Presentation Transcript

1. Specimen Transportand Management

   Version 5.0, August 2012
2. Objectives 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
3. Pre-Assessment Question #1 The following ‘order of draw’ should be followed when performing a venipuncture: Blood culture, Prothrombin Index/Partial Thromboplastin Time (PI/PTT), chemistry (plain tube), Complete Blood Count (CBC) Ethylenediaminetetraacetic Acid (EDTA), glucose (Oxalate/Fluoride) PI/PTT, blood culture, glucose (Oxalate/Fluoride), CBC (EDTA), chemistry (plain tube) Blood culture, chemistry (plain tube), glucose (Oxalate/Fluoride), CBC (EDTA), PI/PTT Chemistry (plain tube), blood culture, PI/PTT, CBC (EDTA), glucose (Oxalate/Fluoride)
4. Pre-Assessment Question #2 Is it important to record the identity of the phlebotomist who collected participant information on the requisition form? Yes No
5. Pre-Assessment Question #3 Which of the following are reasons to reject a specimen? The wrong tube was used to collect the specimen The specimen is not labeled or is labeled incorrectly The request form includes adequate information A and B only B and C only None of the above
6. Pre-Assessment Question #4 Notification records should include which of the following: Identification (ID) of person making the contact Date and time of contact A description of the problems when accomplishing the task B and C only All of the above
7. Pre-Assessment Question #5 Before shipping samples, which of the following tasks must be ensured: Number of specimens in box corresponds to the number listed on the shipping manifest ID numbers on the specimen tubes match those on the shipping manifest Shipping date matches the study protocol A and B only B and C only All of the above
8. What Would You Do? 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?
9. Specimen Quality What is Specimen Integrity?
10. Specimen Quality (cont'd) The reliability and accuracy of all laboratory test results depends on the quality of the specimen submitted
11. Specimen Quality (cont'd) Labeled Collected The specimens should be properly: Transported to thelaboratory Handled
12. Specimen Collection and Transport 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
13. Specimen Management Collection Labeling Transport Receipt Specimen: Referral Processing Storage Disposal Shipping
14. Specimen Collection SOP Specimen labeling Contents: Venipuncture guidelines Order of draw 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).
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
16. Order of Draw (cont’d) Sterile tubes for culture 1 Sodium Citrate 2 Clinical and Laboratory Standards Institute (CLSI) recommends the following order of draw Serum tubes with or without clot activator/gel 3 4 Heparin 5 EDTA 6 Oxalate/Fluoride tubes
17. Specimen Labeling Laboratory should enforce proper specimen labeling practices
18. Specimen Handling Documented guidelines for use by the clinic staff: Sample preparation Sample transport Specimen rejection criteria
19. Requisition Forms Collection Forms Specimen Tracking Forms
20. Requisition Form 1st Section: Laboratory, Study ID Testing Laboratory Study ID
21. Requisition Form (cont’d) 2nd Section: Demographics PID Number Initials (Optional) Gender Date of Birth
22. Requisition Form (cont’d) 3rd Section: Visit Details Specimen Collection Date Specimen Collection Time Visit Phlebotomist
23. Requisition Form (cont’d) 4th Section: Collection Tube quantity and type Visit specific investigations listed Collection instructions
24. Requisition Form (cont’d) 5th Section: Specimen Receipt Specimen receipt confirmation Receipt comments
25. Specimen Transport Documented procedures required to address: Biohazard labeling requirements of transport containers Specimen transport from offsite facilities Specimen transport within the facility
26. Standard Precautions All specimens should be treated as potentially hazardous!
27. Specimen Receipt Assessment of quality and volume Verification of specimen details Identity of the receiving personnel Specimen receipt date and time
28. Specimen Rejection Criteria Unlabeled specimen Mislabeled/incompletely labeled specimen Inadequate information on request form Specimen collected in a wrong tube Insufficient or clotted specimen Specimens received past assay stability
29. Specimen Rejection Requires Prompt notification of rejected specimens to the clinic Documentation of notification Cumulative review of notification records to be discussed at study team meetings
30. Clarification/Notification Form
31. Data Clarification/Notification Form 31
32. Skill Check You are about to perform an Human Immunodeficiency Virus (HIV) enzyme-linked immunosorbentassay (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? Consult with the supervisor; discard the two specimens; notify study clinic Abandon the whole run and seek clarification before proceeding Consult with the supervisor; proceed with testing; if both negative or positive, report results All of the above None of the above
33. Specimen Referral Shipping manifests Analyte stability Specimen audit trail
34. Skill Check 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. Release the results Verify that quality control (QC) and calibration are acceptable before releasing the results Verify QC and calibration; notify the clinic and document notification before releasing the results Check the specimen for hemolysis; verify QC and calibration; notify the clinic; and document notification before releasing the results
35. Specimen Chain of Custody Audit trail information includes Collection Transport Specimen Type Testing Required Receipt Condition Testing Personnel Study, Site
36. Critical Values 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
37. Date and time of notification ID of personnel making the contact Person notified and message relayed Problems encountered with accomplishing the task Critical Values (cont'd) Notification records should include:
38. Critical Values (cont'd) An emergency telephone contact list for the key study personnel The laboratory should implement a policy that personnel receiving verbal or phone orders must read back the entire order to verify accuracy of transcription
39. Skill Check 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.
40. Skill Check What should the laboratory personnel do? Assume that this was a transcription error and process the sample Reject the sample as per SOP instruction Process the sample and withhold release of results until the issue is resolved Place the specimen in the refrigerator for resolution of the query the following week
41. Specimen Retention Protocol-specific procedures Which specimens? How do we store? How long do we store? Policy for disposal of biohazardous waste
42. Specimen Storage Research samples are an invaluable resource 42
43. Specimen Storage (cont'd) 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
44. Specimen Storage (cont'd) 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
45. Specimen Shipping Proper organization, packaging, shipping, and handling of specimens ensure specimen integrity, while maintaining timely and safe transfer of specimens All federal and in country Transportation of Dangerous Goods Regulations must be met for the transportation of specimens
46. Specimen Shipping (cont'd) Before dispatch of samples, ensure that the shipping manifest: 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)
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
48. What Would You Do? 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?
49. Post-Assessment Question #1 The following ‘order of draw’ should be followed when performing a venipuncture: Blood culture, PI/PTT, chemistry (plain tube), CBC (EDTA), glucose (Oxalate/Fluoride) PI/PTT, blood culture, glucose (Oxalate/Fluoride), CBC (EDTA), chemistry (plain tube) Blood culture, chemistry (plain tube), glucose (Oxalate/Fluoride), CBC (EDTA), PI/PTT Chemistry (plain tube), blood culture, PI/PTT, CBC (EDTA), glucose (Oxalate/Fluoride)
50. Post-Assessment Question #2 Is it important to record the identity of the phlebotomist who collected participant information on the requisition form? Yes No
51. Post-Assessment Question #3 Which of the following are reasons to reject a specimen? The wrong tube was used to collect the specimen The specimen is not labeled or is labeled incorrectly The request form includes adequate information A and B only B and C only None of the above
52. Post-Assessment Question #4 Notification records should include which of the following: ID of person making the contact Date and time of contact A description of the problems when accomplishing the task B and C only All of the above
53. Post-Assessment Question #5 Before shipping samples, which of the following tasks must be ensured: Number of specimens in box corresponds to the number listed on the shipping manifest ID numbers on the specimen tubes match those on the shipping manifest Shipping date matches the study protocol A and B only B and C only All of the above
54. References Guideline H18-A3: Procedures for the Handling and Processing of Blood Specimens www.legacyhealth.org www.csmc.edu www.uhl.uiowa.edu www.vh.org
55. Wrap Up