ASISA Specifications

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1. Summary of ASISA Protocol (click here for summary in PDF)
   Acceptable and unacceptable procedures and processes according to the ASISA for the laboratory?
   
    
2. Identification requirements
   
   
3. Procedures prior to testing
   Pre-test counselling is required for each client by means of the following:
   
   
   • Verbally – Personal Pre-tests counselling (PPTC) by appointment at designated pathology laboratories as listed in the PPTC section.
      
   • Written document – Informed Consent Document
      
   
   The client must sign the informed consent section of the pathology request form in the presence of the venesectionist. No presigned forms maybe accepted in the event that the client has presigned the form, he/she must resign in the presence of the venesectionist.
   The client’s medical doctor or clinic must be indicated.
   The client must be positively identified by the venesectionist.
   
    
4. Venesection (blood collection)
        
   A 5ml tube of clotted blood is collected from all applicants for purpose of testing for HIV by Elisa Immuno-Assay methodology. This primary tube of blood is used exclusively for HIV testing. (It is important that an additional 5ml tube of EDTA blood be collected only from applicants who are/have been participants in a vaccine trial. This EDTA sample is required for a Polymerase Chain Reaction Test (PCR) in cases where the Elisa Immuno-Assay test is reactive.)
   
   In terms of the ASISA Protocol, specimen collection can be done by any of the following:
   
   
   • Any medical practitioner registered with the Health Professionals Council of SA (HPCSA). However, medical practitioners with limited registration are not allowed to do venesections.
      
   • Any registered individual entitled to perform venesections by the HPCSA or SA Nursing Council, registered medical practitioner or accredited pathology laboratory.
     
      
   In terms of the ASISA Protocol, the service of house (office, factory etc.) call specimen collection may be delivered by:
   
   
   • Medical practitioners registered with the Health Professionals Council of SA (HPCSA). However, medical practitioners with limited registration are not allowed to do venesections.
   • Registered individual entitled to perform venesections by the HPCSA or SA Nursing Council, registered medical practitioner or accredited pathology laboratory.
   • Persons who are in the salaried employment of the Life Office and also qualified to perform venesections as mentioned above.
   • Third party providers, IE REGISTERED PERSONS ENTITLED TO PERFORM VENESECTIONS, who have an independent contract or relationship with each specific company. It is the responsibility of the company to manage the risks associated with this service.
      
   
   NB. The venesectionist is responsible for the verification of the client’s identity and the collection of the specimen according to the ASISA protocol.
   
   Acceptance of such specimens at the laboratory is subjected to:
   
   
   • Signed confirmation by the venesectionist that the ASISA protocol was followed   
   • Name, contact details and practise number of venesectionist.
      
   • Surname and initials of the client must be written CLEARLY on the specimen during the venesection procedure.
      
   
    
5. Reporting of Results
        
   If the ASISA Protocol has been followed, results should be available to the Chief Medical Officer and Underwriters of the Insurance Company within 24-48 hours (weekends excluded)
   
    
6. Confidentiality
        
   Test results may only be given to the Chief Medical Officer and Underwriters of the Insurance Company
   
   Under no circumstances will test results be given to:
   
   • Private Medical Practitioners
   • Clients
   • Intermediaries or Brokers
      
   
   *Clients and Private Medical Practitioners can obtain a copy of test results by means of a written request to the Insurance Company.
   
    
7. Reasons for tests not performed
   
   
   • The ASISA protocol has not been followed.
   • Specimens are received without correct documentation and appropriate signatures.
   • The specimen is unmarked \ incorrectly marked.
   • The client, insurance intermediary or broker personally delivers the specimen and documentation at the laboratory.
   • Breakage of tube or specimen being haemolysed.
   • Insufficient blood / serum