9. Support Documents and Forms

Transcription

1 9. Suppt Documents and Fms

2 Suppt Documents and Fms hecklist f onducting Rapid HV ests HV Enhance Risk Assessment ool lient est Result Log Product Infmation raining Proficiency esting Panel Results Investigational and Remedial Action on Unacceptable Proficiency esting linic ommunication and omplaint Log

3 General est Preparation hecklist f onducting Rapid HV ests onditions f testing verified (temperature and lighting) lock timer made available Expiration date verified on Pouch lean, disposable absbent wkspace cover Manufacturer s Stand used Stand is on flat level surface est Device left in pouch until needed (not contaminated) Absbent Packet included in Pouch Vial slid into Stand Vial is completely seated in Stand wo holes in back of est Device not covered Sample ollection and est Procedures - Fingerstick Whole Blood ollection Disposable gloves wn lient finger cleaned with antiseptic wipe Finger allowed to dry thoughly drop of blood collected Loop was completely filled with blood Loop stirred into Developer Solution Solution turned pink Pad on the est Device touched the bottom of the vial Results Window faced fward imer used Results read between 20 and 40 minutes after est Device inserted into the vial est Device read while in Developer Solution Vial est results properly recded 9-2

4 hecklist f onducting Rapid HV ests Sample ollection and est Procedures - Venipuncture Whole Blood ollection Specimen collection conducted with an EDA, lithium heparin, sodium heparin sodium citrate test tube Loop was completely filled with blood Loop stirred into Developer Solution Solution turned pink Pad on the esting Device touched the bottom of the vial Results Window faced fward imer used Results read between 20 and 40 minutes after esting Device inserted into the vial est Device read while in Developer Solution Vial Quality ontrol (o be conducted as per manufacturer s guidelines) Kit ontrols run; Date and ime Kit ontrols verify ontrol est Results match the expected results Good lighting used with ontrols est viewed good lighting conditions linic room temperature checked and recded omments: 9-3

5 HV Enhanced Risk Assessment ool 1. Did you receive a blood transfusion solid gan transplant (heart, lung, liver, pancreas, kidney) befe July 1992? 2. Did you receive clotting fact concentrates produced befe 1987? 3. Have you ever received hemodialysis? 4. Have you had blood tests that showed a liver problem? 5. Have you had a needlestick injury wking in a health care setting? 6. Did your mother have hepatitis when you were bn? 7. Have you shared a toothbrush, raz, any other item that might have blood on it (visible not) with a person who has hepatitis? 8. Have you any of your sex partner(s) injected illegal drugs, even if it was only one time many years ago? 9. Have you ever been told by a medical provider that you have HIV infection? No No No No No No No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes linic Name/Site Location: Name/ID Number: ounsel/ester: omments: 9-4

6 linic Name: OraQuick HV Rapid Antibody est lient est Result Log esting Location: Result & How Result ype of Date lient Received by: esting esting Date lient Supplemental Received ounsel est Dates est # Lot #/Exp. Date ime est Room ime est Room Received est Suppl Phone () lient ID/Name ode/initials mm/dd/yy Perfmed of est Perfmed emperature Interpreted emperature est Result Result Result Result in Person () 9-5

7 linic Name: OraQuick HV Rapid Antibody est lient est Result Log esting Location: Result & How Result ype of Date lient Received by: esting esting Date lient Supplemental Received ounsel est Dates est # Lot #/Exp. Date ime est Room ime est Room Received est Suppl Phone () lient ID/Name ode/initials mm/dd/yy Perfmed of est Perfmed emperature Interpreted emperature est Result Result Result Result in Person () Virginia Hall # Mark Dewitt # #938-LB 09/05/11 #938-LB 09/05/11 X X # /23/12 # /23/12 8:45 9: :42 10: /5/11 9/5/11 X X N/A 9/16/03 heresa Howard # #938-LB 09/05/11 X # /23/12 11: : Invalid N/A heresa Howard # X #938-LB 09/05/11 Repeat est # /23/12 12: : /5/11 N/A 9-6

8 OraQuick HV Product Infmation raining linic Name/Site Location: Name: Sce: rainer/ester: Select the best response f statements 1 through 6: 1. he complete stage temperature range of the OraQuick HV est Kit is (a) 2 8 ; (b)2 30 ; (c) comftable room temperature ; he complete stage temperature range of the OraQuick HV Visual Reference Panel is (a) ; (b)2 30 ; (c) comftable room temperature ; he complete stage temperature range of the OraQuick HV Kit ontrols is (a) 2 8 ; (b)2 30 ; (c) comftable room temperature ; he acceptable temperature range f perfming OraQuick HV est is (a) 2 8 ; (b)2 37 ; (c) comftable room temperature ; Accding to the manufacturer s instructions, the acceptable time to read the OraQuick HV est Device result is (a) 10 to 30 minutes (b)20 to 40 minutes (c) 20 to 80 minutes (d)10 to 60 minutes 6. he three possible OraQuick HV est Device result outcomes are (a) reactive, non-reactive, bderline (b)reactive, non-reactive, inconclusive (c) reactive, non-reactive, weakly reactive (d)reactive, non-reactive, invalid 7. he blood-filled Specimen ollection Loop (a) should be rapidly dipped in the Developer Solution Vial and discarded (b)should be stirred in the Developer Solution Vial and then discarded (c) can be left in the Developer Solution Vial f up to 10 minutes and discarded (d)should be stirred in the Developer Solution Vial and then saved until the test is complete 9-7

9 Select rue f Statements 7 16: 8. When conducting an OraQuick HV est ontrol, if the positive and/ negative control does not give the crect result(s), clients can still be tested with the OraQuick HV Kits. rue 9. If the absbent packet is not present when opening the OraQuick HV pouch, the pouch contents should be allowed to remain open f 5 10 minutes befe using. rue 10. he 2 holes in the back of the OraQuick HV est Device must be covered after placing the device into the Developer Solution Vial. rue 11. he built-in procedural control in the OraQuick HV est Device is intended to confirm that the patient sample has moved past the est () area. rue 12. he Developer Solution Vial must turn pink after adding the fingerstick whole blood sample. rue 13. he OraQuick HV est Device should not be removed from the Developer Solution Vial befe reading the est result. rue 14. he first drop of blood from a fingerstick can be use to perfm the OraQuick HV test. rue 15. An OraQuick HV reactive test result is interpreted as positive test f the presence of HV antibodies. rue 16. OraQuick HV is currently LIA-waiver approved f use in the U.S. with fingerstick whole blood specimens only. rue 9-8

10 OraQuick HV Product Infmation raining Answer Key 1) B. Stage conditions f the OraQuick HV est Kits is 2 30 ; ) A. Stage conditions f the OraQuick HV Visual Reference Panel is ; ) A. Stage conditions f the OraQuick HV Kit ontrols is 2 8 ; ). Acceptable temperature range f perfming the OraQuick HV est Device is a comftable room temperature of ; ) B. Acceptable times to read the OraQuick HV est Device is 20 minutes to 40 minutes. DO NO attempt to read the test result after the 40 minute test development. 6) D. he three possible OraQuick HV est result outcomes is (R), (NR) Non- and (INV) Invalid. An Invalid test result cannot be interpreted and is an indication that there was a problem running the test, either related to the specimen the Device. A repeat test should be perfmed with a new Pouch and new sample. 7) B. he blood-filled Specimen ollection Loop should be gently stirred in the Developer Solution Vial and then immediately discarded in a bio-hazard waste container. 8). If the kit controls DO NO produce the expected outcome of a reactive and non-reactive result pri to testing a patient sample, re-run the controls. If the test devices still do not produce a reactive and non-reactive result, contact OraSure echnologies. DO NO conduct any patient testing. 9). An absbent packet is included in each Device Pouch to ensure that moisture levels are maintained and do not compromise the est Device perfmance. he absence of an absbent packet means that the est Device may have been compromised during stage. Immediately discard package, device and developer vial and open a new pouch to proceed. 10). he two holes at the back of the OraQuick HV est Device are part of the design of the lateral flow system. Blocking these holes with labels and other materials will interfere with the test development. 11) rue. he built-in procedural control on the OraQuick est Device is designed to verify that the chemistry of the test has flowed past the est Line of the Device and that a sample was added to the Developer Vial Solution. 12) rue. If the blood-filled loop has been properly introduced to the Developer Solution Vial, the solution will turn a shade of pink indicating sample has been mixed. 13) rue. he OraQuick HV est Device should not be removed from the Developer Solution Vial until the test result has been read, interpreted and documented. 14). he first droplet of blood should be wiped away from the finger. ypically, the first droplet will contain tissue sample as well as blood. his may interfere with the test perfmance. Apply the loop to the second droplet f a clean sample. 15) rue. An OraQuick HV test results is repted as a POSIIVE. OraQuick HV Rapid Antibody est is a qualitative immunoassay test. A positive test result indicates that the presence of HV antibodies have been detected. he patient should undergo appropriate clinical follow-up f supplemental testing. 16). he OraQuick HV Rapid Antibody est is LIA-waived approved in fingerstick AND venipuncture whole blood. 9-9

11 OraQuick HV Rapid est Result Panel raining linic Name/Site Location: Name: Sce: rainer/ester: Result: Result: Result: Result: Result: Result: Result: Result: Result: Result: Write the Result on the line below each est Device: Non- (NR); (R); Invalid (INV) 9-10

12 OraQuick HV est Result Panel raining Answer Key OraQuick Rapid est Result Panel raining - Answer Key 1) NR. est line appears only in the designated area, indicating no detection of HV antibodies are present at the time the test was conducted. Patient is presumed not to be infected with HV. 2) R. est lines appear in the and designated areas, indicating that the presence of HV antibodies have been detected in the specimen. he patient is presumed to be infected with HV. he strength of the line has no direct crelation to a quantitative interpretation of the HV virus. A reactive result in the OraQuick HV Rapid Antibody est should undergo appropriate clinical followup, accding to D recommendations f supplemental testing. 3) INV. No test lines appear in the designated areas. No interpretation can be made. Repeat the test with a new Pouch and a new specimen. 4) R. est lines appear in the and designated areas, indicating that the presence of HV antibodies have been detected in the specimen. he patient is presumed to be infected with HV. he strength of the line has no direct crelation to a quantitative interpretation of the HV virus. A reactive result in the OraQuick HV Rapid Antibody est should undergo appropriate clinical followup, accding to D recommendations f supplemental testing. 5) INV. No test lines appear in the designated area and only a partial line appears in the designated area. his result means there was a problem running the test, either related to the specimen to the Device. No interpretation can be made. Repeat the test with a new Pouch and a new sample. 6) R. est lines appear in the and designated areas, indicating that the presence of HV antibodies have been detected in the specimen. he patient is presumed to be infected with HV. he strength of the line has no direct crelation to a quantitative interpretation of the HV virus. A reactive result in the OraQuick HV Rapid Antibody est should undergo appropriate clinical followup, accding to D recommendations f supplemental testing. 7) INV. No test lines appear in the designated areas. he test result window has not cleared revealing the test result rendering it impossible to read interpret. his result means there was a problem running the test, either related to the specimen to the Device. No interpretation can be made. Repeat the test with a new Pouch and a new sample. 8) INV. Partial test lines appear inside the and designated areas. While on appearance, it would seem that a POSIIVE could be interpreted, the partial development of the test lines are not fully developed within the designated areas. No interpretation can be made. Repeat the test with a new Pouch and a new sample. 9) NR. est line appears only in the designated area, indicating no detection of HV antibodies are present at the time the test was conducted. Patient is presumed not to be infected with HV. 10) R. est lines appear in the and designated areas, indicating that the presence of HV antibodies have been detected in the specimen. he patient is presumed to be infected with HV. he strength of the line has no direct crelation to a quantitative interpretation of the HV virus. A reactive result in the OraQuick HV Rapid Antibody est should undergo appropriate clinical followup, accding to D recommendations f supplemental testing. 9-11

13 Proficiency esting Panel Results Specimen Proficiency Panel Interpretation: F each specimen, indicate the result with a checkmark f either REAIVE, NON-REAIVE, INVALID. Assay Lot #: o be completed by study monit: Specimen A: REAIVE NON-REAIVE INVALID ORRE INORRE Specimen B: REAIVE NON-REAIVE INVALID ORRE INORRE Specimen : REAIVE NON-REAIVE INVALID ORRE INORRE Specimen D: REAIVE NON-REAIVE INVALID ORRE INORRE Specimen E: REAIVE NON-REAIVE INVALID ORRE INORRE linic Name/Site Location: Name: Sce: rainer/ester: omments: 9-12

14 Investigational and Remedial Action on Unacceptable Proficiency esting Date of Investigation: linic Name/Site Location: Prepared by: lient Sample: Yes No ontrol Sample: Yes No Date of esting: ime of esting: Lot # of est Device: Exp. Date of est Device: Unacceptable (Repted) Result: Acceptable Result Range: Day of esting - Quality ontrol Results Reviewed: Indicate rective Action: Yes Acceptable Not Acceptable lerical/ranscription Review: Indicate rective Action: Acceptable Not Acceptable Was Patient Repted Results Affected? Indicate rective Action: No, (skip to next section) Yes lassification of Problem: lerical echnical Methodology Problem with lient raining Issue No Explanation onclusions: rective Actions/System hange(s) o Prevent Recurrence: Supervis: Lab Direct: Upon ompletion - his Recd Must be Maintained Accding to Local Regulations 9-13

15 linic Name/Site Location: linic ommunication and omplaint Log Date Repted: ime: Initiated By: Source of ommunication/omplaint: Date of Occurrence: ime: Narrative of Event (If necessary): Immediate rective Action aken: Does the written procedure cover how to deal with this event? Yes No Not Applicable *If No Procedure must be updated within fifteen days from date of event. If Yes Was the written procedure followed? If No Why not? Explain Below Yes Follow-up Activities Required? Yes No No If Yes-Indicate what and date to be completed below Fm ompleted by: Signature Upon ompletion - his Recd Must be Maintained Accding to Local Regulations 9-14

16 linic ommunication and omplaint Log linic Name/Site Location: Schnectady Women s Health linic - Schnectady, New Yk Date Repted: ime: Initiated By: 9/5/11 9:50 Josephine Parker Source of ommunication/omplaint: Kathy DeWitt s (# ) Rapid HV Screening est revealed a test result. lient verbally provided Infmed onsent but refuses clinical follow-up and supplemental testing. Date of Occurrence: ime: 9/5/11 9:00 Narrative of Event (If necessary): Explained to Ms. DeWitt s the imptance of clinical follow-up appointments and the need to perfm supplemental testing f the detection of viremia as well as including imptance of receiving future medical care and treatment. Reviewed availability of local programs and further counseling infmation. Re-emphasized the issues of protection from potential exposure to partner. Immediate rective Action aken: Does the written procedure cover how to deal with this event? X Yes No Not Applicable *If No Procedure must be updated within fifteen days from date of event. If Yes Was the written procedure followed? If No Why not? Explain Below X Yes No Follow-up Activities Required? Yes X No If Yes-Indicate what and date to be completed below Fm ompleted by: Signature Josephine Parker Diane Lancer - Supervis 9/5/11 9/5/11 Upon ompletion - his Recd Must be Maintained Accding to Local Regulations 9-15

17 220 East Street Bethlehem, PA ORASURE ( ) , 2012 OraSure echnologies, Inc. Item#HV0068 (rev. 04/12)