Chemical Pathology Safety Data Sheet (SDS)

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

Catalogue Number Product Name
15010102 Alcohol and Ammonia – Full Program
15170102 Angiotensin-converting Enzyme- Full Program
15700102 Anti-Fungals – Full Program
15180102 Anti-Mullerian Hormone – Full Program
15030102 Bile Acids – Full Program
15580102 Biogenic Amines – Full Program
15040102 Blood Gases – Full Program
15060102 B-Natriuretic Peptide – Full Program
15070102 Body Fluids – Full Program
15690102 Bone Markers – Full Program
15080102 C Reactive Protein – Full Program
15090102 Compact Serum Chemistry – Full Program
15750102 Condensed Blood Gases – Full Program
15110102 Condensed PoCT Blood Gases – Full Program
15120102 Condensed PoCT Troponin and HCG – Full Program
15100102 Condensed Serum Chemistry – Full Program
15050102 CO-oximetry – Full Program
15140102 CSF: Chemistry – Full Program
15150102 CSF: Oligoclonal Bands – Full Program
15160202 Dried Blood Spot – Full Program
15190102 Endocrine – Full Program
15220102 Endocrine Special – Full Program
15810102 Everolimus – Full Program
15230102 Faecal Occult Blood – Full Program
15720102 Foetal Fibronectin – Full Program
15240102 General Serum Chemistry – Full Program
15590102 General Urine Chemistry – Full Program
15250102 HbA1c: Lyophilised – Full Program
15650102 HbA1c: Whole Blood – Full Program
15260102 IGF-1/C Peptide – Full Program
15820102 i-SENS Glucose Meters
15830102 i-SENS Ketone Meters
15500102 Immunosuppressants – Full Program
15800102 Lactate Meters – Full Program
15270102 Liquid Serum Chemistry – Full Program
15290102 Neonatal Bilirubin – Full Program
15300102 On-Site Urine Toxicology Screening – Full Program
15310102 Oral Fluid Toxicology Screening – Full Program
15330102 Plasma Metanephrines – Full Program
15350102 PoCT Blood Gases – Full Program
15340102 PoCT Troponin and HCG – Full Program
15380102 Porphyrins – Faeces – Full Program
15390102 Porphyrins – Plasma – Full Program
15400102 Porphyrins – Urine – Full Program
15730102 Porphyrins – Urine Qual PBG only – Full Program
15370102 Porphyrins – Whole Blood – Full Program
15200102 Prostate Specific Antigen – Full Program
15430102 QAAMS ACR – Full Program
15440102 QAAMS HbA1c – Full Program
15210102 Red Cell Folate – Full Program
15790102 Renal Calculi
15480202 Roche Solutions Glucose Meters
15460102 Salivary Cortisol – Full Program
15470102 Serum Indices – Full Program
15510102 Special Drugs – Full Program
15490102 Special Lipids – Full Program
15020102 StatStrip Glucose
15660102 StatStrip Ketones
15520102 Sweat Testing – Full Program
15710102 Thiopurines – Full Program
15530102 Trace Elements – Blood – Full Program
15540102 Trace Elements – Serum – Full Program
15550102 Trace Elements – Urine – Full Program
15560102 Tumour Markers – Full Program
15570102 Urine Amylase – Full Program
15600102 Urine Pregnancy Testing – Full Program
15610102 Urine Toxicology – Full Program
15620102 Vitamin C – Full Program
15630102 Vitamins – Blood – Full Program
15640102 Vitamins – Serum – Full Program


Hazard Identification

Chemical hazard: Not applicable

Environmental hazard: Not applicable

Health hazard: Exempt human specimens

No known test method can offer complete assurance that products derived from inactivated microorganisms and/or human sources will not transmit infection. All proficiency testing materials supplied by RCPAQAP must therefore be considered as a potential 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:

CAS# Component Percentage
Not Applicable Human fluids and tissue 0–100%
68551-06-4 Bovine Albumin 0–100%
Not Applicable Aqueous solution of salts and gases 0–100%

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, gown and protective eyewear should be used before cleaning any spills. Dispose any sharps in a safe disposal system. Clean the area with absorbent paper and clean excess with suitable disinfectant (such as bleach or 70% w/v alcohol).

Handling and Storage

On arrival, samples should be stored as per instructions on each sample kit. Samples have been shown to be stable when transported at ambient temperature.

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

Exposure Controls and Personal Protection

Samples are only 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 point of care (non-laboratory) settings Biosafety Level 1 precautions at a minimum should be used.

Physical and Chemical Properties

Products may contain:

Whole blood: red and odourless, pH neutral

Blood spot: red and odourless, pH neutral

Serum/plasma: straw colour and odourless, pH neutral

Urine: straw colour and odourless, pH neutral

Lyophilised serum/urine: straw colour powder, pH neutral

CSF: clear to straw colour and odourless, pH neutral

Amniotic Fluid: clear to straw colour and odourless, pH neutral

Blood Gases only: Aqueous solution of salts and gases including sodium chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Lithium Lactate, Sodium Lactate, Sodium bicarbonate, Glucose, Urea and purified Bovine Albumin

Renal Calculus: Crystallised salts

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

Tested and found non-reactive for the presence of hepatitis B surface antigen (HbsAg), human immunodeficiency virus antigen (HIV-1 Ag), antibody to hepatitis C virus (anti-HCV), and antibody to human immunodeficiency virus (anti-HIV-1/HIV-2).

Ecological Information

Same bio-degradability as human blood, urine and other bodily fluids.

Disposal Information

Dispose as clinical waste in suitably identified containers using a registered clinical waste disposal contractor (same as for patient samples).

Transport Information

Proper Shipping Name: Exempt Human Specimens
UN Number: Not Applicable
Hazard Class/Packing Group: Exempt Human Specimens
Labels Required: Exempt Human Specimens
IATA Packaging Requirements: Sample is not subject to the IATA Dangerous Goods Regulations as long as the specimen is transported in triple packaging that prevents leakage.

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, howsoever arising from the use of this product or the information contained in the Safety Data Sheet.