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SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED UNIT STANDARD: 

Fractionate blood products for transfusion 
SAQA US ID UNIT STANDARD TITLE
257199  Fractionate blood products for transfusion 
ORIGINATOR
SGB Medical Laboratory Assistants 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY
-  
FIELD SUBFIELD
Field 09 - Health Sciences and Social Services Curative Health 
ABET BAND UNIT STANDARD TYPE PRE-2009 NQF LEVEL NQF LEVEL CREDITS
Undefined  Regular  Level 3  NQF Level 03  12 
REGISTRATION STATUS REGISTRATION START DATE REGISTRATION END DATE SAQA DECISION NUMBER
Reregistered  2018-07-01  2023-06-30  SAQA 06120/18 
LAST DATE FOR ENROLMENT LAST DATE FOR ACHIEVEMENT
2024-06-30   2027-06-30  

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.  

This unit standard does not replace any other unit standard and is not replaced by any other unit standard. 

PURPOSE OF THE UNIT STANDARD 
This unit standard will enable the learner to apply the fundamental principles of blood transfusion fractionation in the laboratory, and will provide skills for recognition within a laboratory for upward mobility as well as skills to work in other departments in pathology laboratories. Knowledge and insight gained are essential elements for the quality needed in handling pathology specimens as well as addressing the skills shortage in the country.

Range Statement: Products prepared in a fractionation plant include stabilized human serum, albumin and freeze-dried factor VIII.

On completion of this unit standard, the competent learner will be able to:
  • Handle packs of blood components for fractionation.
  • Prepare the fractionated product.
  • Inspect and package fractionated product.
  • Operate fractionation plant equipment. 

  • LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
  • Communication at NQF Level 2.
  • Mathematical literacy at NQF Level 2.

    Recognition of Prior Learning:

    Relevant prior work experience, qualifications and learning events will be recognised for this qualification, and competence will be measured against the equivalent assessment criteria. RPL will be granted in agreement with the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA. 

  • UNIT STANDARD RANGE 
    The typical context of this unit standard is described in the different range statements listed under the relevant assessment criteria.

    The level assigned to this unit standard is appropriate because the process is moderate in range, and offers clear choices of routine responses. The learning demand employs basic operational knowledge and readily available information. The application of this unit standard is to qualify the person for certification. 

    Specific Outcomes and Assessment Criteria: 

    SPECIFIC OUTCOME 1 
    Handle packs of blood components for fractionation. 
    OUTCOME RANGE 
    Handle includes receive, request and prepare. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Components and required additives are requested, checked and recorded according to product specification. 

    ASSESSMENT CRITERION 2 
    Blood components are pooled under sterile conditions into fractionation vessels and relevant details are recorded for future easy retrieval. 

    SPECIFIC OUTCOME 2 
    Prepare the fractionated product. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Allocated chemical supplements are added to the pooled components as per product specification. 

    ASSESSMENT CRITERION 2 
    Required processing adjustments are recorded and reported, to maintain the audit trail. 
    ASSESSMENT CRITERION RANGE 
    May include pH, temperature, total protein adjustments and osmolality of the product.
     

    ASSESSMENT CRITERION 3 
    Fractionated product is aseptically aliquoted for labelling and distribution. 

    ASSESSMENT CRITERION 4 
    End product may be sterilized and/or freeze-dried as per product specification. 

    SPECIFIC OUTCOME 3 
    Inspect and package fractionated product. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Fractionated products are visually inspected for contamination and moisture. 

    ASSESSMENT CRITERION 2 
    Products and boxes are appropriately labeled and packaged to identify the contents for use and distribution. 

    ASSESSMENT CRITERION 3 
    Random product samples are selected, recorded and submitted for quality assurance. 

    ASSESSMENT CRITERION 4 
    Approved batches are stored and faulty batches are discarded in accordance with the standards of quality control. 

    ASSESSMENT CRITERION 5 
    Non-conformance instances with regard to product preparation are recorded and reported in accordance with quality assurance standards. 

    SPECIFIC OUTCOME 4 
    Operate fractionation plant equipment. 
    OUTCOME RANGE 
    The term 'operate' includes maintaining and monitoring the equipment. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Equipment is operated in accordance with the manufacturer's specifications to ensure optimal operation. 

    ASSESSMENT CRITERION 2 
    Equipment is cleaned appropriately and the required readings are recorded in order to maintain safety regulations. 

    ASSESSMENT CRITERION 3 
    Faulty equipment is recorded and reported, to facilitate timely maintenance and to prevent wastage of precious commodities. 


    UNIT STANDARD ACCREDITATION AND MODERATION OPTIONS 
  • Anyone assessing a learner or moderating the assessment of a learner against this qualification must be registered as an assessor and/or moderator with the relevant Education and Training Quality Assurance body (ETQA) or ETQA that has a Memorandum of Understanding in place with the relevant ETQA.
  • Any institution offering learning for this unit standard must be accredited as a provider with the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA.
  • Assessment and moderation of assessment will be overseen by the relevant ETQA according to the ETQA`s policies and guidelines for assessment and moderation.
  • Anyone wishing to be assessed against this qualification may apply to be assessed by any relevant accredited assessment agency, assessor or provider institution, which is also accredited by the relevant ETQA or ETQA that has a Memorandum of Understanding in place with the relevant ETQA. 

  • UNIT STANDARD ESSENTIAL EMBEDDED KNOWLEDGE 
  • Quality control.
  • Laboratory Safety Procedures.
  • Relevant theoretical knowledge of blood and its components and the practical application thereof.
  • Policies and Procedures of relevant organization.

    Current legislation pertaining to the following will be applicable:
  • Standards for Practice for Blood Transfusion.
  • Occupational Health and Safety.
  • Handling or use of Human Tissue.
  • Medical, Dental and Supplementary Health Services.
  • Regulations defining the scope of the profession of Medical Technology.
  • Statutory guidelines of the Health Professions Council of South Africa (HPCSA) pertaining to Medical Ethics. 

  • UNIT STANDARD DEVELOPMENTAL OUTCOME 
    N/A 

    UNIT STANDARD LINKAGES 
    N/A 


    Critical Cross-field Outcomes (CCFO): 

    UNIT STANDARD CCFO IDENTIFYING 
    Identifying and solving problems in which responses display that responsible decisions using critical thinking have been made.

    Refer to all Specific Outcomes. 

    UNIT STANDARD CCFO WORKING 
    Working effectively with others as a member of a team, group, organization or community.

    Refer to all Specific Outcomes. 

    UNIT STANDARD CCFO ORGANISING 
    Organising and managing oneself and one's activities responsibly and effectively.

    Refer to all Specific Outcomes. 

    UNIT STANDARD CCFO COLLECTING 
    Collecting, analysing, organizing and critically evaluating information.

    Refer to all Specific Outcomes. 

    UNIT STANDARD CCFO COMMUNICATING 
    Communicating effectively using visual, mathematical and/or language skills in the mode of oral and or written persuasion.

    Refer to the following Specific Outcomes:
  • Handle packs of blood components for fractionation.
  • Inspect and package fractionated product.
  • Operate fractionation plant equipment. 

  • UNIT STANDARD CCFO SCIENCE 
    Using science and technology effectively and critically showing responsibility towards the environment and health of others:

    Refer to all Specific Outcomes. 

    UNIT STANDARD CCFO DEMONSTRATING 
    Demonstrate an understanding of the world as a set of related systems.

    Refer to the following Specific Outcomes:
  • Prepare the fractionated product.
  • Inspect and package fractionated product.
  • Operate fractionation plant equipment. 

  • UNIT STANDARD ASSESSOR CRITERIA 
    N/A 

    REREGISTRATION HISTORY 
    As per the SAQA Board decision/s at that time, this unit standard was Reregistered in 2012; 2015. 

    UNIT STANDARD NOTES 
    It is strongly recommended that competency in the following Unit Standards is achieved prior to commencing learning towards this Unit Standard:
  • SAQA ID 252401: Comply with safety requirements in the medical or blood transfusion fields.
  • SAQA ID 119078: Use a GUI-based word processor to enhance a document through the use of tables and columns.
  • SAQA ID 13915: Demonstrate knowledge and understanding of HIV/AIDS in a workplace and its effects on a business sub-sector, own organisation and a specific workplace.
  • SAQA ID 257201: Apply quality practice in the medical laboratory.

    Course requirements: The learner is required to be registered with the HPCSA as a Student Medical Laboratory Assistant for the duration of the period of learning.

    Matrix of Credits Assisgned:

    Activity; Hours:
  • Tutoring:
    > Lecturer; 10 Hours.
    > Learner/self study; 4 Hours.
  • Practical:
    > On job; 105 Hours.
    > Simulation; 1 Hour.

    Total Hours: 120 Hours.
    Total Credits: 12 Credits.

    All actions are measured against the prescribed protocols or standard operating procedures (SOP) of the organization/institution where the learner is currently employed. The prescribed protocols/SOP are written instructions relating to specific tasks. These written instructions are issued to the learner, and signed once they have been studied. 

  • QUALIFICATIONS UTILISING THIS UNIT STANDARD: 
      ID QUALIFICATION TITLE PRE-2009 NQF LEVEL NQF LEVEL STATUS END DATE PRIMARY OR DELEGATED QA FUNCTIONARY
    Elective  63189   National Certificate: Medical Laboratory Assistance  Level 3  NQF Level 03  Passed the End Date -
    Status was "Reregistered" 
    2012-06-30   


    PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS UNIT STANDARD: 
    This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.
     
    NONE 



    All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.