Haematology Safety Data Sheet (SDS)

Catalogue Number Product Name
11010102 Automated Differential – Option 1
11020102 Automated Differential – Option 2
11030102 Automated Differential – Option 3
11040102 Automated Differential – Option 4
11050102 Automated Differential – Option 7
11060102 Bone Marrow Morphology
11070102 CD34 program
11080102 Coagulation Factors II, V, VII, X, XI, and XII
11090102 Coagulation Factors VIII and IX
11110102 Compact Full Blood Count
11180102 Condensed Full Blood Count
11250102 Condensed Haemostasis
11130102 D-Dimer Automated
11140102 D-Dimer Semi-quantitative
11150102 ESR – Option 1
11160102 ESR – Option 2 StaRRsed only
11190102 Full Blood Count
11200102 G6PD
11210102 Haematology Immunophenotyping
11220102 Paroxysmal Nocturnal Haemoglobinuria
11230102 Haemoglobinopathy
11240102 Haemostasis
11260102 Malarial Parasite
11270102 Malarial Parasite Rapid Diagnostic Test
23130102 Acute Myeloid Leukaemia NGS Panel testing
23140102 BCR-ABL Qualitative Testing
23150102 Chimerism Analysis
23160102 FLT-3 ITD and TKD
23170102 Hereditary Haemochromatosis (HFE)
23180102 IDH Mutation Analysis in AML (IDH1, IDH2)
23190102 Immunogenotyping (IgH,TCR)
23200102 Myeloproliferative Neoplasms (JAK2, CALR, MPL)
23210102 NPM1
23220102 PML-RARα
23230102 Thalassaemia (alpha, beta)
23240102 Thrombosis (F5, F2)
23250102 TP53 Deletions at 17p13.1 in CLL (FISH)
11280102 Blood Film Differential Count
11290102 Morphology
11300102 Paediatric Morphology
11310102 Point of Care – Condensed Full Blood Count
11330102 Point of Care – HemoCue WBC Automated Differential
11340102 Point of Care – INR
11350102 Reticulocyte – Option 1 Manual
11360102 Reticulocyte – Option 2 Automated
11370102 Reticulocyte – Option 3 Beckman Coulter
11380102 Activated Protein C resistance
11390102 Apixaban (Anti Xa)
11400102 Dabigatran (direct Thrombin Inhibitor)
11410102 Factor VIII Inhibitor
11420102 Factor XIII
11430102 Low Molecular Weight Heparin monitoring
11440102 Lupus Anticoagulant
11450102 PFA-100/200
11460102 Thrombophilia
11470102 Rivaroxaban (Anti Xa)
11480102 Unfractionated Heparin monitoring
11490102 von Willebrand Factor
11500102 Thromboelastography: TEG-5000
11510102 Thromboelastography: TEG-6s
11520102 Thromboelastometry: ROTEM-Delta
11530102 Thromboelastometry: ROTEM-Sigma

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

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 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 material;

  • 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%
Not Applicable Stabiliser/Diluent 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% 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 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. In point of care (non-laboratory) settings Biosafety Level 1 precautions at a minimum should be used.

Physical and Chemical Properties

Stabilised whole blood: red and odourless, pH neutral

Serum/plasma: straw colour and odourless, pH neutral

Urine: straw colour and odourless, pH neutral

Lyophilised plasma/serum/urine – straw colour powder, pH neutral

Medical Glass microscope slides of human origin: odourless

Purified Deoxyribonucleic Acid (DNA) / Purified Ribonucleic Acid (RNA) – clear liquid, pH 8.0

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), antibodies to Hepatitis C virus (anti-HCV), and antibodies to Human Immunodeficiency Virus (anti-HIV-1/HIV-2).

Ecological Information

Same biodegradability 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: Category C

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