it has been decided that the sacrifice of a limb is necessary to save life b Fainting C 1 il ii Keep the affected person lying flat or sitting forward with the head bent below the knees Loosen the patient s clothing is possible Cool the room down or move the person to a cooler location if heat is a problem This can be especially helpful for someone with a history of heart problems as a cause of fainting Medical Emergency i Call 911 immediately E PROCEDURE FOR REPORTING ASSESSMENT RESULTS TO INIDIVIDUAL BEING ASSESSED AND REFERRAL TO THOSE WITH POSSIBLE RISK FACTORS OR MARKERS a Refer to Appendices I L O Q F DOCUMENTATION SHOWING AUTHROIZATION OF SCREENING STAFF TO PERFORM SKIN PUNCTURES a Refer to Appendix T G DOCUMENTATION SHOWING STAFF HAVE BEEN TRAINED ACCORDING TO MANUFACTURER S DIRECTIVES a Refer to Appendix T H SUPERVISORY COMMITTEE MEMBERS a California licensed physician Roscoe Atkinson MD Assistant Professor of Clinical Pathology Keck School of Medicine 323 442 2736 b Clinical laboratory technologist Jay Santa Ana C Director Laboratory Services USC University Hospital Lic MTA36981 California licensed pharmacist Jeffery A Goad Pharm D MPH Associate Professor of Clinic
66. ore than 30 seconds Evaporation of sample may cause inaccurate results 52 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX O DIABETES CONSENT FORM USC School of Pharmacy Patient s Name Today s Date Your Age Gender Height Weight Race 1 Have you been diagnosed with diabetes Yes No If YES do not complete ADA Risk Assessment Form 2 Have you consumed food or liquid other than water in the past 8 hours Yes No 3 Would you like us to contact your physician with the results of the assessment Yes No If YES please provide physician information Physician s Name Daytime Phone have read or have had explained the information provided about the diabetes screening am to receive have had a chance to ask questions that were answered to my satisfaction believe understand the benefits and risks of diabetes screening and ask that a finger stick be performed on me or on the person named above for whom am authorized to make this request Patient Signature 53 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX O CHOLESTEROL CONSENT FORM USC School of Pharmacy Patient s Name Today s Date Your Age Gender Height Weight Race 1 Have you been diagnosed with high cholesterol Yes No If yes do you take cholesterol lowering Yes No medications 2 Have you consumed food or liquid other than
67. ow I understand the risks and benefits of the results from a cholesterol screening I authorize this pharmacy to release my evaluation and other information to other healthcare providers in order to ensure continuity of care I would like this pharmacy to contact my physician with the results of the assessment If YES please provide physician information Physician Name Address City Zip Phone Patient Signature 23 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX B Follow these suggestions to help you consistently perform good fingersticks Suggestion Reason Perform a deep and firm puncture An adequate puncture is crucial to obtaining a free flowing drop of blood Keep the patient s hand below the level of their heart This will improve the blood flow Hold the capillary tube at a slight descending angle to the drop of blood This will make the capillary tube fill faster Fill the capillary in under 10 seconds This will ensure proper mixing of blood and anticoagulant which prevents clotting Dispense blood from capillary tube in less than five minutes After five minutes the blood will begin to clot in the capillary tube If blood stops flowing wipe finger firmly with gauze You can improve blood flow by reopening the puncture WARNING Squeezing the finger excessively may cause inaccurate test results 24 updated 3 1
68. r do 1 Get testing and risk assessment done on the source patient you were exposd to e Give attached Information Sheet for Attending Physician sheet to the Patients doctor 2 Return for follow up evaluation testing counseling and Treatment e Fill in the following dates at your initial visit gt 2 weeks after exposure If taking HIV Medication 4 weeks after exposure If so directed 6 weeks after exposure For Everyone For testing 3 months after exposure For Everyone For testing 6 months after exposure For Everyone For testing Additional Appointment as indicated Additional Appointment as indicated Vv Vv VV VV Y Additional Appointment as indicated 3 Take all of your prescribed medications as directed This is especially critical for HIV drugs 4 Report and or come in for evaluation of any side effects of therapy and or infection e Common HIV therapy side effects nausea H A tiredness difficulty sleeping back pain kidney stones diarrhea e Common HIV symptoms fever rash swollen lymph nodes sore throat aching ect a bad flu 69 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures e Common Hepatitis symptoms fever nausea vomiting abdominal pain yellow skin and eyes tiredness 5 Call or come in to the Eric Cohen Student Health Center for any problems or questions Numbers to Call Eric Cohen Student Health Center
69. rol oxidase Cholest 4 ene 3 one H202 gt 2 H20 4 aminoantipyrine TOOS Peroxidase Quinoneimine dye 4 H2O a 7 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures TOOS N Ethyl N sulfonydroxypropyl m toluidine sodium salt The CardioChek and Cholestech LDX Analyzers measure triglycerides by an enzymatic method based on the hydrolysis of triglycerides by cholesterol esterase to glycerol and free fatty acids Triglycerides H2O Cholesterol esterase Glycerol Free fatty acids gt Glycerol ATP Glycerol Kinase Mg Glycerol 3 phosphate ADP gt Glycerol 3 phosphate O2 _Glycerol phosphatg Dihyroxyacetone phosphate H202 Oxidase 2 H207 4 Aminoanipyrine TOOS Peroxidase _ Quinoneimine dye 4 H20 b Clinical Application i Studies have shown that cholesterol plays an important role in coronary heart disease and that lowering cholesterol total cholesterol LDL and triglycerides significantly reduces the risk of developing heart disease Studies have also shown that increases in HDL cholesterol are associated with additional reduction in coronary heart disease risk Total cholesterol HDL cholesterol and triglyceride levels are used in the calculation of an estimated LDL cholesterol value 3 SPECIMEN REQUIREMENTS i CardioChek and Cholestech LDX Analyzers require 35 60 microliters uL blood sample from a finger stick The sample will be collected using a capillary tube with plu
70. room temperature falls below 18 C allow the analyzer to warm up at least 30 minutes to 1 hour before testing Each package of PTS Panels Test Strips contains color coded MEMo Chip The color coded MEMo Chip contains settings for each test The top of the MEMo Chip has a finger notch The bottom has a label with the test name and lot number The MEMo Chip reads the test strip expiration date tells the analyzer which test to run contains the calibration curve and the lot number for the specific Test Strip Lot controls test sequences and timing and established the measuring range for the test The MEMo Chip contains the proper settings for the corresponding Test Strip lot The MEMo Chip must be in place to run a test Only the MEMo Chip that is included with each package of strips should be used The lot number code on the Test Strip vial MEMo Chip and analyzer must match If the expiration date in the MEMo Chip has expired the analyzer will display EXPIRED LOT Test strip package should be stored in a cool dry place at room temperature 20 30 C 68 86 F Strips may be stored in a refrigerator 35 46 C 2 8 P but must be brought to room temperature before using Do not freeze Test strip package should be kept away from heat and direct sunlight Dessicant packet in the vial should not be removed The cap should be replaced immediately after removing a test strip and the test strip should be used as soon as it has been removed from
71. s three months from the date the vial is first used discard date Do not use after the expiration date or discard date whichever comes first The control solution should be kept at room temperature 68 77 F 20 25 C before testing Store control solution tightly closed at temperatures below 86 F 30 C Do not refrigerate Shake the vial discard the first drop of control solution and wipe off the tip to ensure a good sample and an accurate result Insert a test strip into the meter Apply a drop of control solution to the edge of test strip and wait for results The results should fall within the expected range printed on the test strip vial If the results are outside this range repeat the test with a new test strip Results that fall outside the range may be due to 1 Error in performing the test 2 An expired or contaminated control solution 4 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures 3 Expired or deteriorated test strips 4 Improper coding of the meter 5 Meter malfunction 6 Or control solution test performed outside proper temperature e Contact the Customer care agency for further assistance if retest results are still not within the acceptable range LifeScan 1 800 227 8562 or www LifeScan com f The control solution test should be performed 1 Once each day before patient samples are tested 2 Whenever using a new vial of test strips 3 When the meter is used for the firs
72. t time before doing a blood test 4 Whenever the meter or test strips are suspected to be improperly working 5 If the blood glucose test results are not consistent with patient s signs and symptoms 6 Ifthe meter is dropped damage or exposed to liquids 9 INTERPRETATION i Blood glucose screening a Results from blood glucose readings and assessments will be based on guidelines from the American Diabetes Association ADA Normal IFG or IGT Pre Diabetes Diabetes Mellitus FPG lt 100 mg dL FPG 100 125 mg dL IFG FPG gt 126 mg dL 2 h PG lt 140 mg dL 2 h PG gt 140 199 mg dL IGT 2 4 PG 200 mg dL Symptoms of DM and RPG concentration 200 mg dL A diagnosis of diabetes mellitus must be confirmed on a subsequent day by measurement of FPG 2 h PG or RPG if symptoms are present The FPG test is greatly preferred because of ease of administration convenience acceptability to patients and lower cost Fasting is defined as no caloric intake for at least 8 h This test requires the use of glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water FPG Fasting plasma glucose PG Post prandial glucose IFG Impaired fasting glucose IGT Impaired glucose tolerance RPG Random plasma glucose DM Diabetes Mellitus 10 LIMITATIONS OF METHOD 1 Blood glucose screening a The measuring range for blood glucose is 20 600mg dL 1 1 33 3 mmol L Results out of this range
73. terol or triglyceride values outside the measuring range will be recommended to see a physician for follow up 11 REFERENCES a b Cholestech LDX Procedure Manual 1999 Cholestech Corporation CardioChek Analyzer Manual http www quickmedical com Polymer cardiochek_guide html Executive Summary of the Third Report of the National Cholesterol Education Program Education Panel on detection evaluation and treatment of high blood cholesterol in adults Adult Treatment Panel III JAMA 285 19 2001 Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines Circulation 2004 110 227 239 University of Southern California Environmental Health and Safety Policies Safety Policy 16 Bloodborne Pathogens March 15 2004 available at http policies usc edu policies safety03 1504 pdf University of Southern California Environmental Health and Safety Policies Safety Policy 007 Hazardous Waste Management March 15 2004 available at http policies usc edu policies safety03 1504 pdf 12 SIGNATURES Please refer to page 1 of Policy and Procedure Manual PROCEDURE FOR DRAWING BLOOD 1 Fingerstick Procedure for Cholestech LDX and CardioChek Analyzer A warm hand and good blood flow from the puncture site are essential in order to collect a good capillary sample Gloves should be worn when working with blood samples and should always be changed between each patient
74. the protective equipment will be used All PPE must be selected with the goal of providing protection from a hazard Selection of alternate choices of PPE should be considered if the user is at risk of physiological discomfort such as contact dermatitis from latex gloves or asthma from wearing certain face masks Proper training on the wearing and function of personal protective equipment is required PRIOR to using PPE Consultation or advice on PPE is provided by the University of Southern California Laboratory Safety Department Eye protection 27 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures Protective eyewear must be worn in the laboratory when it is reasonably anticipated that blood or other potentially infected material may make contact with the eye Face shields may be required if there is a potential for splashes sprays or aerosols Lab coats and uniforms Laboratory coats gowns or other protective clothing must be worn while in the laboratory long sleeves are required Before leaving the laboratory this protective clothing must be removed and left at the work site Sandals and open toed shoes are not permitted Personnel must wear additional PPE apron booties face shield etc that is required All PPE will be removed prior to leaving the work areas and placed in designated areas for disinfection or disposal Faculty staff or students are not permitted to take PPE home to launder Gloves All
75. the vial MEMo Chip should be kept either in the analyzer or stored with the original lot of strips Store the test strips in the original vial Do not combine with other strips and do not store the MEMo Chip in the test strip vial After opening the test strips are stable until the expiration date if vial is properly stored and always capped The analyzer will give an indication on the display that the batteries need to be changed When the display reads CHANGE BATTERY no more tests can be run until the batteries are changed Always replace batteries with high quality alkaline batteries It is recommended to keep a spare set of batteries on hand To extend battery life remove the test strip as soon as the result is displayed The time date and results in memory will not be erased when the batteries are changed Dispose of old batteries properly 9 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures il d No maintenance is required other than routine cleaning if necessary If the exterior of the CardioChek analyzer needs cleaning dampen a cloth with water and wipe the surfaces and the display area carefully Do not use bleach window cleaner or hydrogen peroxide A solution of 70 isopropyl alcohol is an appropriate cleaning agent Be careful not to get the Test Strip Insert Opening wet Carefully wipe he Test Strip Insert Opening with a clean damp not wet lint free tissue or cloth Make sure the glass is very clea
76. to patient name date type of screening and signature of the person providing the screening All supplies needed for the screening as described in the procedures will be available and not expired The laboratory director and consultant laboratory technician will be provided with periodic reports at their request of patients screened and referred using the risk assessment algorithm for lipids appendix H and diabetes patient assessment form appendix O Training of all pharmacists and intern pharmacists is comprehensive competency based and integrated in the USC School of Pharmacy curriculum It includes but is not limited to blood borne pathogens and universal precautions finger stick technique emergency management screening guidelines and instrument specific training By signing above our CLIA waived laboratory director attests to the competency to perform blood glucose and lipid testing of those who have completed our standardized training program at the USC School of Pharmacy In addition our laboratory technologist attests to the accuracy of the following procedures for CLIA waived testing 1 updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures PROCEDURES A TESTING PROCEDURES 1 HEADING a Organization USC Campus Pharmacy and USC School of Pharmacy Mobile Unit b Tests 1 Blood glucose screening REFER TO SECTION 1 2 Cholesterol screening REFER TO SECTION 2 SECTION 1 BLOOD GLUCOSE SCREEN
77. your measurements within 5 years Continue with healthy eating patterns regular physical activity and weight reduction if overweight As a part of good healthcare see your physician regularly Patient receives EVALUATION 2 form see Appendix J Patient receives EVALUATION 1 form see Appendix I updated 3 19 2010 USC Mobile CLIA Waived Testing Policy and Procedures APPENDIX I EVALUATION 1 Patient Cholesterol Level Evaluation lipoprotein good cholesterol Triglycerides fat LDL low density lipoprotein had nhalactaral Name Age Sex What does my cholesterol level mean Total Blood Cholesterol Level Desirable lt 200 mg dl Borderline 200 239 mg dl High risk gt 240 mg dl HDL Cholesterol Level Desirable gt 40 mg dl Risk lt 40 mg dl LDL Cholesterol Level Desirable lt 100 mg dl Borderline 130 159 mg dl High risk gt 160 mg dl Triglyceride TG Level Normal lt 150 mg dl Borderline High 150 199 mg dl High 200 499 mg dl Very High gt 500 mg dl What are my risk factors Male age gt 45 years or Female age gt 55 years Family history of premature coronary heart disease HDL level lt 40mg dL Smoking Hypertension Oooo Negative risk factor Q HDL level gt 60mg dL Risk Factors What do I need to do now See your physician within 2 months for further evaluation and for a lipoprotein analysis regardless of risk factors USC Mobile CLI

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