Regulation 24
Documentation relating to tests
of Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021
A clinical laboratory service licensee must ensure proper documentation of all of the following:
each step of the procedure undertaken in the testing of any specimen;
the source or reference for the procedure undertaken;
the date the procedure is last reviewed;
the calibration standards and controls required;
the criteria used for the acceptance of quality control of the testing of specimens, and any results and actions to be taken when the quality control is unacceptable;
the instructions for handling of any specimen;
how test results are to be issued to the requestor.