Specimen collection and shipment strategy Georgina Tzanakaki and Aftab Jasir European Public Health Microbiology training program (EUPHEM)
Mar 27, 2015
Specimen collection and shipment strategy
Georgina Tzanakaki and Aftab Jasir
European Public Health Microbiology training program (EUPHEM)
• Why collection of specimens is important?
• Why transportation is important?
Learning objective
At the end of this part of the presentation, you should be able to understand the:
Procedures, preparation, processing and transport of specimens
3
Procedures
• Collecting specimens
• Marking and labeling
• Handling
• Packing
• Package labeling
• Necessary documents following the transporting sample
Procedures
• Collecting specimens
• Marking and labeling
• Handling
• Packing
• Package labeling
• Necessary documents following the transporting sample
Specimen collection: key issues
Consider differential diagnoses
Decide on test(s) to be conducted
Decide on specimen/s to be collected to conduct these tests
consultation between microbiologist, clinicians and epidemiologist
6
7
The result of any laboratory examination is only as good as the sample received in the laboratory
8
Sample
Management
PH eventsOutbreaksSurveillanceComplex Emergency situations
Procedures
• Collecting specimens
• Marking and labeling
• Handling
• Packing
• Package labeling
• Necessary documents following the transporting sample
Labeling specimens
1. Name (unique identifier)
2. Clinical specimen
3. Specimen type
4. Date, time and place of collection
5. Name/initials of the person responsible for collection
10
11
Criteria for rejecting samples
Mismatch of information on the label and the request
Inappropriate transport temperature
Excessive delay in transportation
Inappropriate transport medium
- specimen received in a fixative
- dry specimen
- sample with questionable relevance
Insufficient quantity
Leakage
12
Case investigation form
Clinicians/test requester send:
Personal information
– age (or date of birth), sex, complete address
Clinical information
– date of onset of symptoms, clinical and immunization history, risk factors or contact history where relevant, anti-microbial drugs taken prior to specimen collection
Laboratory information
– acute or convalescent specimen
– other specimens from the same patient
Line listing – if large number of patients
13
Procedures
• Collecting specimens
• Marking and labeling
• Handling
• Packing
• Package labeling
• Necessary documents following the transporting sample
Biosafety Principles
To protect:
– the patient
– yourself
– the environment -------(FILM)
15
16
Biosafety: protect the people
Use single use equipment
Disinfect
Work in a clean, dedicated area
17
Biosafety: protect yourself
Use personal protective equipment (PPE):
disposable gloves
laboratory coats / gown
mask
protective eyewear
Biosafety: protect yourself
Collect sharps immediately to prevent needle-stick injury
Have first aid kit readily accessible
Do not reuse contaminated equipment
18
19
Biosafety: protect others, the environment
• Package samples appropriately for transport
• Decontaminate spills
• Disinfect working areas for future use
• Soak contaminated non-disposable material
• Place waste in leak-proof biohazard bags
• Ensure safe final management of waste
• Protect cleaning personnel with PPE
20
Sample Handling
Handle all samples as if infectious
Procedures
• Collecting specimens
• Marking and labeling
• Handling
• Packing
• Package labeling
• Necessary documents following the transporting sample
22
Where do they come from?
Who develops them? United Nations Economic and Social Council
National transport regulations
ICAO/IATA transport regulations
rail, road, and sea traffic agencies
postal services
private couriers
Transport Regulations
Class 2: Non-flammable non-toxic gases
Liquid nitrogen (refrigeration)
Class 3: Flammable liquids
Ethanol (preservation)
Class 6: Toxic and infectious substances
Division 6.1 addresses toxic substancesDivision 6.2 addresses infectious substances
Class 9: Miscellaneous dangerous goods
Dry iceGenetically modified microorganisms and organisms (not classified under 6.2)
Dangerous Goods Classes
Class 2: Non-flammable non-toxic gases
Liquid nitrogen (refrigeration)
Class 3: Flammable liquids
Ethanol (preservation)
Class 6: Toxic and infectious substances
Division 6.1 addresses toxic substancesDivision 6.2 addresses infectious substances
Class 9: Miscellaneous dangerous goods
Dry iceGenetically modified microorganisms and organisms (not classified under 6.2)
Dangerous Goods Classes
Substance Categories (Division 6.2)
Category A (Infectious Substances)– e.g. Ebola virus, Bacillus anthracis (culture only)
Category B (Biological Substances)– e.g.Bacillus anthracis (patient specimen), Highly pathogenic avian influenza
virus (patient specimen)
Exempt– Medical assessment has determined a minimal likelihood that pathogens
are present
– e.g. Pregnancy test, Drug screening
Category A: Infectious substances
An infectious substance which is transported
in a form that, when exposure to it occurs, is
capable of :
• causing permanent disability,
• life-threatening or
• fatal disease in otherwise healthy humans or
animals.
• An infectious substance which does
not meet the criteria for inclusion in
Category A and has not been
determined by a medical
professional to have a minimal
likelihood that pathogens are
present.
e.g. serum, CSF, blood etc
Category B – Biological Substances
Exempt
– Medical assessment has determined a minimal likelihood that pathogens are present
e.g. Pregnancy test, Drug screening
What is the difference between cultures
and patient specimens?
Cultures and Patient Specimens
Cultures are incubated samples (with
purpose of multiplying pathogens)
Patient specimens are collected directly from humans/animals
These differences are important for the classification of infectious substances
This classification will affect the choice of packaging
Categorization and Identification
ProperShipping Name
CategorizationSituation
Sending a culture of Mycobacterium tuberculosis to a reference laboratory.
Patient presents with suspected case of Hepatitis B virus and blood samples are sent.
Medical professional declares human drug test as minimal likelihood for containing pathogens.
The Ebola virus has been found in bats and samples which have not been cultured are being shipped.
Category BBiological
Substance, Category B
Category A
Infectious Substance, Affecting Humans
Category A
Infectious Substance, Affecting Humans
ExemptExempt Human
Specimen
What are the requirements for packaging Category A and B
substances?
2009
World HealthOrganization
Triple Packaging
Primary container
Secondary container
Outer container
Absorbent and cushioning material
Triple packaging provides three layers of containment to protect the substances being shipped. These layers are primary, secondary, and outer containers. The following diagram shows the basic concept of triple packages.
Procedures
• Collecting specimens
• Marking and labeling
• Handling
• Packing
• Labeling packages
• Necessary documents following the transporting sample
Markings and Labels
Infectious Substance
Label
Markings and Labels
Orientation LabelsMandatory on opposite sides when
primary container exceeds 50 ml
Markings and Labels
Shipper’s and Receiver's Address
Markings and Labels
Emergency Contact
Name and Number
(Cat A)
Markings and Labels
Proper Shipping Name and UN
Number
Markings and Labels
UN Specification Marking (Cat A)
Markings and Labels
Procedures
• Collecting specimens
• Marking and labeling
• Handling
• Packing
• Package labeling
• Necessary documents following the transporting sample
Documentation for Shipping Infectious Substances
Overview
Air Waybill : goes with any shipment made by air
shipper or courier must complete the form
Completing the Shipper’s Declaration for Dangerous
Goods
Take home messages
Follow carefully sample collection information
Label samples with all necessary information
Respect biosafety principles to protect the patient, yourself and the environment
Handle all samples as if infectious
Use appropriate packaging according to the category of sample
Respect norms and regulations for transport45
For a good sample management and thus a good laboratory diagnosis you need to:
Sources
Department of Epidemic and Pandemic Alert and Response of the World Health Organization
European Program for Public Health Microbiology (EUPHEM)
46
This presentation used some information of the training package „Laboratory issues for epidemiologists“ put in place by the:
Thank you for your attention
47
?