The person in charge of nucleic acid detection techniques in a laboratory shall be actively involved in determining methods and procedures, staff training and quality control procedures; in reviewing and interpreting laboratory data; and in providing laboratory reports and clinical consultation as outlined in the NPAAC publication Standards for Pathology Laboratories (Standard 2 — Staffing, supervision and consultation).
The level of education and training for pathologists and scientists has been established on a national basis for pathology laboratories in general by the NPAAC publications Standards for Pathology Laboratories and Requirements for Supervision of Pathology Laboratories.
The director of the laboratory must be able to demonstrate by appropriate documentation that the procedures used and tests performed are within the scope of the education, training and experience of individual scientific or technical staff members.
Nucleic acid amplification techniques are a relatively new and rapidly expanding discipline in diagnostic laboratories. Therefore, the laboratory director should ensure that the senior practitioners within the laboratory have wide training and competence appropriate to the complexity of testing undertaken.
At least one senior member of staff shall have significant diagnostic or research experience with nucleic acid detection methods, including their principles and design, and problem solving in their use.
Staff shall have or acquire biological knowledge relevant to the discipline of microbiology. Specifically, this shall include adequate knowledge of pathogenic organisms and the technique for their correct handling and containment.
Laboratories shall comply with the guidelines of the Office of the Gene Technology Regulator when using recombinant DNA probes.
The performance of nucleic acid detection techniques is technically challenging and is highly dependent on operator skills and facilities. Those working in the area need specific training, particularly in how to assess the validity of data and how to troubleshoot problems when they occur.
Alternatively, those working in the area should undertake specific training in nucleic acid detection techniques in a laboratory with established proficiency and competence in nucleic acid detection and the development of inhouse testing.
The presence of experienced supervisors and trainers is essential, given their critical involvement in error detection, error correction and problem solving.
Where a laboratory has only a limited number of staff involved in nucleic acid testing, particular attention must be paid to continuing education and the maintenance of knowledge and expertise in current techniques.