Module 6 Specimen Management.pdf

specimen

1. Module 6: Specimen Management

2. Learning Outcomes
Bytheendofthemodule,youshouldbeableto:
1.Describetheprocessofspecimencollection.
2.Explainhowtoproperlyhandle,label,contain,transport,storeanddispose
ofspecimens.
3.Explaintheimportanceofmaintainingspecimenintegrityandassuringthat
allregulationsandrequirementsaremetwhentransportingspecimens.
4.Explaininternationalandnationalregulationsforshipmentofspecimens.

3. Outline
1.Componentsofspecimenmanagement
2.Importanceofgoodspecimenmanagement
3.Documentation
4.Specimencollection
5.Transport&shipmentofspecimens
6.Handlingofspecimens
7.Specimenreferral
8.Storageofspecimens
9.Specimendisposal
10.PersonnelTraining

4. 1. Components of Specimen Management
Source: CDC Training Package

5. Importance of Good Specimen Management
Enforces biosafety and biosecurity objectives

6. The Laboratory Handbook
●Containsinformationneededbythosewhocollect
samples
●Availabletoallsamplecollectionareas
●Mustbeunderstoodbyalllaboratorystaff
●Referencedinthequalitymanual
●Youneedtodevelopandvalidate an SOP for sample
management based on the information in the laboratory
handbook.

7. Laboratory Handbook Contents
●Name and address of laboratory
●Contact names and telephone numbers
●Hours of operation
●List of tests that can be ordered
●Sample collection procedures
●Sample transport procedures
●Expected turnaround times (TAT)
●How urgent requests are handled

8. 2. Specimen Collection (1/5)
Collection forms

9. 2. Specimen Collection (2/5)
The Laboratory Responsibilities

10. 2. Specimen Collection (3/5)
•The integrity of the samples must be preserved and requirements for
collection and handling must be followed according to the institutional
guidelines on sample collection.

11. 2. Specimen Collection (4/5)
Stages Specimen Collection Process
Before ●Identification of patients and registration of patients in hospital.
●Type of test.
●Preparation of patients.
●Preparation of labeled tubes with patient identification and requisition forms for some
test
During ●Right technique.
●Vein selection for blood sample.
●Using of correct collection tubes and container.
●Labeling of collection tubes with patient identification.
●Correct requisition forms.
After ●Specimen transport.
●Specimen handling and processing.
●Storage of specimen.
Note:Safety precautions are mandatory in all stages

12. 2. Specimen Collection (5/5)
•Delays in reporting test results
•Unnecessary re-draws/re-tests
•Decreased customer satisfaction
•Increased costs
•Incorrect diagnosis/treatment
•Injury
•Death
Outcomes of Improper Specimen Collection

13. 3. Specimen Labeling
Specimen label should contain:
•Patient name
•Patient ID number
•Specimen type
•Date collected
Use computer-generated
barcodes when possible

14. 4. Specimen Transport
•ShippingandtransportofbiologicalmaterialissubjecttostrictNationaland
Internationalregulations:
oProperclassification
oProperpackaging
oProperlabelingandMarking,notification
oCourierrequirement(meansandroutesoftransportation)
oChainofcustody
•Compliance:
oReduceslikelihoodofdamagingpackages
oMinimizesexposure(personnelandenvironment)
oImprovescarrier’sefficiencyandconfidenceinpackagedelivery
oSecurestheitembeingshipped(Chainofcustody)
Ensuresafetyregulationsaremet

15. Transport Regulations

16. Packaging of Specimens for Transport
Triple packaging is a
requirement for category A,
B, and exempt specimens.
However, in resource limited
settings, you may use
available resources to
improvise.

17. Marking
Markings
•Shipper’snameandaddress
•Receiver’snameandaddress
•Name andtelephonenumberof
responsibleperson(whoisavailable24
hoursadayuntilshipmentarrives;
emergencycontact)
•ProperShippingName
•UNNumber
•UNSpecificationmarking

18. Labels
Labels(hazardandhandling)
•Infectioussubstancelabel
•Orientationarrows(blackorred;
mandatory,onoppositesides,only
whenprimary
•containersexceed50ml)
•CargoAircraftOnly(whenthepackage
mayonlybetransportedonacargoaircraft
:4litersor4Kgs–categoryA)

19. 5. Chain of Custody
•Always observe a Chain of Custody
•Evidence (Documentation)
•Collector →Transporter →Laboratory
oEach person to touch the sample must sign for it.
•Laboratory –
oSigned for each time the sample is manipulated
•Confidentiality MUST to be observed to protect:-
oThe client
oThe items being shipped

20. 6. Specimen Receipt

21. Specimen Rejection Criteria

22. 7. Specimen Handling
•Handleallspecimensasifinfectious
•Usetrackingsystemforallspecimens
oAccession/loggingprocess
oConfirmactualreceiptofallspecimens
oDateandtimeofspecimenreceipt
oTrackaliquots-traceabletotheoriginalsample
•Establishproceduresforhandling
oStat/urgentrequests
oDelayedtestinge.g.storage,separationofplasma/serumfromcells
oLeakingcontainers
oContaminatedforms
oPreservationofspecimens

23. 8. Specimen Referral
•Record
oTests/specimensreferred
oDateofreferral
oNameofpersonreferringtest
•Monitor/trackandrecord
oTurnaroundtime(TAT)
oResultsdelivery(fromreferrallaboratorytorequester)
oProblemswithreferral

24. 9. Specimen Storage
•Establishpolicy
oWhatshouldbestored?
•Determineretentiontime
•Determinestoragelocation
oConsidereaseofaccess
•Assureproperstorageconditions
•Indexingofspecimens
oBydayofreceiptoraccessionnumber
•Serumbanks
oEstablishtrackingprocedures
Encourageuseofinformationtechnology(IT)
•Maintainanorganized,accessiblestoragesystem
•Monitorfreeze/thawcycles

25. 10. Specimen Disposal
•Establishpolicyfordisposalofbiologicalwaste
oEstablishandfollowdisinfectionprocedures
oComplywithlocalregulations
oIncludepolicyofdisposalofrejectedspecimens
•Appointsomeonewithoversightresponsibilities
•Establishascheduletoreviewallstoredspecimens

26. 11. Personnel Training (1/2)
Allpersonscomingincontactwithandwhodirectlyaffectthesafe
transportationofspecimenmustbetrainedandcertified.
•Biorisktrainingmustinclude:
•Generalawareness/familiarization
•Function-specifictraining
•Hazard/riskcommunicationskill
•Spillmanagement
•Documentation
•Safetyandsecuritytrainingand
•Drivertraining(foreachBioriskemployeewhowilloperateamotor
vehicle).

27. 11. Personnel Training (2/2)
Trainingschedule:
1.Onemployment,
2.after6months,
3.Thenannuallyoninfectiousmaterialhandling

28. 12. Key Considerations when Handling Specimens
•WearappropriatePPE
•SpecimenreceptionfromsuspectedcasesshouldbedoneintheBiosafety
Cabinet(BSC)
•Standardtriplepackagingshouldbedonewithpropersampletrackingform
•Ensurethecoolerboxandicepacksaredecontaminatedwith70%alcohol
•Testinglaboratoryshouldreviewworkflow

29. Key Messages
1.Have a laboratory handbook with collection information, necessary SOPs, and
forms.
2.Have a system for tracking specimens as they move through the point of
collection, use, storage and disposal
3.Establish and implement a policy for specimen management (collection,
transport, handling, storage and disposal)
4.Maintain specimen integrity
5.Ensure that all transport regulations and requirements are met.

30. The End
You have come to the end of this Module. Kindly attempt the module quiz and
aim to attain a pass mark of 80% before proceeding to module 7.