Standard

S1.8.1
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).

Commentary

C1.8.1
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.

Laboratory director

Standard

S1.8.2
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.

Commentary

C1.8.2
Nucleic acid amplification techniques are a relatively new and rapidly expanding discipline. 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.

Staff skills

Standard

S1.8.3
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.
S1.8.4
Staff shall have or acquire knowledge and understanding of human genetic disorders and the application of nucleic acid amplification techniques in the investigation of such disorders.
S1.8.5
Laboratories shall comply with the guidelines of the Office of the
Gene Technology Regulator when using recombinant DNA probes.

Commentary

C1.8.3
The performance of nucleic acid detection techniques is technically challenging and 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.
C1.8.4
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.
C1.8.5
The presence of experienced supervisors and trainers is essential, given their critical involvement in error detection, error correction and problem solving.

Guideline

G1.8.1
Where a laboratory has only a limited number of staff involved in nucleic acid testing, particular attention should be paid to continuing education and the maintenance of knowledge and expertise in current techniques.