Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 17(2)-(3): Hold a written arrangement providing for direction, control and supervision wherever a laboratory relies on a related laboratory, and operate only in the category the Minister specified as appropriate to the premises on the section 17 criteria

What does 17(2)-(3) require?

An appropriate arrangement, on which GY and B status depends, must be a written arrangement that includes provision for the direction, control and supervision of the relevant laboratory. The category specified in a section 23DN approval must be the category in the section 17 table that is appropriate to the premises having regard to the criteria for that category. Because the category sets the supervision standards that apply under section 18 and the accreditation materials, a change in the laboratory's test menu, governance relationship or supervision model that no longer fits the approved category calls for the accrediting agency to review the category and for the approval to be varied.