Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis
1.8 Staff
Table of contents
- Abbreviations
- Introduction
- Definitions
- Scope
1 - Diagnostic molecular testing for human genetic disease- 1.1 General
- 1.2 Categorisation of Nucleic Acid-Based tests for human genetic disorders
- 1.3 Ethical responsibilities of laboratories providing molecular testing for human genetic disorders
- 1.4 Laboratory services
- 1.5 Reports and records
- 1.6 Retention of specimens and records
- 1.7 Quality systems
- 1.8 Staff
- 1.9 Laboratory facilities
2 - Diagnostic molecular testing of microorganisms causing disease in humans- Glossary
- References
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 theGene Technology Regulator when using recombinant DNA probes.
