Standard

S1.5.1
Reports containing test results shall be provided to the person requesting testing with a minimum of delay, commensurate with good laboratory practice and patient care.
S1.5.2
Records of test requests, equipment history and service, testing procedures, results of test procedures on patient specimens, material for quality control and proficiency testing for consistency (quality assurance) shall be kept in a readily accessible form.
S1.5.3
Laboratory databases that contain information on patients or test results must be secure, password coded and backed up at regular and frequent intervals. Appropriate measures shall be in place to prevent unauthorised physical or electronic access to the databases, especially if the databases are located in nonsecure premises or are stored on network computers.
S1.5.4
Where a test is referred to another laboratory, the report shall be sent to the referring laboratory. A copy of the original report may be provided to the referring practitioner but the referring laboratory must be advised.

Commentary

C1.5.1
Testing may sometimes be performed on deidentified samples using a trusted third party (TTP) intermediary such as a gene trustee (see Essentially Yours, ALRC Report 96, Vol. 1, Chapter 18, pp. 492–4). In such cases, patient and sample identification must use the coded identifiers provided by the TTP. Where a report arises from such patients or samples (or from multiple patients or samples) all with only a coded identifier assigned by the TTP, the report should still conform in other respects with the other Standards and Guidelines in this section.

Understanding the DNA test result in genetic disorders

Commentary

C1.5.2
Apart from the actual performance of a DNA test, the interpretation of its result is critical. The laboratory must ensure that the way in which the result is given facilitates its interpretation; however, the clinical information provided will not always be sufficient for specific interpretation. Therefore, the report must not overinterpret the significance of a DNA test result. The clinician ordering the test must have some knowledge of its significance and interpretation.

Guideline

G1.5.1
Reports should be concise and unambiguous, and should include an appropriate interpretation of the results.
G1.5.2
Reports for predictive genetic tests should be available in as short a time as is practically possible and should be consistent with the recommendations of professional societies with expertise in the field (eg the Australian Cancer Network), unless alternative arrangements have been specifically agreed before sample collection.