specimen collection and shipment strategy georgina tzanakaki and aftab jasir european public health...

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

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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

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The result of any laboratory examination is only as good as the sample received in the laboratory

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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

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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

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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

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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)

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Biosafety: protect the people

Use single use equipment

Disinfect

Work in a clean, dedicated area

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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

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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

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Sample Handling

Handle all samples as if infectious

Procedures

• Collecting specimens

• Marking and labeling

• Handling

• Packing

• Package labeling

• Necessary documents following the transporting sample

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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)

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This presentation used some information of the training package „Laboratory issues for epidemiologists“ put in place by the:

Thank you for your attention

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