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This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases,

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Presentation on theme: "This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases,"— Presentation transcript:

1 This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN C, entitled NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS). Specimen Transport and Management Version 5.0, August 2012

2  Discuss the importance of adequate collection, handling, and transport of specimens  Discuss specimen flow and chain of custody  List the criteria for specimen rejection  Explain the importance of prompt clinic notification regarding specimen quality and panic values  Discuss the importance of maintenance of optimal conditions during specimen storage and shipment Objectives 2

3 The following ‘order of draw’ should be followed when performing a venipuncture: A.Blood culture, Prothrombin Index/Partial Thromboplastin Time (PI/PTT), chemistry (plain tube), Complete Blood Count (CBC) Ethylenediaminetetraacetic Acid (EDTA), glucose (Oxalate/Fluoride) B.PI/PTT, blood culture, glucose (Oxalate/Fluoride), CBC (EDTA), chemistry (plain tube) C.Blood culture, chemistry (plain tube), glucose (Oxalate/Fluoride), CBC (EDTA), PI/PTT D.Chemistry (plain tube), blood culture, PI/PTT, CBC (EDTA), glucose (Oxalate/Fluoride) Pre-Assessment Question #1 3

4 Is it important to record the identity of the phlebotomist who collected participant information on the requisition form? A.Yes B.No Pre-Assessment Question #2 4

5 Which of the following are reasons to reject a specimen? A.The wrong tube was used to collect the specimen B.The specimen is not labeled or is labeled incorrectly C.The request form includes adequate information D.A and B only E.B and C only F.None of the above Pre-Assessment Question #3 5

6 Notification records should include which of the following: A.Identification (ID) of person making the contact B.Date and time of contact C.A description of the problems when accomplishing the task D.B and C only E.All of the above Pre-Assessment Question #4 6

7 Before shipping samples, which of the following tasks must be ensured: A.Number of specimens in box corresponds to the number listed on the shipping manifest B.ID numbers on the specimen tubes match those on the shipping manifest C.Shipping date matches the study protocol D.A and B only E.B and C only F.All of the above Pre-Assessment Question #5 7

8 Fred opens a specimen transport container and prepares to receive a packet of Sodium Heparin tubes for Peripheral Blood Mononuclear Cells (PBMC) processing. He notes from the requisition form that the specimens were collected four days earlier.  What action should he take?  How can this be prevented from recurring in the future? What Would You Do? 8

9 Specimen Quality What is Specimen Integrity? 9

10 Specimen Quality (cont'd) The reliability and accuracy of all laboratory test results depends on the quality of the specimen submitted 10

11 Specimen Quality (cont'd) The specimens should be properly: Collected Handled Labeled Transported to the laboratory 11

12 Inadequate collection and improper transport of specimens result in:  Inaccurate and invalid results  Results delay  Participant discomfort  Increased costs  Misdiagnosis, incorrect treatment  Reduced quality of care Specimen Collection and Transport 12

13 Specimen Management Specimen:Specimen: CollectionCollection LabelingLabeling TransportTransport ReceiptReceipt ReferralReferral ProcessingProcessing StorageStorage DisposalDisposal ShippingShipping 13

14 Specimen Collection SOP Venipuncture guidelines Specimen labeling Order of draw Contents: Standard labeling practices must be implemented and enforced with all users of the laboratory services. All specimen tubes must be properly identified with the Patient Identifications (PID). 14

15 Order of Draw The order in which vacuum tubes are drawn during venipuncture can affect the specimen quality Additives from one tube may contaminate the next tube 15

16 Order of Draw (cont’d) Sterile tubes for culture Clinical and Laboratory Standards Institute (CLSI) recommends the following order of draw Sodium Citrate Serum tubes with or without clot activator/gel Heparin EDTA 6 Oxalate/Fluoride tubes 16

17 Specimen Labeling Laboratory should enforce proper specimen labeling practices Laboratory should enforce proper specimen labeling practices 17

18 Documented guidelines for use by the clinic staff:  Sample preparation  Sample transport  Specimen rejection criteria Specimen Handling 18

19 Collection Forms Requisition Forms Specimen Tracking Forms 19

20 Requisition Form 1st Section: Laboratory, Study ID  Testing Laboratory  Study ID 20

21 Requisition Form (cont’d) 2nd Section: Demographics  PID Number  Initials (Optional)  Gender  Date of Birth 21

22 Requisition Form (cont’d) 3rd Section: Visit Details  Specimen Collection Date  Specimen Collection Time  Visit  Phlebotomist 22

23 Requisition Form (cont’d) 4th Section: Collection  Tube quantity and type  Visit specific investigations listed  Collection instructions 23

24 Requisition Form (cont’d) 5th Section: Specimen Receipt  Specimen receipt confirmation  Receipt comments 24

25 Specimen Transport Documented procedures required to address: Biohazard labeling requirements of transport containers Specimen transport from offsite facilities Specimen transport within the facility 25

26 Standard Precautions All specimens should be treated as potentially hazardous! 26

27 Specimen Receipt Verification of specimen details Specimen receipt date and time Assessment of quality and volume Identity of the receiving personnel 27

28 Specimens received past assay stability Insufficient or clotted specimen Specimen collected in a wrong tube Inadequate information on request form Specimen Rejection Criteria Unlabeled specimen Mislabeled/incompletely labeled specimen 28

29  Prompt notification of rejected specimens to the clinic  Documentation of notification  Cumulative review of notification records to be discussed at study team meetings Specimen Rejection Requires 29

30 Clarification/Notification Form 30

31 Data Clarification/Notification Form 31

32 You are about to perform an Human Immunodeficiency Virus (HIV) enzyme-linked immunosorbent assay (EIA) run on 24 specimens. Upon recording the PIDs on the plate template, you notice two specimens that have the same PID. How would you proceed? A.Consult with the supervisor; discard the two specimens; notify study clinic B.Abandon the whole run and seek clarification before proceeding C.Consult with the supervisor; proceed with testing; if both negative or positive, report results D.All of the above E.None of the above Skill Check 32

33 Specimen Referral Shipping manifests Analyte stability Specimen audit trail 33

34 A Section Supervisor notes that the potassium value generated by the analyzer is 9.2 mmol/l (reference range 3.1 – 5.0). Select the most appropriate steps that should be taken. A.Release the results B.Verify that quality control (QC) and calibration are acceptable before releasing the results C.Verify QC and calibration; notify the clinic and document notification before releasing the results D.Check the specimen for hemolysis; verify QC and calibration; notify the clinic; and document notification before releasing the results Skill Check 34

35 Specimen Chain of Custody Collection Transport Specimen Type Testing Required Study, Site Receipt Condition Testing Personnel Audit trail information includes 35

36 Definition Results that require prompt and rapid clinical attention to avert significant study participant/patient morbidity or mortality Values should be defined by the Laboratory Director, in consultation with clinicians served Policy/procedure for immediate contact of key study personnel Critical Values 36

37 Critical Values (cont'd) Date and time of notification ID of personnel making the contact Person notified and message relayed Notification records should include: Problems encountered with accomplishing the task 37

38 Critical Values (cont'd) The laboratory should implement a policy that personnel receiving verbal or phone orders must read back the entire order to verify accuracy of transcription An emergency telephone contact list for the key study personnel 38

39 The only sample for the day from the study clinic (30-minute drive away) is received at the Central Laboratory for CBC testing on a Friday afternoon. A PID number mismatch is noted between the request form and the specimen label although it appears that one digit seems to have been omitted on the specimen label. The clinic closes early on Fridays. Per the Laboratory Standard Operating Procedure (SOP), specimens with PID mismatches should be rejected. Skill Check 39

40 What should the laboratory personnel do? A.Assume that this was a transcription error and process the sample B.Reject the sample as per SOP instruction C.Process the sample and withhold release of results until the issue is resolved D.Place the specimen in the refrigerator for resolution of the query the following week Skill Check 40

41 Specimen Retention  Which specimens?  How do we store?  How long do we store? Protocol-specific procedures Policy for disposal of biohazardous waste 41

42 Specimen Storage Research samples are an invaluable resource 42

43 Research Laboratories should invest in dedicated sample storage facilities Round the clock monitoring of storage conditions to ensure that the integrity of samples is maintained Fully documented disaster recovery procedures should be implemented Specimen Storage (cont'd) 43

44 Repositories Sample repositories should be created by suitably storing the samples Relevant records for repositories should be traceable and accessible Specimen aliquots must be properly labeled before storage Specimen Storage (cont'd) 44

45 Specimen Shipping All federal and in country Transportation of Dangerous Goods Regulations must be met for the transportation of specimens Proper organization, packaging, shipping, and handling of specimens ensure specimen integrity, while maintaining timely and safe transfer of specimens 45

46 Specimen Shipping (cont'd)  Matches the number of specimens in the box  Matches the ID numbers on specimen tubes  Contains the necessary data for each PID  Includes the shipping date and other laboratory information (e.g., name and address)  Matches the number of specimens in the box  Matches the ID numbers on specimen tubes  Contains the necessary data for each PID  Includes the shipping date and other laboratory information (e.g., name and address) Before dispatch of samples, ensure that the shipping manifest: Before dispatch of samples, ensure that the shipping manifest: 46

47 Specimen Shipping (cont'd) Certification Personnel who ship specimens must have International Air Transport Association (IATA) dangerous goods training Training must be renewed every two years Certification must be on file and available for inspection 47

48 Fred opens a specimen transport container and prepares to receive a packet of Sodium Heparin tubes for PBMC processing. He notes from the requisition form that the specimens were collected four days earlier.  What action should he take?  How can this be prevented from recurring in the future? What Would You Do? 48

49 The following ‘order of draw’ should be followed when performing a venipuncture: A.Blood culture, PI/PTT, chemistry (plain tube), CBC (EDTA), glucose (Oxalate/Fluoride) B.PI/PTT, blood culture, glucose (Oxalate/Fluoride), CBC (EDTA), chemistry (plain tube) C.Blood culture, chemistry (plain tube), glucose (Oxalate/Fluoride), CBC (EDTA), PI/PTT D.Chemistry (plain tube), blood culture, PI/PTT, CBC (EDTA), glucose (Oxalate/Fluoride) Post-Assessment Question #1 49

50 Is it important to record the identity of the phlebotomist who collected participant information on the requisition form? A.Yes B.No Post-Assessment Question #2 50

51 Which of the following are reasons to reject a specimen? A.The wrong tube was used to collect the specimen B.The specimen is not labeled or is labeled incorrectly C.The request form includes adequate information D.A and B only E.B and C only F.None of the above Post-Assessment Question #3 51

52 Notification records should include which of the following: A.ID of person making the contact B.Date and time of contact C.A description of the problems when accomplishing the task D.B and C only E.All of the above Post-Assessment Question #4 52

53 Before shipping samples, which of the following tasks must be ensured: A.Number of specimens in box corresponds to the number listed on the shipping manifest B.ID numbers on the specimen tubes match those on the shipping manifest C.Shipping date matches the study protocol D.A and B only E.B and C only F.All of the above Post-Assessment Question #5 53

54  Guideline H18-A3: Procedures for the Handling and Processing of Blood Specimens     References 54

55 Wrap Up 55


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