Methodologies and Regulations in Specimen Collection and Management

1. Methodologies and Regulations in Specimen Collection and Management Module 2: Specimen Collection & Processing

2. Specimen Collection & Processing My lab collects and cares for specimens properly • Includes… • Collection • Labeling • Processing • Packaging • Storage • Tracking • Disposal

3. Objectives After this unit, you will be able to: • Provide professional friendly patient service • Collect and label specimens properly • Log specimens properly • Inspect quality of all specimens and record rejected samples • Assign priority according to test request • Process & aliquot specimens

4. Objectives After this unit, you will be able to: • Package specimens for shipment to referral site (if needed) • Store specimens in proper place and temperature (if needed) • Track specimen referral status • Dispose of specimens properly • Relate QCC activities to their labs

5. Determine the Type of Specimen to be Collected If blood is required: • Review Procedures • Requirements for (Venous) Blood Collection • Determine volume requirements and type of tube required • Label the tube properly

6. Activity: Role Play • The Laboratorian is drawing blood • See if you can identify any mistakes

7. Specimen Receipt / Logging Process • Confirm specimen receipt • Log date and time of receipt • Assign unique number to each sample • Requisition and sample stay together

8. To Accept or Reject? • Criteria for Specimen Acceptability • Labeling Errors • Unsatisfactory Specimens • Specimens with Hazardous Handling Conditions • Requisition Inadequacies • Review Specimen Management - Collection, Disposal & Rejection • Form to document specimen rejection

9. Activity: Role Play • How to communicate specimen rejection to clinical personnel • Worst Case Scenario • Best Case Scenario

10. Assign Test Priority According to Test Request • Note testing priority placed on requisition • Stat? • Is the patient waiting? • Is this routine? • To which workstation will the specimen be directed?

11. Process & Aliquot Specimens • Case Study #1 • One tube of serum • Liver function tests and hepatitis ordered • How will you aliquot & process these specimens?

12. Process & Aliquot Specimens • Case Study #2 • One tube of EDTA whole blood • Full Blood Profile (FBC) and CD4 requested (CD4 must be sent to another facility for testing) • How will you aliquot & process these specimens?

13. Questions? • How soon should a specimen be transported to the lab after collection? • How soon should a specimen be processed after collection? Serum? Whole Blood? • How soon should centrifugation occur to separate the serum? • Why is it important to process specimens in a timely fashion?

14. The Red Cell vs. The Serum • Glucose (1.2) • Phosphate(1.3) • Sodium (9) • Calcium (10) LDH (160) AST/GOT (40) K+ (23) ALT/GPT (7) LDH (160) AST/GOT (40) K+ (23) ALT/GPT (7)

15. Specimen Transport • Safety • Packaging & Preservation • Temperature control during transport • Transport time • Modes of Transport

16. Specimen Transport • What happens to the patient if we damage or loose his / her specimen during transport? • What happens to the other specimens if we spill or break one specimen?

17. Packaging Specimens for Shipment to Referral Sites If the laboratory receives a quality specimen, then the patient can receive a quality result.

18. Triple Packaging System “Primary receptacles shall be packed in secondary packagings in such a way that, under normal conditions of transport, they cannot break, be punctured or leak their contents into the secondary packaging. Secondary packagings shall be secured in outer packagings with suitable cushioning material. Any leakage of the contents shall not compromise the integrity of the cushioning material or of the outer packaging” (World Health Organization (2004). Transport of Infectious Substances, Annex 2, p27.)

19. General Specimen Packaging and Shipping • Utilize PPE when packaging specimens. • Ensure specimens are in the appropriate transport media (primary containers) for the specimen collected and the test requested (primary containers). Ensure that primary containers will not leak • Determine the requirements temperature (ambient temperature vs refrigerated) and the referral timeframe (i.e., 6 hours) for the specimen collect and the test requested.

20. General Specimen Packaging and Shipping • Consult the driver/courier schedule to ensure that the sample will reach the referral center within the necessary referral timeframe. • Place cool packs on the bottom of a secure leak-proof secondary container to properly preserve the specimens during shipping (specimens shipped at ambient temperature may not require cool packs, although it is often still advisable in warm climates).

21. General Specimen Packaging and Shipping • Place the primary container(s) in the secondary container with sufficient absorbent material —paper towels, cotton balls, commercial products—to absorb the entire contents of the primary containers. • Ambient temperature specimens can be transported in the same secondary packaging as refrigerated specimens, but should be packed as far away from the cool pack as possible and be insulted by at least one layer of absorbent material.

22. General Specimen Packaging and Shipping • Ensure secondary container(s) is labeled properly with a biohazard sticker or stamp. • Place secondary container(s) in an outer shipping container that can be secured with a screw top, latch mechanism or sealed with tape. • Place test requisition forms in a plastic sheath (if possible) inside the outer shipping container with specimen tracking form.

23. General Specimen Packaging and Shipping • Confirm that the contact information for the laboratory is clearly marked on the outer shipping packaging and/or in paperwork inside the outer packaging • Note the date and time of pick-up on the specimen tracking form and/or the driver/courier logbook. • Ensure that the drivers/couriers have received basic safety training in the transportation of specimens. • Disinfectthe bench where the specimens were packaged.

24. Specimen Package Diagram • Outer shipping container fiberboard cylinder with metal screw cap • Secondary container plastic liner with screw cap • Primary receptacle specimen tube

25. Specimen Package Diagram • DO NOT put any patient information on outer container or secondary containers or lids. • Biohazard Label should be on Secondary Container. • DO NOT put Biohazard Label on Outer Container. Mailing Label BIOHAZARD • Fluorescent Orange Red Background • Black lettering

26. Specimen Package Diagram • Outer shipping container (no patient information) • Lab request forms (placed outside secondary container) • Secondary container (no patient information) • Absorbent material • Primary receptacle (specimen inside properly labeled with patient identifier)

27. Activity: Packaging Specimens for Shipment to Referral Sites Purpose : To safely and effectively package specimens using the supplied packing materials. What will you need? • Job Aid 1: Triple Packaging System • Job Aid 2: Specimen Packaging and Shipping • Specimen packing material packets 20 minutes

28. Activity: Packaging Specimens for Shipment to Referral Sites What will you do? Divide into groups of 4-5 • Draw and label a triple packaging system • Package specimens with the supplied packaging materials using Job Aids 1 & 2 as a guide. 20 minutes

29. Step-by-Step Specimen Packaging Example Collect specimens in primary containers and packaging materials Place absorbent into bottom of secondary container.

30. Step-by-Step Specimen Packaging Example Wrap each tube in a paper towel Place tubes and biohazard marker in secondary container

31. Step-by-Step Specimen Packaging Example Put absorbent on top of tubes and screw on cap. Roll lab form around the outside of the secondary container. Place in outer container. Screw on cap.

32. Cross Section of Refrigerated Specimen Packing Ambient or Room Temperature Specimens Paper towels or absorbent materials Refrigerated Specimens Cool Pack Secondary Container Outer Container

33. Specimen Storage • Room Temperature or Refrigerated? • How long are specimens kept after analysis is complete?

34. Specimen Referral & Disposal • Review Specimen Referral Log & Specimen Transfer Form • How do we follow up on referred specimens? • Disposal a safety issue

35. Activity: Tracking Referral Specimens Purpose: To monitor status of a referred specimen by reviewing a specimen log What will you need? • Worksheet 1: Referral Log Questions • Handout 1: Specimen Referral Log • Worksheet 2: Occurrence Report Form • Handout 2: Occurrence Report Example 15+12 minutes

36. Activity: Tracking Referral Specimens What will you do? Step 1: Work in groups of 2 (pairs) • Review Handout 1 and complete the questions on Worksheet 1 • You have 15 minutes.

37. Activity: Tracking Referral Specimens What will you do? Step 2: Divide into groups of 4-6 people • Document the occurrence on Worksheet 2 • Select a spokesperson for your group to present the occurrence documentation to the class. • You have 12 minutes.

38. Specimen Referral Log

39. Review • To care for the patient we must insure proper specimen: • Collection • Labeling • Processing • Packing • Storing • Tracking • Disposal

40. What Would You Do? 1. After hours, a clinician obtained a venipucture specimen from a small child. The clinician left the specimen in the laboratory without notifying the laboratory staff on call. The following morning you receive a call from the clinician asking for the laboratory result. You find no documentation of a result or of even receiving this specimen. After searching, you find the specimen in the refrigerator grossly hemolyzed. • How will you handle this situation? • What steps will you take to prevent a reoccurrence of this situation?

41. What Would You Do? 2. On Thursday, a patient submits 3 specimens of saliva obtained last week for AFB testing. None of the specimens are acceptable. The patient angrily yells in the reception waiting room that they did what you told them to do. After clarifying the procedure to the patient for recollection, you discover that during the patient’s first visit, he was only given the cups with no further explanation. • How will you handle this situation?

42. Quality Assurance/Quality Control Have two teams (3 people each) role play: • Meeting, greeting patient, proper identification, proper venipuncture, labeling tubes, calling results to clinician • One team does a great job and the other team is rude and doesn’t follow protocol • Have audience point out how each role play influences patient/clinician satisfaction and promotes QA/QC within their lab setting

43. Summary Participants can now: • Provide professional friendly patient service • Collect and label specimens properly • Log specimens properly • Inspect quality of all specimens and record rejected samples • Assign priority according to test request…

44. Summary • Process & aliquot specimens • Package specimens for shipment to referral site (if needed) • Store specimens in proper place and temperature (if needed) • Track specimen referral status • Dispose of specimens properly • Relate QCC activity to their labs

45. Are there any questions?