Chemical Pathology UN3373 Safety Data Sheet (SDS)

Recommended use: Quality Assurance/Proficiency Testing programs. Not to be used in the treatment or diagnosis of patients.

Hazard Identification

Chemical hazard: Not applicable

Environmental hazard: Not applicable

Health hazard: Biological Substance, Category B

These samples must be considered as potentially biohazard and should be handled appropriately and with care.  The participant is responsible for the safe handling, storage and disposal of RCPAQAP proficiency testing materials in such a way that ensures that the proficiency testing materials will not cause any harm to any person.

The participant understands and acknowledges that, given the nature and characteristics of RCPAQAP proficiency testing materials;

• laboratory staff should be trained in the handling of infectious materials.
• proficiency testing materials should be processed in a laboratory environment as identified by the relevant legislative requirements.
• they are aware of all matters that concern the safe handling, storage and disposal of proficiency testing materials.
• they have the facilities and processes required for the safe handling, storage and disposal of proficiency testing materials.
• that they follow Standard Safety Precautions when handling potentially infectious materials.
• they utilise Personal Protective Equipment (PPE) as identified by the relevant legislative requirements for the routine handling of potentially infectious materials.

Composition and Information on Ingredients

Products contain the below components:

First-aid Measures

If accidental contact with material occurs, laboratory staff should follow appropriate first aid procedures for exposure to an equivalent clinical specimen. Following exposure, medical advice should be sought. If accidental spillage occurs, follow routine procedures for clean-up of potentially biohazardous materials.

Firefighting Measures

Not applicable, not flammable.

Accidental Release Measures

Personal protective equipment such as gloves, a gown and protective eyewear should be used before cleaning any spills. Dispose of any sharps in a safe disposal system. Clean the area with absorbent paper and clean excess with suitable disinfectant such as bleach. Do not use alcohol in the case of Clostridium difficile spillages.

Handling and Storage

On arrival, samples should be stored as per instructions provided. Samples have been shown to be stable at the nominated transport temperature.

Samples should be re-constituted or prepared according to the Survey Instructions provided.

Exposure Controls and Personal Protection

Samples are generally intended for processing in a clinical laboratory facility and should be handled in the same manner as routine patient samples using universal precautions and appropriate personal protective equipment. Biosafety Level 2 precautions at a minimum should be used in laboratory settings.

Physical and Chemical Properties

Lyophilised stimulated stool – brown/black colour powder, pH neutral

Stability and Reactivity

This material is stable under normal temperatures and pressures, is non-corrosive, and polymerization will not occur.

Conditions to avoid: Avoid excess heat.

Toxicological Information

These samples are potentially infectious and may be positive for hepatitis B, hepatitis C virus, human immunodeficiency virus (anti-HIV-1/HIV-2) or other infectious diseases or microorganisms.

Ecological Information

Same biodegradability as human blood, urine and other bodily fluids.

Samples may contain common environmental microorganisms, which can be found in soil, water, fruits, and showers. For this reason samples must be appropriately discarded as described below.

Disposal Information

Dispose as clinical waste in suitably identified containers using a registered clinical waste disposal contractor (same as for patient samples). Samples must not be discarded in general waste.

Transport Information

Proper Shipping Name: Biological Substance, Category B

UN Number: UN3373

Hazard Class/Packing Group: Category B

Labels Required: UN3373

IATA Packaging Requirements: IATA compliant to PI 650 requirements

Regulatory Information

Not Applicable.

Other Information

Reviewed annually as part of the RCPAQAP compliance with ISO/IEC 17043

The information provided in this document is believed to be accurate and represents the best information currently available to us. The RCPAQAP make no warranty or merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability from its use. Users should make their own investigations to determine the suitability of the information for their particular purpose. In no event shall the RCPAQAP be liable for any claims, losses or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, arising from the use of this product or the information contained in this Safety Data Sheet.