Identify the appropriate tests for at least two H&I clinical presentations.

• The repertoire, specimen requirements, referral pattern and storage, ordering, reference ranges and turnaround times of the methods used in H&I.
• The major clinical users of the H&I service.
• The range of investigative techniques used in H&I and their application.

Receive, label and store a range of immunological specimens

• Serum specimens
• DNA specimens
• Lymphocyte specimens

• Minimum data set required for identification of samples and the importance of ensuring that this is complete and correct.
• Factors affecting sample integrity and appropriate corrective action.
• Procedures for handling samples which may contain category 2,3, and 4 pathogens.
• Types and implications of hazards and risks associated with handling of specimens and relevant control measures.
• The quality management process that ensures the correct location and storage of documentation and specimens at each stage of process.
• Safe laboratory practices including principles of decontamination of equipment and work areas.
• Local and national Health and Safety policies and procedures and their application.
• Relevant records, their importance and how to complete these correctly.
• Correct use of manual and computerised systems for generating labels for the products and component.
• Specimen preservation, distribution, separation, storage and disposal procedures.

Select and apply appropriate control materials.

• Selection and use of suitable and appropriate controls.
• Use and application of reagents for analysis.
• Correct conditions and locations for storage of test reagents.

Use automated methods, techniques and instrumentation to include at least four of the following:

• Immunoassay
• Electrophoresis
• Immunoflourescence
• Microscopy
• Flow cytometry
• X map technology
• Complement dependent cytotoxicity
• PCR

• Capabilities and limitations of methods, techniques and equipment.
• Use, care, monitoring, calibration and routine maintenance of clinical immunology laboratory equipment to include (relevant to automated methods available) from the following list:
  • Pipettes
  • Balances
  • Centrifuges
  • Refrigerators
  • Water baths
  • Incubators
  • pH meters
  • freezers
  • automated analysers
  • flow cytometer
  • thermal cycler

Interpret laboratory data in the light of clinical details on patients with common disorders where transplantation is the therapy of choice, including at least 2 of the following;

• Autoimmune disorders
• Immunodeficiency disorders
• Renal disorders
• Other solid organ disorders
• Haematological malignancies
• Disease associations
• Drug hypersensitivity

• Organisation and components of the immune system.
• Ranges and values needed for interpretation of results.
• Cellular components (lymphocytes; granulocytes; monocytes/macrophages).
• Humoral components (autoantibodies, the range of autoantibodies and the role they play in autoimmune disease; immunoglobulins and the importance of their levels and their absence; complement and the importance of their levels and their absence).
• Central molecules of the immune system (major histocompatibility molecules, classes I ⅈ Cluster of Differentiation (CD) molecules/cell surface markers; receptor molecules; recognition molecules; adhesion molecules; effector molecules).
• Antigen presentation.
• Innate immune response (endothelial cells; neutrophils; macrophages; natural killer cells; complement).
• Adaptive immune response (antigen processing; dendritic cells; T cell responses; B cell responses; primary and secondary responses; vaccination/immunisation).
• The adaptive immune system routine assays which can be usefully examined in an H&I laboratory.
• Outcome of immune responses (immunity/immunological memory; direct and indirect functions of antibodies).
• Major assays performed in an H&I laboratory.

Produce interpretative reports on laboratory investigations.

• The information to be included in an interpretative report.
• How to construct an interpretative report and the format required for presentation.
• Limits of responsibility in the authorisation and issue of interpretative reports.
• Clinical conditions which may require urgent action and how to instigate such action.
• Normal and abnormal results and their significance to clinical question or condition.

Control infection risks in accordance with departmental protocols.

• Protocol for hand washing and awareness of how effective hand washing contributes to control of infection.
• Protocols and requirements for hygiene and infection control related to the relevant range of investigations, including preparation, conduct and completion of investigation.

Minimise risks and hazards in compliance with Health and Safety policies.

• The relevant health and safety regulations for laboratory and clinical investigations.
• Any specific health and safety regulations required in H and I, taking into account the sample and the investigation.”
• The potential hazards and risks and the actions to be taken to minimise these.
• Responsibilities and scope of practice of laboratory personnel involved in performing investigations and reporting those investigations to users.